Efficacy and Safety of Mirodenafil in Men Taking Antihypertensive Medications

Jae Seung Paick, Je-Jong Kim, Sae Chul Kim, Ki Hak Moon, Kweon Sik Min, Kwangsung Park, Jun Kyu Suh, Dae Yul Yang

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Introduction: Mirodenafil is a recently developed oral phosphodiesterase type 5 inhibitor, which was observed to significantly improve erectile function and was well tolerated in men with broad-spectrum erectile dysfunction (ED). Aim: To investigate the efficacy and safety of mirodenafil treatment compared with placebo in men taking at least one antihypertensive medication. Methods: A multicenter, double-blind, placebo-controlled, parallel group, fixed-dose study was conducted with 109 subjects who were randomized to placebo or mirodenafil 100 mg for 12 weeks on an " as needed" basis. Main Outcome Measures: The primary efficacy measures were the changes from baseline in sum of scores on International Index of Erectile Function-erectile function domain (IIEF-EF) questions 1 to 5 and 15 with treatment. The secondary efficacy measures included scores on IIEF question 3 and 4 (Q3 and Q4), all domain scores of IIEF, and Sexual Encounter Profile Question 2 and 3 (SEP2 and SEP3) along with responses to Global Assessment Question (GAQ) and Life Satisfaction Checklist (LSC). The safety assessments included laboratory tests, vital signs, 12-lead electrocardiogram recordings, and patients' reporting of adverse events. Results: The mirodenafil group showed significantly greater increase in IIEF-EF scores at 12 weeks compared with the placebo group (9.35 ± 6.86 vs. 2.66 ± 6.44, P < 0.001). The mirodenafil group also demonstrated significantly greater improvement in scores of IIEF Q3 and Q4, other four domains of IIEF, SEP2, SEP3, and LSC along with percentages of patients responding positively to GAQ compared with the placebo group. During the study, no clinically significant changes were observed regarding blood pressure, heart rate, electrocardiographic findings, or laboratory values. Facial flushing and headache were the most common treatment-associated adverse events, which were mild or moderate in severity, resolving spontaneously. Conclusions: Mirodenafil was effective and safe in men with ED concomitantly taking antihypertensive medications.

Original languageEnglish
Pages (from-to)3143-3152
Number of pages10
JournalJournal of Sexual Medicine
Volume7
Issue number9
DOIs
Publication statusPublished - 2010 Jan 1

Fingerprint

Antihypertensive Agents
Safety
Placebos
Erectile Dysfunction
Checklist
Phosphodiesterase 5 Inhibitors
Vital Signs
Headache
mirodenafil
Electrocardiography
Therapeutics
Heart Rate
Outcome Assessment (Health Care)
Blood Pressure

Keywords

  • Antihypertensives
  • Erectile dysfunction
  • Mirodenafil
  • PDE5 inhibitor

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynaecology
  • Urology

Cite this

Paick, J. S., Kim, J-J., Kim, S. C., Moon, K. H., Min, K. S., Park, K., ... Yang, D. Y. (2010). Efficacy and Safety of Mirodenafil in Men Taking Antihypertensive Medications. Journal of Sexual Medicine, 7(9), 3143-3152. https://doi.org/10.1111/j.1743-6109.2010.01926.x

Efficacy and Safety of Mirodenafil in Men Taking Antihypertensive Medications. / Paick, Jae Seung; Kim, Je-Jong; Kim, Sae Chul; Moon, Ki Hak; Min, Kweon Sik; Park, Kwangsung; Suh, Jun Kyu; Yang, Dae Yul.

In: Journal of Sexual Medicine, Vol. 7, No. 9, 01.01.2010, p. 3143-3152.

