Beste apotheek van Nederland

stimulation and a challenge test with clomiphene citrate. Twenty-nine percent of men presented
with a reduced LH level and 5 percent with a reduced FSH level. 69
Prevalence of Hypogonadism and Hyperprolactinemia by Age
We descriptively examined patients’ age distribution (mean and range) in individual studies
to determine whether age could account for the between-study differences in the reported
prevalence rates of hypogonadism and hyperprolactinemia. The results did not reveal any
numerical trends between the age distribution and the prevalence rates.
Studies reporting age-stratified prevalence rates of hypogonadism. Buvat et al. 1997 38
reported the prevalence of hypogonadism in patients older than 50 years as being twice as high
as that among patients younger than 50 years (9 percent versus 4 percent). 38 In Fahmy et al.
1999 64 the corresponding rates were 24.2 percent versus 14.3 percent, respectively. In another
study, the prevalence rate in men older than 50 years was 20.25 percent (all patients were older
than 50 years). 73 All three studies indicated higher prevalence of hypogonadism in men aged 50
years or older compared with those under 50 years of age.
Studies reporting age-stratified prevalence rates of hyperprolactinemia or abnormal
levels of LH/ FSH. There was no report providing evidence on prevalence of
hyperprolactinemia, or on abnormal levels of LH/FSH, by age group among patients with ED.
The Efficacy of Hormonal Therapy in Treating Erectile
Dysfunction in Patients with Hormonal Abnormalities
Overview of Trials
Two studies were identified and were judged to be eligible to address the present question.
Both trials were randomized 5,77 comparing the efficacy of combined treatment of testosterone
(gel or patch) plus sildenafil to that of sildenafil alone in ED patients with low testosterone levels
who failed to respond (score of 2–3 on IIEF–Q3/Q4) to prior treatment with sildenafil. More
detailed information on trial design, patient population, and efficacy/harms results for these trials
are presented in the section for Questions 2-3, Hormonal Treatments. (Evidence Table F-9,
Appendix F)
Gel testosterone plus sildenafil versus sildenafil. In this double-blind trial 5 75 hypogonadal
men (mean age: 58 years; total testosterone <400 ng/dL) with ED were randomized to 1 percent
gel testosterone plus 100 mg sildenafil versus 100 mg sildenafil for 12 weeks. At the end of the
study, the proportions of men with scores of 4-5 on IIEF–Q3/Q4 was statistically
nonsignificantly greater in the combination therapy group than in the sildenafil only group (51.4
versus 39.4 percent; RR = 1.30, 95 percent CI 0.77–2.21). Men who received gel testosterone
plus sildenafil also had greater mean change from baseline in the IIEF “EF” domain score at
week 4 (4.4 versus 2.1, 95 percent CI: 0.3–4.7). One patient withdrew from the combination
treatment arm due to an adverse event.
Testosterone patch plus sildenafil versus sildenafil. In this open label trial,77 20
hypogonadal men (mean age:56 years; total testosterone:10-13 nmol/L) with ED were
randomized to receive either 5 mg patch testosterone plus 100 mg sildenafil or 100 mg sildenafil
plus placebo patch. After one month of treatment, patients in the patch testosterone plus
sildenafil group had either numerically or statistically significant improvements for the following
outcomes: “EF domain” score (21.8 +/- 2.1 versus 14.2 +/- 0.7, WMD = 7.60, 95 percent CI:
28