Tuesday, June 18, 2013

SAVOR-TIMI-53 - CV Outcome study on Onglyza fails to Impress - All eyes now on TECOS

AstraZeneca and Bristol-Myers Squibb announced today top-line results of the Phase IV SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza (saxagliptin). In this study of adult patients with type 2 diabetes with either a history of established cardiovascular disease or multiple risk factors, Onglyza met the primary safety objective of non inferiority, but did not meet the primary efficacy objective of superiority, for a composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke, when added to a patient's current standard of care (with or without other anti-diabetic therapies), as compared to placebo.

Implications of SAVOR-TIMI-53

Onglyza is a DPP-IV inhibitor and apart from Onglyza there are  four other DPP-IV's on the market which includes - Januvia, Nesina, Tradjenta, Galvus currently on the market.  Currently the DPP-IV take about 12 percent share in the the oral diabetes market.  Had Onglyza been able to demonstrate a statistically significant reduction in CV outcome, this would have not only helped Onglyza enhance its market share within the DPP-IV space, but also help the DPP-IV class in further increasing its dominance in the overall oral anti-diabetes market.

These are preliminary data, a detailed analysis which will be potentially presented at ESC, would also be important as it would also provide signals on the other long term safety of the DPP-IV class, especially with regard to the pancreatitis.

Other Ongoing CV outcome  studies on DPP-IV inhibitors

  1. CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes 
  2. Sitagliptin Cardiovascular Outcome Study (0431-082 AM1)
  3. Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE


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