San Diego, CAAs more information on a recent Vytorin study is released, Merck has continued to tout the positive findings of that study. Vytorin side effects have been at the heart of Vytorin lawsuits, alleging patients were put at risk of health problems due to their use of the drug.
The study, known as IMPROVE-IT, involved more than 18,000 patients. According to Merck, who funded the study, patients on Vytorin did better than patients who took only a statin. Vytorin is a combination of a statin with a non-statin drug. Results of the study, which were shared at the 2015 American College of Cardiology Scientific Sessions, found patients had a six percent reduced risk of heart attack and stroke when taking Vytorin, compared to patients who took only a statin.
Despite those positive results, some critics say there is still cause for caution regarding Vytorin. They note that there was no difference between the control group and the treatment group when it came to overall deaths - including coronary or cardiovascular death. The reduction was in myocardial infarction, stroke and ischemic stroke. And a six percent reduction is a modest improvement, but not a huge one.
Furthermore, although the study followed participants for six years, it took a full nine years to complete the study. The journey to publishing the results reportedly involved repeated delays and changes to patient enrollment.
Results of the study were previously made public on November 17 at the American Heart Association Scientific Sessions. At that time, the study had reportedly not been subject to a peer review process. This means that people not involved in the study have not had the chance to analyze the study design or scrutinize the results. So while Merck says Vytorin has been vindicated with the IMPROVE-IT study, not everyone is convinced.
Meanwhile, previously published studies have returned conflicting results. One study was halted early while another found that although Vytorin did lower levels of LDL cholesterol, it did not slow the progression of atherosclerosis. Merck and Schering-Plough also came under attack for an 18-month delay in reporting the results of a trial that found Vytorin was not more effective than a different drug.
For some patients, the modestly decreased risk of heart attack or stroke might be enough to warrant use of the drugs. But others may want to wait for more studies to confirm the positive results that Merck touts.
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