More Evidence That Saxagliptin Does Not Increase Risk for AMI in Diabetes

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Investigators noted a major strength of this study was the ability to analyze real-word data prospectively.
Investigators noted a major strength of this study was the ability to analyze real-word data prospectively.

Individuals with diabetes taking saxagliptin do not have a higher risk for acute myocardial infarction (AMI) than individuals taking pioglitazone, second-generation sulfonylureas, sitagliptin, or long-acting insulin, according to a prospective study published in Diabetes Care.

The study included adults with diabetes who took saxagliptin during a 5-year postmarket-approval period (n=82,264) and comparator groups taking pioglitazone (n=146,045), second-generation sulfonylureas (n=452,969), sitagliptin (n=220,912), or long-acting insulin (n=262,117). The investigators compared incidence of AMI in the saxagliptin group with AMI incidence in the comparator groups.

The follow-up duration for saxagliptin was approximately 8 months, compared with 7 to 8 months for pioglitazone, second-generation sulfonylureas, and sitagliptin, and 4 months for long-acting insulin.

At the end of the 5-year period, the hazard ratio for AMI among patients taking sitagliptin vs the other medications was 1.08 (95% CI, 0.90-1.28). Additionally, hazard ratios for AMI were 1.11 (95% CI, 0.87-1.42) for pioglitazone, 0.79 (95% CI, 0.64-0.98) for sulfonylureas, and 0.57 (95% CI, 0.46-0.70) for long-acting insulin.

The investigators of this study note that they may not have adjusted for confounding based on diabetes severity or duration, which presents a potential limitation of the findings. Additionally, the investigators did not adjust for prior diabetes medications, and the short follow-up period of up to 8 months across the treatment arms may not have been sufficient to judge risk for AMI accurately.

Overall, the findings of this study, “provide additional reassurance about the safety of saxagliptin with respect to AMI” among people with diabetes who are prescribed this medication.

Reference

Toh S, Reichman ME, Graham DJ, et al; Mini-Sentinel Saxagliptin-AMI Surveillance Writing Group. Prospective postmarketing surveillance of acute myocardial infarction in new users of saxagliptin: a population-based study [published online November 9, 2017]. Diabetes Care. doi:10.2337/dc17-0476

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