✓ Translated by DotMD AI Clinical Council Source: Clinical therapeutics • Randomized Controlled Trial
Verify Primary Source: NIH PubMed PMID #27422590 ↗

Randomized Controlled Trial: Pharmacokinetic Interaction Between Rosuvastatin, Telmisartan, and Amlodipine in Healthy Male Korean Subjects

Original Paper Title: “Pharmacokinetic Interaction Between Rosuvastatin, Telmisartan, and Amlodipine in Healthy Male Korean Subjects: A Randomized, Open-label, Multiple-dose, 2-period Crossover Study”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Randomized Controlled Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Forty-eight subjects were enrolled, of whom 19 in part 1 and 22 in part 2 completed the study. In Part 1, the 90% CIs of the geometric mean ratios (GMRs) (coadministration of rosuvastatin and telmisartan/amlodipine to monotherapy with rosuvastatin) of the primary pharmacokinetic parameters (AUCτ and Cmax,ss) were: rosuvastatin, 1.1436 to.
  • Study Design & Sample: Randomized Controlled Trial published in Clinical therapeutics (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Clinical therapeutics (2016), this randomized controlled trial evaluating human clinical outcomes investigated: Rosuvastatin, a hydroxy methylglutaryl coenzyme A reductase inhibitor; telmisartan, an angiotensin receptor blocker; and amlodipine, a calcium channel inhibitor, are commonly prescribed together for the treatment of hypertension nonresponsive to monotherapy and accompanied by dyslipidemia. Key clinical takeaway: Forty-eight subjects were enrolled, of whom 19 in part 1 and 22 in part 2 completed the study. In Part 1, the 90% CIs of the geometric mean ratios (GMRs) (coadministration of rosuvastatin and telmisartan/amlodipine to monotherapy with...

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Clinical therapeutics, 2016-08-15; Randomized Controlled Trial; Rigor 82/100): Forty-eight subjects were enrolled, of whom 19 in part 1 and 22 in part 2 completed the study. In Part 1, the 90% CIs of the geometric mean ratios (GMRs) (coadministration of rosuvastatin and telmisartan/amlodipine to monotherapy with rosuvastatin) of the primary pharmacokinetic parameters (AUCτ and Cmax,ss) were: rosuvastatin, 1.1436 to.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Randomized Controlled Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: rosuvastatin-calcium → Rx: rosuvastatin → Rx: telmisartan → Rx: amlodipine-besylate → Condition: pelvic-floor-disorders → Condition: period-pain →
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