Type 2 diabetes increased risk for sudden cardiac death in patients after MI
Junttila M. Heart Rhythm. 2010;7:1396 -1403.
Patients with type 2 diabetes may be at a higher risk for sudden cardiac death after MI than nondiabetic patients, new data from Hearth Rhythm suggests.
“Type 2 diabetes mellitus is a well-established risk factor for atherosclerosis, but its contribution to sudden cardiac death risk after MI is not well defined,” the researchers wrote. “Sudden cardiac death in the post-MI patient is of special interest because of the magnitude of risk, the challenge of individual risk profiling and the potential for prevention in high-risk individuals.”
The study included 3,276 patients (mean age, 60 ± 11 years) who were enrolled at the time of acute MI between 1996 and 2005, and they were followed until 2009. At baseline, 629 patients (19.2%) had type 2 diabetes based upon WHO criteria. Patients with type 1 diabetes and patients with cardiac arrest during or before MI were excluded from the study.
Among patients with type 2 diabetes, rate of sudden cardiac death was notably higher than for nondiabetic patients (5.9% vs. 1.7%; adjusted HR=2.3; 95% CI, 1.4-3.8). The incidence of sudden cardiac death in diabetic patients with left ventricular ejection fraction of more than 35% was nearly identical to nondiabetic patients with LVEF of 35% or less (4.1% vs. 4.9%; P=.48).
Researchers also noted that an excess in the incidence of non-sudden cardiac death among diabetic patients started to appear within the first 6 months of follow-up (P<.001). This was not the case for both the incidence and excess of sudden cardiac death for diabetic patients, which did not begin to appear until more than 6 months after the index event.
“Patients with type 2 diabetes are at higher risk for sudden cardiac death after MI than are nondiabetic patients. The incidence of sudden cardiac death in post-MI type 2 diabetic patients with LVEF >35% is equal to that of nondiabetic patients with LVEF <35%,” the researchers concluded. “Further prospective information on post-MI diabetic patients is needed to evaluate indications for, and efficacy of, implantable cardioverter defibrillators and other therapies for this higher-risk subgroup.”
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FDA requests withdraw of sibutramine from U.S. market
The FDA has issued a recommendation against the continued prescription and use of sibutramine due to elevated CV risks to certain patients taking the drug, according to a press release.
The agency determined that the CV risks outweighed the marginal benefits associated with the drugs and requested that the manufacturer of sibutramine (Meridia, Abbott Laboratories) voluntarily withdraw the product from the market in the U.S. Abbott Laboratories agreed to the request.
The withdraw came after new data from the approximately 10,000-patient Sibutramine Cardiovascular Outcomes (SCOUT) trial indicated a 16% increased risk for major adverse CV events (a composite of nonfatal MI, nonfatal stroke, resuscitation after MI and CV death) in patients taking sibutramine vs. placebo (HR=1.16; 95% CI, 1.03-1.31). The primary endpoint of the trial was driven, according to data cited in an FDA press release, by nonfatal MI (HR=1.28; 95% CI, 1.04-1.57) and nonfatal stroke (HR=1.36; 95% CI, 1.04-1.77).
The agency recommended in a press release that patients currently taking sibutramine cease taking the medication and consult their physicians about alternative weight loss management strategies and programs.
Sibutramine was approved by the FDA in 1997 for weight loss and maintenance of weight loss in patients with a BMI ≥30 kg/m2 or for patients with a BMI ≥27 kg/m2 with other CV risk factors. The FDA announced the continued review of clinical trial data regarding sibutramine in November 2009 and January 2010 due to reports of adverse effects on the heart following use of the drug.
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