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Lead officials from the Bush Administration involved in efforts to
computerize the nation's medical records are warning the U.S.
Congress against hasty legislative action that could inadvertently
impede the initiative.

"We are already well underway with the development of standards and
architecture to allow electronic systems to talk to each other while
protecting patient privacy," Dr. David Brailler, National
Coordinator of Health Information Technology told a subcommittee of
the Senate Committee on Commerce, Science, and Transportation
Thursday.

"Our concern is about legislation slowing down the process," he
added.

Dr. Hratch Semerjian, acting director of the National Institute of
Standards and Technology, agreed. "Everybody's already working as
hard as they can to make this happen," he told the subcommittee.

Speeding the development of information technology in the health
sector is among the most popular subjects for legislation in the
U.S. Congress this year. The prospect of using computerized records
to improve quality, reduce medical errors, and save money has
attracted bills co-authored by such unlikely combinations as Senate
Majority Leader Bill Frist, Republican of Tennessee, and Sen.
Hillary Rodham Clinton, Democrat of New York -- both of whom are
expected to vie for their respective party's presidential nomination
in 2008.

But Brailler said things are already moving along well, with the
administration and private groups working first to
develop "interoperability" standards so computer systems can talk to
each other. The goal, Brailler said, "is to have information that
follows patients where they want it to, and doesn't follow them
where they don't."

Brailler told reporters after the hearing that while he is pleased
that most of the legislation introduced so far highlights the
interoperability issue, he worries that such well-intentioned
efforts as providing funds for acquisition too soon could jeopardize
development of compatible systems. "We're trying to take advantage
of the low adoption so far" of electronic systems, he said.

Lower vital capacity independently predicts the development of type
2 diabetes, according to a report in the June Diabetes Care.

"Diabetes and lung function are connected," Dr. Frederick L.
Brancati from Johns Hopkins University, Baltimore, Maryland told
Reuters Health. "We don't know why yet, but this is new and deserves
attention."

Dr. Brancati and colleagues used data from the Atherosclerosis Risk
in Communities (ARIC) study to test their hypothesis that lower lung
function, as indicated by lower vital capacity, is associated with
features of insulin resistance and is an independent predictor of
new onset type 2 diabetes.

Lower forced vital capacity (FVC) (% predicted) was associated with
higher fasting glucose, insulin, and triglycerides, higher systolic
blood pressure, and lower HDL cholesterol among men and women in the
database, the authors report.

During 9 years of follow-up, there was an inverse relationship
between FVC (% predicted) and the incidence of type 2 diabetes, the
report indicates. The age- and race-adjusted incidence in the lowest
FVC (% predicted) group (28.3 cases per 1000 person-years) was more
than twice that in the highest FVC (% predicted) group for both men
and women.

Adjustment for the presence of metabolic syndrome or for fasting
glucose, insulin resistance, and systolic blood pressure slightly
attenuated the association between vital capacity and incident type
2 diabetes, the researchers note, but the association was stronger
among men and women who did not smoke.

FVC was significantly more likely to be lower among individuals who
were African American, older, and less educated; those who smoked
more cigarettes; those who were less physically active; those with
higher body-mass index, waist circumference, and waist-to-hip ratio;
those with metabolic syndrome; and those with higher white blood
cell counts and fibrinogen levels, the results indicate.

"The main implication of our study is that lower vital capacity of
the lung deserves attention as an emerging, novel risk factor for
type 2 diabetes," the authors conclude. "Even if it turns out not to
lie within a causal pathway to diabetes, FVC might still be a useful
risk predictor, and the FVC-diabetes link could suggest explanations
for other phenomena, like the elevated risk of heart disease
associated with low vital capacity."

"We're looking at rate of decline of FVC in adults with already
established diabetes, on the hunch that there could be a cycle," Dr.
Brancati said. "We're also collaborating with sleep experts to study
sleep related breathing disturbances in relation to insulin
resistance. Finally, we're investigating a 'fetal origins' angle,
using data from a cohort study of mothers and offspring that started
in the 1950s."

Diabetes Care 2005;28:1472-1479

Nearly one in ten saphenous vein grafts (SVGs) that have been in
place for more than 1 year harbor a ruptured atherosclerotic plaque,
according to a new report. On ultrasound, these plaques resemble
those seen in native coronary arteries.

The present study represents the first time intravascular ultrasound
has been used to characterize plaque rupture in SVGs, senior author
Dr. Neil J. Weissman, from Washington Hospital Center in Washington,
DC, and colleagues note. Previous studies have involved post-mortem
analysis, assessment of explanted SVGs, or the use of intracoronary
angioscopy.

The researchers reviewed 791 pre-intervention ultrasound SVG studies
and identified 95 ruptured plaques in 73 patients. Their findings
are described in the Journal of the American College of Cardiology
for June 21.

The majority of ruptured plaques had angiographically complex
morphology, ulceration, and an intimal flap. By contrast, aneurysmal
formation was only seen in 14% of plaques.

Patient factors significantly associated with a ruptured plaque in
an SVG included acute coronary syndromes, hypercholesterolemia, and
hypertension. In addition, the average age of SVGs with a ruptured
plaque was 12.3 years compared with 8.6 years for SVGs lacking such
plaques.

Diabetes was tied to an increased risk of multiple plaque ruptures,
but the association fell short of statistical significance, the
report indicates.

Positive remodeling and eccentricity, key features of ruptured
plaques in native coronaries, were also commonly found in SVG
ruptured plaques, the authors point out.

"It seems that plaque rupture may be a part of the natural history
of vein graft disease and may correlate with graft aging, but not
always with angiographically defined degeneration or lumen
compromise," Dr. Weissman's team concludes.

J Am Coll Cardiol 2005;45:1974-1979

The combination of clopidogrel with a statin drug improves outcomes
in patients with non-ST-segment elevation acute coronary syndromes
(ACS), according to a report in the June European Heart Journal.

"Our study showed that even though there may be in vitro evidence of
drug interaction between these two drugs, clinically there appears
to be no harm observed with the combination and, in fact, the effect
of the two drugs appears to be synergistic," Dr. Rajendra H. Mehta
from Duke Clinical Research Institute, Durham, North Carolina told
Reuters Health.

Dr. Mehta and colleagues used data from the Global Registry of Acute
Coronary Events (GRACE) to investigate the benefits or possible
antagonistic effects of the combination of clopidogrel and statin
treatment compared with clopidogrel alone in 15,693 patients with a
diagnosis of unstable angina or non-ST-segment elevation myocardial
infarction (NSTEMI).

The incidence of rehospitalization and stroke between hospital
discharge and 6 months after the acute event did not differ
significantly between the treatments, the authors report, but 6-
month mortality was two-fold higher in the clopidogrel-only group
than in the clopidogrel-plus-statin group.

Six-month mortality remained higher in the clopidogrel-only group
after adjustment for confounders using the GRACE risk score and
propensity score, the researchers note.

