Effectiveness and Safety of Glimepiride Plus Metformin in Everyday Practice in Egyptian Patients: Smart Study
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- Category: Vol. 85, December 2017
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Effectiveness and Safety of Glimepiride Plus Metformin in Everyday Practice in Egyptian Patients: Smart Study, MOHAMED F. ABD AL-AZIZ and FAWZY EL-MESALAMY
Abstract
Objectives: To assess the effectiveness of glimepiride plus metformin fixed combination for treatment of Type 2 diabetic patients in Egypt, uncontrolled on either of the two drugs alone (HbA1c >7%). As secondary endpoints, Adverse Events (AE), serious AE, number of hypoglycemic events, and the mean dosage used were assessed.
Methods: An observational, national, multicenter, drug registry conducted in Egypt. A total of 2000 male or female patients ³18 years old with Type 2 diabetes, who were uncon-trolled on either glimepiride or metformin alone, and for whom their physicians decided to change the therapy, were planned for enrollment (1700 patients actually enrolled), in 400 sites around Egypt. For any single patient the study spanned 4 month duration and comprised of 3 visits (baseline, 2 month, and 4 month visit). At the end of study, we evaluated the number of patients achieving metabolic control (HbA1c £7), the mean daily dose of glimepiride and metformin, and a safety profile based on the incidence of adverse events, especially number of hypoglycemic events.
Results: 1700 patients were enrolled, of which 130 patients (7.6%) were lost to follow-up, and one patient (0.1%) died with no causal relation to study medication. Out of 1569 patients analyzed for efficacy, 632 patients (40.3%) success-fully achieved the HbA1c target (HbA1c £7%). Likewise, mean Fasting Blood Glucose (FBG) values showed a reduction from 216.3±65.14mg/dl at baseline to 139.44±50.38mg/dl at visit 3, with mean reduction of 76.86mg/dl (35.53% reduction in FBG baseline values). The mean total daily dose of glimepir-ide/metformin fixed combination at baseline was 3.03±0.03mg of glimepiride/750.32±7.76mg of metformin, and it was increased at the end of the study (after 4 months) to reach 3.25±1.38mg of glimepiride/813.37±8.74mg of metformin. Fig. (2) shows the details of dosing regimen at baseline and at end of study (visit 3). The mean reduction in body weight at the end of the study was 1.6kg representing mean percent reduction of 1.8% of mean body weight at baseline. A total of 19 Adverse Events (AEs) were reported by 16 patients (0.94%). All AEs were non-serious, apart from one (0.06%) serious adverse event (sudden death of a male patient, 46 years old; with no causal relation to study medication). All