AIMS: To evaluate long term efficacy and safety of lixisenatide, a short-acting, prandial GLP-1 RA (Glucagon-Like Peptide-1 Receptor Agonists) as add-on therapy in type 2 diabetes mellitus. METHODS: A meta-analysis of 76-week results of five placebo-controlled clinical trials from the GetGoal program was performed including 3,000 inadequately controlled adult diabetic patients where lixisenatide 20 µg once-daily was administered in combination with metformin (GetGoal-M and GetGoal-F1), sulphonylurea ± metformin (GetGoal-S), basal insulin ± metformin (GetGoal-L) or pioglitazone ± metformin (GetGoal-P). RESULTS: A significant reduction in HbA1c at 76 weeks was observed in the intervention arm compared to placebo (LSM difference: -0.41%, 95%CI: -0.51, -0.32, p < 0.00001). Compared to placebo, lixisenatide induced a larger decrease in fasting plasma glucose (LSM difference -0.49 mmol/l, 95% CI -0.71, -0.27, p < 0.0001) and postprandial glucose excursion after a standard test meal (LSM difference -3.29 mmol/l, 95% CI -4.17, -2.42, p < 0.00001). A body weight reduction was observed in the lixisenatide arm (LSM difference -0.40 kg, 95%CI: -0.8, -0.01, p = 0.05). The risk of hypoglycemia was slightly higher with lixisenatide vs placebo (risk difference +0.02, 95% CI: 0, 0.04, p = 0.04). The most commonly observed non severe adverse events were nausea and vomiting, which after week 16 and 8, were respectively steadily <4% and < 1% in the lixisenatide arm. CONCLUSIONS: Lixisenatide, a once-daily prandial GLP-1 RA, provides long term glycemic control, a sustained beneficial effect on weight with a good safety profile.

Beneficial effect of lixisenatide after 76 weeks of treatment in patients with type 2 diabetes mellitus: a meta-analysis from the GetGoal program / Broglio, Fabio; Mannucci, Edoardo; Napoli, Raffaele; Nicolucci, Antonio; Purrello, Francesco; Nikonova, Elena; Stager, William; Trevisan, Roberto. - In: DIABETES, OBESITY AND METABOLISM. - ISSN 1462-8902. - ELETTRONICO. - (2016), pp. 1-1. [10.1111/dom.12810]

Beneficial effect of lixisenatide after 76 weeks of treatment in patients with type 2 diabetes mellitus: a meta-analysis from the GetGoal program

MANNUCCI, EDOARDO;
2016

Abstract

AIMS: To evaluate long term efficacy and safety of lixisenatide, a short-acting, prandial GLP-1 RA (Glucagon-Like Peptide-1 Receptor Agonists) as add-on therapy in type 2 diabetes mellitus. METHODS: A meta-analysis of 76-week results of five placebo-controlled clinical trials from the GetGoal program was performed including 3,000 inadequately controlled adult diabetic patients where lixisenatide 20 µg once-daily was administered in combination with metformin (GetGoal-M and GetGoal-F1), sulphonylurea ± metformin (GetGoal-S), basal insulin ± metformin (GetGoal-L) or pioglitazone ± metformin (GetGoal-P). RESULTS: A significant reduction in HbA1c at 76 weeks was observed in the intervention arm compared to placebo (LSM difference: -0.41%, 95%CI: -0.51, -0.32, p < 0.00001). Compared to placebo, lixisenatide induced a larger decrease in fasting plasma glucose (LSM difference -0.49 mmol/l, 95% CI -0.71, -0.27, p < 0.0001) and postprandial glucose excursion after a standard test meal (LSM difference -3.29 mmol/l, 95% CI -4.17, -2.42, p < 0.00001). A body weight reduction was observed in the lixisenatide arm (LSM difference -0.40 kg, 95%CI: -0.8, -0.01, p = 0.05). The risk of hypoglycemia was slightly higher with lixisenatide vs placebo (risk difference +0.02, 95% CI: 0, 0.04, p = 0.04). The most commonly observed non severe adverse events were nausea and vomiting, which after week 16 and 8, were respectively steadily <4% and < 1% in the lixisenatide arm. CONCLUSIONS: Lixisenatide, a once-daily prandial GLP-1 RA, provides long term glycemic control, a sustained beneficial effect on weight with a good safety profile.
2016
1
1
Broglio, Fabio; Mannucci, Edoardo; Napoli, Raffaele; Nicolucci, Antonio; Purrello, Francesco; Nikonova, Elena; Stager, William; Trevisan, Roberto
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1063474
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