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Beneficial effect of lixisenatide after 76 weeks of treatment in patients with type 2 diabetes mellitus: A meta-analysis from the GetGoal programme.
Diabetes Obes Metab. 2017 02; 19(2):248-256.DO

Abstract

AIMS

To evaluate the long-term efficacy and safety of lixisenatide, a short-acting, prandial glucagon-like peptide-1 receptor agonists (GLP-1 RA) as add-on therapy in type 2 diabetes mellitus.

METHODS

A meta-analysis of 76-week results of 5 placebo-controlled clinical trials from the GetGoal programme was performed, including 3000 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 < .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 < .0001) and postprandial glucose excursion after a standard test meal (LSM difference -3.29 mmol/L, 95% CI -4.17, -2.42, P < .00001). A bodyweight reduction was observed in the lixisenatide arm (LSM difference -0.40 kg, 95%CI: -0.8, -0.01, P = .05). The risk of hypoglycaemia was slightly higher with lixisenatide vs placebo (risk difference +0.02, 95% CI: 0, 0.04, P = .04). The most commonly observed non-severe adverse events were nausea and vomiting, which after week 16 and week 8, were steadily <4% and <1% in the lixisenatide arm, respectively.

CONCLUSIONS

Lixisenatide, a once-daily prandial GLP-1 RA, provides long-term glycaemic control, a sustained beneficial effect on weight and with a good safety profile.

Authors+Show Affiliations

S.C.D.U. Endocrinology, Diabetology and Metabolism Diseases, Azienda Ospedaliero-Universitaria San Giovanni Battista "le Molinette", Turin, Italy.Diabetology, University of Florence, Florence, Italy.Department of Translational Medical Sciences, Federico II University, Naples, Italy.Center for Outcomes Research and Clinical Epidemiology, CORESEARCH, Pescara, Italy.Department of Clinical and Experimental Medicine, UOC Internal Medicine, Garibaldi-Nesima Hospital, University of Catania, Catania, Italy.Endocrinology and Diabetes Unit, Papa Giovanni XXIII Hospital, Bergamo, Italy.Endocrinology and Diabetes Unit, Papa Giovanni XXIII Hospital, Bergamo, Italy.Sanofi, Bridgewater, New Jersey.

Pub Type(s)

Journal Article
Meta-Analysis

Language

eng

PubMed ID

27762096

Citation

Broglio, Fabio, et al. "Beneficial Effect of Lixisenatide After 76 Weeks of Treatment in Patients With Type 2 Diabetes Mellitus: a Meta-analysis From the GetGoal Programme." Diabetes, Obesity & Metabolism, vol. 19, no. 2, 2017, pp. 248-256.
Broglio F, Mannucci E, Napoli R, et al. Beneficial effect of lixisenatide after 76 weeks of treatment in patients with type 2 diabetes mellitus: A meta-analysis from the GetGoal programme. Diabetes Obes Metab. 2017;19(2):248-256.
Broglio, F., Mannucci, E., Napoli, R., Nicolucci, A., Purrello, F., Nikonova, E., Stager, W., & Trevisan, R. (2017). Beneficial effect of lixisenatide after 76 weeks of treatment in patients with type 2 diabetes mellitus: A meta-analysis from the GetGoal programme. Diabetes, Obesity & Metabolism, 19(2), 248-256. https://doi.org/10.1111/dom.12810
Broglio F, et al. Beneficial Effect of Lixisenatide After 76 Weeks of Treatment in Patients With Type 2 Diabetes Mellitus: a Meta-analysis From the GetGoal Programme. Diabetes Obes Metab. 2017;19(2):248-256. PubMed PMID: 27762096.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Beneficial effect of lixisenatide after 76 weeks of treatment in patients with type 2 diabetes mellitus: A meta-analysis from the GetGoal programme. AU - Broglio,Fabio, AU - Mannucci,Edoardo, AU - Napoli,Raffaele, AU - Nicolucci,Antonio, AU - Purrello,Francesco, AU - Nikonova,Elena, AU - Stager,William, AU - Trevisan,Roberto, Y1 - 2016/12/08/ PY - 2016/07/21/received PY - 2016/10/12/revised PY - 2016/10/13/accepted PY - 2016/10/21/pubmed PY - 2017/11/2/medline PY - 2016/10/21/entrez KW - GLP-1 RA KW - diabetes mellitus KW - glycosylated KW - haemoglobin A KW - hypoglycaemia KW - lixisenatide KW - long-term efficacy KW - long-term safety SP - 248 EP - 256 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 19 IS - 2 N2 - AIMS: To evaluate the long-term efficacy and safety of lixisenatide, a short-acting, prandial glucagon-like peptide-1 receptor agonists (GLP-1 RA) as add-on therapy in type 2 diabetes mellitus. METHODS: A meta-analysis of 76-week results of 5 placebo-controlled clinical trials from the GetGoal programme was performed, including 3000 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 < .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 < .0001) and postprandial glucose excursion after a standard test meal (LSM difference -3.29 mmol/L, 95% CI -4.17, -2.42, P < .00001). A bodyweight reduction was observed in the lixisenatide arm (LSM difference -0.40 kg, 95%CI: -0.8, -0.01, P = .05). The risk of hypoglycaemia was slightly higher with lixisenatide vs placebo (risk difference +0.02, 95% CI: 0, 0.04, P = .04). The most commonly observed non-severe adverse events were nausea and vomiting, which after week 16 and week 8, were steadily <4% and <1% in the lixisenatide arm, respectively. CONCLUSIONS: Lixisenatide, a once-daily prandial GLP-1 RA, provides long-term glycaemic control, a sustained beneficial effect on weight and with a good safety profile. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/27762096/Beneficial_effect_of_lixisenatide_after_76_weeks_of_treatment_in_patients_with_type_2_diabetes_mellitus:_A_meta_analysis_from_the_GetGoal_programme_ L2 - https://doi.org/10.1111/dom.12810 DB - PRIME DP - Unbound Medicine ER -