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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.

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.

Aim: Liraglutide is a GLP-1 analogue introduced in Italy in 2010; its efficacy and safety have been tested within the comprehensive "LEAD program". The aim of this paper was to evaluate whether and to what extent routine practice outcomes are consistent with research findings., Methods: One diabetes outpatient clinic reviewed data of patients receiving incretin-based therapies. Differences in characteristics of patients treated with liraglutide, exenatide, or DPP-IV inhibitors were evaluated. The subgroups of patients treated with liraglutide, exenatide or DPP-IV inhibitors (sitagliptin, vildagliptin, saxagliptin) and followed for at least eight months were analyzed longitudinally. Hierarchical linear models for repeated measurements were applied to assess trends over time., Results: Incretin-based treatments were prescribed to 312 patients (liraglutide: 130, exe-natide: 72, DPP-IV inhibitors: 110). Diabetes duration, HbA1c levels, and BMI were substantially higher in exenatide and liraglutide groups than in the DPP-IV inhibitors group. Liraglutide was often administered in combination with metformin alone, while exenatide was often added to two or more drugs. Overall, 20 (15.4%) liraglutide interruptions were recorded, especially due to nausea. Treatment drop out rate was higher in exenatide and DPP-IV inhibitors groups (in exenatide mostly for gastrointestinal side effects, in DPP-IV for inefficacy). After eight months, overall levels of HbA1c were reduced from 8.1±1.1 to 7.1±0.8 (P<0.0001) with liraglutide. Furthermore, fasting blood glucose was reduced by 37.9±6.2 mg/dL (P<0.0001), body weight by 4.1±0.5 kg (P<0.0001), systolic blood pressure by 8.9±2.7 mmHg (P<0.001), total cholesterol by 8.8±4.1 mg/dL (P=0.04), and triglycerides by 24.4±14.6 mg/dL (P=0.07). Patients who had their therapy replaced at baseline from exenatide or DPP-IV had a further reduction in HbA1c, FBG and body weight., Conclusion: Liraglutide is penetrating diabetes care with results strictly mimicking the promising beneficial effects found in the LEAD program.