Latest Research

Poor Bedside Manner Linked to Patient Complaints

Physicians with lower communication scores are more likely to have complaints filed against them

Physicians with the lowest patient communication scores on a national clinical skills exam are more likely to have a patient complain to regulatory authorities than physicians with high scores, according to study findings published in the Sept. 5 issue of the Journal of the American Medical Association.

Robyn Tamblyn, Ph.D., of McGill University in Montreal, Canada, and colleagues conducted a study of 3,424 physicians who took the Medical Council of Canada clinical skills exam between 1993 and 1996. They followed physicians until 2005 in order to assess the relationship between test scores and the prevalence of patient complaints.

Patients filed a total of 1,116 complaints, including 696 that were retained after investigation. Almost one-fifth of all physicians had at least one retained complaint, the majority of which involved communication or quality-of-care problems. Lower patient-physician communication scores were associated with a higher rate of retained complaints, especially for scores in the bottom quartile. Scoring 2 standard deviations below the mean was associated with a 38 percent increase in the complaint rate.

"In summary, we found that communication and clinical decision-making ability were important predictors of future complaints to regulatory authorities. Current examinations could be modified to test these attributes more efficiently and at earlier points in the training process," the authors conclude.

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Residents Lack Tools to Interpret Medical Literature

Study suggests their knowledge of biostatistics is limited

Many medical residents have a suboptimal knowledge of basic biostatistics, which may hamper their ability to correctly interpret many of the results in published clinical research, according to a report in the Sept. 5 issue of the Journal of the American Medical Association.

Donna M. Windish, M.D., of Yale University School of Medicine in New Haven, Conn., and colleagues administered a biostatistics and study-design multiple choice survey to 277 residents in 11 internal medicine residency programs.

The mean percentage of correct answers on the survey was 41.1 percent for residents, compared to 71.5 percent for fellows and general medicine faculty with research training. Higher scores among residents correlated with additional advanced degrees, prior biostatistics training, enrollment in university-based programs, and male sex. Most residents understand the concept of relative risk (81.6 percent), but fewer correctly interpreted an adjusted odds ratio from a multivariate regression (37.4 percent) or a Kaplan-Meier analysis (10.5 percent).

"If physicians cannot detect appropriate statistical analyses and accurately understand their results, the risk of incorrect interpretation may lead to erroneous applications of clinical research," the authors conclude. "Educators should re-evaluate how this information is taught and reinforced in order to adequately prepare trainees for lifelong learning."

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Drug Duo May Cut Diabetes-Related Mortality

Perindopril and indapamide combo reduced morbidity and mortality among type 2 diabetics

Patients with type 2 diabetes who take the angiotensin-converting enzyme inhibitor perindopril and the diuretic indapamide are at reduced risk for major vascular events compared with those who do not take the combination therapy, according to study findings published online Sept. 2 in The Lancet.

Anushka Patel, of the University of Sydney in Australia, and other investigators in the ADVANCE Collaborative Group conducted a trial of 11,140 type 2 diabetics across 215 collaborating centers in 20 countries. The participants were randomized to receive either a fixed combination of perindopril and indapamide or placebo in addition to current therapy.

The cohort was followed up for a mean 4.3 years, by which time the treatment group had a 9 percent lower risk of major macrovascular or microvascular events versus the placebo group, and the relative risks of cardiovascular death and death from any cause were reduced by 18 percent and 14 percent, respectively, relative to the placebo group.

"If the benefits seen in ADVANCE were applied to just half the population with diabetes worldwide, more than a million deaths would be avoided over five years," the authors conclude. "There is now a case for considering such treatment routinely for patients with type 2 diabetes."

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Diabetics Misunderstand Blood Glucose Monitoring

Crucial role of health professionals in educating and motivating patients

Many patients with type 2 diabetes are uncertain about the benefit of blood glucose monitoring, partly because they perceive a lack of interest on the part of their providers, researchers report in the September issue of BMJ.

Elizabeth Peel, of Aston University in Birmingham, U.K., and colleagues conducted in-depth interviews with 18 type 2 diabetes patients over a four-year period following their initial clinical diagnosis.

