6533b7d8fe1ef96bd126a508

RESEARCH PRODUCT

Zofenopril and Ramipril in Combination with Acetyl Salicylic Acid in Postmyocardial Infarction Patients with Left Ventricular Systolic Dysfunction: A Retrospective Analysis of the SMILE-4 Randomized, Double-Blind Study in Diabetic Patients

Claudio BorghiEttore AmbrosioniStefano OmboniSalvatore NovoDragos VinereanuGiuseppe AmbrosioAlexopolulus DimitriosNanas IoannisAgrusta MarcoBarsotti AntonioBergerone SerenaCaliendo LuigiCaso PioCastello AntonioCianflone DomenicoCipolla TommasoDe Ferrari GaetanoDe Nittis GiuseppeDei Cas LivioDi Pasquale PaoloEvola RosarioFattore LucianoFerrante RaffaeleFiscella AntonioGaspardone AchilleIelasi GiuseppeMarchionni NiccolóMarenzi GiancarloMarte FilippoMiccoli FedericoNoussan PatriziaOrlandi MarioPiovaccari GiancarloPorcu MaurizioPresbitero PatriziaRaviele AntonioRenaldini EmilianoSalerno Uriarte JorgeStorti GiovanniTamburino CorradoTerrosu PierfrancoTesta RobertoTrinchero RitaTuccillo BernardinoVasquez LudovicoVillani Giovanni QuintoAlvés Mario GarciaAndrade AuroraCardoso SilvaMoreira Joseà IlidioArsenescu Georgescu CatalinaCinteza MirceaDorobantu MariaIonescu DominicManitiu IoanOrtan FlorinPop CalinRadoi MarianaAlexandrovich Vasyuk YuriyAvenirovitch Kostenko VictorBorisovich Karpov YuriyIosifovna Tseluiko ViraLvovich Syrkin AbramMikhailovich Goloschekin BorisMikhaylovich Nifontov EvgeniyNikolaevich Tereschenko SergeyNikolaevna Burova NataliaNikolayevich Zrazhevsky KonstantinPavlovich Arutuynov GrigorySergeevich Moiseev ValentinVictorovich Rudenko LeonidYurievich Vishnevsky AlexanderD. L. Y. De La Yera DiazRomero FernándezKirma CevatMeral KayikciogluOğuzhan AbdurrahmanUral Komsuoglu DilekAnkindinovna Koval OlenaNikolaevich Parkhomenko AlexanPetrovich Vakalyuk IgorTihonovich Vatutin MykolaVladimirovich Batushkin Valerii

subject

MaleCaptoprilDiabetic CardiomyopathiesMyocardial InfarctionInfarctionAngiotensin-Converting Enzyme Inhibitors030204 cardiovascular system & hematologychemistry.chemical_compoundVentricular Dysfunction Left0302 clinical medicineDiabetes mellitusRamiprilRetrospective StudieCardiovascular DiseaseMedicinePharmacology (medical)030212 general & internal medicineMyocardial infarctionDiabetic CardiomyopathieRandomized Controlled Trials as TopicAspirinLeft ventricular dysfunctionGeneral MedicineAcetyl salicylic acid; Acute myocardial infarction; Angiotensin-converting enzyme inhibitors; Diabetes mellitus; Left ventricular dysfunction; Ramipril; Zofenopril; Cardiology and Cardiovascular Medicine; Pharmacology (medical); PharmacologyMiddle AgedZofenoprilAcetyl salicylic acidCardiovascular DiseasesCardiologyPlatelet aggregation inhibitorDrug Therapy CombinationFemaleCardiology and Cardiovascular Medicinemedicine.drugHumanRamiprilmedicine.medical_specialtyDiabetes mellituSystoleAcute myocardial infarctionZofenopril03 medical and health sciencesDiabetes mellitusInternal medicineHumansAgedRetrospective StudiesPharmacologyAspirinbusiness.industryPlatelet Aggregation InhibitorAngiotensin-Converting Enzyme Inhibitormedicine.diseasechemistryAngiotensin-converting enzyme inhibitorbusinessMacePlatelet Aggregation Inhibitors

description

Summary Objective In the SMILE-4 study, zofenopril + acetyl salicylic acid (ASA) was more effective than ramipril + ASA on 1-year prevention of major cardiovascular events (MACE) in patients with acute myocardial infarction complicated by left ventricular dysfunction. In this retrospective analysis, we evaluated drug efficacy in subgroups of patients, according to a history of diabetes mellitus. Methods The primary study endpoint was 1-year combined occurrence of death or hospitalization for cardiovascular causes. Diabetes was defined according to medical history (previous known diagnosis). Results A total of 562 of 693 (81.0%) patients were classified as nondiabetics and 131 (18.9%) as diabetics. The adjusted rate of MACE was lower under zofenopril than under ramipril in both nondiabetics [27.9% vs. 34.9% ramipril; odds ratio, OR and 95% confidence interval: 0.55 (0.35, 0.86)] and diabetics [30.9% vs. 41.3%; 0.56 (0.18, 1.73)], although the difference was statistically significant only for the nondiabetic group (P = 0.013). Zofenopril was superior to ramipril as regards to the primary study endpoint in the subgroup of 157 patients with uncontrolled blood glucose (≥126 mg/dL), regardless of a previous diagnosis of diabetes [0.31 (0.10, 0.90), P = 0.030]. Zofenopril significantly reduced the risk of hospitalization for cardiovascular causes in both nondiabetics [0.64 (0.43, 0.96), P = 0.030] and diabetics [0.38 (0.15, 0.95), P = 0.038], whereas it was not better than ramipril in terms of prevention of cardiovascular deaths. Conclusions This retrospective analysis of the SMILE-4 study confirmed the good efficacy of zofenopril plus ASA in the prevention of long-term MACE also in the subgroup of patients with diabetes mellitus.

yearjournalcountryeditionlanguage
2016-01-01
10.1111/1755-5922.12175http://hdl.handle.net/11585/550077