All mortality comparisons favored the clopidogrel-plus-statin group,
the report indicates, including those limited to diabetics or non-
diabetics and those limited to patients taking or not taking
clopidogrel prior to their admission for ACS.

"Our data suggest that the combination of clopidogrel with a statin
has significant synergistic effects on the clinical outcomes of
patients with non-ST-elevation ACS," the investigators
conclude. "Thus, despite evidence of adverse drug interaction in
vitro, our findings are that the concomitant use of these drugs
improves the outcomes of patients with ACS."

Eur Heart J 2005;26:1063-1069

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CARDIOMEDICS APPLIES FOR SOLE MEDICARE COVERAGE OF ITS ECP
SYSTEM FOR TREATING HEART FAILURE

CARDIOMEDICS, INC. today announced it has submitted an application to
the Centers for Medicare and Medicaid (CMS) for sole Medicare
coverage of
its External Counter Pulsation (ECP) System for the treatment of
heart failure.
There are an estimated 2.5 million heart failure patients in Classes
II, III and IV
in the United States, of which 400,000 die each year. The treatment
of heart
failure is the largest single cost to Medicare, $40 billion per year.

Cardiomedics has requested that Medicare coverage of ECP for the
treatment
of heart failure be limited to the use of ECP devices under a
graduated low
pressure regimen that has demonstrated in a clinical study, published
in a
peer-reviewed cardiology journal, mortality in the year following ECP
therapy
of 2% or less and a reduction of 80% or more in the number of
hospital
admittances in the year following ECP therapy, compared to the year
before.
Cardiomedics' new Graduated(TM) Low Pressure Treatment Regimen
(patent
pending) achieves such results.

No other ECP device or treatment regimen has demonstrated mortality
and
hospital admittance reductions comparable to those of Cardiomedics'
ECP
System in treating heart failure. In a recent clinical study on the
use of an
EECP(R) device made by Vasomedical, Inc. (Symbol "VASO") in treating
heart failure, there were no statistically significant differences in
mortality or
hospital admittances between the EECP(R) treated patients and the
controls.
EECP is a registered trademark of Vasomedical, Inc.

Cardiomedics, which is privately held, pioneered the development of
ECP
and received the first FDA clearance to market an ECP System in the
United
States. All other ECP Systems "piggy-backed" on Cardiomedics' FDA
clearance. However, none have perfected the device or its method of
use and
demonstrated their ECP devices produce heart failure results
comparable to
those of Cardiomedics' ECP System.

Intravenous infusion of culture-expanded autologous mesenchymal stem
cells (MSCs) may improve neurological and functional recovery in
patients with severe cerebral infarction, results of a small
prospective study suggest.

"Preclinical studies have established the potential for MSCs to be a
useful and safe treatment for stroke in humans," Dr. Oh Young Bang
and colleagues from Ajou University in Suwon, South Korea note in
the June Annals of Neurology. "After peripheral injection, MSCs
cross the blood-brain barrier preferentially in areas that have
experienced brain damage."

In the current study examining the feasibility, efficacy and safety
of MSC therapy, patients with cerebral infarcts within the middle
cerebral artery and with severe neurological deficits were randomly
allocated to receive intravenous autologous MSCs (n = 5) more than 1
month after symptom onset at a dose shown to be effective in rats or
no treatment (the control group; n=25).

MSC therapy was safe and well tolerated in this patient population,
the researchers report. "Despite the large size of MSCs and the ex
vivo culture expansion of these cells, there was neither immediate
nor delayed infusion-related toxicity," they point out.

All outcome measurements showed a trend toward improved scores in
tests of functional recovery (the Barthel Index and the modified
Rankin score) at 3, 6 and 12 months in MSC-treated patients compared
with controls.

Magnetic resonance imaging scans of the MSC group showed "less
prominent atrophy throughout the brain including the peri-infarct
zones, which was consistent with a diffuse action of MSCs throughout
the brain," according to the team.

Rather than replacing infracted tissue, the researchers think that
MSCs may "upregulate endogenous recovery mechanisms either at the
peri-infarct area (neurogenesis) or at areas that are remote from
the infarct (neuronal plasticity)." They are hopeful that ongoing
imaging studies will provide a clearer picture of the mechanisms of
action of MSCs in stroke recovery.

Double-blind studies involving a larger number of patients are
needed to reach definitive conclusions regarding the clinical
efficacy of MSC therapy in stroke recovery, the team adds.

Ann Neurol 2005;57:874-882

The effects of blood pressure (BP) lowering medications are broadly
comparable in patients with and those without diabetes in preventing
major cardiovascular events, investigators report.

BP level is a major determinant of cardiovascular complications
among diabetics, Dr. Fiona Turnbull and members of the Blood
Pressure Lowering Treatment Trialists' Collaboration point out.
Whether specific regimens are more effective in preventing
macrovascular disease in diabetes remains unclear.

To further investigate this issue, they conducted an overview of
prospective randomized trials that compared the effects of different
BP lowering regimens in patients with and without diabetes. Their
findings appear in the Archives of Internal Medicine for June 27th.

Included were 27 trials involving 33,395 individuals with diabetes
and 125,314 without diabetes. The studies examined outcomes for
angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists,
diuretics, beta-blockers, and angiotensin receptor blockers (ARBs).
Mean follow-up duration ranged from 2.0 to 8.0 years.

For the outcome stroke, there were no differences in the effects of
treatment regimens in the two patient groups, except that ARBs
appeared to provide less protection to patients with diabetes (p =
0.05).

For coronary heart disease and heart failure, again, the only type
of drug that influenced outcome more among diabetics was ARBs, which
in these cases seemed to provide better protection (p = 0.002).

Trials that examined total major cardiovascular events,
cardiovascular deaths and total mortality were generally similar for
the two patient groups. However, there was some evidence that ACE-
inhibitor-based regimens provided more protection than placebo
against cardiovascular death (p = 0.05) and total mortality (p =
0.03).

The authors also looked at trials comparing the effects of more
intensive and less intensive BP-lowering regimens, and found that
diabetics tended to benefit more from intensive treatment for total
major cardiovascular events (p = 0.03) and cardiovascular deaths (p
= 0.02).

"Clinicians may reasonably choose from a wide range of BP-lowering
agents in their efforts to reduce the short- to medium-term risks of
macrovascular complications in patients with diabetes," the authors
write.

They caution, however, that their overview did not characterize
longer-term results or the drugs' effects on other outcomes, such as
renal function.

Arch Intern Med 2005;165:1410-1419

In patients with chronic obstructive pulmonary disease (COPD), even
mild hypoxemia is associated with right ventricular hypertrophy,
according to a report by Dutch investigators.

Hypoxemia is a major determinant of pulmonary hypertension, the
authors explain in the June issue of Chest, but little is known
about the effects of normoxemia or mild hypoxemia on right
ventricular structure and function in patients with COPD.

