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Combined Oral Therapy with Sildenafil and Doxazosin for the Treament Of International Journal of Impotence Research (2002) 14, 50–53 ß 2002 Nature Publishing Group All rights reserved 0955-9930/02 $25.00 www.nature.com/ijir Combined oral therapy with sildenafil and doxazosin for the treament of non-organic erectile dysfunction refractory to sildenafil monotherapy AF De Rose1*, M Giglio1, P Traverso1, P Lantieri2 and G Carmignani1 1Department of Urology, S. Martino Hospital, University of Genoa, Italy; and 2Department of Medical Statistics, S. Martino Hospital, University of Genoa, Italy The purpose of this work was to investigate the efficacy and safety of sildenafil in combination with doxazosin for the treatment of non-organic erectile dysfunction in patients who did not respond to sildenafil. We enrolled 28 patients with non-organic erectile dysfunction, for whom 3 months of sildenafil monotherapy had failed. They were divided in two random and homogeneous groups: 14 were treated with doxazosin (4 mg daily) and sildenafil (100 mg 1 h before sexual intercourse); the other 14 patients received sildenafil and placebo. The results were assessed by means of the IIEF questionnaire before the beginning of the study, after 30 days of therapy and after 60 days. Of the 14 patients treated with doxazosin and sildenafil, 11 (78.6%) showed a statistically significant increase of IIEF; in the placebo group, only one patient (7.1%) recorded a significant IIEF increase. The differences observed in the two groups were statistically very significant (P ¼ 0.0016). Blood pressure did not show significant alterations. Side effects were minimal and even present during sildenafil monotherapy. The combination therapy with sildenafil and doxazosin resulted in the safe and effective treatment of men with non-organic erectile dysfunction for whom sildenafil alone had failed. International Journal of Impotence Research (2002) 14, 50–53. DOI: 10.1038=sj=ijir=3900815 Keywords: erectile dysfunction; drug therapy, combination; administration, oral; doxazosin; sildenafil Introduction efficacy and tolerability of sildenafil are extremely high, failure rates of 30 – 35% are however reported.3,4 The prevalence of erectile disorders in the world’s The inhibitory action of the sympathetic nervous male population has reached high values: according system and of the alpha-adrenergic mediators on to recent epidemiological studies, more than 30 erection have been exhaustively documented;5–7 million men in the United States are affected by good results for ED achieved with alpha-blockers 1 erectile dysfunction (ED) of varying severity. Due to have also been reported after intracavernosal injec- progressive prolongevity, it goes without saying that tion as well as oral administration.8–12 Doxazosin is the impact of this problem will continue to grow. an alpha1-blocker commonly used in the oral The introduction of new oral drugs such as therapy for hypertension and benign prostatic sildenafil has radically transformed the therapeutic hyperplasia, and therefore considered worth trying. approach of ED, reducing the use of other therapeu- The aim of our study was to investigate the tic options such as intracavernosal pharmacother- efficacy and safety of combined sildenafil – doxazo- apy, intraurethral prostaglandin (MUSE), vacuum sin oral therapy for non-organic ED patients who did constrictor devices, vascular surgery and penile not respond to sildenafil monotherapy. prostheses. It has generally been accepted that patients presenting with ED are treated with sildenafil regardless of etiology.2 Even though the Materials and methods During the last year, 28 patients with chronic ED *Correspondence: AF De Rose, Via Donato Somma 77, who had failed at least 12 weeks of sildenafil I-16146, Genova, Italy. E-mail: [email protected] (100 mg) therapy were enrolled in this prospective, Received 29 June 2001; accepted 29 October 2001 randomized and placebo-controlled study. The age Combined oral therapy of non-organic ED AF De Rose et al 51 of patients varied between 36 and 62 y (average 51), with sildenafil þ doxazosin compared with the one while the ED had persisted from 8 months to 3 y. All treated with sildenafil þ placebo. It should be noted patients were referred to our public andrological that the positive progression of the IIEF score vis-a`- office; all were heterosexual, 21 (75%) were married vis the assessment phases (V0, V1 and V2) is highly and 7 (25%) had a stable partner. Exclusion criteria significant (P < 0.0001) and that the response to the included patients with significant cardiovascular pharmacological association between sildenafil and disease, unbalanced diabetes mellitus, neurological doxazosin shows a significant score increases as and psychiatric disorders, previous genitourinary early as the second visit (P ¼ 0.0023). Tables 1 and 2 surgery, or a history of intolerance to alpha-blockers. show