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Saxagliptin fails to reduce cardiovascular events

The New England Journal of Medicine has published the results of a study that aimed to assess the cardiovascular safety and efficacy of saxagliptin (Onglyza®).

The study recruited 16,492 patients with type 2 diabetes who had a history of or were at risk of cardiovascular event. The participants were randomly assigned saxagliptin or placebo and followed them for a median of 2.1 years. All other therapies for the management of the patient could be adjusted at the discretion of the physicians managing the patient; this included drugs for the treatment of diabetes. The primary outcome of the study was a composite cardiovascular outcome consisting of cardiovascular death, myocardial infarction or stroke.

7.3% (613/8280) of the patients who received saxagliptin experienced the primary outcome compared to 7.2% (609/8212) in those who received placebo. There was a statistically significant increase in the rate of hospital admission for heart failure in the saxagliptin group with a hazard ratio 1.27 (95% CI 1.07–1.51, p=0.007).

The authors propose several explanations for the apparent lack of benefit in terms of cardiovascular outcomes including a relatively short period of follow up (2 years), small differences in the levels of glycated haemoglobin in the treatment and placebo arms of the study (7.5% versus 7.8% at the end of the study), and large proportions of patient in the trial received statins, antiplatelet therapy and blood-pressure–lowering agents which may have mitigated any cardiovascular benefit.

The authors conclude that, "saxagliptin did not increase or decrease the rate of ischemic events" and they recommend that "other approaches are necessary to reduce cardiovascular risk in patients with diabetes".

Action: The absence of a cardiovascular benefit leaves no compelling reason to use saxagliptin ahead of other second line oral hypoglycaemic agents. Clinicians should continue to follow the existing NICE guideline for Type 2 Diabetes.

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2 Comments to “Saxagliptin fails to reduce cardiovascular events”

  1. The paper's conclusion states ''Although saxagliptin improves glycemic control, other approaches are necessary to reduce cardiovascular risk in patients with diabetes" which is not the same as the conclusion given above. Following what many people consider to be NICE guidance (metformin then SU) may be inadvisable in view of the Phung 2013 systematic review and meta-analysis which suggested an increased risk of CVE with SU. https://www.ncbi.nlm.nih.gov/m/pubmed/23663156/?i=4&from=phung%20oj%202013

    Comment by Beverley Bostock — October 8, 2013 #

    1. @Beverley,

      Thanks for highlighting that meta-analysis. I guess it's all down to how you read the NICE Guideline. To me it says metformin is first-line and all of the other oral agents are second-line with individual reasons to use and not use. This new data for Saxagliptin (and the data for SUs for that matter) doesn't really change anything, it just needs to be considered when a choice of second-line treatment is made.

      Comment by Matthew Robinson — October 8, 2013 #

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