Dr. Anton Vonk-Noordegraaf and colleagues from Vrije Universiteit
Medical Center, Amsterdam, assessed the early changes in right
ventricular structure and right and left ventricular function in 25
COPD patients with normoxemia or mild hypoxemia.

Echocardiographic images showed right ventricular hypertrophy in the
COPD patients, along with altered right and left ventricular
morphology, the authors report.

Compared with age-matched controls, the COPD patients had
significantly lower stroke volume and higher right ventricular wall
mass, as well as lower right ventricular end-diastolic and end-
systolic volumes.

Right ventricular and left ventricular ejection fractions were
similar in the COPD and control groups, the researchers note, but
five COPD patients (20%) had right ventricular systolic dysfunction
(ejection fraction below 45%). Four COPD patients (16%) had left
ventricular ejection fraction below 45%, but none of the controls
had an ejection fraction below 45%.

There was no evidence of pulmonary hypertension in the COPD patients
during resting conditions, the results indicate.

"The data obtained in this study indicate that concentric right
ventricular hypertrophy is already present in COPD patients with
normoxemia or mild hypoxemia, probably due to intermittent increases
in pulmonary artery pressures that occur during exercise or sleep,"
the authors conclude.

"Concentric right ventricular hypertrophy does not impair right
ventricular or left ventricular systolic function," the
investigators add.

Chest 2005;127:1898-1903

Pancreas transplant alone has a variety of lasting beneficial
effects in nephropathy in type 1 diabetic patients who retain their
own kidneys, Italian researchers report.

Dr. Piero Marchetti of the University of Pisa and colleagues note
that although such transplantation is helpful, long-term effects on
conditions such as diabetic nephropathy are not well defined.

To investigate, the researchers evaluated 32 type 1 diabetic
patients before and 1 year after successful pancreas transplant.
Also evaluated were 30 matched control patients who did not undergo
transplantation.

Transplant alone restored sustained normoglycemia without exogenous
insulin administration, Dr. Marchetti's group reports in the June
issue of Diabetes. It also reduced plasma lipid levels and
significantly decreased blood pressure levels.

Furthermore, there was a significant decrease in urinary protein
excretion. In fact, four microalbuminuric patients and three
macroalbuminuric patients became normoalbuminuric. Creatinine
clearance was substantially unchanged.

No such changes were seen in patients who did not undergo
transplantation.

The researchers call for longer-term studies, but add that "the
beneficial effects of pancreas transplantation...on the native
kidneys of diabetic patients supports the concept of considering
pancreas transplantation alone as a useful therapeutic option."

Summing up, Dr. Marchetti told Reuters Health, "restoration of the
lost insulin secretory function by the new pancreas determines
sustained normalization of glycemia and, as a consequence,
improvement of diabetic nephropathy in patients with proteinuria."

Dr. Marchetti added that the 32 transplant patients were part of a
cohort of 60 patients. At 4 years, 98.3% of this group has survived
and more than 80% are insulin independent. The procedure, he
concluded, has led to "very positive results."

Diabetes Care 2005;28:1366-1370

In adults with childhood onset growth hormone deficiency, treatment
with growth hormone (GH) improves cardiac contractile performance,
according to a report in the May 25th International Journal of
Cardiology.

"In patients with childhood onset growth hormone deficiency,
treatment with GH should be continued after the end of their linear
growth," Dr. Andrzej Minczykowski from University School of Medical
Sciences, Poznan, Poland told Reuters Health.

Dr. Minczykowski and colleagues investigated the effects of GH
replacement on cardiac structure and functional indices in 16
patients with childhood onset GH deficiency. The mean age was 42.3
years, ranging from 18 to 60. Three of the subjects had been treated
with GH several years earlier.

Heart rate and blood pressure did not change significantly after 12
months of GH treatment, the report indicates, and left atrial end-
systolic diameter and left ventricular end-diastolic diameter
remained the same.

The systolic increase in left ventricular wall thickness increased
significantly after treatment, the authors report, but the left
ventricular diastolic wall thickness was not altered by GH treatment.

Ejection fraction increased significantly after 12 months, the
results indicate, and left ventricular end-systolic volume decreased
significantly.

Growth hormone treatment also brought significant improvements in
integrated backscatter, another measure of cardiac architecture and
performance, the investigators report.

"Therapy with GH in patients with childhood onset GH deficiency is
usually discontinued at the end of linear growth," Dr. Minczykowski
explained. "The majority of patients with GH deficiency occurring in
adulthood do not receive GH treatment." The current findings and the
results of other studies "have shown that in such situations GH
treatment can give some important benefits to patients, but they
disappear with GH discontinuation."

"GH should be administered in supplementing doses," Dr. Minczykowski
concluded. "It is difficult to recommend an endpoint other than the
serum IGF-I response to GH treatment. The dose of GH should aim at
the low to middle range of the normal age-predicted values of the
serum IGF-I levels."

Int J Cardiol 2005;101:257-263

The results of a study published in the June 15th issue of the
American Journal of Epidemiology suggest that high levels of serum
iron coupled with either high levels of very low density lipoprotein
cholesterol (VLDL-C) or low levels of high density lipoprotein
cholesterol (HDL-C) appear to interact to increase the risk of
cancer.

"Iron and lipids combine to create oxidative stress, and oxidative
stress has a role in the development of cancer," Dr. Arch G. Mainous
III, of the Medical University of South Carolina, Charleston, and
colleague write. The researchers examined the risk of cancer among
3278 subjects in the Framingham Offspring Study who had elevated
iron and lipid levels.

Adults at least 30 years of age at baseline underwent assessment
between 1979 and 1982 for serum iron and HDL-C, LDL-C, and VLDL-C.
They were followed up for development of cancer until 1996 to 1997.
The authors computed Cox regression models, adjusting for age,
gender, smoking status, and body mass index.

The incidence of cancer in this cohort was 6.0 per 1000 person-years
of follow-up. Elevated iron (hazard ratio = 1.66) and VLDL-C (HR =
1.54) were significantly independently associated with the
development of cancer.

Combining elevated iron with elevated VLDL-C increased the adjusted
relative risk of cancer (HR = 2.68). Elevated iron combined with low
HDL-C also increased the risk (HR = 2.82).

"These findings support the hypothesis that iron-mediated oxidation
of cholesterol increases oxidative stress, which can lead to cancer
formation," Dr. Mainous and colleagues conclude. "If this finding
can be replicated in other studies, this would suggest the need for
interventional studies to reduce iron and/or lipid levels in persons
with dual elevations in these substance as a strategy to decrease
cancer risk."

Am J Epidemiol 2005;161:1115-1122

Individuals who are morbidly obese have severely reduced
cardiorespiratory fitness that mirrors that found in individuals
with heart failure, according to a study in the June issue of the
journal Chest.

The study also shows an inverse graded association between BMI and
cardiorespiratory fitness, suggesting that the respiratory
impairment in morbidly obese individuals is at least partially
related to an unhealthy BMI.

