Long-term effectiveness and safety of liraglutide in clinical practice.

AIM: The rising adoption of liraglutide in clinical practice calls for an update on its long-term effectiveness and safety. The aims of this paper were to review characteristics of patients treated with liraglutide under routine clinical practice conditions, to describe therapeutic schemes, to assess the durability of liraglutide after two years of therapy, to evaluate changes in clinical parameters obtained after 20-24 months and to identify elective phenotype of patients that are able to respond better to this treatment. METHODS: One diabetes outpatient clinic in Italy systematically collected data of patients receiving liraglutide every four months during a two-year follow-up. Mean levels and changes vs. baseline of HbA1c, fasting blood glucose (FBG), body weight, body mass index, waist circumference, blood pressure and lipid profile were evaluated. Rate of treatment discontinuation and side effects were also investigated. RESULTS: Overall, 205 patients were analyzed. Liraglutide was prescribed as an add-on drug in 39% of patients and as a replacement in 61%. It was used both in patients with short (21% ≤5 years) and long (32% >15 years) diabetes duration and both in obese and non-obese individuals (38% BMI≤30 Kg/m2). Liraglutide was used within many different therapeutic schemes, also including insulin (20%). On average, HbA1c levels were reduced of 1% vs. baseline at each visit, but magnitude of reduction was inversely related to diabetes duration, i.e., to the preservation of beta-cell function. However, clinically relevant improvements of glycaemic control were obtained and sustained during two years in all subgroups of patients, despite of classes of diabetes duration, BMI and antidiabetic therapeutic regimen. Durability of effectiveness on body weight and waist circumference was also documented. Liraglutide treatment was also associated with a reduction of systolic blood pressure and improvement of lipid profile. Side effects, that occurred in 20% of patients during the first four months of treatment, decreased at 2% at 20 months. The rate of drop-out was 16.1% of the patients treated. CONCLUSION: The analysis of our clinical practice shows that treatment with liraglutide was safe, well tolerated and effective in reducing HbA1c, fasting blood glucose and body weight significantly, with positive effects on systolic blood pressure and lipid profile. Therefore, results of LEAD studies are substantially reproduced in the context of routine clinical practice. Even if the maximum effectiveness of liraglutide occurs in patients with short disease duration, preferably treated with metformin, also in patients with long duration of disease, treated with several drugs or in insulin therapy, the use of this GLP-1 analogue allows to obtain more than satisfactory results. Improvements in metabolic control and body weight are maintained after two years, suggesting durability and safety of liraglutide in the long run.