US FDA to review heart failure risks for saxagliptin

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Reactions 1490, p3 - 1 Mar 2014 US FDA to review heart failure risks for saxagliptin A safety review of saxagliptin [Onglyza and Kombiglyze XR] has been commenced by the US FDA following results from the SAVOR-TIMI 53 * trial investigating the drug’s association with cardiovascular outcomes. Data from the randomized, placebo-controlled trial, supported by AstraZeneca and Bristol-Myers Squibb showed no overall risk in the primary composite end point of cardiovascular death, myocardial infarction or ischemic stroke in saxagliptin recipients compared with placebo. However, the risk of hospitalisation for heart failure was significantly greater in the saxagliptin treatment group. The FDA states that, at this time the data is considered preliminary, and it has not concluded that saxagliptin raises the risk of heart failure. The agency advises patients to contact their healthcare professional if they have concerns about saxagliptin, and to not stop taking the drug unless instructed to by such a professional. * The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)–Thrombolysis in Myocardial Infarction (TIMI) 53 trial FDA. FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR). Internet Document : [2 pages], 11 Feb 2014. Available from: URL: http://www.fda.gov/ downloads/Drugs/DrugSafety/UCM385315.pdf 803099766 1 Reactions 1 Mar 2014 No. 1490 0114-9954/14/1490-0001/$14.95 Adis © 2014 Springer International Publishing AG. All rights reserved

Transcript of US FDA to review heart failure risks for saxagliptin

Page 1: US FDA to review heart failure risks for saxagliptin

Reactions 1490, p3 - 1 Mar 2014

US FDA to review heart failurerisks for saxagliptin

A safety review of saxagliptin [Onglyza andKombiglyze XR] has been commenced by the US FDAfollowing results from the SAVOR-TIMI 53* trialinvestigating the drug’s association with cardiovascularoutcomes.

Data from the randomized, placebo-controlled trial,supported by AstraZeneca and Bristol-Myers Squibbshowed no overall risk in the primary composite endpoint of cardiovascular death, myocardial infarction orischemic stroke in saxagliptin recipients compared withplacebo. However, the risk of hospitalisation for heartfailure was significantly greater in the saxagliptintreatment group. The FDA states that, at this time thedata is considered preliminary, and it has not concludedthat saxagliptin raises the risk of heart failure.

The agency advises patients to contact theirhealthcare professional if they have concerns aboutsaxagliptin, and to not stop taking the drug unlessinstructed to by such a professional.* The Saxagliptin Assessment of Vascular Outcomes Recorded inPatients with Diabetes Mellitus (SAVOR)–Thrombolysis in MyocardialInfarction (TIMI) 53 trial

FDA. FDA Drug Safety Communication: FDA to review heart failure risk withdiabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR). InternetDocument : [2 pages], 11 Feb 2014. Available from: URL: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM385315.pdf 803099766

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Reactions 1 Mar 2014 No. 14900114-9954/14/1490-0001/$14.95 Adis © 2014 Springer International Publishing AG. All rights reserved

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