The investigators found that patients' blood glucose self-monitoring decreased over time. Many felt that self-monitoring was not important, partly because their physicians seemed to care more about glycosylated hemoglobin levels and did not pay much attention to their recorded meter readings. In addition, patients felt unsure of how to manage high blood glucose readings. Overall, patients did not appear to be using recorded values to guide or maintain behavior change.

The authors encourage better patient-provider communication as a means to improving self-monitoring practices. "Health professionals should be explicit about whether and when such patients should self-monitor and how they should interpret and act upon the results, especially high readings," Peel and colleagues conclude.

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Procrit Does Not Reduce Need for Transfusion in Critically Ill

May lower mortality in trauma patients and increase thrombotic events

Procrit (epoetin alfa) does not reduce the need for a blood transfusion in patients in the intensive care unit, although it may lower mortality in trauma patients and increase hemoglobin concentration and thrombotic events, according to the results of a trial published in the Sept. 6 issue of the New England Journal of Medicine.

Howard L. Corwin, M.D., from Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and colleagues randomized 1,460 medical, surgical and trauma patients admitted to intensive care units to recombinant human erythropoietin (epoetin alfa, 40,000 U) or placebo weekly for a maximum of three weeks. All patients had a hemoglobin concentration of less than 12 g per deciliter.

The researchers found that during a follow-up of 140 days, both groups had similar numbers of patients who received a red-cell transfusion and a similar mean number of red cells transfused. The hemoglobin concentration increased significantly and mortality tended to be lower (adjusted hazard ratio 0.86) in patients receiving epoetin alfa, particularly those with trauma (adjusted hazard ratio 0.40). However, epoetin alfa increased the risk of thrombotic events (hazard ratio 1.41).

"Without a clear indication for initiating erythropoietin in all critically ill patients, new prescriptions for this drug should be restricted to randomized trials with independent research oversight carefully examining fatal and non-fatal clinically important outcomes," Deborah Cook, M.D., and Mark Crowther, M.D., from McMaster University in Hamilton, Ontario, Canada, write in an accompanying editorial.

The study was funded by Johnson & Johnson Pharmaceutical Research and Development.

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New Atrial Fibrillation Treatments Found Effective

Studies show benefits of dronedarone and dual-chamber minimal ventricular pacing

Dronedarone, a new antiarrhythmic agent, and dual-chamber minimal ventricular pacing are effective treatments for patients with atrial fibrillation, according to two studies published in the Sept. 6 issue of the New England Journal of Medicine.

Bramah N. Singh, M.D., of the Veterans Affairs Greater Los Angeles Healthcare System, and colleagues randomly assigned 828 patients to receive either 400 milligrams of dronedarone or placebo and followed them for one year. During recurrences of arrhythmia, they found that the dronedarone group had significantly better sinus rhythm maintenance and a lower ventricular rate than the placebo group.

Michael O. Sweeney, M.D., of Brigham and Women's Hospital in Boston, and colleagues randomly assigned 1,065 patients to receive either conventional dual-chamber pacing or dual-chamber minimal ventricular pacing. They found that dual-chamber minimal ventricular pacing was more effective at preventing ventricular desynchronization and that it also moderately reduced the risk of persistent atrial fibrillation.

"Pulmonary-vein ablation is successful in selected patients but is unlikely to satisfy the needs of the millions of patients with atrial fibrillation," states the author of an accompanying editorial. "My bet is on the multimechanism approach [which targets several different electrophysiological mechanisms simultaneously]. Singh and his colleagues may have signaled that the best is yet to come."

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Airway Function in Infancy Predicts Obstruction in Adults

Lung changes leading to chronic obstructive pulmonary disease may begin in utero

Poor airway function in infancy is associated with an increased risk of childhood respiratory infections and impaired airflow in young adulthood, according to a report in the Sept. 1 issue of The Lancet.

Debra A. Stern, M.D., of the University of Arizona in Tucson, Ariz., and colleagues investigated the relationship between poor airway function in infancy and the risk of airflow obstruction in young adults. They measured maximal expiratory flows at functional residual capacity (VmaxFRC) in 169 infants (mean age 2.3 months), and conducted follow-up spirometry at ages 11, 16 and 22 years.

Infants with VmaxFRC in the lowest quartile had diminished airflow measures of FEV1/FVC ratio, FEF25-75 and FEV1 values up to age 22, as well as an increased risk of respiratory illness in the first three years of life, compared to infants in the upper three quartiles combined.

