Daniel Caldeira1, Mariana Alves2, Cláudio David3, João Costa4, Joaquim J Ferreira4, Fausto J Pinto5. 1. Centro Cardiovascular da Universidade de Lisboa - CCUL, CAML, Faculdade de Medicina, Universidade de Lisboa, Portugal; Serviço de Cardiologia, Hospital Universitário de Santa Maria - CHULN, Portugal; Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Portugal; Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Portugal. Electronic address: dgcaldeira@hotmail.com. 2. Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Portugal; Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Portugal; Serviço de Medicina III, Hospital Pulido Valente, CHLN, Lisboa, Portugal. 3. Centro Cardiovascular da Universidade de Lisboa - CCUL, CAML, Faculdade de Medicina, Universidade de Lisboa, Portugal; Serviço de Cardiologia, Hospital Universitário de Santa Maria - CHULN, Portugal; Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Portugal. 4. Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Portugal; Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Portugal. 5. Centro Cardiovascular da Universidade de Lisboa - CCUL, CAML, Faculdade de Medicina, Universidade de Lisboa, Portugal; Serviço de Cardiologia, Hospital Universitário de Santa Maria - CHULN, Portugal.
Abstract
AIMS: The publication of new trials brought additional data to the controversial topic of aspirin use in diabetic patients for primary prevention. Therefore, we aimed to systematically review all randomized controlled trials evaluating the clinical impact of aspirin in this setting. METHODS: We searched for randomized controlled trials (RCTs) evaluating the impact of aspirin in patients with diabetes in primary prevention, in MEDLINE, EMBASE, CENTRAL (November/2018). The primary outcomes were all-cause mortality and the composite outcome of major adverse cardiovascular events (MACE). A meta-analysis was performed deriving risk ratios (RR) and 95% confidence intervals (CI). RESULTS: All-cause mortality was not significantly reduced with RR 0.96 (95% CI 0.90-1.03; 7RCT; 27,595 patients). Regarding MACE, there was an 8% risk reduction (RR 0.92, 95% CI 0.84-0.999; I2=0%; 8RCT; 29,814 patients). The risks of major bleeding (RR 1.30, 95% CI 1.10-1.53; 2RCTs, 18,019 patients), and major GI bleeding (RR 1.39, 95% CI 1.08-1.80; 2RCTs, 18,019 patients) were significantly increased. The risks of cardiovascular mortality, myocardial infarction, stroke and amputation were not significantly different from control arm. CONCLUSIONS: Aspirin use among diabetic patients in primary prevention appears was associated with increased risk of major bleeding, a modest decrease of MACE and lack of mortality benefit.
AIMS: The publication of new trials brought additional data to the controversial topic of aspirin use in diabeticpatients for primary prevention. Therefore, we aimed to systematically review all randomized controlled trials evaluating the clinical impact of aspirin in this setting. METHODS: We searched for randomized controlled trials (RCTs) evaluating the impact of aspirin in patients with diabetes in primary prevention, in MEDLINE, EMBASE, CENTRAL (November/2018). The primary outcomes were all-cause mortality and the composite outcome of major adverse cardiovascular events (MACE). A meta-analysis was performed deriving risk ratios (RR) and 95% confidence intervals (CI). RESULTS: All-cause mortality was not significantly reduced with RR 0.96 (95% CI 0.90-1.03; 7RCT; 27,595 patients). Regarding MACE, there was an 8% risk reduction (RR 0.92, 95% CI 0.84-0.999; I2=0%; 8RCT; 29,814 patients). The risks of major bleeding (RR 1.30, 95% CI 1.10-1.53; 2RCTs, 18,019 patients), and major GI bleeding (RR 1.39, 95% CI 1.08-1.80; 2RCTs, 18,019 patients) were significantly increased. The risks of cardiovascular mortality, myocardial infarction, stroke and amputation were not significantly different from control arm. CONCLUSIONS:Aspirin use among diabeticpatients in primary prevention appears was associated with increased risk of major bleeding, a modest decrease of MACE and lack of mortality benefit.
Authors: Hadar Haim-Pinhas; Gil Yoskovitz; Michael Lishner; David Pereg; Yona Kitay-Cohen; Guy Topaz; Yaron Sela; Ori Wand; Ilan Rozenberg; Sydney Benchetrit; Keren Cohen-Hagai Journal: Sci Rep Date: 2022-10-22 Impact factor: 4.996