Template:WikiDoc News: Today in Medicine

January 6, 2008: Cytochrome P450 2C19 polymorphism linked to poor outcomes for young MI patients treated with clopidogrel

• Patients who had CYP2C19*2 genetic variant in the CYP2C19 gene and were treated with clopidogrel after a myocardial infarction (MI) demonstrated worse cardiovascular outcomes than patients with a normal copy of the cytochrome P450 2C19 encoding gene, according to a study published in the Lancet. The study population was composed of 259 patients, all under the age of 45, who received clopidogrel treatments for at least one month (median exposure time was 1.07 years (IQR 0.28-3.0)). Patients who were carriers of the CYP2C19*2 genetic variant had 15 primary endpoint events, which was a composite of death, MI, and urgent revascularisation during treatment with clopidogrel, while non-carriers had only 11 primary endpoint events (HR 3.69 (95% CI 1.69-8.05), p=0.0005). Further, the study demonstrated that the CYP2C19*2 genetic variant "was the only independent predictor of cardiovascular events (HR 4.04 (1.81-9.02), p=0.0006)." The investigators noted that additional genetic variants, such as CYP2C19*17, may play a role in the reduced responsiveness to clopidogrel and that it remains unclear if a higher maintenance dose could overcome this reduced clopidogrel responsiveness.(Lancet by Jean-Philippe Collet, et al.)

December 22, 2008: Tenecteplase did not improve outcomes compared to placebo during CPR for out-of-hospital cardiac arrest

• Thrombolysis with tenecteplase did not improve survival in patients receiving cardiopulmonary resuscitation (CPR) when compared to placebo, according to a study published in the New England Journal of Medicine. Between 2004 to early 2006, 1050 adults with a witnessed cardiac arrest outside of the hospital were prospectively randomized to either intravenous tenecteplase or placebo during the administration of CPR without the additional use of antiplatelets or antithrombins. The difference in rates of 30-day survival (14.7% tenecteplase vs. 17.0% placebo, p=0.36), 24 hour survival (30.6% vs. 33.3%, p=0.39), hospital admission (53.5% vs. 55.0%, p=0.67), or neurological outcome (p=0.69) was not statistically significant between the two groups. The inefficacy of the tenecteplase treatment lead to the trial's early termination. The authors suggest that their results may have differed from previous smaller studies because this trial did not use adjunctive heparin and aspirin and had a shorter collapse-to-drug administration time. Furthermore, CPR may not have provided enough sustained perfusion pressure to enable the tenecteplase to travel to clots in the coronaries. Noted limitations of the study include: an inability to determine the causes of underlying disease for all patients; the underlying variable nature of the prehospital setting; and differences in post-CPR care between the different European centers involved. (NEJM by Bernd W Bottiger et al.)

December 22, 2008: Diabetes Drugs to Face Tougher Risk Scrutiny

• The FDA recently announced that it is recommending drug companies conduct clinical trials to "demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies." To accomplish this task, the FDA recommends that clinical trials include more patients that are at high risk for cardiovascular events and follow these patients for up to two years. Additionally, the FDA suggests that cardiovascular events should be analyzed by an independent, blinded committee of cardiologists. The recommendation only applies to new treatments for Type 2 diabetes and will impact the ongoing approval process for saxagliptin (Bristol-Myers Squibb and AstraZeneca) and Byetta (Eli Lilly and Amylin Pharmaceuticals). (Wall Street Journal by Jennifer Corbett Dooren)

December 12, 2008: Arthritis Patients Remain at 50% Higher Risk of Cardiovascular Disease Death

• Rheumatoid arthritis patients face a 50% greater risk of cardiovascular death when compared to the general population, according to a meta-analysis published by a Canadian research team in the most recent issue of Arthritis Care & Research. The meta-analysis pooled 111,758 patients, who experienced 22,927 cardiovascular events, from 24 observational studies. In addition to the overall increased risk of cardiovascular mortality, patients with rheumatoid arthritis displayed both a 59% increased risk of death due to myocardial infarction and a 52% increased risk of death due to stroke. These findings highlight that although the rate of cardiovascular mortality has been decreasing among the general population in recent years, rheumatoid arthritis patients do not appear to be experiencing the full benefit. A noted limitation of the meta-analysis was that the majority of studies did not include the prevalent usage of biologic therapies, which may reduce the risk of cardiac death for patients with rheumatoid arthritis when compared to other therapies. (Medscape by Lisa Nainggollan and Charles Vega)