Dr. Peter A. McCullough from the William Beaumont Hospital in Royal
Oak, Michigan and colleagues prospectively studied the comparative
impact of morbid obesity versus heart failure on cardiorespiratory
fitness in 43 morbidly obese patients, 235 with established systolic
dysfunction heart failure, and 222 age-matched medical controls
referred for diagnostic exercise testing.

The mean BMI values for the three groups were 47.8, 30.1, and 33.8,
respectively, and the mean left ventricular ejection fraction for
the heart failure patients was 21.5.

Despite achieving higher peak heart rate and blood pressure values,
the morbidly obese patients had a mean maximum oxygen uptake
(VO2/max) that was similar to that of the heart failure patients
(17.8 vs 16.5 mL/kg/min, respectively; p = 0.14) and was
considerably lower than that of the control patients (17.8 vs 21.3
mL/kg/min, respectively; p = 0.007), the investigators report.

In addition, there was a graded inverse relation between BMI and
VO2/max among the medical control patients.

"The primary focus of our study was to accurately characterize the
cardiorespiratory fitness of one of the most rapidly growing cohorts
in the US population, that is, morbidly obese adults," the authors
note in their report.

"Basically, our study shows that obese individuals are as impaired
as patients with serious heart failure," Dr. McCullough told Reuters
Health. "Their levels of peak oxygen consumption are sufficiently
low to imply high intermediate-term mortality. We are currently
using this as a screening test before bariatric surgery," he added.

Chest 2005;127:2197-2203

Ischemia-modified albumin is a poor indicator of serious short-term
cardiac outcomes in patients presenting to the emergency department
with potential cardiac symptoms, Canadian researchers report.

"This study suggests that ischemia-modified albumin is of limited
value, as a stand-alone marker, to predict short-term cardiac
outcomes or the lack thereof, senior investigator Dr. Stephen A.
Hill told Reuters Health. "Based on this study, we cannot justify
implementing this test for patients in the emergency department."

Dr. Hill of Hamilton General Hospital, Ontario and colleagues
evaluated 186 patients presenting to the emergency department with
potential cardiac ischemia symptoms within 6 hours of experiencing
chest pain.

The patients were followed for 72 hours, during which time 24 had a
serious cardiac outcome such as myocardial infarction or congestive
heart failure.

However, the likelihood ratio for an ischemia-modified albumin of 80
U/mL or less predicting such an outcome was 1.35. The use of
ischemia-modified albumin beyond this level yielded a ratio of 0.98,
the researchers report in the in the June 21st issue of the Canadian
Medical Association Journal.

In an accompanying editorial, Dr. Marc S. Sabatine of Brigham and
Women's Hospital, Boston agrees that the study reinforces the fact
that ischemia-modified albumin elevation is "relatively non-
specific" and unlikely to help identify high-risk patients.

However, he suggests the marker may be helpful in some
circumstances, such as ruling out ischemia in patients with chest
pain or providing prognostic information in patients with angina.

CMAJ 2005;2005;172:1685-1690,1697-1698

Clinical outcomes are worse with Staphylococcus aureus endocarditis
than with endocarditis caused by other bacteria, according to a
report by researchers in France and the US.

S. aureus infections account for as many as 40% of infective
endocarditis cases, the authors explain in the July issue of Heart,
but few studies have compared S. aureus infective endocarditis with
endocarditis caused by other microorganisms.

Dr. Christophe Tribouilloy from Hopital Sud, Amiens and colleagues
analyzed clinical, echocardiographic, and prognostic features of S.
aureus infective endocarditis compared with endocarditis caused by
other pathogens in 192 consecutive patients.

Compared with other cases, patients with S. aureus endocarditis had
more severe comorbidity, a shorter duration of symptoms before
admission, a higher prevalence of history of renal failure and
dialysis, and a greater likelihood of right-sided endocarditis, the
authors report. S. aureus patients were also more likely to have a
cutaneous portal of entry, severe sepsis, admission to the intensive
care unit, multiple organ failure, and major neurological events.

Echocardiographic findings were similar in patients with
endocarditis, without regard to the causative pathogen, the report
indicates, although patients with S. aureus endocarditis were less
likely to have severe valvar regurgitation or multiple valve
endocarditis.

In-hospital mortality among patients with S. aureus endocarditis
(34%) was more than triple that in patients with endocarditis caused
by other pathogens (10%), the researchers note. Severe sepsis was
also more common in S. aureus endocarditis patients who died in the
hospital.

Three-year overall survival was lower in the S. aureus endocarditis
group (47%) than in the group with endocarditis caused by other
microorganisms (68%), the results indicate, but survival among those
who survived hospitalization did not differ between the groups.

"The excess mortality associated with S. aureus infective
endocarditis in the current study, essentially related to the
severity of sepsis and the particularly high risk clinical setting,
mainly occurs during the hospital phase as indicated by actuarial
survival curves, which tend to become parallel in the two groups
after discharge from hospital," the investigators conclude. "Rapid
management is therefore essential with a need for early surgery in
selected patients."

Heart 2005;91:932-937

http://news.findlaw.com/andrews/h/hea/20050119/20050119tenet.html

Wednesday, Jan. 19, 2005  Print This | Email This     

Tenet Pays $395 Million to Settle Heart Surgery Suit
By Jason Schossler
Health Law Litigation Reporter

Hospital operator Tenet Healthcare Corp. has agreed to pay $395
million to
settle a lawsuit brought by former cardiac patients who say that one
of its
California hospitals repeatedly performed unnecessary heart surgeries.

In an agreement reached with the patients' attorneys, Tenet will
arrange for
the money to be allocated among more than 750 patients who had filed
civil
lawsuits against the corporation and its subsidiaries. The cases
arose from
allegations that certain doctors performed unnecessary cardiac
catheterizations and bypass surgeries while practicing at Redding
Medical
Center in California.

The litigation against the individual physicians, however, is not
part of the
agreement.

"We believe this settlement is the fair and honorable way to conclude
this very
sad chapter," Tenet CEO Trevor Fetter said in a statement. "It would
likely
have taken multiple trials and many years to assess liability in
these cases. By
settling all the cases at once, we put this matter behind both the
plaintiffs and
us, and we bring closure to this unfortunate event."

Plaintiffs' attorney Robert G. Simpson of Reiner, Simpson, Timmons &
Slaughter in Redding, Calif., said the firm is "extremely proud" of
its clients
and is pleased that they are being compensated for the "egregious
acts"
committed against them.

"This has been a long and difficult road for our clients," Simpson
said in a
press release confirming the settlement. "They courageously stood up
for their
rights against tremendous criticism from a community that did not
understand
the depth of deception behind these unnecessary surgical procedures."

Simpson's firm represented more than 345 patients who allegedly
underwent
unnecessary cardiac procedures, as reportedly confirmed by
board-certified
cardiologists and cardiovascular surgeons.

