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.