Commentary by Danise Schiliro-Chuang MD, NYU Chief Resident
Let’s start on the theme of cardiovascular disease risk reduction, a topic making headlines this week. A September 28 New York Times article previews the release of new guidelines on perioperative care for patients undergoing noncardiac surgery. The guidelines, written by a panel of experts from the ACC and AHA, will recommend that patients undergo evaluation and treatment before noncardiac surgery only for active cardiac diseases such as severe angina, late-stage heart failure, significant arrhythmias and severe valvular disease. These new guidelines, the first published since 2002, also point to a lack of sufficiently large clinical trials that look at the safety and efficacy of starting and stopping drugs like aspirin, beta blockers and statins before surgery and urges researchers to conduct such studies. The new guidelines will appear in the October 23 issue of Circulation. Stay tuned…
A study released in the September 27th issue of NEJM looks at the effect of HDL cholesterol in patients with clinically significant CHD who were receiving statin therapy to reduce LDL levels. This post hoc multivariate analysis from a previous trial showed that HDL levels were a significant inverse predictor of subsequent major cardiovascular events and this effect remained significant in patients whose LDL level was less than 70mg/dl. While limitations of this study include a dissimilarity of other cardiovascular risk factors among patients separated into quintiles of HDL levels, the results should remind us to remain aware that low HDL levels may predict adverse cardiovascular events even in the setting of LDL targets being reached.
The September 18th issue of the Annals published a study that looks at the question of whether the triglyceride level is an independent risk factor for CHD. The authors measured triglyceride levels and performed cardiac stress tests 5 years apart on over 13,000 young Israeli male soldiers. Coronary angiography was performed if the stress test was abnormal. The study outcome was clinically significant CHD (>50% stenosis in at least 1 coronary artery) or fatal or nonfatal MI. After adjustment for known CHD risk factors and lifestyle, triglycerides and change in triglyceride levels strongly predicted incident CHD, and decreases in triglyceride levels were associated with adoption of a healthier lifestyle and lower CHD risk. While this study was observational, participants were healthy, and a low incidence rate of CHD was reported, evidence for the potential value of targeting triglyceride levels to reduce CHD risk in young men is provided.
Moving away from matters of the heart, on September 28, the Department of Health and Human Services released a report that may shed light on how federal regulation on clinical trials is conducted, or not conducted. The report highlights the significant understaffing of FDA inspectors that police the estimated 350,000 sites participating in human clinical trials. The report also points to a lack of follow-up on human trials sited by FDA inspectors as having serious flaws as well as a lack of systemic data collection. In the report, the inspector general, Daniel R. Levinson, recommended the agency create a registry of all continuing clinical trials. This recommendation was signed into law by President Bush on September 27.