Efficacy of sildenafil at 12 hours after its intake: Re-exploring the therapeutic window

Moncada, Ignacio; Jara, Jessica; Subirá, D.; Moralejo, M.; Benavente, R. Cabello; Hernandez, Christian

doi:10.1016/s1569-9056(03)80375-5

Cited by 4 publications

(4 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The median for the IIEF at the in-take visit was 17 (percentile 10-90: [11][12][13][14][15][16][17][18][19][20][21][22][23], and there were no significant differences between groups of treatment order (P = 0.277). In short, there was good intergroup heterogeneity.…”

Section: Resultsmentioning

confidence: 94%

“…Numerous studies back up the efficacy and tolerance of the three PDE-5 inhibitors in the treatment of erectile dysfunction [13][14][15][16][17][18][19][20]; but, these are only two of the factors that are involved in a person's decision to continue using a given treatment. There are other issues, such as the couple's relationship, privacy, and quality of life [21][22][23][24], that can tip the balance to one side or the other when deciding.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Prospective, Randomized, Open-Label, Fixed-Dose, Crossover Study to Establish Preference of Patients with Erectile Dysfunction After Taking the Three PDE-5 Inhibitors

Tolrá

Campaña

Ciutat

et al. 2006

The Journal of Sexual Medicine

View full text Add to dashboard Cite

Introduction We conducted a prospective, randomized, open-label, fixed-dose preference study, with a crossover design, using sildenafil, vardenafil, and tadalafil. Aim To assess patient preference for sildenafil (100 mg), vardenafil (20 mg), and tadalafil (20 mg) for the treatment of erectile dysfunction. Secondary objectives included finding out whether patients would follow treatment with a second or third option, in the event that the preferred drug was not available, and to assess side effects. Main Outcome Measures Patient preference for any treatment, and evaluation of the elements that patients would assess when choosing one of these drugs. Material and Methods Sildenafil (100 mg), vardenafil (20 mg), and tadalafil (20 mg) were taken at least six times over a period of 45–60 days with a washout period of 7 days. A total of 132 patients were enrolled to achieve a valid sample of 90 cases (15 per randomized group, total of six groups). Enrolled patients had mild to moderate erectile function. Results The International Index of Erectile Function (IIEF) score improved from baseline and was statistically significant in all cases (P < 0.0001). When we compared the IIEF scores, we found a statistically significant difference between tadalafil and vardenafil (P = 0.0002) favoring the former; similar results were obtained with the Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) Questionnaire (P = 0.000075). We also found a significant difference (P = 0.012) between tadalafil and sildenafil, again in favor of the former. In assessing drug preference, 25 patients (27.77%) chose sildenafil, 18 (20%) vardenafil, and 47 (52.22%) tadalafil. A total of 94% of patients would be willing to take another drug if the preferred choice was not available. All drugs were well tolerated. Conclusions Although this is a preference study based on subjective elements, statistically significant differences comparing the IIEF score and the EDITS Questionnaire lead us to believe that beyond patients’ subjective preference per se, said preference is probably also based on a genuinely superior response to one drug over another.

show abstract

Section: Resultsmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Prospective, Randomized, Open-Label, Fixed-Dose, Crossover Study to Establish Preference of Patients with Erectile Dysfunction After Taking the Three PDE-5 Inhibitors

Tolrá

Campaña

Ciutat

et al. 2006

The Journal of Sexual Medicine

View full text Add to dashboard Cite

show abstract

“…On the other hand, in our experience, 16 SCI patients using sildenafil reported the ability to have sexual intercourse successfully two or more times within 24 h of dosing, and consequently, we advised our patients to make multiple attempts for up to 24 h without taking another tablet. Recently, Moncada et al 17 reported that of the total 40 patients 74% reported a successful erection 12 h after the intake of the drug, so it would be likely that the inhibition of the PDE5 activity that sildenafil caused should be much longer lasting than the half-life of the drug in the blood, and so the duration of action of sildenafil is not well-known. Although various studies reported the undoubtedly superior pharmacokinetic properties of tadalafil compared to other PDE5 inhibitors such as sildenafil and vardenafil in men, these findings should be interpreted with caution, because at this time it is unclear how much of a positive impact the pharmacokinetic profile could have on clinical effectiveness, especially in SCI patients.…”