"Our results suggest that in utero alterations in airway development predispose individuals both to lower respiratory illnesses and to subsequent deficits in lung function during adult life," the authors write.

"As chronic obstructive pulmonary disease is set globally to become the third most important cause of death, now is the time to add research into its earliest origins to the agenda," according to an accompanying editorial.

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Genetic Link Found Between Lupus, Rheumatoid Arthritis

STAT4 polymorphism associated with substantially greater risk for both diseases

Researchers have discovered a genetic link between rheumatoid arthritis and systemic lupus erythematosus, according to a report in the Sept. 6 issue of the New England Journal of Medicine.

Elaine F. Remmers, Ph.D., of the National Institute of Arthritis and Musculoskeletal and Skin Diseases in Bethesda, Md., and colleagues genotyped 1,620 patients with established rheumatoid arthritis, 1,529 patients with early rheumatoid arthritis and 1,039 patients with lupus, along with controls, from several sample populations from North America and Sweden. Thirteen candidate genes were identified from a linkage peak on chromosome 2, followed by fine mapping of the STAT1-STAT4 region.

Analysis of the rheumatoid arthritis sample groups and a subsequent meta-analysis found a significant association with the single-nucleotide polymorphism rs7574865 on the third intron of STAT4 (odds ratio 1.32). Strong evidence of association with the rs7574865 minor allele was then identified in the lupus sample groups and again in a subsequent meta-analysis (odds ratio 1.55). Homozygosity of the risk allele was associated with a more than doubled risk for lupus and a 60 percent increased risk for rheumatoid arthritis.

There may be additional risk alleles in the STAT4 gene, the authors note. "Nevertheless, even in the absence of precise molecular mechanisms, the discovery of these new disease associations with STAT4 should generate a variety of new hypotheses about the pathogenesis of autoimmunity," they conclude.

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Heart Disease Patients' Families Should Be Screened

The risk for premature heart disease doubles for siblings of patients with the condition

Screening the families of premature heart disease patients could prevent more than one-third of premature heart attacks, according to the results of a study published in the Sept. 8 issue of BMJ.

Jill P. Pell, M.D., of the University of Glasgow in the United Kingdom, and colleagues conducted a meta-analysis of data from previous studies on heart disease showing that first-degree relatives of premature heart disease patients, defined as heart disease occurring before 55 years of age in men and 60 in women, are also at increased risk.

The risk of myocardial infarction doubles for first-degree relatives, and in the United Kingdom one-fifth of hospitalizations for myocardial infarction are considered to be premature. Screening and treating first-degree relatives of premature heart disease patients could reduce hospital admission for myocardial infarction by more than one-third, the authors write.

The authors conclude that families of premature coronary heart disease patients are a prime target for family counseling, as is the case with inherited cancers. However, they caution that motivation to change may be an issue.

"Motivation to attend cancer screening is higher in people with a positive family history. However, familial risk in cardiovascular disease is complex, and overemphasizing the genetic component may reduce motivation to change lifestyle," the authors write.

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Many Patients' Mental Health Needs Unmet Worldwide

Service usage is lowest in developing nations, but adequate service is also low in the United States

Patient usage of mental health services for anxiety, mood and substance use disorders is low worldwide, especially in less-developed countries, researchers report in the Sept. 8 issue of The Lancet. Delivery of adequate service is also low in many countries worldwide, including the United States.

Philip S. Wang, M.D., director of the National Institute of Mental Health Division of Services and Intervention Research in Rockville, Md., and colleagues analyzed face-to-face survey data on 84,850 adults living in 17 countries.

The researchers found that usage rates ranged from a high of 18 percent in the United States to 11 percent in France and a low of 1.6 percent in Nigeria. Although they found that rates of adequate service -- which they defined as at least eight visits to any service sector, or being in ongoing treatment at the time of the interview, or receiving a medication for at least one month with four or more visits to a medical professional over a 12-month period -- were lowest in less-developed countries, they also found that the U.S. rate (18 percent) was significantly lower than in other developed countries such as Japan (32 percent), and France and Germany (43 percent each).

"Alleviation of these unmet needs will require expansion and optimum allocation of treatment resources," the authors conclude.

