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Efficacy and safety of liraglutide, a once‐daily human glucagon‐like peptide‐1 receptor agonist, in African‐American people with Type 2 diabetes: a meta‐analysis of sub‐population data from seven phase III trials
AIM: To evaluate the efficacy and safety of the glucagon‐like peptide‐1 (GLP‐1) receptor agonist liraglutide in African‐American people with Type 2 diabetes. METHODS: Analyses were performed on patient‐level data from individuals self‐defined as African‐American or non‐African‐American in seven phas...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5248619/ https://www.ncbi.nlm.nih.gov/pubmed/27412701 http://dx.doi.org/10.1111/dme.13185 |
Sumario: | AIM: To evaluate the efficacy and safety of the glucagon‐like peptide‐1 (GLP‐1) receptor agonist liraglutide in African‐American people with Type 2 diabetes. METHODS: Analyses were performed on patient‐level data from individuals self‐defined as African‐American or non‐African‐American in seven phase III studies. Endpoints included change in HbA(1c) level, fasting plasma glucose level and body weight from baseline, proportion of patients reaching HbA(1c) target [< 53 mmol/mol (< 7.0%)], and incidence of hypoglycaemia and nausea. Analyses used data obtained after 26 weeks. Within‐population comparisons of liraglutide were performed vs placebo for African‐American and non‐African‐American patient groups. In addition, between‐population comparisons with non‐African‐American patients were performed for each treatment. RESULTS: In African‐American patients (n = 225), HbA(1c) was significantly reduced at 26 weeks with liraglutide 1.2 and 1.8 mg (−11 and −14 mmol/mol, respectively compared with placebo; P < 0.0001). There were also significant reductions in fasting plasma glucose (−2.4 and −3.1 mmol/l, respectively, compared with placebo; P < 0.0001). Statistically significant reductions in body weight were observed with 1.8 mg liraglutide (−2.1 kg compared with placebo; P = 0.0056), but not with 1.2 mg liraglutide (−0.26 kg; P = 0.7307). The P value for interaction between treatment and race was significant for body weight (P = 0.0355). The incidence of non‐severe hypoglycaemia with liraglutide was low (11–15% of patients), and < 25% of patients receiving liraglutide experienced nausea. CONCLUSIONS: This meta‐analysis suggests that liraglutide is well tolerated and efficacious for treatment of Type 2 diabetes in African‐American patients, with an efficacy that was shown not to differ from that observed in non‐African‐American patients over 26 weeks. |
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