Sustained-release carvedilol approved for multiple indications
October 27, 2006 | Steve Stiles

Philadelphia, PA - The US Food and Drug Administration has approved a once-daily form of the beta blocker carvedilol (Coreg CR) for the treatment of patients with hypertension, postinfarction LV dysfunction, or mild to severe heart failure, manufacturer GlaxoSmithKline (GSK) has announced [1]. The drug had previously been available only in a form that required twice-daily dosing.

GSK plans to begin shipping Coreg CR, which will be available in dosage strengths of 10 mg, 20 mg, 40 mg, and 80 mg, "in the first quarter of 2007," according to the company's press release.

The post-MI indication, according to the FDA's approval letter to the company, is for reducing mortality in clinically stable patients with an LVEF <40% [2].

"Once-a-day Coreg CR will simplify the treatment regimen and offer the potential for improved compliance for patients with heart disease," observes Dr Michael A Weber (State University of New York Downstate Medical College of Medicine, Brooklyn) in the GSK statement. "The combination of this benefit with the proven effectiveness of Coreg offers a treatment advantage for the growing number of heart patients who take multiple medications every day," he is quoted as saying.

Weber was a lead investigator for clinical trials on the efficacy of sustained-release carvedilol in hypertension and, according to the GSK website, is an advisor to the Grants Awards Committee of the GSK Research and Education Foundation.

Sources
  1. FDA approves new, once-a-day COREG CR for the treatment of three key cardiovascular conditions. October 20, 2006. Available at: http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=918.
  2. FDA's approval letter. October 20, 2006. Available at: http://www.fda.gov/cder/foi/appletter/2006/022012s000ltr.pdf





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