Research output: Contribution to journalArticle

Paick, JS, Kim, J-J, Kim, SC, Moon, KH, Min, KS, Park, K, Suh, JK & Yang, DY 2010, 'Efficacy and Safety of Mirodenafil in Men Taking Antihypertensive Medications', Journal of Sexual Medicine, vol. 7, no. 9, pp. 3143-3152. https://doi.org/10.1111/j.1743-6109.2010.01926.x
Paick, Jae Seung ; Kim, Je-Jong ; Kim, Sae Chul ; Moon, Ki Hak ; Min, Kweon Sik ; Park, Kwangsung ; Suh, Jun Kyu ; Yang, Dae Yul. / Efficacy and Safety of Mirodenafil in Men Taking Antihypertensive Medications. In: Journal of Sexual Medicine. 2010 ; Vol. 7, No. 9. pp. 3143-3152.
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N2 - Introduction: Mirodenafil is a recently developed oral phosphodiesterase type 5 inhibitor, which was observed to significantly improve erectile function and was well tolerated in men with broad-spectrum erectile dysfunction (ED). Aim: To investigate the efficacy and safety of mirodenafil treatment compared with placebo in men taking at least one antihypertensive medication. Methods: A multicenter, double-blind, placebo-controlled, parallel group, fixed-dose study was conducted with 109 subjects who were randomized to placebo or mirodenafil 100 mg for 12 weeks on an " as needed" basis. Main Outcome Measures: The primary efficacy measures were the changes from baseline in sum of scores on International Index of Erectile Function-erectile function domain (IIEF-EF) questions 1 to 5 and 15 with treatment. The secondary efficacy measures included scores on IIEF question 3 and 4 (Q3 and Q4), all domain scores of IIEF, and Sexual Encounter Profile Question 2 and 3 (SEP2 and SEP3) along with responses to Global Assessment Question (GAQ) and Life Satisfaction Checklist (LSC). The safety assessments included laboratory tests, vital signs, 12-lead electrocardiogram recordings, and patients' reporting of adverse events. Results: The mirodenafil group showed significantly greater increase in IIEF-EF scores at 12 weeks compared with the placebo group (9.35 ± 6.86 vs. 2.66 ± 6.44, P < 0.001). The mirodenafil group also demonstrated significantly greater improvement in scores of IIEF Q3 and Q4, other four domains of IIEF, SEP2, SEP3, and LSC along with percentages of patients responding positively to GAQ compared with the placebo group. During the study, no clinically significant changes were observed regarding blood pressure, heart rate, electrocardiographic findings, or laboratory values. Facial flushing and headache were the most common treatment-associated adverse events, which were mild or moderate in severity, resolving spontaneously. Conclusions: Mirodenafil was effective and safe in men with ED concomitantly taking antihypertensive medications.

AB - Introduction: Mirodenafil is a recently developed oral phosphodiesterase type 5 inhibitor, which was observed to significantly improve erectile function and was well tolerated in men with broad-spectrum erectile dysfunction (ED). Aim: To investigate the efficacy and safety of mirodenafil treatment compared with placebo in men taking at least one antihypertensive medication. Methods: A multicenter, double-blind, placebo-controlled, parallel group, fixed-dose study was conducted with 109 subjects who were randomized to placebo or mirodenafil 100 mg for 12 weeks on an " as needed" basis. Main Outcome Measures: The primary efficacy measures were the changes from baseline in sum of scores on International Index of Erectile Function-erectile function domain (IIEF-EF) questions 1 to 5 and 15 with treatment. The secondary efficacy measures included scores on IIEF question 3 and 4 (Q3 and Q4), all domain scores of IIEF, and Sexual Encounter Profile Question 2 and 3 (SEP2 and SEP3) along with responses to Global Assessment Question (GAQ) and Life Satisfaction Checklist (LSC). The safety assessments included laboratory tests, vital signs, 12-lead electrocardiogram recordings, and patients' reporting of adverse events. Results: The mirodenafil group showed significantly greater increase in IIEF-EF scores at 12 weeks compared with the placebo group (9.35 ± 6.86 vs. 2.66 ± 6.44, P < 0.001). The mirodenafil group also demonstrated significantly greater improvement in scores of IIEF Q3 and Q4, other four domains of IIEF, SEP2, SEP3, and LSC along with percentages of patients responding positively to GAQ compared with the placebo group. During the study, no clinically significant changes were observed regarding blood pressure, heart rate, electrocardiographic findings, or laboratory values. Facial flushing and headache were the most common treatment-associated adverse events, which were mild or moderate in severity, resolving spontaneously. Conclusions: Mirodenafil was effective and safe in men with ED concomitantly taking antihypertensive medications.

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