December 11, 2008: Backward health-care reform

• Peter J. Pitts, a former assocciate commisioner of the FDA and current president of the Center for Medicine in the Public Interest, warns that the recently proposed national comparitive effectiveness center would limit the ability of physicians to effectively treat patients and reduce the quality of healthcare in the United States. The proposed center would fund comparative effectiveness trials, in which new drugs and medical treatments are measured against older therapies. Pitts maintains that a comparative effectiveness center would be concerned primarily with the price of treatments and, as such, would "restrict patient access to cutting-edge pharmaceuticals, hamstring physicians practices, and profoundly compromise the well-being of countless sick Americans" by restricting access to newer, and more expensive, drugs. Pitts concludes that a comparative effectiveness center would "solve a problem that's not a problem" because "drug prices aren't straining the country's health-care system." (Washington Times by Peter Pitts)

December 10, 2008: Sex Differences in Medical Care and Early Death After Acute Myocardial Infarction

• In an analysis of data from the Get With the Guidelines - Coronary Artery Disease (GWTG- CAD) registry, researchers investigated gender differences in methods of care and in-hospital deaths based on 78,425 acute myocardial infarction (AMI) patients in 420 US hospitals between 2001 to 2006. After multivariable adjustment, there were no significant differences found for in-hospital mortality between men and women overall; however, in an analysis of the STEMI subpopulation, researchers reported that women had a 12% greater risk of in-hospital mortality (p=0.015). Additional differences were found in issues of medical care. Females were less likely to be treated within 24 hours with aspirin (adjusted odds ratio: 0.86, p <0.0001) or beta-blockers (adjusted odds ratio: 0.90, p <0.0001), were less likely to receive reperfusion therapy within 30 minutes of arriving at the hospital (adjusted odds ratio: 0.78, p=0.004) and were less likely to undergo catheterization after their MI (adjusted odds ratio: 0.91, p<0.0001). These differences in guidelines-based treatment and outcomes reveal "the existing opportunities to improve the provision of healthcare among women hospitalized with AMI." (Circulation by Hani Jneid et al.)

December 10, 2008: Drugmakers Tap the Brakes on Ad Spending

• Pharmaceutical companies are decreasing the amount they spend on drug advertisements, according to a recent report by TNS Media Intelligence. Between January and August 2008, drug companies spent $3.2 billion on advertising, a decrease of 6% when compared to the same time period in 2007. In addition, spending fell 3% in 2007. Reasons for this decrease in advertising include: the small number of drugs gaining FDA approval, the introduction of more niche drugs that target small patient populations, greater congressional vigilance, and growing concerns among drug company executives that consumer directed promotion is destroying the credibility of the pharmaceutical industry. (WSJ Health Blog by Sarah Rubenstein)

December 9, 2008: Irbesartan does not benefit heart failure patients with preserved LVEF: Results of I-PRESERVE

• For heart failure patients with preserved left ventricular ejection fraction (LVEF), irbesartan therapy did not improve clinical outcomes, according to results published in the New England Journal of Medicine. The Irbesartan in Heart Failure with Preserved Ejection Fraction Study (I-PRESERVE) enrolled 4128 patients in 25 countries. Heart failure patients with LVEF >= 45% were randomized to either 75mg irbesartan or placebo daily, with the dosage doubling every 1-2 weeks. Irbesartan, an angiotensin II receptor antagonist, is used as a treatment for hypertension. Researchers hypothesized that because the renin-angiotensin-aldosterone system plays a role in heart failure, irbesartan therapy might provide a benefit to the 50% of heart failure patients with a preserved LVEF. At a mean follow-up of 49.5 months, however, there was no significant difference in rates of all-cause death or cardiovascular-related hospitalization between drug and placebo groups (100.4/1000 patient-years vs 105.4/1000 patient-years, p=0.35). Researchers suggested that the negative results may have been due to a suboptimal drug dosage, a high rate of drug discontinuation (34%), as well as high rates of patients taking other renin-angiotensin-aldosterone system inhibitors. (NEJM by Barrie Massie et al.)