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Food Additives May Increase Hyperactivity in Children

Adverse effects from food color, additives observed in general population of young children

Artificial food color and additives found in food, candy and drinks may increase hyperactivity in children at least up to age 9, according to the results of a randomized study published online Sept. 6 in The Lancet.

Jim Stevenson, Ph.D., of the University of Southampton in the U.K., and colleagues randomly assigned 153 children aged 3 years and 144 children aged 8 to 9 years, to receive either challenge drinks containing sodium benzoate, a placebo drink, and one of two mixes of artificial food colors and additives (the equivalent to the food coloring in two or four 56-gram bags of sweets a day, the estimated amount consumed by children).

The researchers found that the first mix -- which contained sunset yellow, carmoisine, tartrazine and ponceau -- was significantly associated with higher global hyperactivity scores in both groups of children compared to placebo. They also found that the second mix -- which contained sunset yellow, carmoisine, quinoline yellow and allura red -- was significantly associated with higher hyperactivity scores in the older children.

"These findings show that adverse effects are not just seen in children with extreme hyperactivity (i.e., ADHD), but can also be seen in the general population and across the range of severities of hyperactivity," the authors write. "Although the use of artificial coloring in food manufacture might seem superfluous, the same cannot be said for sodium benzoate, which has an important preservative function. The implications of these results for the regulation of food additive use could be substantial."

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Depression Exacts Higher Toll Than Chronic Conditions

Mean health scores are lower with depression than with angina, arthritis, asthma and diabetes

Depression, especially when accompanied by other chronic physical health conditions, has a greater effect on reducing mean health scores than conditions such as angina, arthritis, asthma and diabetes alone, according to study findings published in the Sept. 8 issue of The Lancet.

Somnath Chatterji, M.D., of the World Health Organization in Geneva, Switzerland, and colleagues analyzed data from the WHO's World Health Survey on 245,404 adults from 60 countries.

The researchers found that one-year prevalence rates were 3.2 percent for depression, 4.5 percent for angina, 4.1 percent for arthritis, 3.3 percent for asthma and 2 percent for diabetes. They also found that between 9.3 percent and 23 percent of subjects with one or more these chronic physical conditions also had depression. Their analysis showed that depression was associated with lower mean health scores than the other chronic conditions and that depressed subjects with one or more comorbid conditions had the lowest health scores of all.

"The comorbid state of depression incrementally worsens health compared with depression alone, with any of the chronic diseases alone, and with any combination of chronic diseases without depression," the authors conclude. "These results indicate the urgency of addressing depression as a public-health priority to reduce disease burden and disability, and to improve the overall health of populations."

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Vitamin D Modestly Reduces Death Risk from Any Cause

Intake of ordinary doses linked to decline in total mortality rates

Vitamin D supplements modestly reduce the risk of mortality from any cause, according to a report in the Sept. 10 issue of the Archives of Internal Medicine.

Philippe Autier, M.D., from the International Agency for Research on Cancer in Lyon, France, and Sara Gandini, Ph.D., from the European Institute of Oncology in Milan, Italy, performed a meta-analysis of 18 randomized controlled trials examining the impact of vitamin D supplementation (mean, 528 IU per day) on any health condition. The trials involved 57,311 participants.

The researchers found there were 4,777 deaths from all causes during a mean of 5.7 years. The summary relative risk of mortality from any cause was 0.93 for patients taking supplements, which was independent of additional calcium supplements. In the nine trials where blood samples were collected, serum 25-hydroxyvitamin D levels were 1.4- to 5.2-fold higher in the supplemented group.

"In conclusion, the intake of ordinary doses of vitamin D supplements seems to be associated with decreases in total mortality rates," Autier and Gandini write.

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Vitamin E May Protect Women Against Blood Clots

Supplement reduced risk of venous thromboembolism by 18 percent

Vitamin E may protect women from the risk of venous thromboembolism, particularly those with a history of emboli or a genetic susceptibility, according to study findings published online Sept. 10 in Circulation: Journal of the American Heart Association.

Robert J. Glynn, Ph.D., of Brigham and Women's Hospital in Boston, and colleagues conducted a study of 39,876 women who were randomized to receive either 600 IU of natural source vitamin E or placebo on alternate days. Blood samples were provided by 26,779 subjects to determine two genetic polymorphisms known to increase susceptibility to venous thromboembolism.

