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Aleglitazar, a balanced PPARα/γ agonist, has no clinically relevant pharmacokinetic interaction with high-dose atorvastatin or rosuvastatin
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Foley-Comer, Adam J., Young, Annie M., Russell-Yarde, Fiona and Jordan, Paul (2010) Aleglitazar, a balanced PPARα/γ agonist, has no clinically relevant pharmacokinetic interaction with high-dose atorvastatin or rosuvastatin. Expert Opinion on Investigational Drugs, 20 (1). pp. 3-12. doi:10.1517/13543784.2010.539559 ISSN 1354-3784.
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Official URL: http://dx.doi.org/10.1517/13543784.2010.539559
Abstract
Background: Aleglitazar, a dual PPAR-α/γ agonist, combines the lipid benefits of fibrates and the insulin-sensitizing benefits of thiazolidinediones. Objective: To investigate the pharmacokinetic effects of co-administration of atorvastatin or rosuvastatin with aleglitazar. Research design and methods: In a two-cohort, open-label, randomised, three-period crossover study, 44 healthy subjects received once-daily oral doses of aleglitazar 300 μg, statin (atorvastatin 80 mg or rosuvastatin 40 mg) and aleglitazar co-administered with each statin for 7 days. Plasma concentrations of each drug were measured and pharmacokinetic parameters determined on day 7 in each period. Main outcome measures: Peak observed plasma concentration (Cmax) and total exposures (AUC0 24) of aleglitazar, atorvastatin and rosuvastatin. Results: Cmax and AUC0 24 to aleglitazar were similar, whether administered alone or in combination with a statin. Total exposure to either statin was unaffected by co-administration with aleglitazar. Cmax treatment ratios for both statins exceeded the conventional no-effect boundary (1.25) when administered with aleglitazar. Conclusions: Co-administration of aleglitazar with a statin does not alter the pharmacokinetic profile of either drug. © 2011 Informa UK, Ltd.
| Item Type: | Journal Article | ||||||
|---|---|---|---|---|---|---|---|
| Subjects: | R Medicine > R Medicine (General) | ||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Journal or Publication Title: | Expert Opinion on Investigational Drugs | ||||||
| Publisher: | Routledge | ||||||
| ISSN: | 1354-3784 | ||||||
| Official Date: | 29 November 2010 | ||||||
| Dates: |
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| Volume: | 20 | ||||||
| Number: | 1 | ||||||
| Page Range: | pp. 3-12 | ||||||
| DOI: | 10.1517/13543784.2010.539559 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Restricted or Subscription Access |
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