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Efficacy and safety of sildenafil in Asian males with erectile dysfunction and cardiovascular risk.
J Med Assoc Thai. 2007 Jun; 90(6):1100-8.JM

Abstract

OBJECTIVE

Assess the effectiveness of sildenafil in Asian males with erectile dysfunction (ED) and one or more of the co-morbidities, mild-to-moderate hypertension, dyslipidemia, and diabetes.

MATERIAL AND METHOD

A six-week, double-blind, randomized, placebo-controlled, multicenter study was carried out in Thailand, Malaysia and Singapore. One hundred and fifty five male subjects were randomized (2:1) to sildenafil (n = 104) or placebo (n = 51). Sildenafil was started at 50 mg and increased (100 mg) or decreased (25 mg) at week 2 if necessary.

RESULTS

On the primary efficacy endpoint, sildenafil-treated subjects had significantly better scores on the International Index of Erectile Function (IIEF) questions 3 and 4 than placebo (p < 0.001, both questions). When accumulated into IIEF domains, all five domains were significant in favor of sildenafil. In addition, sildenafil-treated subjects were more satisfied with treatment and had a higher intercourse success rate. The majority of adverse events were mild in severity; the most commonly reported treatment-related events were dizziness (7.7%) and tinnitus (2.9%).

CONCLUSION

Sildenafil (25, 50, and 100 mg) was found to be an effective, safe, and well-tolerated treatment for ED in the present study population of Thai, Malaysian, and Singaporean males who also had increased cardiovascular risk

Authors+Show Affiliations

Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Prannok Rd, Bangkoknoi, Bangkok 10700, Thailand. sipbn@mahidol.ac.thNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17624203

Citation

Buranakitjaroen, Peera, et al. "Efficacy and Safety of Sildenafil in Asian Males With Erectile Dysfunction and Cardiovascular Risk." Journal of the Medical Association of Thailand = Chotmaihet Thangphaet, vol. 90, no. 6, 2007, pp. 1100-8.
Buranakitjaroen P, Mangklabruks A, Leungwattanakij S, et al. Efficacy and safety of sildenafil in Asian males with erectile dysfunction and cardiovascular risk. J Med Assoc Thai. 2007;90(6):1100-8.
Buranakitjaroen, P., Mangklabruks, A., Leungwattanakij, S., Ngaothamatasn, W., Malhotra, C., Chee, C., Mohamed, S. R., & Dato'Johan, R. M. (2007). Efficacy and safety of sildenafil in Asian males with erectile dysfunction and cardiovascular risk. Journal of the Medical Association of Thailand = Chotmaihet Thangphaet, 90(6), 1100-8.
Buranakitjaroen P, et al. Efficacy and Safety of Sildenafil in Asian Males With Erectile Dysfunction and Cardiovascular Risk. J Med Assoc Thai. 2007;90(6):1100-8. PubMed PMID: 17624203.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of sildenafil in Asian males with erectile dysfunction and cardiovascular risk. AU - Buranakitjaroen,Peera, AU - Mangklabruks,Ampica, AU - Leungwattanakij,Somboon, AU - Ngaothamatasn,Weerapatn, AU - Malhotra,Charan, AU - Chee,Christopher, AU - Mohamed,Sahabudin Raja, AU - Dato'Johan,Rohan Malek, AU - ,, PY - 2007/7/13/pubmed PY - 2007/9/20/medline PY - 2007/7/13/entrez SP - 1100 EP - 8 JF - Journal of the Medical Association of Thailand = Chotmaihet thangphaet JO - J Med Assoc Thai VL - 90 IS - 6 N2 - OBJECTIVE: Assess the effectiveness of sildenafil in Asian males with erectile dysfunction (ED) and one or more of the co-morbidities, mild-to-moderate hypertension, dyslipidemia, and diabetes. MATERIAL AND METHOD: A six-week, double-blind, randomized, placebo-controlled, multicenter study was carried out in Thailand, Malaysia and Singapore. One hundred and fifty five male subjects were randomized (2:1) to sildenafil (n = 104) or placebo (n = 51). Sildenafil was started at 50 mg and increased (100 mg) or decreased (25 mg) at week 2 if necessary. RESULTS: On the primary efficacy endpoint, sildenafil-treated subjects had significantly better scores on the International Index of Erectile Function (IIEF) questions 3 and 4 than placebo (p < 0.001, both questions). When accumulated into IIEF domains, all five domains were significant in favor of sildenafil. In addition, sildenafil-treated subjects were more satisfied with treatment and had a higher intercourse success rate. The majority of adverse events were mild in severity; the most commonly reported treatment-related events were dizziness (7.7%) and tinnitus (2.9%). CONCLUSION: Sildenafil (25, 50, and 100 mg) was found to be an effective, safe, and well-tolerated treatment for ED in the present study population of Thai, Malaysian, and Singaporean males who also had increased cardiovascular risk SN - 0125-2208 UR - https://www.unboundmedicine.com/medline/citation/17624203/Efficacy_and_safety_of_sildenafil_in_Asian_males_with_erectile_dysfunction_and_cardiovascular_risk_ L2 - http://www.diseaseinfosearch.org/result/9682 DB - PRIME DP - Unbound Medicine ER -