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Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt.
J Sex Med. 2009 Oct; 6(10):2826-35.JS

Abstract

INTRODUCTION

Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy.

AIM

Assess the tolerability and efficacy of sildenafil initiated at the 100-mg dose in men with ED.

METHODS

Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function) who had received < or =6 total doses of a phosphodiesterase type 5 inhibitor and none within 4 weeks were randomized to 8 weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo) followed by 4 weeks of open-label flexible-dose sildenafil (50 or 100 mg).

MAIN OUTCOME MEASURES

Efficacy, tolerability, treatment satisfaction, and other end points were measured at baseline and/or the end of the double-blind and open-label phases and compared between placebo and sildenafil initiated at doses of 50 and 100 mg.

RESULTS

Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and 100 mg compared with placebo. At the end of DBPC treatment, 56% of men on the 100-mg dose felt no anxiety about the next intercourse attempt compared with 39% in the 50-mg group (odds ratio 2.03; P = 0.0197). Changes in functional scores from baseline were not statistically significant with the 100-mg dose compared with the 50-mg dose in the DBPC. Measures of treatment satisfaction and sexual experience significantly favored the 100-mg dose compared with the 50-mg dose in the DBPC. There was no increase in adverse events with the higher dose.

CONCLUSIONS

Sildenafil at 50 mg or 100 mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Sildenafil 100 mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the 50-mg dose.

Authors+Show Affiliations

Department of Urology, Russian Medical Academy of Postgraduate Education, 2nd Botkinsky Street, 5 Moscow Russian Federation 125101, Moscow, Russia. urosurfer@mail.ruNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19817982

Citation

Loran, Oleg B., et al. "Sildenafil Citrate 100 Mg Starting Dose in Men With Erectile Dysfunction in an International, Double-blind, Placebo-controlled Study: Effect On the Sexual Experience and Reducing Feelings of Anxiety About the Next Intercourse Attempt." The Journal of Sexual Medicine, vol. 6, no. 10, 2009, pp. 2826-35.
Loran OB, Ströberg P, Lee SW, et al. Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt. J Sex Med. 2009;6(10):2826-35.
Loran, O. B., Ströberg, P., Lee, S. W., Park, N. C., Kim, S. W., Tseng, L. J., Collins, S., & Stecher, V. J. (2009). Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt. The Journal of Sexual Medicine, 6(10), 2826-35. https://doi.org/10.1111/j.1743-6109.2009.01428.x
Loran OB, et al. Sildenafil Citrate 100 Mg Starting Dose in Men With Erectile Dysfunction in an International, Double-blind, Placebo-controlled Study: Effect On the Sexual Experience and Reducing Feelings of Anxiety About the Next Intercourse Attempt. J Sex Med. 2009;6(10):2826-35. PubMed PMID: 19817982.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt. AU - Loran,Oleg B, AU - Ströberg,Peter, AU - Lee,Sung Won, AU - Park,Nam Cheol, AU - Kim,Soo-Woong, AU - Tseng,Li-Jung, AU - Collins,Suzanne, AU - Stecher,Vera J, PY - 2009/10/13/entrez PY - 2009/10/13/pubmed PY - 2010/11/5/medline SP - 2826 EP - 35 JF - The journal of sexual medicine JO - J Sex Med VL - 6 IS - 10 N2 - INTRODUCTION: Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy. AIM: Assess the tolerability and efficacy of sildenafil initiated at the 100-mg dose in men with ED. METHODS: Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function) who had received < or =6 total doses of a phosphodiesterase type 5 inhibitor and none within 4 weeks were randomized to 8 weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo) followed by 4 weeks of open-label flexible-dose sildenafil (50 or 100 mg). MAIN OUTCOME MEASURES: Efficacy, tolerability, treatment satisfaction, and other end points were measured at baseline and/or the end of the double-blind and open-label phases and compared between placebo and sildenafil initiated at doses of 50 and 100 mg. RESULTS: Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and 100 mg compared with placebo. At the end of DBPC treatment, 56% of men on the 100-mg dose felt no anxiety about the next intercourse attempt compared with 39% in the 50-mg group (odds ratio 2.03; P = 0.0197). Changes in functional scores from baseline were not statistically significant with the 100-mg dose compared with the 50-mg dose in the DBPC. Measures of treatment satisfaction and sexual experience significantly favored the 100-mg dose compared with the 50-mg dose in the DBPC. There was no increase in adverse events with the higher dose. CONCLUSIONS: Sildenafil at 50 mg or 100 mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Sildenafil 100 mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the 50-mg dose. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/19817982/Sildenafil_citrate_100_mg_starting_dose_in_men_with_erectile_dysfunction_in_an_international_double_blind_placebo_controlled_study:_effect_on_the_sexual_experience_and_reducing_feelings_of_anxiety_about_the_next_intercourse_attempt_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)32273-6 DB - PRIME DP - Unbound Medicine ER -