results in detail. A normal blood testosterone, a normal nocturnal In two of the 11 patients who responded penile tumescence and rigidity (evaluated by NPTR- positively to the sildenafil – doxazosin association, RigiScan) and normal dynamic duplex ultrasound it was possible to lower sildenafil dosage to 50 mg. were adopted as inclusion criteria. During the In particular, eight of the 11 positive responders dynamic tests, the intracavernosal injection of (72.2%) said that they achieved erection far more 10 mg of prostaglandin E1 (PGE1) produced an easily and without fatigue and of having managed to erection of sufficient stiffness and duration in all keep their penis constantly erect during the entire patients. On the basis of the outcomes of these intercourse. diagnostic tests, we can define the ED as ‘non- Blood pressure monitoring did not point out organic’ or ‘without an identifiable organic aetiol- significant oscillations: 130 mm Hg Æ 10=80 Æ 5at ogy’. We can not nevertheless label these patients as V0 and 120 mm Hg Æ 10=75 Æ 5 at V2. None of the suffering from psychogenic ED, because no psycho- patients mentioned lipothymic episodes. Two pa- metric tests were performed; however none of the tients in the sildenafil – doxazosin group reported patients were afflicted with psychiatric disorders or facial flushing and one a mild headache. One patient were on psychotropic medications. reported heartburn, which was treated with anta- The patients where randomized in two homo- cids. In the placebo group a patient reported mild genous groups: 14 of them received daily doxazosin headache. Of all the reported side effects, heartburn titrated to 4 mg and 100 mg of sildenafil 1 h before was the only addition to the sildenafil – doxazosin sexual intercourse; the other 14 patients, apart from association: all the others were present before the 100 mg of sildenafil before intercourse, received treatment. a placebo instead of doxazosin. The results were assessed by means of the erectile function domain of the IIEF13 questionnaire before Discussion the beginning of the study (V0), after 30 days of therapy (V1) and after 60 days (V2). During treatment, all patients had at least two sexual Today, sildenafil is the therapy of choice for patients encounters weekly. During each clinic visit blood presenting with ED regardless of etiology.2 Recent pressure measurements were taken. The IIEF scores of the two groups were statistically compared with Table 1 Statistical values of IIEF variations relative to the ANOVA; for each group the results during the erectile function during sildenafil – doxazosin therapy. Stratifi- various visits were also assessed using Friedman’s cation by IIEF groups and visit non-parametric test and the corresponding internal IIEF changes. The comparison between the frequency of IIEF cases that responded positively in the two groups groups Patients V0 V1 V2 was carried out using Fischer’s exact probability 6 – 10 3 9.33 Æ 0.58 16.67 Æ 3.21 19.00 Æ 5.00 test. 11 – 16 8 14.38 Æ 1.60 20.50 Æ 3.51 22.00 Æ 2.62 17 – 25 3 19.33 Æ 2.08 19.33 Æ 1.15 19.67 Æ 2.52 Total 14 14.36 Æ 3.69 19.43 Æ 3.30 20.86 Æ 3.23 Results Table 2 Statistical values of IIEF variations relative to the Of the 14 patients treated with doxazosin and erectile function during sildenafil – placebo therapy. Stratification sildenafil, 11 (78.6%) showed a statistically signifi- by IIEF groups and visit cant increase of IIEF, moving on average from 13.0 (V0) to 21.2 (V2). In the placebo group, only one IIEF IIEF patient (7.1%) recorded a significant IIEF increase groups Patients V0 V1 V2 from 12 (V0) to 22 (V2), while all the others experienced no changes in the IIEF score. 6 – 10 4 9.00 Æ 0.82 9.25 Æ 0.96 9.25 Æ 0.96 Result assessment of the two groups in terms of 11 – 16 7 13.43 Æ 1.81 14.14 Æ 2.34 14.29 Æ 3.90 17 – 25 3 19.67 Æ 1.53 18.67 Æ 1.15 18.67 Æ 1.15 IIEF score highlighted a significant difference Total 14 13.50 Æ 4.13 13.71 Æ 3.85 13.50 Æ 4.13 (P ¼ 0.0016) to the advantage of the group treated International Journal of Impotence Research Combined oral therapy of non-organic ED AF De Rose et al 52 studies have confirmed its high efficacy and ex- erections and a constant erection during the entire cellent safety. However, approximately 30 – 35% of intercourse. Side effects did not increase and blood patients treated with this drug in monotherapy did pressure showed no significant alterations. In 2000, not achieve satisfactory results in terms of an Mydlo22 reported that 60 of 65 patients (92%) with improved erectile function.3,4 Most of these silde- ED and minimal or no response to intracavernosal nafil-refractory patients seem to suffer from organic alprostadil or sildenafil monotherapy had satisfac- dysfunction, especially of vascular etiology.14 It has tory responses with combination therapy (sildenafil become acceptable to offer various second-line ED and alprostadil).
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