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. 2019 Apr;10(2):451-462.
doi: 10.1007/s13300-018-0558-2. Epub 2019 Jan 17.

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

Helmut Brath  1 , Heidemarie Abrahamian  2 , Tvrtko Karuza  3 , Roman Mihaljevic  3 , Martin Pfohl  4
Affiliations

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

Helmut Brath et al. Diabetes Ther. 2019 Apr.

Abstract

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/m2, 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.

Keywords: HbA1c; Lixisenatide; PATIO; Real-life data; Short-acting GLP-1 receptor agonists; Type 2 diabetes.

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Figures

Fig. 1
Fig. 1
Patients flow diagram in the study
Fig. 2
Fig. 2
Change in HbA1c and weight during the study
Fig. 3
Fig. 3
Change in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) during the study
Fig. 4
Fig. 4
Mean 7-point SMBG profiles from visit 3 to visit 5
Fig. 5
Fig. 5
Gastrointestinal disturbances reported at visit 2 and visit 3
See this image and copyright information in PMC

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