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An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy.

Bai WJ, Li HJ, Dai YT, He XY, Huang YR, Liu JH, Sorsaburu S, Ji C, Jin JJ, Wang XF - Asian J. Androl. (2015 Jan-Feb)

Bottom Line: The SEP2 (penetration), SEP3 (successful intercourse), and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups.After tadalafil and sildenafil treatments, more Chinese men with ED naοve to PDE5 inhibitor preferred tadalafil.Both sildenafil and tadalafil treatments were effective and safe.

View Article: PubMed Central - PubMed

Affiliation: Department of Urology, People's Hospital of Peking University, Beijing, China.

ABSTRACT
The study was to compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in Chinese men naοve to phosphodiesterase 5 (PDE5) inhibitor therapies. This multicenter, randomized, open-label, crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil. After a 4 weeks baseline assessment, 383 eligible patients were randomized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension. Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Questionnaire (PITPQ). Secondary efficacy was analyzed by PITPQ Question 2, the International Index of Erectile Function (IIEF) erectile function (EF) domain, sexual encounter profile (SEP) Questions 2 and 3, and the Drug Attributes Questionnaire. Three hundred and fifty men (91%) completed the randomized treatment phase. Two hundred and forty-two per 350 (69.1%) patients preferred 20-mg tadalafil, and 108/350 (30.9%) preferred 100-mg sildenafil (P < 0.001) as their treatment in the 8 weeks extension. Ninety-two per 242 (38%) patients strongly preferred tadalafil and 37/108 (34.3%) strongly the preferred sildenafil. The SEP2 (penetration), SEP3 (successful intercourse), and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups. For patients who preferred tadalafil, getting an erection long after taking the medication was the most reported reason for tadalafil preference. The only treatment-emergent adverse event reported by > 2% of men was headache. After tadalafil and sildenafil treatments, more Chinese men with ED naοve to PDE5 inhibitor preferred tadalafil. Both sildenafil and tadalafil treatments were effective and safe.

No MeSH data available.


Related in: MedlinePlus

IIEF domain change (LS mean). *Analyses were conducted on an intent-to-treat basis for all randomized patients with baseline and at least one postbaseline outcome. Note: the estimate and 95% confidence interval for difference between tadalafil and sildenafil on IIEF domain score change were from a crossover analysis of variance model, which contained terms for centered baseline score, treatment, pooled site, period, sequence and centered baseline-by-treatment interaction (if P < 0.1). IIEF: International Index of Erectile Function.
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Figure 4: IIEF domain change (LS mean). *Analyses were conducted on an intent-to-treat basis for all randomized patients with baseline and at least one postbaseline outcome. Note: the estimate and 95% confidence interval for difference between tadalafil and sildenafil on IIEF domain score change were from a crossover analysis of variance model, which contained terms for centered baseline score, treatment, pooled site, period, sequence and centered baseline-by-treatment interaction (if P < 0.1). IIEF: International Index of Erectile Function.

Mentions: Figure 4 demonstrates the point estimates and 95% CIs for the differences (tadalafil minus sildenafil) in the least-square mean change from baseline on each of the five IIEF domains.


An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy.

Bai WJ, Li HJ, Dai YT, He XY, Huang YR, Liu JH, Sorsaburu S, Ji C, Jin JJ, Wang XF - Asian J. Androl. (2015 Jan-Feb)

IIEF domain change (LS mean). *Analyses were conducted on an intent-to-treat basis for all randomized patients with baseline and at least one postbaseline outcome. Note: the estimate and 95% confidence interval for difference between tadalafil and sildenafil on IIEF domain score change were from a crossover analysis of variance model, which contained terms for centered baseline score, treatment, pooled site, period, sequence and centered baseline-by-treatment interaction (if P < 0.1). IIEF: International Index of Erectile Function.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4291880&req=5

Figure 4: IIEF domain change (LS mean). *Analyses were conducted on an intent-to-treat basis for all randomized patients with baseline and at least one postbaseline outcome. Note: the estimate and 95% confidence interval for difference between tadalafil and sildenafil on IIEF domain score change were from a crossover analysis of variance model, which contained terms for centered baseline score, treatment, pooled site, period, sequence and centered baseline-by-treatment interaction (if P < 0.1). IIEF: International Index of Erectile Function.
Mentions: Figure 4 demonstrates the point estimates and 95% CIs for the differences (tadalafil minus sildenafil) in the least-square mean change from baseline on each of the five IIEF domains.

Bottom Line: The SEP2 (penetration), SEP3 (successful intercourse), and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups.After tadalafil and sildenafil treatments, more Chinese men with ED naοve to PDE5 inhibitor preferred tadalafil.Both sildenafil and tadalafil treatments were effective and safe.

View Article: PubMed Central - PubMed

Affiliation: Department of Urology, People's Hospital of Peking University, Beijing, China.

ABSTRACT
The study was to compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in Chinese men naοve to phosphodiesterase 5 (PDE5) inhibitor therapies. This multicenter, randomized, open-label, crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil. After a 4 weeks baseline assessment, 383 eligible patients were randomized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension. Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Questionnaire (PITPQ). Secondary efficacy was analyzed by PITPQ Question 2, the International Index of Erectile Function (IIEF) erectile function (EF) domain, sexual encounter profile (SEP) Questions 2 and 3, and the Drug Attributes Questionnaire. Three hundred and fifty men (91%) completed the randomized treatment phase. Two hundred and forty-two per 350 (69.1%) patients preferred 20-mg tadalafil, and 108/350 (30.9%) preferred 100-mg sildenafil (P < 0.001) as their treatment in the 8 weeks extension. Ninety-two per 242 (38%) patients strongly preferred tadalafil and 37/108 (34.3%) strongly the preferred sildenafil. The SEP2 (penetration), SEP3 (successful intercourse), and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups. For patients who preferred tadalafil, getting an erection long after taking the medication was the most reported reason for tadalafil preference. The only treatment-emergent adverse event reported by > 2% of men was headache. After tadalafil and sildenafil treatments, more Chinese men with ED naοve to PDE5 inhibitor preferred tadalafil. Both sildenafil and tadalafil treatments were effective and safe.

No MeSH data available.


Related in: MedlinePlus