Austrian Experience with Lixisenatide Under Real-Life Conditions: A Prospective Observational Study.

INTRODUCTION: Lixisenatide has been studied extensively in randomized clinical trials; however, data on its use in the real-life practice are scarce. METHODS: This study was a prospective, 26-week, multicenter, observational study conducted in Austrian diabetes centers and office-based practices to evaluate efficacy and safety of lixisenatide under real-life conditions in patients with type 2 diabetes. RESULTS: Out of 144 patients (mean BMI 36.4 kg/m, disease duration 12.4 years), 113 completed the documentation at 6 months and 42% received basal insulin with or without oral antidiabetic drugs. The HbA1c declined from 8.7% (72 mmol/mol) to 7.9% (63 mmol/mol) and at study end 24.8% of the patients reached an HbA1c level below 7%. Fasting and postprandial glucose after lixisenatide administration were reduced by 27 ± 58 mg/dl and 45 ± 67 mg/dl, respectively. At study end body weight (- 4.5 ± 5.4 kg), triglycerides (- 10.8 ± 105 mg/dl), systolic blood pressure (- 4.8 ± 17.1 mmHg), and LDL cholesterol (- 3.7 ± 25 mg/dl) were reduced. The most commonly reported adverse events were gastrointestinal disorders (18.8%). Forty-three patients (30%) discontinued prematurely, mostly caused by lack of efficacy, occurrence of gastrointestinal disorders, and missing reimbursement. The average dose of insulin decreased slightly by 1.5 units (from 29.4 to 27.9). CONCLUSION: Lixisenatide demonstrated a similar efficacy and safety profile under real-life conditions as previously shown in randomized clinical trials. FUNDING: sanofi-aventis GmbH Austria.