Populations

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The included trials involved men diagnosed with ED. The total and mean numbers of patients randomly assigned to study interventions or placebo across the 30 trials were 10, 718 and 358, respectively. The number of patients randomly assigned across the trials ranged from 20²³² to 4, 262.²¹⁴

The inclusion criteria in all trials except five ^218, ^222, ^226, ^233, ²³⁹ were: adult males aged ≥ 18 years, diagnosed with ED for ≥ 3 months, and in a stable monogamous heterosexual relationship. The inclusion criteria in two studies^222, ²²⁶ were restricted to patients who either additionally had diabetes (Type I or II)²²⁶ or who had undergone bilateral nerve-sparing retropubic prostatectomy 1–4 years before their enrolment into the trial.²²² In one trial, ²¹⁸ the study population consisted of mostly older men, aged 59–71 years, who had two or more risk factors for coronary artery disease (CAD) (e.g. total cholesterol level > 5.20 mmol/L, diabetes Type II, hypertension > 135/85 mmHg, tobacco smoking, family history). Only 50 percent of these patients had ED. In two other trials^233,²³⁹ the patient populations comprised those with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)²³³ and patients with ED undergoing three-dimensional conformal external-beam radiotherapy (3DCRT) for prostatic carcinoma.²³⁹ In the former trial, ²³³ only 65 percent (183, 281) of the patients had ED. In one trial, ¹⁶³ only PDE-5 naï ve patients were enrolled.

The exclusion criteria in the majority of included trials were pelvic surgery, ^103, ^118, ^121, ^215, ^216, ²¹⁹^–^223, ^225, ^229, ^233, ²³⁵^–²⁴⁰penile/testicular deformity, ^103, ^215, ^216, ^219, ²²¹^–^225, ^227, ^228, ^230, ²³⁴^–^236, ²³⁸ unstable angina/myocardial infarction, ^103, ^118, ^121,^163, ²¹⁵^–^218, ²²⁰^–^222, ^224, ^225, ²²⁷^–^229, ²³²^–²⁴⁰ prostatectomy, ^103, ^216, ^217, ^220, ^221, ²²³^–^225, ²²⁷^–^230, ²³³^–^238, ²⁴⁰ HIV-positivity/AIDS, ^103, ^118, ^121, ²²¹^–^223, ^227, ^229, ^230, ²³⁵^–^238, ²⁴⁰ use of nitrates, ^103, ^118, ^121, ^163, ^214, ^215, ^217, ^219, ^220, ^222, ^227, ^229,^230, ²³²^–^235, ²³⁷^–²⁴⁰ any major hepatic/renal disease, ^103, ^216, ²¹⁹^–^224, ^227, ^228, ^233, ^234, ²³⁶^–^238, ²⁴⁰ previous ineffective treatment with sildenafil, ^216, ^217, ^221, ^223, ^224, ^227, ^229, ^230, ^234, ^235, ²³⁸ stroke, ^103, ^118, ^121, ^214, ^215, ^217, ^219, ^224, ^225, ^228, ²³³^–^235, ^238, ²³⁹endocrine disease, ^103, ^118, ^216, ^221, ^223, ^230, ²³⁴^–^236, ²³⁸ retinitis pigmentosa, ^103, ^118, ^121, ^163, ²²⁸ or a history of cancer.^214, ^215,^219, ^227, ^229, ^230, ^233, ^239, ²⁴⁰ Other exclusion criteria were cancer chemotherapy²³²^–^235, ²³⁷^–²⁴⁰ premature ejaculation, ²³⁴^–^236, ²³⁸spinal cord injury^215, ^219, ²³³^–^235, ²³⁹ uncontrolled hypertension, ^103, ^217, ^233, ^235, ^236, ²³⁸ use of alpha-blockers/androgens, ^163, ²³⁸and diabetes.^216, ²²¹^–^223, ^233, ^234, ²³⁶ One trial additionally excluded patients with prostate-specific antigen levels > 10 ng/mL.²³³None of the trials failed to report exclusion criteria.

The mean age of the study participants across the included trials ranged from 46²¹⁹ to 69²³⁹ years. The patients' race was not reported in eight trials.²¹⁷^–^219, ^223, ^228, ^229, ^232, ²³⁹ Three trials included Southeast Asian, ^236, ^237, ²⁴⁰ one trial Japanese, ²³⁸ and one trial Turkish and Egyptian patients.²³⁴ The approximate proportion of Caucasians in the remaining 17 trials ranged from 73 percent²²⁴ to 100 percent.^163, ²²⁰ The duration of ED of patients was not reported in four trials.^218, ^219, ^221, ²²² In 24 of the remaining 26 trials, ^103, ^118, ^121, ²¹⁴^–^217, ^220, ²²³^–^230, ²³²^–^238, ²⁴⁰ eligible patients had to have been diagnosed with ED for at least 3 months before their enrolment into the trial. In two trials, patients had been diagnosed with ED for at least 6¹⁶³ and 12 months²³⁹before trial enrolment. In 22 trials, the majority of patients (≥ 70 percent) had been diagnosed with ED for at least 1 year before trial entry.^103, ^118, ^121, ²¹⁴^–^217, ^220, ²²³^–^227, ^229, ^230, ²³⁴^–²⁴⁰