Over the course of a mean 10.2 years follow-up, 482 women had a venous thromboembolism, including 213 in the vitamin E group and 269 in the placebo group. For women with no previous venous thromboembolism, vitamin E supplementation conferred an 18 percent hazard reduction. Women with a prior venous thromboembolism had a 44 percent reduction, and those with a genetic susceptibility had a 49 percent reduction.

"It seems that women who would particularly be interested in a preventive agent actually seemed to have a larger benefit," said Glynn, in a statement. However, until the findings can be confirmed by other studies, warfarin remains the gold standard therapy, he adds. "This is an exciting and interesting finding, but I don't think it's proven."

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Weight Gain Predicts Heart Failure Hospitalization

Gains as low as two pounds significant warning sign for those with heart disease

Weight gains of as little as two pounds are associated with a greater risk of hospitalization in patients with heart failure, according to a study published online Sept. 10 in Circulation: Journal of the American Heart Association.

Sarwat I. Chaudhry, M.D., of Yale School of Medicine in New Haven, Conn., and colleagues conducted a study of 134 patients with heart failure and 134 control patients without heart failure who monitored their weight on a daily basis.

Approximately 30 days before hospitalization, heart failure patients began to gradually gain weight, and weight gain patterns between the two groups significantly diverged a week before hospitalization. Mean increases of two to five pounds, five to 10 pounds, and more than 10 pounds resulted in odds ratios for heart failure hospitalization of 2.34, 3.69 and 4.98, respectively.

Gains as small as just over two pounds predicted hospitalization. The fact that the gain begins well before hospitalization gives doctors and patients a window of opportunity to avoid hospitalization, according to Chaudhry.

"Heart failure is the most common reason for hospitalization among Americans, and more Medicare dollars are spent for heart failure than for any other diagnosis," Chaudhry said in a statement. "Our data suggest that a simple bathroom scale could empower patients in managing their own disease and alert their physicians to early signs of heart failure decompensation."

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Children's Blood Pressure on the Rise in United States

After decades of decline, obesity is pushing blood pressure back up again

The incidence of high blood pressure and pre-high blood pressure among U.S. children and adolescents is on the rise, which may result in an increased risk of early organ damage and cardiovascular disease, according to study findings published online Sept. 10 in Circulation: Journal of the American Heart Association.

Rebecca Din-Dzietham, M.D., Ph.D., of the Morehouse School of Medicine in Atlanta, and colleagues analyzed national data from 1963 to 2002 on 8- to 17-year-old children. They found that from 1963 to 1988 blood pressure rates trended downward, but then began to rise again through to 2002.

Between 1988 and 1999, there was a 2.3 percent increase in pre-high blood pressure and a 1 percent increase in high blood pressure. Obesity in general, and abdominal obesity in particular, partially explained the increase.

Ethnic and gender gaps also emerged. Rates of both high blood pressure and pre-high blood pressure were greater among males than females, and among non-Hispanic blacks and Mexican Americans compared with non-Hispanic whites.

"This is a major public health problem," said Din-Dzietham, in a statement. "Unless this upward trend in high blood pressure is reversed, we could be facing an explosion of new cardiovascular disease cases in young adults and adults."

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Adverse Drug Events Nearly Tripled Since 1998

Twenty percent of drugs account for 87 percent of adverse events in the United States

The number of adverse events reported to the U.S. Food and Drug Administration has nearly tripled since 1998, with 20 percent of drugs accounting for 87 percent of those events, researchers report in the Sept. 10 issue of the Archives of Internal Medicine.

Thomas J. Moore, from the Institute for Safe Medicine Practices in Huntingdon Valley, Penn., and colleagues analyzed adverse drug events and medication errors reported to the FDA through the Adverse Event Reporting System from 1998-2005.

The researchers found that the number of serious adverse events increased 2.6-fold and the number of fatal adverse drug events increased 2.7-fold. Drugs involved in safety withdrawals initially accounted for 26 percent of events but fell to less than 1 percent by 2005. The number of serious events from 13 new biotechnology products increased 15.8-fold.

"These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period," Moore and colleagues conclude. "The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs."

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BP, Cholesterol Big Players in Heart Disease in Overweight

About half of increased heart disease risk due to these two factors

Blood pressure and cholesterol levels account for about half the increased risk of coronary heart disease due to overweight, according to study findings published in the Sept. 10 issue of the Archives of Internal Medicine.

