Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study
Autor: | Sengwee, Toh, Marsha E, Reichman, David J, Graham, Christian, Hampp, Rongmei, Zhang, Melissa G, Butler, Aarthi, Iyer, Malcolm, Rucker, Madelyn, Pimentel, Jack, Hamilton, Samuel, Lendle, Bruce H, Fireman, Connie Mah, Trinacty |
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Rok vydání: | 2017 |
Předmět: |
Male
medicine.medical_specialty Endocrinology Diabetes and Metabolism Myocardial Infarction Postmarketing surveillance Adamantane 030204 cardiovascular system & hematology Saxagliptin 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine Internal Medicine medicine Product Surveillance Postmarketing Humans Hypoglycemic Agents 030212 general & internal medicine Prospective Studies Propensity Score Proportional Hazards Models Advanced and Specialized Nursing Dipeptidyl-Peptidase IV Inhibitors Pioglitazone Proportional hazards model business.industry Incidence Hazard ratio Sitagliptin Phosphate Dipeptides Middle Aged Interim analysis United States Insulin Long-Acting Sulfonylurea Compounds chemistry Sitagliptin Propensity score matching Acute Disease Cardiology Female Thiazolidinediones business medicine.drug Follow-Up Studies |
Zdroj: | Diabetes care. 41(1) |
ISSN: | 1935-5548 |
Popis: | OBJECTIVE The cardiovascular safety of saxagliptin, a dipeptidyl-peptidase 4 inhibitor, compared with other antihyperglycemic treatments is not well understood. We prospectively examined the association between saxagliptin use and acute myocardial infarction (AMI). RESEARCH DESIGN AND METHODS We identified patients aged ≥18 years, starting from the approval date of saxagliptin in 2009 and continuing through August 2014, using data from 18 Mini-Sentinel data partners. We conducted seven sequential assessments comparing saxagliptin separately with sitagliptin, pioglitazone, second-generation sulfonylureas, and long-acting insulin, using disease risk score (DRS) stratification and propensity score (PS) matching to adjust for potential confounders. Sequential testing kept the overall chance of a false-positive signal below 0.05 (one-sided) for each pairwise comparison. RESULTS We identified 82,264 saxagliptin users and more than 1.5 times as many users of each comparator. At the end of surveillance, the DRS-stratified hazard ratios (HRs) (95% CI) were 1.08 (0.90–1.28) in the comparison with sitagliptin, 1.11 (0.87–1.42) with pioglitazone, 0.79 (0.64–0.98) with sulfonylureas, and 0.57 (0.46–0.70) with long-acting insulin. The corresponding PS-matched HRs were similar. Only one interim analysis of 168 analyses met criteria for a safety signal: the PS-matched saxagliptin-pioglitazone comparison from the fifth sequential analysis, which yielded an HR of 1.63 (1.12–2.37). This association diminished in subsequent analyses. CONCLUSIONS We did not find a higher AMI risk in saxagliptin users compared with users of other selected antihyperglycemic agents during the first 5 years after U.S. Food and Drug Administration approval of the drug. |
Databáze: | OpenAIRE |
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