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Effects of standard and supratherapeutic doses of nelfinavir on cardiac repolarization: a thorough QT study.

Author: ClaxPamela, DamleBharat, FosserCecilia, GluePaul, ItoKaori, TranAnh, UdermanHoward

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

This randomized, 4-way crossover, third-party-blinded study evaluated the effect of nelfinavir on the QTc interval in 68 healthy subjects. Treatments included nelfinavir 1250 mg every 12 hours for 4 days (A), nelfinavir 1250 mg every 12 hours for 3 days plus 3125 mg on day 4 (B), placebo (C), and moxifloxacin 400 mg every 24 hours for 4 days (D). Pharmacokinetics and triplicate 12-lead electrocardiograms were performed over 12 hours on days 1 and 4. Neither dose of nelfinavir had a clinically relevant effect on the QTcF interval on days 4 (primary endpoint) and 1, as the upper 90% confidence limit remained below 10 milliseconds and the mean difference was below 5 milliseconds at each time point. There were no clinically relevant effects on QTcB (Bazett's correction), uncorrected QT, or the RR interval on days 1 or 4. Pharmacokinetics confirmed adequate systemic exposure to nelfinavir and moxifloxacin. Despite higher nelfinavir exposure in poor compared to extensive metabolizers of CYP2C19 isozyme, no significant differences were observed in QTcF change from placebo. At clinically relevant doses, nelfinavir is unlikely to cause QTc prolongation.
Paper Details　
Original Abstract of the Article :
This was a randomized, 4-way crossover, third-party-blinded study in 68 healthy subjects to assess the effect of nelfinavir on QTc interval. Treatments included (A) nelfinavir 1250 mg every 12 hours on days 1-4, (B) nelfinavir 1250 mg every 12 hours on days 1-3 plus 3125 mg on day 4, (C) placebo, an...See full text at original site
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引用元：
https://doi.org/10.1177/0091270008329551

データ提供：米国国立医学図書館（NLM）

Investigating the Heartbeat: Nelfinavir's Impact on Cardiac Repolarization

This study delves into the world of cardiac repolarization, a crucial process for maintaining a steady heartbeat. It's like a well-orchestrated dance where electrical signals travel through the heart, ensuring rhythmic contractions. But sometimes, certain medications can disrupt this delicate dance, leading to irregular heart rhythms. This study focuses on nelfinavir, a medication used to combat HIV, and its potential impact on cardiac repolarization. The researchers used a clever approach, a randomized crossover study, to compare the effects of different doses of nelfinavir with a placebo and a known heart rhythm-altering drug, moxifloxacin. The study's results suggest that nelfinavir, even at higher doses, doesn't have a significant effect on the heart's rhythm. It's like a calm oasis in the midst of a potential storm. This finding is reassuring for patients taking nelfinavir, as it indicates that the drug is unlikely to cause concerning heart rhythm problems.

Nelfinavir: A Heart-Friendly Option?

The study's results are encouraging for both doctors and patients. They demonstrate that nelfinavir, even at therapeutic doses, doesn't seem to cause significant heart rhythm disruptions. This is a vital piece of information for patients who rely on nelfinavir for their health. Imagine a desert traveler relieved to find a reliable oasis in the midst of their journey. This study provides that same reassurance, indicating that nelfinavir can be used safely without causing major disruptions in cardiac rhythm.

A Heartbeat of Hope: Nelfinavir's Potential

This study paints a positive picture of nelfinavir's effect on the heart. It indicates that the drug is unlikely to cause significant heart rhythm issues. This is a crucial piece of information, especially for patients who may have concerns about the potential side effects of medication. It's like finding a hidden spring of fresh water in the desert – a source of hope and reassurance. As we continue to explore the intricate workings of the human body, studies like this provide invaluable insights into the safety and efficacy of medications. This study opens up a world of possibilities for understanding the interactions between medications and the heart, paving the way for safer and more effective treatment options.

Dr. Camel's Conclusion

This study, like a camel navigating a vast desert, has uncovered valuable information about the impact of nelfinavir on the heart. It suggests that nelfinavir is unlikely to cause significant heart rhythm problems. This finding is a beacon of hope for patients, providing reassurance and a sense of security in their treatment journey.

Date :
  1. Date Completed 2009-04-01
  2. Date Revised 2018-12-01
Further Info :

Pubmed ID

19246729

DOI: Digital Object Identifier

10.1177/0091270008329551

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Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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