Rik P. Bogers, Ph.D., from the National Institute for Public Health and the Environment in Bilthoven, the Netherlands, and colleagues performed a meta-analysis of 21 prospective cohort studies involving 302,296 healthy individuals to examine the effect of moderate overweight (body mass index 25-29.9) and obesity (body mass index of 30 or greater) on the risk of coronary heart disease.

The researchers found there were 18,000 cases of coronary heart disease during the follow-up period. The adjusted relative risk of heart disease was 1.32 for moderately overweight individuals and 1.81 for obese individuals, which was reduced to 1.17 and 1.49, respectively, after further adjusting for blood pressure and cholesterol levels.

"Adverse effects of overweight on blood pressure and cholesterol levels could account for about 45 percent of the increased risk of coronary heart disease," the authors conclude. "Even for moderate overweight, there is a significant increased risk of coronary heart disease independent of these traditional risk factors, although confounding (e.g., by dietary factors) cannot be completely ruled out."

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Carvedilol Not Linked to Better Heart Outcomes in Youths

Study design, differences between causes in adult and youth heart failure could explain results

In what one editorialist called a disappointing finding, carvedilol does not offer significant improvement in clinical heart failure outcomes for children and adolescents with systolic heart failure, according to study findings published in the Sept. 12 issue of the Journal of the American Medical Association.

Robert E. Shaddy, M.D., of the University of Utah School of Medicine in Salt Lake City, and colleagues enrolled 161 subjects younger than 18 who had chronic heart failure due to systemic ventricular systolic dysfunction. For eight months, participants received conventional medications for heart failure, then low-dose or high-dose carvedilol, or a placebo.

When it came to how many patients worsened, improved or remained unchanged during the study, there was no difference between treatment groups. However, results suggested the drug's usefulness may vary depending on the patient's ventricular morphology; it showed benefit in patients with a systemic left ventricle, but not in those whose systemic ventricle wasn't a left ventricle.

"It is unclear why carvedilol would be beneficial in adults with heart failure but not in children and adolescents," write the authors, who point out that the results might have been influenced by several study parameters. "It is possible that the differences in the etiologies of heart failure in children and adolescents (dilated cardiomyopathy and congenital heart disease) compared with adults (primarily ischemic heart disease) could influence its efficacy."

Several of the study authors have financial ties to GlaxoSmithKline.

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Strategies Needed to Treat Comorbid Chronic Diseases

Understanding associated disease patterns key to improving health care management in elderly

Rather than treat a specific disease in older adults, clinicians may better improve overall health by identifying associated conditions and developing appropriate intervention strategies, according to a research letter published in the Sept. 12 issue of the Journal of the American Medical Association.

Carlos O. Weiss, M.D., of the Johns Hopkins University School of Medicine in Baltimore, and colleagues analyzed data from the National Health and Nutrition Examination Survey involving 4,349 patients aged 65 and older with any of five diseases linked to higher mortality rates -- arthritis, cerebrovascular accident, chronic lower respiratory tract disease, coronary heart disease and diabetes mellitus. They looked at the number of patients with a single disease and those with at least one other coincident disease and compared outcomes to pinpoint effective interventions.

The majority of patients with a chronic disease had at least one related condition. Among older women, 47.2 percent with arthritis, 17 percent with heart disease, 18.6 percent with respiratory disease, and 17.1 percent with diabetes had no associated conditions; rates were similar to those of older men.

"Single-disease clinical practice guidelines may not be relevant for large proportions of individuals with disease, particularly if the guidelines do not consider drug-drug and drug-disease interactions," the authors write. "Recognizing that some specific combinations of diseases are common may allow strategies targeted to a pattern."

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Glycemic Control Drugs Linked with Heart Failure in Diabetics

Researchers offer different take-home messages for pioglitazone, rosiglitazone

Two blood glucose-lowering thiazolidinediones -- pioglitazone (Actos) and rosiglitazone (Avandia) -- can increase heart failure risk in diabetes patients, but the net cardiovascular effect of pioglitazone may be favorable because it is linked to a lower risk of myocardial infarction and stroke, according to a pair of meta-analyses in the Sept. 12 issue of the Journal of the American Medical Association.

