Trial reportAntimicrobial agents and chemotherapy2011
Effect of the hepatitis C virus protease inhibitor telaprevir on the pharmacokinetics of amlodipine and atorvastatin.
Trial report in Antimicrobial agents and chemotherapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 67 citations in OpenAlex.
- Pharmacokinetic Variability of Direct Oral Anticoagulants and Calcium Channel Blockers: A Comparative Analysis of Exposure Data from Clinical Studies.Pharmaceutics · 2026Article
- Safety of combined drug use in patients with cardiovascular and cerebrovascular diseases: an analysis based on the spontaneous reporting database of adverse drug reactions in Hubei Province.Frontiers in pharmacology · 2024Article
- Population pharmacokinetic modelling to quantify the magnitude of drug-drug interactions between amlodipine and antiretroviral drugs.European journal of clinical pharmacology · 2021Article
- Effects of cytochrome P450 oxidoreductase genotypes on the pharmacokinetics of amlodipine in healthy Korean subjects.Molecular genetics & genomic medicine · 2020Article
- Effects of Danshen tablets on pharmacokinetics of amlodipine in rats.Pharmaceutical biology · 2019Article
- A Generic Model for Quantitative Prediction of Interactions Mediated by Efflux Transporters and Cytochromes: Application to P-Glycoprotein and Cytochrome 3A4.Clinical pharmacokinetics · 2019Article
- Effects of triptolide on pharmacokinetics of amlodipine in rats by using LC-MS/MS.Pharmaceutical biology · 2018Article
- Host-targeting therapies for hepatitis C virus infection: current developments and future applications.Therapeutic advances in gastroenterology · 2018Review
- Lipid dysregulation in hepatitis C virus, and impact of statin therapy upon clinical outcomes.World journal of gastroenterology · 2015Review
- Different interaction profiles of direct-acting anti-hepatitis C virus agents with human organic anion transporting polypeptides.Antimicrobial agents and chemotherapy · 2014Article
- Drug interactions and protease inhibitors used in the treatment of hepatitis C: how to manage?European journal of clinical pharmacology · 2014Review
- Drug-drug interactions with oral anti-HCV agents and idiosyncratic hepatotoxicity in the liver transplant setting.Journal of hepatology · 2014Review
- Statin efficacy in the treatment of hepatitis C genotype I.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2014Article
- Drug-drug interactions between HMG-CoA reductase inhibitors (statins) and antiviral protease inhibitors.Clinical pharmacokinetics · 2013Review
- Drug-drug interaction studies: regulatory guidance and an industry perspective.The AAPS journal · 2013Review
- Telaprevir: clinical pharmacokinetics, pharmacodynamics, and drug-drug interactions.Clinical pharmacokinetics · 2013Review
- Case report of successful peginterferon, ribavirin, and daclatasvir therapy for recurrent cholestatic hepatitis C after liver retransplantation.Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society · 2012Article
- Review and management of drug interactions with boceprevir and telaprevir.Hepatology (Baltimore, Md.) · 2012Review
- Managing drug-drug interactions with boceprevir and telaprevir.Clinical liver disease · 2012Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Telaprevir is a hepatitis C virus protease inhibitor that is both a substrate and an inhibitor of CYP3A. Amlodipine and atorvastatin are both substrates of CYP3A and are among the drugs most frequently used by patients with hepatitis C. This study was conducted to examine the effect of telaprevir on atorvastatin and amlodipine pharmacokinetics (PK). This was an open-label, single sequence, nonrandomized study involving 21 healthy male and female volunteers. A coformulation of 5 mg amlodipine and 20 mg atorvastatin was administered on day 1. Telaprevir was taken with food as a 750-mg dose every 8 h from day 11 until day 26, and a single dose of the amlodipine-atorvastatin combination was readministered on day 17. Plasma samples were collected for determination of the PK of telaprevir, amlodipine, atorvastatin, ortho-hydroxy atorvastatin, and para-hydroxy atorvastatin. When administration with telaprevir was compared with administration without telaprevir, the least-square mean ratios (90% confidence limits) for amlodipine were 1.27 (1.21, 1.33) for the maximum drug concentration in serum (C(max)) and 2.79 (2.58, 3.01) for the area under the concentration-time curve from 0 h to infinity (AUC(0-∞)); for atorvastatin, they were 10.6 (8.74, 12.9) for the C(max) and 7.88 (6.84, 9.07) for the AUC(0-∞). Telaprevir significantly increased exposure to amlodipine and atorvastatin, consistent with the inhibitory effect of telaprevir on the CYP3A-mediated metabolism of these agents.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.