Transl Clin Pharmacol.  2016 Jun;24(2):90-95. 10.12793/tcp.2016.24.2.90.

Effects of mirodenafil on the hemodynamics in hypertensive patients taking amlodipine

• Choi HK
• Shim EJ
• Shon J
• Jung JA
• Ghim JL
• Ryu JH
• Bae KS
• Shin JG

• KMID: 2290475
• DOI: http://doi.org/10.12793/tcp.2016.24.2.90

Abstract

While phosphodiesterase type 5 inhibitors have been used for erectile dysfunction with acceptable safety profile, they can induce orthostatic hypotension in patients taking antihypertensive drugs with blood pressure lowering effect. This study evaluated the hemodynamic effects of 100 mg mirodenafil in hypertensive patients taking an amlodipine. Thirteen hypertensive patients who were taking 5 or 10 mg of amlodipine once daily participated in a randomized, double-blind, placebo-controlled, crossover study. A single oral dose of mirodenafil 100 mg or placebo was administered at 4.5 hour after administration of amlodipine. The maximal change in systolic and diastolic blood pressure (ΔmaxSBP and ΔmaxDBP) and pulse rate (ΔmaxPR) were compared between mirodenafil and placebo periods. Twelve patients completed this study and were included analysis. The values of ΔmaxPR in standing and supine position were significantly greater in the mirodenafil period (13.25±7.12 and 11.17±4.86 beats/minute) when compared to the placebo (8.50±4.72 and 6.58±3.90 beats/minute). The ΔmaxSBP and ΔmaxDBP in standing position appeared to be lower in the mirodenafil period, but they were not statistically different from those in the placebo period (ΔmaxSBP = -7.42±5.6 vs -4.42±5.37 mmHg and ΔmaxDBP = -7.17±5.72 vs -3.50±3.37 mmHg). Both ΔmaxSBP and ΔmaxDBP in standing and supine position were not significantly different between mirodenafil and placebo. This study demonstrated that mirodenafil exerted minimal hemodynamic effects in the patients taking amlodipine, that is unlikely associated with a clinically significant hypotensive event.

Keyword

mirodenafil; amlodipine; hemodynamics; PDE5 inhibitor

MeSH Terms

Amlodipine*
Antihypertensive Agents
Blood Pressure
Cross-Over Studies
Erectile Dysfunction
Heart Rate
Hemodynamics*
Humans
Hypotension, Orthostatic
Male
Phosphodiesterase 5 Inhibitors
Posture
Supine Position
Amlodipine
Antihypertensive Agents
Phosphodiesterase 5 Inhibitors

Figure

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  Figure 1. Effects of mirodenafil on hemodynamic variables while standing. Mean systolic (a) and diastolic (b) blood pressure, and pulse rate (c) following administration of amlodipine. Mirodenafil or placebo was administered at 4.5 h. All data are reported±standard deviations.

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  Figure 2. Effects of mirodenafil on hemodynamic variables while supine. Mean systolic (a) and diastolic (b) blood pressure, and pulse rate (c) following administration of amlodipine. Mirodenafil or placebo was administered at 4.5 h. All data are reported±standard deviations.

Reference

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