The most commonly reported comorbidities among study participants were diabetes, ^103, ^118, ^163, ²¹⁴^–^217, ^220, ^221, ^223, ^224, ²²⁶^–^230,^232, ²³⁴^–^238, ²⁴⁰ hypertension, ^103, ^118, ^163, ²¹⁴^–^217, ^220, ^223, ^224, ²²⁶^–^230, ^232, ²³⁴^–²⁴⁰ coronary artery disease (CAD), ^103, ^118, ^163,^214, ^215, ^217, ^221, ^224, ^228, ^229, ²³⁵ hyperlipidemia, ^163, ^214, ^216, ^217, ^223, ^224, ^226, ^227, ^229, ^230, ^232, ^234, ^235, ^237, ^238, ²⁴⁰ BPH, ^223, ^224,^233, ^234, ²³⁶^–^238, ²⁴⁰ and depression.^103, ^118, ^214, ^224, ^230, ²³⁵ The presence or absence of comorbidities could not be ascertained for six trials.^121, ^218, ^219, ^222, ^225, ²³³ In three trials, ^103, ^215, ²³⁹ the proportion of ED patients with diabetes was below 10 percent; in five trials, ^216, ^220, ^223, ^235, ²³⁷ this proportion ranged from 11 percent²²⁰ to 14 percent; ²³⁵ in four trials^118, ^214, ^224, ²⁴⁰ it ranged from 17 percent^118, ²²⁴ to 18 percent; ^214, ²⁴⁴^–²⁴⁷ and in 10 trials^217, ^221, ²²⁷^–^230, ^232, ^234, ^236, ²³⁸ the proportion ranged from 20 percent^217, ^227, ²³² to 31 percent.²³⁶ In two trials^234, ²⁴⁰ the proportion of ED patients with hypertension ranged from 14 percent²⁴⁰to 17 percent.²³⁴ In other 12 trials^103, ^118, ^214, ^218, ^220, ²²⁷^–^229, ^232, ²³⁷^–²³⁹ this proportion ranged from 20 percent ²³² to 29 percent, ²²⁸ and in eight trials²¹⁵^–^217, ^223, ^224, ^230, ^235, ²³⁶ from 30 percent ^216, ²³⁶ to 43 percent.²³⁵ The remaining eight trials^121,^163, ^219, ^221, ^222, ^225, ^226, ²³³ failed to report the proportion of hypertensive patients. The proportion of ED patients with CAD in six trials^103, ^118, ^214, ^215, ^224, ^229, ²⁴¹ was below 10 percent, and in three trials^217, ^228, ²³⁵ it ranged around 10–11 percent. The proportion of patients with CAD could not be ascertained from the remaining 21 trials.

The approximate proportion of smokers was ascertained for 17 trials, ^103, ^118, ^121, ^214, ^215, ²¹⁷^–^221, ^225, ²²⁷^–^229, ^232, ^234, ²³⁸ and ranged from 15–16 percent ^215, ²¹⁷ to 37–40 percent.^229, ²³⁸ The authors of 13 trials^163, ^216, ²²²^–^224, ^226, ^230, ^233, ²³⁵^–^237, ^239, ²⁴⁰did not report the proportion of smokers.

The majority of the trials included patients with ED of all three etiologic groups (i.e., organic, psychogenic, and mixed.^103, ^118, ^121,^163, ²¹⁴^–^217, ^219, ^220, ²²³^–^225, ²²⁷^–^229, ^232, ²³⁴^–^238, ²⁴⁰ In eight trials^118, ²¹⁵^–^217, ^227, ^229, ^234, ²³⁵ the proportion of patients with ED of psychogenic origin was below 10 percent, whereas in 13 other trials^103, ^121, ^214, ^219, ^220, ²²³^–^225, ^228, ²³⁶^–^238, ²⁴⁰ this proportion ranged from about 10 percent ²²⁴ to 29 percent.²³⁸

The approximate proportion of patients with severe ED (IIEF “EF” domain score: 1–10) across 24 trials^103, ^118, ^121, ²¹⁴^–^217, ²¹⁹^–^225,²²⁷^–^230, ²³⁴^–^238, ²⁴⁰ ranged from 18–23 percent ^223, ^228, ²⁴⁰ to 50–52 percent.^217, ²²² In 14 trials, ^103, ²¹⁴^–^216, ²¹⁹^–^221, ^224, ^225, ^227,^230, ^235, ^237, ²³⁸ the approximate proportion of patients with severe ED ranged from 30–32 percent ^103, ^237, ²⁴¹ to 40–42 percent.^220, ^224, ²³⁵ In seven trials, ^118, ^121, ^223, ^228, ^229, ^234, ²³⁶ this proportion was from 20 to 30 percent. The proportion of patients by ED severity groups was not reported in six trials.^163, ^218, ^226, ^232, ^233, ²³⁹

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