Cialis ® (tadalafil)

För fullständig produktresumé för Cialis® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Cialis (tadalafil) : Tid till effekt vid behandling av symtom på BPH

Tadalafil 5 mg once daily may help improve the symptoms of BPH within one week, although it may take as long as four weeks to begin working.

The primary outcome measure in studies to evaluate the effect of tadalafil on symptoms of BPH (BPH-LUTS) was the International Prostate Symptom Score (IPSS). The questions of the IPSS ask patients about their urinary symptoms over the past month. A modified version of the IPSS (mIPSS) which has the same questions as the IPSS but which asks patients about their urinary symptoms since their last visit (rather than over the past month) was used in some tadalafil clinical studies to determine the effects of tadalafil 5 mg once daily on symptoms of BPH at 1 or 2 weeks post treatment.


Efficacy at 1 week

In two clinical trials, the change in mIPSS was evaluated at 1 week. In one trial, the mIPSS improved for both tadalafil and placebo groups; however, the difference between the groups was not statistically different. In the other trial, treatment with tadalafil resulted in a statistically significant improvement in the mIPSS compared to placebo after 1 week of treatment (Oelke, 2012; Porst, 2011).


Efficacy at 2 weeks

In one clinical trial, the change in IPSS was evaluated at 2 weeks. In this trial, treatment with tadalafil for 2 weeks resulted in a statistically significant improvement in the mIPSS compared to placebo (Egerdie, 2012).


Efficacy at 4 weeks

In four clinical trials, treatment with tadalafil for 4 weeks resulted in statistically significant improvements in IPSS compared to placebo, and this change was maintained through the 12 week endpoint (Egerdie, 2012; Oelke, 2012; Porst, 2011; Roehrborn, 2008).


REFERENCE


Egerdie RB, Auerbach S, Roehrborn CG, et al. Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo controlled, double blind study. J Sex Med. 2012;9(1):271-281.


Oelke M, Giuliano F, Mirone V, et al. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomized, parallel, placebo-controlled clinical trial. Eur Urol. 2012;61(5):917-925.


Porst H, Kim ED, Casabé AR, et al; for the LVHJ study team. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. Eur Urol. 2011;60(5):1105-13.


Roehrborn CG, McVary KT, Elion-Mboussa A, et al. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol. 2008;180(4):1228-1234.

Datum fӧr senaste ӧversyn 2017 M07 18

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