Moreover, partners were more satisfied with Cenforce overall, and their responses correlated with the satisfaction of the patients. In comparison, treatment-related adverse events were responsible for discontinuation by 1.2 f men treated with Cenforce 100 mg in 6-month, double-blind, placebo-controlled trials ( Morales et al 1998 ) and by 2 f 1008 men enrolled in 36-week or 52-week, open-label extension studies ( Steers et al 2001 ). Adverse events were responsible for similarly low rates of discontinuation in clinical practice studies of varying duration conducted worldwide; in California 2.7 f 74 men discontinued ( Marks et al 1999 ), in Brazil none of 256 men discontinued ( Moreira et al 2000 ), and in China none of 1,290 men discontinued ( Jiann et al 2003 ). Among 22,471 men treated with Cenforce in general practice in the UK, headache was the most frequently reported treatment-related adverse event and was cited as the reason for discontinuation in 0.3 f men ( Boshier et al 2004
koenigmeldgaard6595 am 04.07.2018 um 20:18 (UTC) |
| | Each treatment year, less than 1 f the men who started the year discontinued Cenforce 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). 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. 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 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.
Men who previously completed and were compliant with Cenforce or placebo treatment in 1 of 4 double-blind, placebo-controlled trials, and subsequently completed and were compliant with Cenforce treatment in initial open-label extension, were eligible for inclusion in this long-term extension study. Our objective was to assess the long-term safety and effectiveness of Cenforce treatment in men with ED. The population included patients with ED of organic and psychogenic etiology and typical concomitant medical conditions for this population (ie, hypertension, diabetes, hyperlipidemia, and a history of ischemic heart disease).
For example, 1,358 men with ED completed 1 of 4 double-blind trials and continued with open-label Cenforce treatment in extension studies for a total treatment duration of approximately 1 year ( Morales et al 1998 ; Steers et al 2001 ). In the current study, 979 of these men subsequently received up to 4 more years of open-label, flexible-dose (25, 50, and 100 mg) Cenforce.
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