Drug-drug interactions between raltegravir and pravastatin in healthy volunteers

To evaluate the potential drug-drug interaction between raltegravir and pravastatin. This was an open-label, randomized, 3-period, cross-over, single-centre trial in 24 healthy volunteers. Subjects received the following treatments: pravastatin 40 mg every day for 4 days, raltegravir 400 mg twice a...

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Veröffentlicht in:Journal of acquired immune deficiency syndromes (1999) 2010-09, Vol.55 (1), p.82-86
Hauptverfasser: van Luin, Matthijs, Colbers, Angela, van Ewijk-Beneken Kolmer, Eleonora W J, Verweij-van Wissen, Corrien P W G M, Schouwenberg, Bas, Hoitsma, Arjen, da Silva, Hugo G, Burger, David M
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Sprache:eng
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Zusammenfassung:To evaluate the potential drug-drug interaction between raltegravir and pravastatin. This was an open-label, randomized, 3-period, cross-over, single-centre trial in 24 healthy volunteers. Subjects received the following treatments: pravastatin 40 mg every day for 4 days, raltegravir 400 mg twice a day for 4 days, and pravastatin 40 mg every day + raltegravir 400 mg twice a day for 4 days. The treatments were separated by washout periods of 10 days. On day 4 of each treatment period, blood samples for pharmacokinetics were collected throughout a 24-hour period. Geometric mean ratios (90% confidence interval) for pravastatin + raltegravir versus pravastatin alone were 0.96 (0.83 to 1.11) for AUC0-24 and 1.04 (0.85 to 1.26) for Cmax. The mean low-density lipoprotein cholesterol decrease after 4 days of pravastatin was 0.42 mmol/L both in the presence and the absence of raltegravir. The geometric mean ratio (90% confidence interval) AUC0-12, Cmax, and C12 for raltegravir + pravastatin versus raltegravir alone were 1.13 (0.77 to 1.65), 1.31 (0.81 to 2.13), and 0.59 (0.39 to 0.88), respectively. Raltegravir did not influence the pharmacokinetics or the short-term lipid-lowering effects of pravastatin, whereas pravastatin increased the Cmax but decreased the C12 of raltegravir. The effects of pravastatin on raltegravir pharmacokinetics are not likely to be clinically relevant.
ISSN:1525-4135
1944-7884
DOI:10.1097/QAI.0b013e3181d9a354