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Long‐term treatment of erectile dysfunction with a phosphodiesterase‐5 inhibitor and dose optimization based on nocturnal penile tumescence
Author(s) -
Mathers Michael J.,
Klotz Theodor,
Brandt Alexander S.,
Roth Stephan,
Sommer Frank
Publication year - 2008
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2007.07376.x
Subject(s) - vardenafil , erectile dysfunction , nocturnal penile tumescence , sildenafil , medicine , urology , erectile function , cgmp specific phosphodiesterase type 5 , phosphodiesterase inhibitor , regimen , surgery , tadalafil
Associate Editor Michael G. Wyllie Editorial Board Ian Eardley, UK Jean Fourcroy, USA Sidney Glina, Brazil Julia Heiman, USA Chris McMahon, Australia Bob Millar, UK Alvaro Morales, Canada Michael Perelman, USA Marcel Waldinger, Netherlands OBJECTIVE To test the hypothesis that a variable dosage of the oral phosphodiesterase type 5 (PDE5) inhibitor sildenafil (25, 50, 100 mg) or vardenafil (5, 10, 25 mg) determined according to results obtained from nocturnal penile tumescence and rigidity (NPTR, RigiScan), given nightly for 1 year, can improve spontaneous erectile function (EF) in men with mild‐to‐moderate arteriogenic erectile dysfunction (ED); this regimen was compared with a fixed daily dosage of sildenafil 25 mg or vardenafil 5 mg. PATIENTS AND METHODS In a prospective open‐label, parallel‐group trial 154 men with ED were randomized either to fixed low‐dose sildenafil 25 mg or vardenafil 5 mg (group 1) or to the lowest erectile dosage of sildenafil (25, 50 or 100 mg) or vardenafil (5, 10 or 20 mg) (group 2) provoking an erectile event as measured by NPTR nightly for 1 year. The EF domain of the International Index of Erectile Function (IIEF) was assessed before and 1 year after the beginning of treatment, and at 4 weeks after ending treatment. RESULTS After 1 year, 27 of 63 (64%) evaluable men in group 1 had an EF domain score in the normal range, vs 46 of 61 (75%) men in group 2. After the subsequent 4‐week wash‐out phase, both groups continued to have improved EF domain scores; 22 of 63 (35%) men in group 1 still had a score in the normal range, whereas 38 of 61 (62%) in group 2 had a normal score. The EF domain score in group 1 and 2 improved significantly after 1 year of treatment, from 13.6 to 18.9, and 15.1 to 23.9, respectively ( P < 0.01). After the subsequent 4‐week wash‐out phase, men from both groups maintained this significant level of EF, at 17.1 and 22.4, respectively ( P < 0.05). CONCLUSION Nightly PDE5‐inhibitor treatment 1 year in a dosage determined by NPTR measurements results in better EF than giving a fixed dosage of sildenafil (25 mg) or vardenafil (5 mg). This improvement persisted for >4 weeks beyond the end of treatment. The results from this open‐label, randomized trial warrant verification under double‐blind, placebo‐controlled conditions.