Heart Beat: September 2014
GENERIC BETA BLOCKERs RECALLED AMID EFFECTIVENESS CONCERNS
If you used a generic version of AstraZeneca’s Toprol XL in recent years and you found the medications didn’t treat your symptoms as effectively as the name brand, you’re not alone. Two large Indian manufacturers of generic versions of Toprol recalled more than 100,000 bottles of the beta blockers earlier this year. The drugs failed dissolution tests, which measure how quickly a medication dissolves in the body and starts working. The drugs were also the subjects of many complaints by physicians, including Cleveland Clinic cardiologist Harry Lever, MD. Dr. Lever appealed to the U.S. Food and Drug Administration (FDA) in 2012 and earlier this year traveled to Washington, D.C., asking Congress to intervene. Like many cardiologists, Dr. Lever found that when many of his patients switched backed to Toprol from the generic drugs, their symptoms diminished. The manufacturers in question are Wockhardt and Dr. Reddy’s Laboratories. The recalls are considered Class II, which means they may cause temporary health problems, but aren’t likely to pose immediate or significant health threats. In an interview with the New York Times, Dr. Lever said he wants the FDA to be more transparent and forthright about possible problems with generic drugs. “The doctors in this country need to know what’s going on, because we’re ultimately writing the prescriptions and we’re responsible,” he said. “There’s been this assumption that one generic is the same as another. Not in this case.”
NEWER STENTS MAY BE AS SAFE, EFFECTIVE AS CABG FOR DIABETES PATIENTS
Individuals who have diabetes and blocked coronary arteries face elevated risks for heart attack and death. But new research suggests that receiving a second-generation drug-eluting stent may be just as safe as undergoing coronary artery bypass grafting (CABG). Earlier studies had shown that patients with diabetes and blocked coronary arteries did worse with first-generation stents than with CABG. But these newer stents, especially a cobalt-chromium everolimus-eluting stent, appear just as safe and effective as CABG, an open-heart operation commonly referred to as open-heart surgery or bypass surgery. The results, which were published in the journal Circulation, are especially important to people with diabetes. Patients with diabetes are more likely to experience the rapid progression of heart disease than individuals who have atherosclerosis but not diabetes. This research, which included the analysis of 68 trials involving more than 24,000 patients, only indirectly compared the results of patients given the newer stents to those of patients who underwent surgery. Researchers say further studies are needed to show that the newer stents are not inferior to CABG for death or heart attack. Advances in stent technology and the drugs used to coat the stents are already resulting in fewer revascularization procedures. One of the concerns with treating blocked arteries with stents is the likelihood of more stents being needed because blockages return to those arteries.
STUDY SHOWS LIFE-SAVING BENEFITS OF “CLOT-BUSTING” DRUGS
Adding clot-busting medications known as thrombolytics to conventional approaches when treating sudden-onset pulmonary embolism is associated with 47 percent fewer deaths than using standard intravenous anticoagulant medications alone. That’s according to research published in the Journal of the American Medical Association. A sudden-onset pulmonary embolism refers to sudden blockage in one of the pulmonary arteries (the vessels that deliver blood from the heart to the lungs), usually caused by a blood clot that has traveled from the legs. An estimated 300,000 to 600,000 people in the U.S. are affected by the condition annually, and about 100,000 people die from a pulmonary embolism. Researchers analyzed 16 published trials, involving more than 2,000 patients from the past 40 years. The effectiveness of adding thrombolytics was significant. Thrombolysis is a treatment that includes the injection of a clot-busting drug such as alteplase and tenecteplase. These medications do carry a higher risk of bleeding, however, and can only be administered under certain circumstances. Researchers say they hope that further research will better identify the types of patients who are most likely to benefit from thrombolysis, and those who should not be treated with these powerful medications.