A. Michael Lincoff, M.D., of the Cleveland Clinic in Ohio, and colleagues compiled manufacturer-provided data from 19 trials with 16,390 subjects to measure a composite of all-cause death, of myocardial infarction, or stroke. Secondary outcomes included serious heart failure. The hazard ratio for the primary endpoint events in pioglitazone-treated subjects versus controls was 0.82. Serious heart failure was higher in treated subjects versus controls (hazard ratio 1.41), but this was not associated with increased mortality risk.

Sonal Singh, M.D., of Wake Forest University School of Medicine in Winston-Salem, N.C., and colleagues analyzed four long-term trials involving 14,291 subjects and found that rosiglitazone significantly increased the risk of myocardial infarction (relative risk 1.42) and heart failure (relative risk 2.09), though without a significant rise in cardiovascular mortality risk.

"Health plans and physicians should not wait for regulatory actions. They should avoid using rosiglitazone in patients with diabetes who are at risk of cardiovascular events, especially since safer treatment alternatives are available," Singh and colleagues write.

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B Vitamins Fail to Reduce Deaths in Kidney Patients

Folic acid also not helpful for those with end-stage renal disease

Among patients with chronic kidney disease and end-stage renal disease, treatment with folic acid and B vitamins did not reduce their mortality or lower their incidence of cardiovascular events, according to the results of a study published in the Sept. 12 issue of the Journal of the American Medical Association.

Rex L. Jamison, M.D., of the Veterans Affairs Palo Alto Health Care System in California, and colleagues analyzed data on 2,056 subjects with a mean age in the mid-60s who had advanced chronic kidney disease or end-stage renal disease. Participants received either a daily dose of 40 milligrams of folic acid, 100 mg of vitamin B6, and 2 mg of vitamin B12, or a placebo. The primary outcome was all-cause mortality, and the secondary measures included myocardial infarction, stroke and lower-extremity amputation.

The vitamin group's homocysteine levels dropped by nearly 26 percent after three months of treatment. However, the B vitamin treatment did not affect all-cause mortality or reduce the risk of any of the major vascular events utilized as secondary end points.

A meta-analysis may shed additional light on the usefulness of supplemental B vitamins on preventing vascular disease, states an accompanying editorial, which adds that the findings present "insufficient evidence to justify routine use of homocysteine-lowering vitamin supplements for the prevention of vascular events among individuals at high risk for vascular disease."

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Birth Control Pills Associated with Lower Cancer Risk

Study shows reduction in risk of 3 to 12 percent in women who have ever used oral contraceptive pills

Taking oral contraceptive pills may reduce the overall risk of developing certain types of cancer, according to the results of a study published online Sept. 11 in BMJ.

Philip C. Hannaford, M.D., of the University of Aberdeen in Scotland, and colleagues investigated the relationship between oral contraceptive use and the risk of cancer, analyzing data spanning 36 years from a British study that recruited over 46,000 women.

Women who had used oral contraceptives had a 3 to 12 percent reduction in the risk of developing any cancer compared to those who had never used oral contraceptives. However, women who had taken the pill for eight or more years had an increased risk of developing cancer, particularly cervical and central nervous system cancer, but a reduced risk of ovarian cancer.

"In this U.K. cohort, oral contraception was not associated with an overall increased risk of cancer; indeed, it may even produce a net public health gain. The balance of cancer risks and benefits, however, may vary internationally, depending on patterns of oral contraception usage and the incidence of different cancers," the authors conclude.

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Breastfeeding Does Not Reduce Allergy, Asthma Risk

Neither exclusive nor extended breast-feeding make a difference

Neither extended nor exclusive breast-feeding have an impact on the risk of allergy and asthma development in children, according to research published online Sept. 11 in BMJ.

Michael S. Kramer, M.D., of Montreal Children's Hospital in Quebec, Canada, and colleagues conducted a study of 17,046 mother-infant pairs from 31 Belarussian hospitals and clinics, of whom 13,889 were followed-up at 6.5 years. Half the pairs were in hospitals that provided breast-feeding support and promotion in line with the WHO/UNICEF baby friendly hospital initiative, while the other half were not.

By three months after birth, 43.3 percent of the women in the intervention group were exclusively breast-feeding, versus 6.4 percent in the control group. The women in the former group were also significantly more likely to be still breast-feeding at the 12-month mark.

