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Apr 18, 2014

Researchers Abandon Trials of New Diabetes Drug

Clinical trials involving aleglitazar for patients with acute coronary syndrome are ended early due to safety concerns.

Studies involving a promising diabetes drug, aleglitazar, have been abandoned due to safety concerns, according to research presented at the American College of Cardiology’s 63rd Annual Scientific Session.

Decisions were based on the ALECARDIO trial, which involved 7,228 diabetic patients hospitalized for acute coronary syndrome. Acute coronary syndrome is a term used to describe any situation where the flow of blood to the heart is suddenly stopped, causing chest pain, cardiac arrest or heart attack. For patients hospitalized with acute coronary syndrome, restoring normal blood flow is top priority. But after addressing the medical emergency, it’s important that patients work with their doctors to reduce risk of a future heart event. Individuals with acute coronary syndrome have much higher risk for heart attack and diabetic patients are especially vulnerable to these complications.

Through the ALECARDIO trial, researchers hoped to find that the diabetes drug, aleglitazar, reduces risk of cardiac events in diabetic patients with acute coronary syndrome. Past studies suggest that this new drug helps diabetes patients manage their blood sugar and reduce cholesterol levels, which helps reduce cardiovascular risk. Unfortunately, the 2.5 year study ended early due to safety concerns. Not only did researchers find that patients taking aleglitazar had higher rates of bone fractures, heart failure and internal bleeding, the drug failed to reduce risk of cardiac events.

Initial results of the study were recently published in the Journal of the American Medical Association, but a complete analysis will now be conducted to better understand findings of the trial. In the meantime, all current trials involving aleglitazar have been abandoned, which may spell the end for this new class of diabetes drugs.

Questions for You to Consider

  • Why are some clinical trials ended early
  • In some cases, clinical trials may be terminated due to safety concerns, a lack of efficacy, or both. If a clinical trial is testing a new drug and the drug either increases risk of negative outcomes or doesn’t demonstrate the intended benefit, the study will be ended early.
  • What is acute coronary syndrome?
  • Acute coronary syndrome is an umbrella term used to describe situations where there is sudden, reduced blood flow to the heart. Acute coronary syndrome encompasses chest pain and heart attack, both of which can be serious and life-threatening.
  • How is acute coronary syndrome treated?

  • Acute coronary syndrome can be treated with a variety of medications and/or procedures, depending on how blocked the arteries are. Medications can include any combination of aspirin, thrombolytics, beta blockers, cholesterol-lowering drugs and ACE inhibitors, among others. Procedures can also help treat acute coronary syndrome, including angioplasty, stenting and coronary bypass surgery.

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