Cardiovascular safety of vildagliptin in patients with type 2 diabetes: A European multi-database, non-interventional post-authorization safety study.
The aim of this non-interventional, multi-database, analytical cohort study was to assess the cardiovascular (CV) safety of vildagliptin vs other non-insulin antidiabetic drugs (NIADs) using real-world data from 5 European electronic healthcare databases. Patients with type 2 diabetes aged ≥18 years on NIAD treatment were enrolled. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) for the outcomes of interest (myocardial infarction [MI], acute coronary syndrome [ACS], stroke, congestive heart failure [CHF], individually and as a composite) were estimated using negative binomial regression. Approximately 2.8% of the enrolled patients (n = 738 054) used vildagliptin at any time during the study, with an average follow-up time of 1.4 years, resulting in a cumulative current vildagliptin exposure of 28 330 person-years. The adjusted IRRs (vildagliptin [±other NIADs] vs other NIADs) were in the range of 0.61 to 0.97 (MI), 0.55 to 1.60 (ACS), 0.02 to 0.77 (stroke), 0.49 to 1.03 (CHF), and 0.22 to 1.02 (composite CV outcomes). The IRRs and their 95% CIs were close to 1, demonstrating no increased risk of adverse CV events, including the risk of CHF, with vildagliptin vs other NIADs in real-world conditions.
Clinical Practice Research Datalink, London, UK.|Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Rachael
R
Williams
Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.|Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Frank
F
de Vries
Novartis Pharma AG, Basel, Switzerland.
Wolfgang
W
Kothny
Novartis Pharma AG, Basel, Switzerland.
Carmen
C
Serban
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Sandra
S
Lopez-Leon
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.|Sanofi-Aventis US LLC, Bridgewater, New Jersey.
Changan
C
Chu
Novartis Pharma AG, Basel, Switzerland.
Raymond
0000-0001-5160-0872
R
Schlienger
D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D066126:Cardiotoxicity / Q000453:epidemiology; D015331:Cohort Studies; D016208:Databases, Factual / Q000706:statistics & numerical data; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D058065:Diabetic Cardiomyopathies / Q000139:chemically induced / Q000453:epidemiology; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects* / Q000627:therapeutic use; D011759:Pyrrolidines / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies; D000077597:Vildagliptin
D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin; D000218:Adamantane
DPP-4 inhibitor; cardiovascular disease; observational study; type 2 diabetes; vildagliptin