Comparable pharmacodynamics, efficacy, and safety of linagliptin 5 mg among Japanese, Asian and white patients with type 2 diabetes
Rattachement africain : jp, ch, de, gb. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
AIMS/INTRODUCTION: The efficacy and safety of drugs can vary between different races or ethnic populations because of differences in the relationship of dose to exposure, pharmacodynamic response or clinical efficacy and safety. In the present post-hoc analysis, we assessed the influence of race on the pharmacokinetics, pharmacodynamics, efficacy and safety of monotherapy with the dipeptidyl peptidase-4 inhibitor, linagliptin, in patients with type 2 diabetes enrolled in two comparable, previously reported randomized phase III trials. MATERIALS AND METHODS: Study 1 (with a 12-week placebo-controlled phase) recruited Japanese patients only (linagliptin, n = 159; placebo, n = 80); study 2 (24-week trial) enrolled Asian (non-Japanese; linagliptin, n = 156; placebo, n = 76) and white patients (linagliptin, n = 180; placebo, n = 90). RESULTS: Linagliptin trough concentrations were equivalent across study and race groups, and were higher than half-maximal inhibitory concentration, resulting in dipeptidyl peptidase-4 inhibition >80% at trough. Linagliptin inhibited plasma dipeptidyl peptidase-4 activity to a similar degree in study 1 and study 2. Linagliptin reduced fasting plasma glucose concentrations by a similar magnitude across groups, leading to clinically relevant reductions in glycated hemoglobin in all groups. Glycated hemoglobin levels decreased to a slightly greater extent in study 1 (Japanese) and in Asian (non-Japanese) patients from study 2. Linagliptin had a favorable safety profile in each race group. CONCLUSIONS: Trough exposure, pharmacodynamic response, and efficacy and safety of linagliptin monotherapy were comparable among Japanese, Asian (non-Japanese) and white patients, confirming that the recommended 5-mg once-daily dose of linagliptin is appropriate for use among different race groups.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Comparable pharmacodynamics, efficacy, and safety of linagliptin 5 mg among Japanese, Asian and white patients with type 2 diabetes
- Date Crossref
- 02/03/2016
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Boehringer Ingelheim (Japan) pays non établi dans la noticeEntreprise
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Boehringer Ingelheim (Switzerland) pays non établi dans la noticeEntreprise
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Boehringer Ingelheim (Germany) pays non établi dans la noticeEntreprise
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Boehringer Ingelheim (United Kingdom) pays non établi dans la noticeEntreprise
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Clinical Pharmacokinetics/Pharmacodynamics Department Nippon Boehringer Ingelheim Co. pays non établi dans la noticeÉtablissement de santé
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Boehringer Ingelheim Pharma GmbH & pays non établi dans la noticeEntreprise
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Boehringer Ingelheim Ltd Bracknell UK Nippon Boehringer Ingelheim Co. pays non établi dans la noticeEntreprise
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Clinical Research Department Nippon Boehringer Ingelheim Co. pays non établi dans la noticeÉtablissement de santé
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Ltd Tokyo Japan Medical Data Service Department Nippon Boehringer Ingelheim Co. pays non établi dans la noticeEntreprise
Boehringer Ingelheim (Japan), Boehringer Ingelheim (Switzerland) et Boehringer Ingelheim (Germany), avec 6 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.