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Lixisenatide treatment for older patients with type 2 diabetes mellitus uncontrolled on oral antidiabetics: meta-analysis of five randomized controlled trials.
Adv Ther. 2014 Aug; 31(8):861-72.AT

Abstract

AIM

Evaluate the efficacy and safety of lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, in older patients with type 2 diabetes mellitus (T2DM) insufficiently controlled on oral antidiabetics (OADs).

METHODS

A meta-analysis was conducted on data from older patients (≥65 years) from five of the GetGoal trials, in which patients with T2DM were treated with lixisenatide 20 µg once daily or placebo, as an add-on to OADs. The primary endpoint in all trials was change from baseline at week 24 in glycated hemoglobin (HbA1c). Other endpoints included changes in post-prandial plasma glucose (PPG), fasting plasma glucose (FPG) and weight. Composite and safety endpoints were also analyzed.

RESULTS

A total of 501 patients aged ≥65 years were included in this meta-analysis: 304 received lixisenatide plus OADs and 197 received placebo as add-on to OADs. Lixisenatide as an add-on to OADs significantly reduced HbA1c, PPG, FPG and weight, with placebo-corrected treatment effects at week 24 of -0.54% (p<0.0001), -126 mg/dL (p<0.0001), -13 mg/dL (p=0.0005) and -0.90 kg (p=0.0021), respectively. Patients receiving lixisenatide plus OADs were significantly more likely to achieve composite (HbA1c levels<7%, HbA1c levels<7% and no symptomatic hypoglycemia, and HbA1c levels<7%, no weight gain and no symptomatic hypoglycemia) and safety endpoints than those receiving placebo plus OADs. Symptomatic hypoglycemia was experienced by 8.55% and 3.55% of patients in the lixisenatide plus OADs and placebo plus OADs groups, respectively (p=0.0276), although no serious hypoglycemic episodes were reported.

CONCLUSIONS

Lixisenatide plus OADs improved glycemic control in older patients inadequately controlled on OADs compared with placebo plus OADs. Lixisenatide is well tailored to the pathophysiology of T2DM in older patients.

Authors+Show Affiliations

GWT-TUD, Study Centre Prof. Hanefeld, Dresden Technical University, Fiedlerstr. 34, 01307, Dresden, Germany, hanefeld@gwtonline-zks.de.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25143188

Citation

Hanefeld, Markolf, et al. "Lixisenatide Treatment for Older Patients With Type 2 Diabetes Mellitus Uncontrolled On Oral Antidiabetics: Meta-analysis of Five Randomized Controlled Trials." Advances in Therapy, vol. 31, no. 8, 2014, pp. 861-72.
Hanefeld M, Berria R, Lin J, et al. Lixisenatide treatment for older patients with type 2 diabetes mellitus uncontrolled on oral antidiabetics: meta-analysis of five randomized controlled trials. Adv Ther. 2014;31(8):861-72.
Hanefeld, M., Berria, R., Lin, J., Aronson, R., Darmon, P., Evans, M., & Van Gaal, L. (2014). Lixisenatide treatment for older patients with type 2 diabetes mellitus uncontrolled on oral antidiabetics: meta-analysis of five randomized controlled trials. Advances in Therapy, 31(8), 861-72. https://doi.org/10.1007/s12325-014-0146-4
Hanefeld M, et al. Lixisenatide Treatment for Older Patients With Type 2 Diabetes Mellitus Uncontrolled On Oral Antidiabetics: Meta-analysis of Five Randomized Controlled Trials. Adv Ther. 2014;31(8):861-72. PubMed PMID: 25143188.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lixisenatide treatment for older patients with type 2 diabetes mellitus uncontrolled on oral antidiabetics: meta-analysis of five randomized controlled trials. AU - Hanefeld,Markolf, AU - Berria,Rachele, AU - Lin,Jay, AU - Aronson,Ronnie, AU - Darmon,Patrice, AU - Evans,Marc, AU - Van Gaal,Luc, Y1 - 2014/08/21/ PY - 2014/06/05/received PY - 2014/8/22/entrez PY - 2014/8/22/pubmed PY - 2016/3/10/medline SP - 861 EP - 72 JF - Advances in therapy JO - Adv Ther VL - 31 IS - 8 N2 - AIM: Evaluate the efficacy and safety of lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, in older patients with type 2 diabetes mellitus (T2DM) insufficiently controlled on oral antidiabetics (OADs). METHODS: A meta-analysis was conducted on data from older patients (≥65 years) from five of the GetGoal trials, in which patients with T2DM were treated with lixisenatide 20 µg once daily or placebo, as an add-on to OADs. The primary endpoint in all trials was change from baseline at week 24 in glycated hemoglobin (HbA1c). Other endpoints included changes in post-prandial plasma glucose (PPG), fasting plasma glucose (FPG) and weight. Composite and safety endpoints were also analyzed. RESULTS: A total of 501 patients aged ≥65 years were included in this meta-analysis: 304 received lixisenatide plus OADs and 197 received placebo as add-on to OADs. Lixisenatide as an add-on to OADs significantly reduced HbA1c, PPG, FPG and weight, with placebo-corrected treatment effects at week 24 of -0.54% (p<0.0001), -126 mg/dL (p<0.0001), -13 mg/dL (p=0.0005) and -0.90 kg (p=0.0021), respectively. Patients receiving lixisenatide plus OADs were significantly more likely to achieve composite (HbA1c levels<7%, HbA1c levels<7% and no symptomatic hypoglycemia, and HbA1c levels<7%, no weight gain and no symptomatic hypoglycemia) and safety endpoints than those receiving placebo plus OADs. Symptomatic hypoglycemia was experienced by 8.55% and 3.55% of patients in the lixisenatide plus OADs and placebo plus OADs groups, respectively (p=0.0276), although no serious hypoglycemic episodes were reported. CONCLUSIONS: Lixisenatide plus OADs improved glycemic control in older patients inadequately controlled on OADs compared with placebo plus OADs. Lixisenatide is well tailored to the pathophysiology of T2DM in older patients. SN - 1865-8652 UR - https://www.unboundmedicine.com/medline/citation/25143188/Lixisenatide_treatment_for_older_patients_with_type_2_diabetes_mellitus_uncontrolled_on_oral_antidiabetics:_meta_analysis_of_five_randomized_controlled_trials_ L2 - https://dx.doi.org/10.1007/s12325-014-0146-4 DB - PRIME DP - Unbound Medicine ER -