"Our clients and their families suffered horrible complications such
as death,
amputations, heart and brain surgery, loss of mental acuity, and
strokes
because of these unnecessary procedures," liaison counsel Russell
Reiner
said in a statement.

Houston law firms Moriarty & Leyendecker and Hackerman Frankel also
represented former patients in the cases.

The settlement agreement is still subject to approval by the
individual plaintiffs
and other customary court requirements.
--------------------------------------------------
----------------------
In re Tenet Healthcare Cases III, No. JCCP 4301, settlement reached
(Cal.
Super. Ct., Shasta County Dec. 21, 2004).
Health Law Litigation Reporter
Volume 12, Issue 09
01/19/2005


Copyright 2005
West, a Thomson business. All Rights Reserved.

The results of a new study suggest that expression of gremlin, a
gene involved in nephrogenesis, may not end after embryonic
development and can reemerge in the context of diabetic nephropathy.

As reported in the American Journal of Kidney Disease for June, Dr.
Vincent Dolan, of University College Dublin, and colleagues
evaluated gremlin expression in normal human adult kidneys and in
kidneys with diabetic nephropathy.

Gremlin expression was not seen in the normal kidneys, whereas
abundant expression was observed in the nephropathic kidneys, the
investigators note. Further analysis revealed that gremlin
expression was primarily confined to areas of tubulointerstitial
fibrosis, typically in association with the expression of
transforming growth factor-beta.

Although gremlin mRNA levels did not correlate with the degree of
proteinuria, they were directly linked with the level of renal
dysfunction, the authors note. Moreover, gremlin expression was
strongly associated with the tubulointerstitial fibrosis score.

"Considered with reports from other investigators highlighting the
prominence of gremlin expression in fibroblast cultures, these data
suggest a role for gremlin in the pathogenesis of tubulointerstitial
fibrosis," the researchers state. As such, gremlin could serve as a
target for therapeutic intervention, they add.

Am J Kidney Dis 2005;45:1034-1039

Patients with low HDL cholesterol (HDL-C) during statin treatment
have better lipid profiles during fibrate treatment, according to
the results of a small study reported in the May 25th International
Journal of Cardiology.

Physicians should not just focus on LDL-C, but should also pay
attention to HDL-C, Dr. Dirk Devroey from University of Brussels,
told Reuters Health. "For patients with a decreased HDL-C during
lipid-lowering treatment (with statins) the diet and drug treatment
should be questioned."

Dr. Devroey and colleagues analyzed the lipid levels, drug
treatment, and medical history of 14 patients with low HDL-C (< 40
mg/dL) during treatment with statins who had ever been treated with
fibrates.

"Compared to the control group these patients, whom we called 'bad
HDL-C responders to statins,' were characterized by an increased
prevalence of myocardial infarction," the investigators report.

Eight of the patients had received fibrates before statins, and six
had received statins before fibrates. None had received both drugs
at the same time.

Total cholesterol was 8% higher and LDL-C was 6% higher during
fibrate therapy than during statin therapy, the authors report. In
contrast, triglycerides were 24% lower and HDL-C was 49% higher with
fibrates than with statins, the results indicate.

The ratio of total cholesterol to HDL-C was 26% lower and the ratio
of LDL-C to HDL-C was 27% lower with fibrates than with statins, the
researchers note.

"The main target for lipid-lowering treatment remains LDL-C," Dr.
Devroey said. "Statins remain the best drugs to reach treatment
goals, but not in all patients. For some patients, the less
expensive fibrates are preferable."

"For patients with low HDL-C and low LDL-C, fibrate monotherapy is
sufficient," Dr. Devroey said. "For patients with low HDL-C but with
high LDL-C, the combination of fibrates and a statins is desired."

"A randomized double-blind crossover trial with simvastatin and
fenofibrate has been initiated to corroborate these findings," the
authors add.

Int J Cardiol 2005;101:231-235

Nearly one out of every five pediatric patients with type 2 diabetes
also has a neurodevelopmental disorder, psychiatric illness or
behavioral disorder, according to a study conducted at Children's
Hospital of Philadelphia. Psychotropic medications are often
prescribed, many of which are associated with weight gain,
hyperglycemia or glucose intolerance.

"We started seeing pediatric patients who had gained a tremendous
amount of weight while they were on some of the newer atypical
antipsychotic agents," lead investigator Dr. Lorraine E. Levitt Katz
told Reuters Health. "We thought initially this would all be
medication related, but it appears to be more multifactorial than
that."

Dr. Katz and her associates reviewed the charts of their patients
who had type 2 diabetes to determine how many were being treated for
a neuropsychiatric disease at the time of their diabetes diagnosis.
The findings are reported in the June issue of Pediatric Diabetes.

Among the 237 patients, 46 (19.4%) had been diagnosed with a
neuropsychiatric disease. Twenty-nine were prescribed at least one
psychotropic medication, most frequently mood stabilizers and
atypical antipsychotics.

Body mass index was not significantly different among those with
neuropsychiatric illnesses (mean 33.7 versus 34.3). Gender
distribution, race and age at onset were also similar in those with
and those without a neuropsychiatric disease.

The authors theorize that "diabetes could appear in these patients
due to a common neuroendocrine basis between the two diseases, a
sudden increase in weight, overeating related to poor impulse
control, and altered brain physiology due to neuropsychiatric
disease."

They recommend that obese children with neuropsychiatric conditions
be tested for diabetes, and that those with diabetes or insulin
resistance be screened for psychiatric disorders.

"Before putting children on medications that may cause weight gain
and an increase in insulin resistance, a risk-benefit analysis needs
to be done," Dr. Katz said.

She noted that children with psychiatric diagnoses may be more
sedentary and less prone to regular physical activity.

"I think there needs to be an individualized lifestyle related
program," she added, "because for these kids there are more
challenges associated with their additional diagnoses."

Pediatr Diabetes 2005;6:84-89

A C-reactive protein (CRP) level > 3.0 mg/L is associated with a
nearly 50% increased risk of coronary heart disease (CHD) among
individuals age 65 years and older, even after adjusting for
conventional risk factors, results of a prospective study suggest.

Although CRP level is a recognized risk factor for CHD in middle-
aged subjects, there are no long-term prospective studies assessing
CRP and CHD risk in elderly men and women, Dr. Mary Cushman and
colleagues explain in their report, published in the June 28th
online edition of Circulation: Journal of the American Heart
Association.

Their study included 3971 subjects age 65 or older without prior
vascular disease at baseline, when subclinical disease was measured
by carotid ultrasound, ECG, and ankle-brachial blood pressure index,
and other risk factors were documented. CRP levels were measured in
blood collected at baseline.

CRP levels were > 3 mg/L in 26% of subjects. After 10 years of
follow-up, there were 547 first MIs or CHD deaths.

After adjusting for demographics and vascular risk factors, the
relative risk for a coronary event was 1.45 for those with CRP > 3.0
mg/L versus those with < 1.0 mg/L. After further adjustment for
subclinical disease the relative risk was still higher (1.37).