Section: Introductionmentioning

confidence: 99%

Time/duration effectiveness of sildenafil versus tadalafil in the treatment of erectile dysfunction in male spinal cord-injured patients

Popolo¹,

Marzi²,

Mondaini³

et al. 2004

Spinal Cord

View full text Add to dashboard Cite

show abstract

“…PDE5 inhibitors have revolutionized the treatment of erectile dysfunction (ED). The currently available drugs—sildenafil, vardenafil, and tadalafil—are all relatively safe and highly effective [1–8]. Differences have been noted, however, among the pharmacokinetic properties of each drug, such as C max (maximum plasma concentration), t max (time to C max ), and half‐life, which may result in differences in the pharmacodynamic properties of each drug, such as minimal time to onset of action and duration of action.…”

Section: Introductionmentioning

confidence: 99%

Determining the Earliest Time Within 30 Minutes to Erectogenic Effect After Tadalafil 10 and 20 mg: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, At-Home Study

Rosen

Padma‐Nathan²,

Shabsigh

et al. 2004

The Journal of Sexual Medicine

View full text Add to dashboard Cite

Introduction Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of erectile dysfunction (ED). The minimal time to onset of erectogenic effect in the at-home setting has not been evaluated. Aim The goal was to determine the earliest time to erectogenic effect leading to successful intercourse within 30 minutes after taking tadalafil 10 and 20 mg. Methods The multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase-2 study enrolled men at least 21 years old with a minimum 3-month history of ED. Four single doses each of placebo, tadalafil 10 mg, or 20 mg were taken at home once every 8–10 days. Using a stopwatch, couples recorded in Sexual Encounter Profile diaries the earliest time within 30 minutes after dosing to the first erection adequate for vaginal penetration, and whether the erection led to successful intercourse. Main Outcome Measures The primary analysis compared the percentage of erections resulting in successful intercourse between tadalafil groups and placebo at one-minute intervals using a step-down procedure. A secondary analysis compared the overall distribution of time to erectogenic effect between treatment groups using the Cox Regression Method. Results Compared to placebo, a significant erectogenic response to tadalafil 20 mg was found from 30 minutes down to 16 minutes after dosing (P = 0.012). Response to tadalafil 10 mg approached significance (P = 0.054) at 30 minutes. As analysed by the Cox Regression Method, a significant erectogenic response was found from 30 minutes down to 15 minutes after dosing for tadalafil 20 mg (P = 0.020), and from 30 minutes down to 26 minutes for tadalafil 10 mg (P = 0.042). Fifty-two percent of men taking tadalafil 20 mg had at least one successful intercourse attempt within 30 minutes compared to 35.1% of men taking placebo (P = 0.038). Conclusions This stopwatch-based study demonstrated a pharmacodynamic effect within 30 minutes after dosing for tadalafil 10 and 20 mg.

show abstract

Efficacy of sildenafil at 12 hours after its intake: Re-exploring the therapeutic window

Cited by 4 publications

References 0 publications

Prospective, Randomized, Open-Label, Fixed-Dose, Crossover Study to Establish Preference of Patients with Erectile Dysfunction After Taking the Three PDE-5 Inhibitors

Prospective, Randomized, Open-Label, Fixed-Dose, Crossover Study to Establish Preference of Patients with Erectile Dysfunction After Taking the Three PDE-5 Inhibitors

Time/duration effectiveness of sildenafil versus tadalafil in the treatment of erectile dysfunction in male spinal cord-injured patients

Determining the Earliest Time Within 30 Minutes to Erectogenic Effect After Tadalafil 10 and 20 mg: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, At-Home Study

Contact Info

Product

Resources

About