December 9, 2008: Sex Differences in Morphology and Outcomes of Mitral Valve Prolapse

• In a retrospective cohort study at the Mayo Clinic, researchers found that mitral valve prolapse (MVP) occurs more frequently in females but that surgery for severe mitral valve regurgitation occurs more frequently in men. In an examination of echocardiograms from 1989 through 1998, 4461 women and 3768 men were diagnosed with MVP. 52% of females and 60% of males with severe regurgitation underwent surgery (adjusted risk ratio: 0.79) and women in this category of severe regurgitation had a lower survival rate compared to men (60% vs 68% respectively, adjusted risk ratio: 1.13). Women also had lower posterior leaflet prolapsed (22% vs 31%, p<0.001), greater thickening (32% vs 28%, p<0.001), and less flail (2% vs 8%, p<0.001). Importantly, the difference in survival at 10 years was not statistically significant between women and men who underwent mitral valve surgery (77% vs 79%, p=0.14). These results suggest that the benefits in outcome arising from surgery occur for both genders. Future studies of MVP and severe mitral regurgitation should further elucdiate the gender-specific differences (Annals of Internal Medicine by Jean-Francois Avierinos et al.)

December 2, 2008: Arrogant, Abusive and Disruptive -- and a Doctor

• Disruptive behavior, such as verbal abuse and intimidation, has been anecdotally correlated to medical mistakes, and physicians appear to be the most frequent offenders. 40 percent of healthcare workers indicated in a recent survey by the Institute for Safe Medication Practices that they failed to voice their concerns over a medication because they were too intimidated by a doctor. Disruptive behavior is generally attributable to a small minority of physicians, especially those in high-stress specialties, and efforts are being made to curtail such behavior. Medical schools and residency programs are emphasizing leadership and good communication as essential tools for physicians in training. Additionally, hospitals are adopting stricter behavior codes and putting measures into place to help enforce them. (New York Times by Lauri Tarkan)

December 1, 2008: Scrutiny Grows of Drug Trials Abroad

• Drug companies are being placed under the microscope by regulatory agencies and consumer watchdog groups to ensure that clinical trials in developing countries are being conducted in accordance with currently accepted medical and ethical practices. Pharmaceutical companies are increasingly carrying out clinical trials in low-income countries because of benefits, such as lower cost, faster enrollment, and greater patient willingness to participate, offered within these nations. Along with these benefits, though, there are a number of concerns. Within the past year, patient deaths in clinical trials testing new vaccines by Wyeth and Novartis have raised questions about the recruitment and screening of patients. Many regulators and watchdog groups are concerned that investigators in developing countries may improperly recruit patients to boost enrollment or produce questionable data in order to gain the favor of large drug manufacturers. Additionally, critics of this practice are concerned that patients in low-income countries will be unable to afford the study drugs when they become available on the open market. (Wall Street Journal by Shirley S. Wang, Geeta Anand, and Jeanne Whalen))

December 1, 2008: Heart disease 'reversed in mice'

• Researchers found that a drug that blocks microRNA-21 improved heart function in mice, as reported in Nature. MicroRNAs regulate gene expression; microRNA-21 has previously been shown to play a part in fibroblast scarring and high levels have been found in patients with failing hearts. The potential use of anti-micorRNA-21 therapy is exciting, but future studies are being conducted in other animal models before human testing will begin. Professor Eric Olsen from UT Southwestern Medical Center, however, predicts human trials are really only a few years away. (BBC News)

November 25, 2008: New Arena for Testing of Drugs: Real World

• Support is growing for a new type of medical research, dubbed "pragmatic" clinical research. These studies investigate the safety and efficacy of new drugs or devices among "typical patients" (those who receive several medications for multiple chronic conditions) rather than in the carefully selected patient populations studied in most clinical trials. Pragmatic trials provide broader insight into the applicability of a treatment or therapy for a greater range of patients. Some experts do warn, though, that these trials are limited in their applicability. While they answer questions such as whether or not a treatment improves outcomes, the trials often fail to provide insight into why the treatment improves outcomes. (New York Times by Gina Kolata)

