Effectiveness and safety of liraglutide after three years of treatment.

BACKGROUND: The aim of this study was to evaluate long-term effectiveness and safety of liraglutide in real world. METHODS: A diabetes clinic in Italy systematically collected data of all patients treated with liraglutide. Generalized hierarchical linear regression models for repeated measures were applied to assess trends over time of HbA1c, fasting plasma glucose (FPG), body weight, blood pressure and lipid profile. RESULTS: Overall, 255 patients (mean age: 63.5±9.7 years, men: 56.9%, mean diabetes duration: 12.0±8.1 years) were treated with liraglutide during 36 months. Mean HbA1c levels decreased by -1.0±0.1% (P<0.0001), FPG by -46±6 mg/dL (P<0.0001), and body weight by -3.9±0.8 Kg (P<0.0001). HbA1c reduction was inversely related to diabetes duration, while body weight reduction was directly related to baseline BMI. Significant improvements in HDL-cholesterol and triglycerides levels were also documented. Trends of improvement in systolic blood pressure (SBP) levels were also found, with significant reduction in patients with baseline SBP≥140 mmHg. Treatment was well-tolerated by the vast majority of the patients. Neither severe hypoglycemia nor pancreatitis occurred. Drop-out rate was of 28.2%. Main causes of drop-out were gastrointestinal side effects and lack of efficacy. CONCLUSION: Our analysis documents a prolonged effectiveness and safety of liraglutide, even after three years of treatment. In addition to significant improvement in glycemic control and body weight, liraglutide also provides additional benefits on cardiovascular risk profile, while minimizing the risk of hypoglycemia. However, magnitude of benefits reflects specific patient characteristics that deserve further investigation.