Hardness, Function, Emotional Well-being, Satisfaction and the Overall Sexual Experience in Men using 100-mg Fixed-dose or Flexible-dose Sildenafil Citrate

P Ströberg; JC Kaminetsky; NC Park; E R Goldfischer; DL Creanga; VJ Stecher


Int J Impot Res. 2010;22(4):284–289 

In This Article

Abstract and Introduction


The prescribing information for sildenafil citrate (VIAGRA, Pfizer, New York, NY, USA) recommends flexible dosing (50 mg initially, adjusted to 100 or 25 mg based on effectiveness and tolerability) in most men with erectile dysfunction (ED). In many men, however, 100 mg may be the most appropriate initial dose because it would reduce the need for titration and could prevent discouragement and treatment abandonment should 50 mg be insufficient. Results of two previously published double-blind, placebo-controlled sildenafil trials of similar design except for a fixed-dose vs flexible-dose regimen were analyzed. Relative to the flexible-dose, approximately one-third more men were satisfied with an initial and fixed dose of 100 mg. In addition, tolerability was similar, and improvements from baseline in outcomes on validated, ED-specific, patient-reported questionnaires were either similar (erectile function and the percentage of completely hard and fully rigid erections) or greater (emotional well-being and the overall sexual experience). The similarity in outcomes is not surprising given that almost 90% of the men in the flexible-dose trial titrated to 100 mg after 2 weeks. These data suggest prescription of an initial dose of 100 mg for men with ED, except in those for whom it is inappropriate.


For most men with erectile dysfunction (ED), the prescribing information for sildenafil citrate (VIAGRA, Pfizer) recommends an initial dose of 50 mg, increased to 100 mg or decreased to 25 mg based on effectiveness and tolerability (flexible dose).[1] However, 100 mg sildenafil produced optimal erection hardness (fully hard and rigid) in a substantial proportion of men with ED.[2] In addition, in dose-optimization studies[3,4] and at the end of double-blind, placebo-controlled (DBPC) treatment in recent reports of flexible-dose trials,[5,6] 100 mg was the dose that was used by most men. Thus, the 100-mg dose may provide some additional benefit beyond that achieved with the 50-mg dose and may be the most appropriate choice for initiation of therapy in many men.

This report assesses erection hardness, erectile function, emotional well-being, satisfaction (disease related and treatment related) and the overall sexual experience in men treated with 100 mg fixed-dose sildenafil and in men treated with flexible-dose sildenafil (50 and 100 mg), using data from two DBPC trials that were similarly designed except for a fixed-dose vs flexible-dose regimen.[7,8] The objective was to assess the efficacy and tolerability of an initial dose of sildenafil 100 mg relative to the flexible-dosage regimen recommended in the prescribing information.


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