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      Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials and the postmarketing safety database

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          Abstract

          Aim:

          To review special safety topics associated with sildenafil and to document the tolerability of 50- and 100-mg doses, overall and by age, in men with erectile dysfunction (ED).

          Methods:

          Data were collated from 67 double-blind placebo-controlled (DBPC) trials (> 14,000 men) conducted by the manufacturer and from the manufacturer’s postmarketing safety database (39,277 patients). The DBPC data were stratified by dose, starting dose and age (≥ 65 and ≥ 75 years). Special safety topics included cardiovascular risk, priapism, non-arteritic anterior ischaemic optic neuropathy (NAION), impaired renal and hepatic function, drug interactions (i.e. nitrates, cytochrome P3A4 inhibitors, other ED therapies and α-blockers) and incorrect use.

          Results:

          Sildenafil was well tolerated at a dose of 50 or 100 mg in men with ED, overall, in those aged ≥ 65 years, and in those aged ≥ 75 years. Analyses of the databases did not reveal any causal link between sildenafil and cardiovascular events, or any new safety risks relating to cardiovascular events, priapism, NAION, hearing loss or drug interactions. In the small number of men with moderate impairment of renal function or hepatic function who were treated with sildenafil in DBPC trials, the safety profile was similar to that in men with no impairment of renal or hepatic function. Overdose with sildenafil was rare in the ED population. No new safety issues, emerging trends or adverse reactions were identified in conjunction with overdose, dependence, abuse or misuse.

          Conclusion:

          This collated review confirms generally the good tolerability and established safety profile of sildenafil 50 and 100 mg in men with ED and reveals no new safety issues.

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          Most cited references 78

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          Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study.

          We provide current, normative data on the prevalence of impotence, and its physiological and psychosocial correlates in a general population using results from the Massachusetts Male Aging Study. The Massachusetts Male Aging Study was a community based, random sample observational survey of noninstitutionalized men 40 to 70 years old conducted from 1987 to 1989 in cities and towns near Boston, Massachusetts. Blood samples, physiological measures, socio-demographic variables, psychological indexes, and information on health status, medications, smoking and lifestyle were collected by trained interviewers in the subject's home. A self-administered sexual activity questionnaire was used to characterize erectile potency. The combined prevalence of minimal, moderate and complete impotence was 52%. The prevalence of complete impotence tripled from 5 to 15% between subject ages 40 and 70 years. Subject age was the variable most strongly associated with impotence. After adjustment for age, a higher probability of impotence was directly correlated with heart disease, hypertension, diabetes, associated medications, and indexes of anger and depression, and inversely correlated with serum dehydroepiandrosterone, high density lipoprotein cholesterol and an index of dominant personality. Cigarette smoking was associated with a greater probability of complete impotence in men with heart disease and hypertension. We conclude that impotence is a major health concern in light of the high prevalence, is strongly associated with age, has multiple determinants, including some risk factors for vascular disease, and may be due partly to modifiable para-aging phenomena.
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            Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group.

            Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] in the corpus cavernosum and therefore increases the penile response to sexual stimulation. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, and mixed causes. In a 24-week dose-response study, 532 men were treated with oral sildenafil (25, 50, or 100 mg) or placebo. In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this dose-escalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a patient log, and a global-efficacy question. In the dose-response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001). For the men receiving 100 mg of sildenafil, the mean score for the question about achieving erections was 100 percent higher after treatment than at base line (4.0 vs. 2.0 of a possible score of 5). In the last four weeks of treatment in the dose-escalation study, 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil, as compared with 22 percent for those receiving placebo (P<0.001). The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo (P<0.001). Headache, flushing, and dyspepsia were the most common adverse effects in the dose-escalation study, occurring in 6 percent to 18 percent of the men. Ninety-two percent of the men completed the 32-week extension study. Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction.
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              The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences.

              To project the likely worldwide increase in the prevalence of erectile dysfunction (ED) over the next 25 years, and to identify and discuss some possible health-policy consequences using the recent developments in the UK as a case study. Using the United Nations projected male population distributions by quinquennial age groups for 2025, the prevalence rates for ED were applied from the Massachusetts Male Aging Study (MMAS) to calculate the likely incidence of ED. The MMAS has the advantage of being the first study to provide population-based rates rather than rates based on clinical samples. All the projections were age-adjusted. It is estimated that in 1995 there were over 152 million men worldwide who experienced ED; the projections for 2025 show a prevalence of approximately 322 million with ED, an increase of nearly 170 million men. The largest projected increases were in the developing world, i.e. Africa, Asia and South America. The likely worldwide increase in the prevalence of ED (associated with rapidly ageing populations) combined with newly available and highly publicized medical treatments, will raise challenging policy issues in nearly all countries. Already under-funded national health systems will be confronted with unanticipated resource requests and challenges to existing government funding priorities. The projected trends represent a serious challenge for healthcare policy makers to develop and implement policies to prevent or alleviate ED.
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                Author and article information

                Journal
                Int J Clin Pract
                ijcp
                International Journal of Clinical Practice
                Blackwell Publishing Ltd
                1368-5031
                1742-1241
                January 2010
                : 64
                : 2
                : 240-255
                Affiliations
                [1 ]AP-HP, Neuro-Uro-Andrology, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital Garches, France
                [2 ]Cardiac Department, St. Thomas’ Hospital London, UK
                [3 ]Department of Urology, Università-Vita Salute San Raffaele Milan, Italy
                [4 ]Servicio de Urologia, Complejo, Hospitalario Carlos Haya Málaga, Spain
                [5 ]Safety and Risk Management, Pfizer Inc New York, NY, USA
                Author notes
                François Giuliano, Pr, MD, PhD, Raymond Poincaré Hospital, Physical Medicine and Rehabilitation, Neuro-Uro-Andrology, 104 Boulevard Raymond Poincaré, Garches 92380, France Tel.:+ 33 147107832 Fax:+ 33 147104443 Email: giuliano@ 123456cyber-sante.org

                Disclosures François Giuliano is a consultant for Johnson & Johnson, Pfizer Inc, Bayer Schering Pharma, Sanofi-Aventis and Lilly; a meeting participant for Johnson & Johnson, Pfizer Inc and Lilly; and a study investigator for Pfizer Inc and Bayer. Graham Jackson is a consultant for Lilly and Pfizer Inc; and a meeting participant for Lilly, Pfizer Inc and Bayer. Francesco Montorsi is a consultant for Pfizer Inc, Bayer, GSK and AMS; and a study investigator for Astra, Pfizer Inc, Eli Lilly, GSK, MSD, Bayer, Novartis and Lilly ICOS. Antonio Martin-Morales is a consultant for Pfizer Inc, Bayer Schering Pharma, Lilly ICOS, Ipsen Pharma, Prostrakan, Pierre-Fabre and Johnson & Johnson; a meeting participant/lecturer for Pfizer Inc, Bayer Schering Pharma, Lilly ICOS, Ipsen Pharma, Johnson & Johnson and a scientific study/trial investigator for Pfizer Inc, Bayer Schering Pharma, Lilly ICOS, Johnson & Johnson and Prostrakan Pierre Raillard is an employee of Pfizer Inc.

                Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://www3.interscience.wiley.com/authorresources/onlineopen.html

                Article
                10.1111/j.1742-1241.2009.02254.x
                2810448
                19900167
                © 2009 Blackwell Publishing Ltd

                Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.

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                Review Articles

                Medicine

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