The elevated risk associated with CRP was even more apparent among
subjects with high Framingham risk scores. Among women with a 10-
year predicted risk > 20%, the observed incidence was 31% for those
with CRP > 3 mg/L versus 16% for those with low CRP. Among men at
high predicted risk, an elevated CRP was associated with an observed
risk of 41%.

"If elevated CRP represents a causal risk factor," the authors
suggest, "...correction of elevated CRP could eliminate up to 11% of
incident CHD in this age group."

Circulation 2005;11

In adults with childhood onset growth hormone deficiency, treatment
with growth hormone (GH) improves cardiac contractile performance,
according to a report in the May 25th International Journal of
Cardiology.

"In patients with childhood onset growth hormone deficiency,
treatment with GH should be continued after the end of their linear
growth," Dr. Andrzej Minczykowski from University School of Medical
Sciences, Poznan, Poland told Reuters Health.

Dr. Minczykowski and colleagues investigated the effects of GH
replacement on cardiac structure and functional indices in 16
patients with childhood onset GH deficiency. The mean age was 42.3
years, ranging from 18 to 60. Three of the subjects had been treated
with GH several years earlier.

Heart rate and blood pressure did not change significantly after 12
months of GH treatment, the report indicates, and left atrial end-
systolic diameter and left ventricular end-diastolic diameter
remained the same.

The systolic increase in left ventricular wall thickness increased
significantly after treatment, the authors report, but the left
ventricular diastolic wall thickness was not altered by GH treatment.

Ejection fraction increased significantly after 12 months, the
results indicate, and left ventricular end-systolic volume decreased
significantly.

Growth hormone treatment also brought significant improvements in
integrated backscatter, another measure of cardiac architecture and
performance, the investigators report.

"Therapy with GH in patients with childhood onset GH deficiency is
usually discontinued at the end of linear growth," Dr. Minczykowski
explained. "The majority of patients with GH deficiency occurring in
adulthood do not receive GH treatment." The current findings and the
results of other studies "have shown that in such situations GH
treatment can give some important benefits to patients, but they
disappear with GH discontinuation."

"GH should be administered in supplementing doses," Dr. Minczykowski
concluded. "It is difficult to recommend an endpoint other than the
serum IGF-I response to GH treatment. The dose of GH should aim at
the low to middle range of the normal age-predicted values of the
serum IGF-I levels."

Int J Cardiol 2005;101:257-263

Background
Low HDL-cholesterol concentrations can be successfully raised by
niacin. A low HDL-cholesterol level is recognized as a coronary risk
factor and increases the risk of unfavorable events related to
coronary atherosclerosis. Unlike for LDL cholesterol, the National
Cholesterol Education Program guidelines do not provide target
levels for HDL-cholesterol concentration. Few studies have
investigated the effect of niacin on coronary events, alone or in
combination with statin therapy.

Objectives
To explore the effect of niacin on carotid intima-media thickness
(CIMT), and to find out whether extended-release niacin therapy
provides added cardiovascular protection to patients receiving
statin monotherapy for coronary artery disease.

Design
The Arterial Biology for the Investigation of the Treatment Effects
of Reducing Cholesterol (ARBITER) 2 trial was a US-based,
randomized, placebo-controlled, double-blind study carried out from
December 2001 to May 2003. Patients aged over 30 years old were
eligible for the study if they had coronary vascular disease, were
receiving statin therapy and had HDL-cholesterol levels below 1.7
mM/l (45 mg/dl) and LDL-cholesterol levels under 3.4 mM/l (130
mg/dl). Men and women were excluded if their liver-associated enzyme
levels were 3 times the upper normal limit, if they had previous
liver disease or were intolerant to niacin.

Intervention
Eligible patients were randomly assigned 500 mg extended-release
niacin (Niaspan,® Kos Pharmaceuticals) daily or placebo, both to be
taken at night. After 30 days, niacin dose was raised to 1000 mg
daily and maintained at this dose for 1 year. Each patient's CIMT
was assessed by linear-array 8 MHz probe ultrasonography at baseline
and at 1 year. Analysis of CIMT images was masked.

Outcome Measures
The main endpoint was change in CIMT over 1 year. An increase in
liver-associated enzymes, changes in serum lipid levels and
admission to hospital for stroke, arterial revascularization, acute
coronary syndrome or sudden cardiac death, among others, were some
of the secondary endpoints.

Results
Of the 167 patients on baseline statin treatment, 87 patients were
assigned additional niacin therapy and 80 were assigned placebo. In
total, 149 patients (89.2%) were reassessed at 1 year (study end).
Treatment with statin and niacin significantly increased HDL-
cholesterol levels by 21%, from 1.0 0.2 mM/l (39 7 mg/dl) to 1.2 ±
0.4 mM/l (47 16 mg/dl), when compared with statin and placebo ( P =
0.002). Although not significant, patients treated with statin and
placebo had a higher average increase in CIMT than the statin and
niacin-treated patients (0.044 ± 0.100 mm vs 0.014 ± 0.104 mm, P =
0.08). Importantly, the rise in average CIMT was significant for
statin and placebo-treated patients but not for patients receiving
niacin (0.044 ± 0.100 mm, P < 0.001 and 0.014 ± 0.104 mm, P = 0.23,
respectively).

Conclusion
Extended-release niacin slowed the development of atherosclerosis in
adults with coronary artery disease, independently from statin
therapy.

Background
Portable coagulometers have enabled patients to test their own
international normalized ratio (INR) and therefore manage their own
anti coagulation therapy, independent from their physician. In this
paper, Menéndez-Jándula et al. investigate whether self-managed anti
coagulation therapy is an efficient and feasible option.

Objective
To determine whether oral anticoagulation therapy managed by the
patient and anticoagulation therapy managed by a clinic provide the
same safety and quality of control.

Design and Intervention
Between January 2001 and July 2002, this trial randomly preselected
patients from a database of patients already receiving clinically
managed anticoagulant therapy. Patients who were over 18 years old
and had received anticoagulant therapy for 3 months or more were
included. Eligible patients were interviewed and consenting patients
were randomly assigned to self-managed or clinic-managed anti
coagulation. All patients randomized to the self-management group
underwent at least 4 h training to teach them how to use a
coagulometer, interpret their INR and adjust their anticoagulant
dose accordingly. Patients only entered the study when their self-
management was considered competent. Self-managed patients performed
an INR test once a week using the CoaguChek S portable coagulometer
(Roche Diagnostics, Mannheim, Germany). Patients in the clinically
managed group had INR tests every 4 weeks using a KC10 coagulometer
Is self-management of oral anticoagulation a feasible and safe
option? (Amelung, Lemgo, Germany). All patients were followed up by
telephone interview each month. Outcomes were diagnosed by an
independent masked physician. All analyses were done by intention to
treat.