However, skin prick tests for five inhalant antigens showed that the intervention group did not have reduced allergic reactions. "In fact, after exclusion of six sites (three experimental and three control) with suspiciously high rates of positive skin prick tests, risks were significantly increased in the experimental group for four of the five antigens," the authors write.

"These results do not support a protective effect of prolonged and exclusive breast-feeding on asthma or allergy," they conclude.

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Diesel Exhaust Has Ischemic and Thrombotic Effects

Study of male myocardial infarction survivors suggests pollution may contribute to adverse events

In men with stable heart disease, even limited exposure to diesel exhaust fosters myocardial ischemia and inhibits endogenous fibrinolytic capacity, according to a report in the Sept. 13 issue of the New England Journal of Medicine.

Nicholas L. Mills, M.D., of Edinburgh University in the United Kingdom, and colleagues randomly assigned 20 male myocardial infarction survivors to be exposed to either one hour of diluted diesel exhaust or filtered air during one hour of rest and moderate exercise.

Although heart rate increased in both groups during exercise and all subjects experienced exercise-induced ST-segment depression, the researchers found that the diesel-exhaust group had a greater increase in ischemic burden (-22 millivolt seconds versus -8 millivolt seconds). They also found that diesel exhaust prompted an acute release of endothelial tissue plasminogen activator.

"Environmental health policy interventions targeting reductions in urban air pollution should be considered in order to decrease the risk of adverse cardiovascular events," the authors conclude.

"Considering the unequivocal benefit of habitual exercise, including its established role in decreasing the risk that isolated episodes of exertion may trigger the onset of an acute cardiovascular event, the risk-benefit ratio may be optimized if people exercise away from traffic when possible," states the author of an accompanying editorial.

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Idraparinux Not Superior for Venous Thromboembolism

Studies conclude that net benefit of idraparinux is marginal compared to standard therapy

In patients with venous thromboembolism, initial and extended treatment with idraparinux yields only marginal benefits compared to standard treatment, according to two reports published in the Sept. 13 issue of the New England Journal of Medicine.

Harry R. Buller, M.D., of the Academic Medical Center in Amsterdam, the Netherlands, and colleagues randomly assigned 2,904 patients with deep vein thrombosis and 2,215 patients with pulmonary embolism to receive either subcutaneous idraparinux or heparin plus a vitamin K antagonist. At three and six months, the investigators found that both regimens were similarly effective in deep vein thromobosis, but that idraparinux was less effective in pulmonary embolism.

In a separate study, the same researchers randomly assigned 1,215 patients with venous thromboembolism who had completed six months of therapy with idraparinux or a vitamin K antagonist and needed extended anticoagulation to receive either six months of treatment with idraparinux or a placebo. They found that idraparinux helped prevent thromboembolism recurrence, but also increased the risk of major hemorrhage.

"We conclude that the net benefit of such treatment is marginal," the authors conclude.

The studies were supported by Sanofi-Aventis.

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Stem Cell Rescue Not Beneficial in AL Amyloidosis

Survival is lower with high-dose chemotherapy plus rescue than with standard chemotherapy

In patients with systemic immunoglobulin-light-chain amyloidosis, treatment with high-dose melphalan plus autologous stem cell rescue is not superior to treatment with standard chemotherapy, according to a report in the Sept. 13 issue of the New England Journal of Medicine.

Arnaud Jaccard, M.D., of the Centre Hospitalier Universitaire in Limoges, France, and colleagues randomly assigned 100 patients aged 18 to 70 to receive either high-dose intravenous melphalan followed by autologous hematopoietic stem cell rescue or standard-dose oral melphalan and high-dose dexamethasone. The patients were followed for a median of three years.

The investigators found that estimated median survival in the standard-dose oral melphalan and high-dose dexamethasone group was significantly higher than in the high-dose intravenous melphalan followed by autologous hematopoietic stem cell rescue group (56.9 months versus 22.2 months). They also found that there were no significant group differences in treatment response rates.

"A trial comparing the two treatments in a tertiary referral center, where the treatment-related mortality rate is likely to be lower, may have different results," the authors state.

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Prepared jointly by the editors of Medical Economics and HealthDay's Physicians' Briefing (www.physicianbriefing.com)