H 102 pill
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H 102 Pill: Safety and Efficacy Insights
Introduction to H 102 Pill
The H 102 pill, also known as RHB-102, is a 24-mg bimodal-release formulation of ondansetron. Ondansetron is commonly used to prevent nausea and vomiting caused by various conditions, including chemotherapy, radiation therapy, and surgery. This article synthesizes recent research on the safety and efficacy of the H 102 pill, particularly focusing on its impact on the QT interval, a measure of heart rhythm.
QT Interval and Cardiac Safety
No QT Prolongation with RHB-102
A key concern with ondansetron is its potential to prolong the QT interval, which can lead to serious cardiac arrhythmias. A recent multicenter, double-blind, placebo-controlled trial specifically investigated this issue with the H 102 pill. The study included 147 patients aged 12 and older who presented with symptoms of acute gastroenteritis. The primary safety endpoint was the change in the corrected QT (QTc) interval from baseline to 4 hours post-administration, the time at which ondansetron serum levels peak.
The results showed no significant difference in QTc changes between the RHB-102 group and the placebo group. The mean baseline QTc was 410 ms for the RHB-102 group and 406 ms for the placebo group. Four hours after administration, the QTc change was +4 ms (95% CI 1-8 ms) for the RHB-102 group and +5 ms (95% CI 1-9 ms) for the placebo group. Importantly, no patient in either group experienced a QTc change greater than 60 ms, indicating that RHB-102 does not significantly prolong the QT interval in patients with a normal baseline QTc.
Safety and Tolerability
General Safety Profile
In addition to cardiac safety, the overall safety and tolerability of the H 102 pill were assessed. The study reported that 6.6% of patients in the RHB-102 group had a QTc change greater than 30 ms, compared to 3.6% in the placebo group, a difference that was not statistically significant (p = 0.48). This further supports the conclusion that RHB-102 is safe for use in patients with normal baseline QTc intervals.
Conclusion
The H 102 pill (RHB-102) has been shown to be safe and well-tolerated, with no significant impact on the QT interval in patients with normal baseline QTc. This makes it a viable option for preventing nausea and vomiting without the added risk of cardiac arrhythmias. Further studies could provide additional insights into its long-term safety and efficacy across different patient populations.
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