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N for the satisfaction question (“Are you satisfied with the effect of treatment on your erections?”) is equal to the number of men who answered. *Some of the discontinued subjects supplied satisfaction data.

At the time female viagra cheap the study started, the FDA stated that there were sufficient routine safety data on sildenafil to make collection of standard adverse event data unnecessary. Therefore, only serious adverse events and adverse events leading to changes in dosing or to temporary or permanent discontinuation were recorded and evaluated by the investigators for relatedness to sildenafil treatment.

Because the major focus of this study was safety, and it was designed before the development and validation of patient-reported outcomes to assess satisfaction with the quality of erection (eg, Quality of Erection Questionnaire (Porst et al 2007)) or satisfaction with ED treatment (eg, the Erectile Dysfunction Inventory of Treatment Satisfaction (Althof et al 1999)), effectiveness was assessed by asking, at yearly intervals or at discontinuation, simple, unvalidated general efficacy questions, “Are you satisfied with the effect of treatment on your erections?” and “If yes, has treatment improved your ability to engage in sexual activity?” The second question was based on the ED definition of the National Institutes of Health Consensus Conference: “…inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.” (NIH Consensus Conference. NIH Consensus Development Panel on Impotence 1993).

Overall, 979 men initially agreed to participate in the study, most of whom were white (89%) and

whose

years

The duration of the double-blind trials plus initial open-label extension was 0.9 to 1.2 years (48–60 weeks).

Median duration of participation in the open-label, long-term extension study was 4 years, the median number of doses taken was 420 (range, 1–1469) ( Figure 2 ), and the preferred dose was 100 mg in more than 88% of the men.

The retention rate was 84% (818/979) the first year, 75% (731/979) the second year, and 66% (648/979) the third year; the entire 4-year extension study was completed by 584 of the initial 979 men (60%) ( Figure 1 ).

Reasons for discontinuation included loss of interest in participation in a clinical study, loss of sexual partner, loss to follow-up, ability to afford sildenafil after approval (thus, no longer needing to participate in a clinical study to obtain the medication), insufficient clinical response, and adverse events. Usage of flexible-dose (25, 50, and 100 mg) sildenafil over 2–1561 days by the 979 participants who entered the study.

Age, mean (range) years 58.2 (27–82) Weight, mean (range) kg 89.2 (53.5–158.8) Race, n (%) White 873 (89.2) Black 68 (6.9) Asian 8 (0.8) Other 30 (3.1) ED duration, mean (range) years 4.5 (0.1–35.8) ED etiology, % organic/mixed/psychogenic 72/17/11 Common concomitant medical conditions, n (%) Hypertension 272 (27.8) Diabetes mellitus 213 (21.8) Hyperlipidemia 139 (14.2) History of ischemic heart disease 83 (8.5) Tolerability.

Over the 4-year study period, 37 (3.8%) of the men had 1 or more adverse events that led to changes in dosing or cheap prescription viagra to temporary or permanent discontinuation and were determined by the investigators to be treatment-related ( Table 2 ). Of the 47 events, headache and dyspepsia were most common (n = 10 each), followed by rhinitis (n = 6), flushing (n = 5), abnormal vision (n = 4), dizziness (n = 3), and 1 report each of mild palpitations, moderate tachycardia, diarrhea, nausea, myalgia, hypertonia, respiratory disorder, conjunctivitis, and photophobia.

Of the few cardiovascular events determined by the investigator to be treatment related (4 cases of mild flushing and 1 each of moderate flushing, mild palpitations, and moderate tachycardia), only 1 led to permanent discontinuation.

In this case the man experienced mild flushing with the first dose of sildenafil 100 mg but continued therapy after a dose reduction. After 629 days of therapy, at which time his dosage was

once

Two other cardiovascular events led to temporary discontinuation (mild flushing and moderate tachycardia), and the remainder were addressed with a cheap prescription viagra change in dosing.

Of the 149 serious adverse events that occurred during the 4 years of the study, including 18 acute myocardial infarctions, none were considered by the investigator to be treatment related. Adverse events that led to changes in dosing or to temporary or permanent discontinuation. Adverse events (AEs) in 979 men Treatment-related a All causality Patients with AEs, n (%) 37 (3.8) 210 (21.5) Discontinued because of AEs, cheap prescription viagra n (%) 11 (1.1) 55 (5.6) Most frequent (?0.5%) AEs, n (%) Headache 10 (1.0) 10 (1.0) Dyspepsia 10 (1.0) 12 (1.2) Rhinitis 6 (0.6) 6 (0.6) Flushing 5 (0.5) 5 (0.5) Coronary artery disorder 0 24 (2.5) Prostatic disorder 0 16 (1.6) Carcinoma 0 14 (1.4) Myocardial infarction 0 11 (1.1) b Arthritis 0 9 (0.9) Bone fracture accidental 0 9 (0.9) Accidental injury 0 7 (0.7) Cerebrovascular disorder 0 7 (0.7) Atrial fibrillation 0 6 (0.6) Cholecystitis 0 6 (0.6) Sepsis 0 5 (0.5) Heart failure 0 5 (0.5) Gastrointestinal carcinoma 0 5 (0.5) Bone disorder 0 5 (0.5) Each treatment year, less than 1% of the men who started the year discontinued sildenafil because of treatment-related adverse events, for a total of only 11 (1.1%) of the original 979 participants over the 4 years of the study ( Table 3 ).

Discontinuations were caused by dyspepsia (n = 4), rhinitis (n = 2), abnormal vision plus headache (n = 1), dyspepsia plus rhinitis (n = 1), and flushing, dizziness, and myalgia (n = 1 each).

Percentage of participants who discontinued, (n/N) a Study year Treatment-related adverse event Insufficient response Other reasons (not treatment related) 1 0.5 (5/979) 2.2 (22/979) 13.7 (134/979) 2 0.2 (2/818) 2.3 (19/818) 8.1 (66/818) 3 0.1 (1/731) 1.9 (14/731) 9.3 (68/731) 4 0.5 (3/648) 1.1 (7/648) 8.3 (54/648) Effectiveness.

Of the 979 men who participated in the study, 932 (95%) were analyzed for efficacy. At the completion of each year, at least 94% of cheap prescription viagra the annually decreasing number of participants reported satisfaction with the effect of sildenafil treatment on their erections, with only a 3.3 percentage point variation across the 4 yearly assessments ( Table 4 ).

Almost all of these men reported improved ability to engage in sexual activity. Percentage of participants (n/N) a Study year Satisfied with treatment

effect

There are numerous data published on the efficacy and safety of sildenafil treatment for ED.