Daniel Lockhart | PubMed Health

PubMed2005

Sensitivity of the psychological and interpersonal relationship scales to oral therapies for erectile dysfunction.

INTRODUCTION: Studies of erectile dysfunction (ED) therapies typically assess erectile function end- points, although other treatment outcomes may also be of value to men and their partners. Aim. To examine the treatment sensitivity of the Psychological and Interpersonal Relationship Scales (PAIRS) associated with the use of two phosphodiesterase type 5 (PDE5) inhibitors with different duration of action. METHODS: Men with ED were recruited from three clinical trials of tadalafil and sildenafil citrate to complete post-treatment questionnaires that included the PAIRS. In study 1, the PAIRS was assessed after 6 months of open-label tadalafil (20 mg) treatment and after 2 months of real-world sildenafil use (25-100 mg). In studies 2 and 3, the PAIRS was assessed at the end of the trial assessment phase. In study 2, men with a 6-24 week history of sildenafil use (25-100 mg) received 3 weeks of open-label sildenafil treatment (dosage at study entry), and then switched to 9 weeks of tadalafil treatment. In study 3, a double-blind, crossover study, men were randomized to 12 weeks of either tadalafil (20 mg) or sildenafil (50 mg) treatment, followed by 12 weeks of the alternate treatment; PAIRS scores for the second treatment period were evaluated. MAIN OUTCOME MEASURE: Treatment outcomes were assessed with the PAIRS, a new reliable and valid self-report measure of sexual self-confidence, spontaneity, and time concerns before sex. RESULTS: Significant mean differences were observed on all PAIRS domain scores associated with tadalafil and sildenafil treatment. Across studies, men had significantly higher sexual self-confidence and spontaneity scores, and lower time concerns scores in reference to tadalafil compared with their scores in reference to sildenafil. CONCLUSIONS: Mean differences observed on PAIRS domains across studies support the sensitivity of the measure to differentiate between these two ED treatments.

Adult↗

PubMed2004

A multicenter, randomized, double-blind, crossover study to evaluate patient preference between tadalafil and sildenafil.

PURPOSE: To assess patient preference for erectile dysfunction treatment between either sildenafil or tadalafil, each administered with their respective dosing instructions, and to evaluate preference for either sildenafil or tadalafil dosing instructions during tadalafil therapy. METHODS: We conducted a randomized, double-blind, crossover study consisting of four treatment arms. Because the dosing instructions for sildenafil and tadalafil are different, a unique methodology using sham placebo arms was employed to maintain the blind. To assess drug preference, 219 patients were randomized to either sildenafil 50 mg or tadalafil 20 mg, with dosing instructions reflecting their respective product profiles. To assess dosing instruction preference during tadalafil therapy, 46 patients were randomized to tadalafil 20 mg with either tadalafil or sildenafil dosing instructions. After 12 weeks, patients were crossed-over. After 4 weeks of each treatment, all patients following sildenafil dosing instructions were offered the opportunity for an upward dose titration. In a double-blind fashion, all patients who requested an upward titration received additional capsules. To mimic the pattern of dose usage observed in clinical practice, the number of patients who received additional double-blind active medication was limited to 35% of patients taking sildenafil in each treatment period in each country. Following the crossover treatment period, patients chose their preferred double-blind treatment with dosing instructions to receive in the 12-week extension period. RESULTS: In the drug preference assessment, 132 of 181 (73%) evaluable patients chose to receive tadalafil (p < 0.001) during the extension period. In the dosing instruction preference assessment, 24 of 36 (67%) evaluable patients preferred tadalafil with tadalafil dosing instructions (p = 0.046). Sildenafil and tadalafil were well tolerated. CONCLUSIONS: In the doses utilized in this study, 73% of patients preferred tadalafil with tadalafil dosing instructions for the treatment of their erectile dysfunction over sildenafil with sildenafil dosing instructions. During tadalafil therapy, 67% of patients preferred tadalafil dosing instructions over sildenafil dosing instructions.

Adult↗