Outcome Measures
The study measured the percentage of INR values within the target
range of 2.5–3.5. Major events included thromboembolic
complications, bleeding requiring hospital admission or blood
transfusion, and life-threatening bleeding.

Results
The original database included 5,000 patients. After random
preselection, 737 eligible patients gave their consent and joined
the study. Of these, 368 patients were assigned to self-managed
anticoagulation and 369 were assigned clinic-managed
anticoagulation. Due to patient withdrawal, lack of confidence and
inability to manage self-monitoring, only 300 self-managed patients
entered the study. When analyzed by intention to treat, a greater
percentage of self-managed patients had INR values within the target
range compared with clinic-managed patients (58.6% vs 55.6%, 95% CI
0.4–5.4, P = 0.02). There were fewer anticoagulation-related major
events in the selfmanaged group than the clinic-managed group (8 vs
27, unadjusted risk difference 5.1%, 95% CI 1.7–8.5) and fewer self-
managed patients died compared with the clinic-managed patients (6
vs 15, unadjusted risk difference 2.5%, 95% CI 0.0–5.1).

Conclusion
Conventional clinic-managed anticoagulation therapy and self-managed
oral anticoagulation therapy offer a similar quality of INR control.
Furthermore, self-managed anticoagulation reduced the number of
deaths and major events but Menéndez-Jándula et al. point out that
not all patients will be suited to managing their own INR levels.

Background: Percutaneous coronary intervention (PCI) is increasingly
used in patients with high-risk baseline characteristics. A prior
stroke may identify patients who have a higher risk for post-PCI
complications. However, no comparative data exist on post-PCI
outcomes of patients with or without prior stroke.
Methods: Review of a PCI database of 9,088 consecutive PCIs from
7/97 to 12/02 identified 812 PCIs in patients with a history of
prior stroke and 8,044 PCIs without prior stroke.
Results: Patients with prior stroke had high-risk baseline
characteristics [diabetes, hypertension, hyperlipidemia, smoking,
peripheral arterial disease, congestive heart failure, chronic renal
failure, history of prior myocardial infarction and prior coronary
artery bypass graft (CABG)] and high-risk coronary anatomy (p <
0.001 for each one). The triple composite (death, myocardial
infarction and emergent CABG) and the triple composite plus post-PCI
stroke were higher in patients with prior stroke (11.2% vs. 4.8%; p
< 0.001; z = 7.617 and 12.1% vs. 5.0%; p < 0.001; z = 8.271,
respectively.
Conclusion: Patients with prior stroke constitute a high-risk PCI
cohort with higher rates of in-hospital adverse events. A prior
stroke history should be considered in evaluating potential
candidates for PCI.

Prolonged temporary pacing is associated with frequent complications.
We describe a patient with aortic endocarditis and acquired tri-
fascicular block in whom back-up pacing was indicated. Using a
Seldinger technique via a subclavian approach, a permanent active-
fixation lead was positioned in the right ventricle. The lead was
tunnelled subcutaneously for 6cm, and the proximal end was connected to
a standard single chamber pulse generator. The procedure was well
tolerated and over a period of four months there were no complications
or infection. The PR interval subsequently reduced in duration to 200
ms and as no episodes of AV block had occurred, the lead was easily
removed with retraction of the helix and gentle traction.

A scoring system based on a patient's age, blood pressure, clinical
features and duration of symptoms (ABCD score) can be used to
estimate the risk of stroke in the 7 days after a transient ischemic
attack (TIA), and thereby identify patients who should be handled as
emergencies, British investigators report.

The risk score will also be useful for raising public awareness of
the symptoms of stroke, Dr. Peter M. Rothwell, from the University
of Oxford, and his colleagues note in their report, published online
in The Lancet on June 21st.

Dr. Rothwell's team studied factors reported as significant
predictors of stroke in one population-based cohort of 209 patients
with TIA, among whom there were 18 strokes within 7 days.

Their investigation generated a 6-point score based on age (60 years
or older = 1 point), blood pressure at presentation (systolic > 140
mm Hg and/or diastolic > 90 mm Hg = 1), clinical features
(unilateral weakness = 2, speech disturbance without weakness = 1,
other = 0), and duration (60 minutes or longer = 2, 10 to 59 minutes
= 1, < 10 = 0).

The authors validated the risk score in a second population-based
cohort of 375 TIA referrals. Nineteen of the 20 strokes that
occurred within 7 days occurred in patients with a risk score of
five or six. The 7-day risks were 1.1% for those with a score of
four; 12.1% for those with a score of five; and 31.4% for those with
a score of six.

In a second cohort of 206 TIA patients, corresponding risks were
9.1%, 11.8% and 23.8%, respectively.

"An ABCD score of 6 necessitates not only emergency investigation
and treatment but also admission to hospital during the acute
phase," the authors indicate.

Even if stroke can't be prevented, they add, hospital admission
should allow for immediate thrombolytic treatment if one occurs.

Lancet 2005

Late neonatal ingestion of breast milk and the duration of breast-
feeding do not appear to independently influence the risk of
overweight or impaired glucose tolerance in the children of diabetic
mothers, according to researchers. However, breast-feeding during
the first week of life may have a more important influence.

The offspring of diabetic mothers have an increased risk of
developing these two conditions, principal investigator Dr. Andreas
Plagemann and colleagues from Charite-University Medicine Berlin,
Germany, note in the June issue of Diabetes Care. "Recently, we
observed that early neonatal ingestion of breast milk from diabetic
mothers may dose-dependently increase the risk of overweight in
childhood."

To investigate, the researchers evaluated 112 children of diabetic
mothers who were breast-fed. Mean age at follow-up was 2.1 years.

"Exclusive breast-feeding was associated with increased childhood
relative body weight (p = 0.011)," the investigators report. "Breast-
fed offspring of diabetic mothers had an increased risk of
overweight (odds ratio 1.98)."

A positive relation was observed between breast-feeding duration and
childhood relative body weight (p = 0.004). Duration of breast-
feeding was also positively related to 120-min blood glucose during
oral glucose tolerance test (p = 0.022).

However, all of the associations with late neonatal breast-feeding
and its duration were eliminated after adjusting for the breast milk
volume ingested during the early neonatal period (1st week of life).

Dr. Plagemann's group hypothesizes that the first week after birth
is a "critical period, when exposure to diabetic breast milk may
have a negative long-term influence on risk of overweight and
diabetes in offspring of diabetic mothers. This might have important
practical consequences."

Diabetes Care 2005;28:1457-1462

The results of a study published in the June issue of the American
Journal of Hypertension suggest that consumption of dark chocolate
may exert a protective effect on the cardiovascular system in
healthy subjects.

"Epidemiological studies suggest that high flavonoid intake confers
a benefit on cardiovascular outcome," Dr. Charalambos Vlachopoulos,
of Athens Medical School in Greece, and colleagues
write. "Endothelial function, arterial stiffness, and wave
reflection are important determinants of cardiovascular performance
and are predictors of cardiovascular risk."