November 25, 2008: Subtle Science: Heading Off Heart Attacks in Women

• A report from the Agency for Healthcare Research and Quality (AHRC) found that more women are hospitalized for idiopathic chest pain than men. The AHRC also found that women were almost two times less likely to be sent to the catheterization lab and two times less likely to be diagnosed with coronary artery disease (CAD) as compared with men. These results suggest that chest pain in women, although non-specific and not necessarily attributable to CAD, is nonetheless deemed admission-worthy by American doctors. Differences in cardiovascular health between the genders has been acutely studied; one noted hypothesis suggests that women's chest pain may be due to microvasculature dysfunction rather than CAD. The physicians referenced in the article all agree, however, that if patients of any gender have symptoms of a heart attack that persist, they should immediately go to the hospital. (Wall Street Journal by Melinda Beck)

November 24, 2008: Studies Say Private Medicare Plans Have Added Costs, for Little Gain

• A study published in Health Affairs and a recent article by two Medicare Payment Advisory Commision analysts both conclude that private health insurance plans for Medicare patients are doing little to keep healthcare costs down. In fact, in some cases these plans are more expensive than providing patients with traditional Medicare health plans from the US government. The article by analysts Carlos Zarabozo and Scott Harrision demonstrates that the government pays on average 13% more to provide patients with private Medicare Advantage plans. Supporters of Medicare Advantage plans point out that the plans offered through health management organizations (HMO) and preferred provider organizations (PPO) result in better coordination of patient care, although the majority of growth in Medicare Advantage plans has been for fee-for-service insurance offerings rather than those offered through HMOs and PPOs. President elect Barack Obama and his secretary of health and human services, Senator Tom Daschle, have both singled out Medicare Advantage plans as targets for the reduction of healthcare spending. (New York Times by Robert Pear)

November 11, 2008: A Call for Caution in the Rush to Statins

• New York Times health writer Tara Parker-Pope warns that the recent media hype surrounding the results of the JUPITER Trial may lead to excessive use of statins. The article notes that although a 50% reduction in the relative risk of serious cardiovascular events was observed in the rosuvastatin patient population, the absolute reduction in events was only 0.9%. Additionally, Ms. Parker-Pope points out that the patient population studied in JUPITER may not be as broadly representative of the general population as some headlines and media reports may have led consumers to believe, due to the fact that the JUPITER Trial excluded around 80% of the 90,000 patients screened for the study. The article acknowledges that the trial represents a breakthrough in the efficacy of statins for a previously unstudied group of patients (those with normal LDL counts and elevated hsCRP levels), but cautions consumers that statins should not be viewed as "magic pills" for the prevention of cardiovascular disease. (New York Times by Tara Parker-Pope)

November 10, 2008: Adjusting Clopidogrel loading dose according to platelet reactivity monitoring is associated with a decreased rate of stent thrombosis and no increase in bleeding

• Investigators from France report today that adjusting the loading dose (LD) of Clopidogrel according to platelet reactivity monitoring decreases the rate of stent thrombosis at 30 days without any increase in bleeding in patients with Clopidogrel low-response

November 10, 2008: JUPITER Trial Demonstrates Effectiveness of Statin Therapy in Reducing Cardiovascular Events among Healthy Patients

• The results of the JUPITER trial suggest that rosuvastatin effectively reduces the occurrence of myocardial infarction (MI), stroke, and cardiovascular death among patients who have low LDL levels but elevated high sensitivity C-reactive protein (hsCRP) levels

November 10, 2008: GWAS results about susceptibility loci for intracranial aneurysm in European and Japanese populations are released

• The multistage GWAS (Genome-Wide Association Study) investigators reported that, the loci on 2q, 8q (new) and the 9p locus (previously reported) found to be associated with arterial diseases, including intracranial aneurysm

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