In a randomized, sham-procedure-controlled, crossover study, the
researchers examined the effects of flavonoid-rich dark chocolate on
the endothelial function, aortic stiffness, wave reflections, and
oxidant status of 17 young, healthy volunteers over a 3-h period.
The subjects consumed 100 g of a commercially available, procyanidin-
rich dark chocolate.

Flow-mediated dilation of the brachial artery, aortic augmentation
index, and carotid-femoral pulse wave velocity were measured, along
with plasma levels of malondialdehyde and total antioxidant capacity
to evaluate plasma oxidant status.

A significant increase was observed in the flow-mediated dilation of
the brachial artery at 60 min (absolute increase 1.43%, p < 0.5),
the authors report.

Chocolate consumption led to a significant decrease in the aortic
augmentation index throughout the study (maximum absolute decrease
7.8%, p < 0.001). This indicated a decrease in wave reflections.

No significant change in pulse wave velocity was observed.

The team also found no significant changes in plasma total
antioxidant capacity or malondialdehyde values during chocolate
consumption or control session, indicating no alteration in the
oxidant status.

"The predominant mechanism appears to be dilation of small and
medium-sized peripheral arteries and arterioles," Dr. Vlachopoulos
and colleagues suggest.

"The dilatory effect of chocolate under resting conditions (dilation
of brachial artery, decrease in wave reflections) can be attributed
to improved nitric oxide bioavailability, prostacyclin increase,
direct effect on chocolate in smooth muscle cells, or activation of
central mechanisms."

Am J Hypertens 2005;18:785-791

US officials approved on Thursday the first drug for patients of one
specific race, a heart-failure treatment that sharply reduced deaths
among blacks.

Nitromed Inc.'s BiDil cut deaths by 43% in a company study, but the
company's strategy of marketing it just for one race has generated
controversy.

A Nitromed trial of 1050 subjects "clearly showed that blacks
suffering from heart failure will now have an additional safe and
effective option for treating their condition," Dr. Robert Temple,
the Food and Drug Administration's associate director of medical
policy, said in a statement.

"In the future, we hope to discover characteristics that identify
people of any race who might be helped by BiDil," Temple added.

The FDA's clearance of the drug specifically for blacks benefits
Nitromed because the company holds patent rights for that use until
2020. The patent for BiDil for general use expires in 2007, a fact
that has prompted criticism.

"This approval of BiDil isn't about personalizing medicine. It's
about exploiting race to make money by extending patent protection,"
said Jonathan Kahn, a law professor and ethicist at Hamline
University in Minnesota who has studied BiDil's development.

Kahn and other critics argued BiDil should be approved for all
patients, regardless of race, because there is no biological reason
blacks should react differently than others.

Nitromed officials insist their effort is based on solid science and
will address a major public health problem. African-Americans are
more likely than others to develop heart failure and to die early
from the disease, studies have found.

"FDA approval of BiDil represents an important leap forward in
addressing this health disparity," said Dr. Anne Taylor, a NitroMed
consultant and lead researcher on the BiDil study.

Future research may identify a genetic variation in people of
different races that indicates a good outcome from BiDil, company
officials have said.

BiDil is a combination of two generic drugs -- isosorbide dinitrate
and hydralazine -- that dilate blood vessels, and was developed to
treat congestive heart failure.

About 750,000 African-Americans have been diagnosed with heart
failure, NitroMed said. Half the people with heart failure die
within 5 years of diagnosis.

Tests of BiDil in the 1980s did not show a benefit for patients
overall, but researchers said blacks fared better than others.

Nitromed and the Association of Black Cardiologists then studied
1050 advanced heart failure patients who identified themselves as
black, and gave them standard drug therapy plus either BiDil or a
placebo.

Deaths were so much lower in the BiDil group that researchers ended
the study early so all patients could take BiDil. Fifty-four
patients (10.2%) in the placebo group died, compared with 32 deaths
(6.2%) in the BiDil group.

Hospitalizations from heart failure also were reduced in the BiDil
group.

Even with an approval for blacks only, doctors could prescribe BiDil
for anyone they thought it might help.

In women free of known coronary artery disease, depression is
associated with coronary and aortic calcification, and decreased
heart rate variability, according to the results of two studies
published in the June 13th issue of the Archives of Internal
Medicine.

Depression is recognized as a risk factor for coronary artery
disease (CAD), co-author Dr. Karen A. Matthews and her associates at
the University of Pittsburgh note in the first report, but its
relationship with subclinical atherosclerosis is unclear. The
researchers evaluated 210 women ages 42 to 52 years with no history
of clinical heart disease or diabetes.

The results of structured clinical interviews showed that 25% had a
history of recurrent major depression. Electron beam tomography was
used to obtain calcium scores for the coronary arteries and aorta;
calcification was observed in 45%.

After adjusting for demographics and other risk factors, a history
of recurrent major depression was associated with any coronary
calcium (odds ratio 2.46), a high coronary calcium score (OR 2.71)
and a high aorta calcium score (OR 3.39), compared with no
depression or a single episode. Current depression was not
associated with coronary calcification.

Dr. Matthews' group suggests that depression may mediate its effects
on coronary calcification through its effects on lifestyle, levels
of inflammatory markers, or activation of the hypothalamic-pituitary-
adrenal axis.

In the second paper, Dr. David S. Sheps, from the University of
Florida in Gainesville, and his team theorize that dysregulation of
the cardiac autonomic system may be responsible for the link between
depression and CAD.

To explore this notion, the researchers assessed depression among
2627 women ages 50 to 83 years without a prior history of heart
disease using a shortened version of the Center for Epidemiological
Studies Depression Scale and the Diagnostic Interview Schedule.
Subjects underwent 24-hour ambulatory electrocardiographic
monitoring.

The mean values for standard deviation of N-N intervals were 113.3
for subjects determined to have depressive symptoms versus 119.1 in
those without (p = 0.005). Heart rates averaged 77.4/minute and
75.5/minute, respectively (p = 0.002). The differences remained
significant after adjusting for medical and demographic covariates,
the authors note.

"Decreased heart rate variability may not only contribute to
increased cardiac morbidity and mortality in participants with CAD
but also may be a link that places individuals with depressive
symptoms or clinical depression with no known history of CAD at risk
for cardiovascular disease," Dr. Sheps' group concludes.

In a related editorial, Drs. Grant R. Grissom and Robert A.
Phillips, from Polaris Health Directions Inc. in Fairless Hills,
Pennsylvania, point out that depression is "not on the radar screens
of cardiologists and many internists," reflecting their lack of
training in detecting depression, skepticism that treatment can
alter medical outcomes and limitations of depression assessment
tools.

With better screening tools being developed, they say, barriers to
addressing depression will be overcome, offering the opportunity "to
significantly improve the quality of life, and perhaps the prognosis
for event-free survival" of patients with depression.

Arch Intern Med 2005;165:1214-1216,1229-1236,1239-1244