Biomedical subjects
E Meuleman
Publications and source records attributed to E Meuleman.
A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction.
OBJECTIVE: To assess the efficacy and safety of sildenafil citrate (Viagra, Pfizer Inc., USA) in a double-blind, placebo-controlled, dose-escalation study over a period of 26 weeks in men with erectile dysfunction of a broad spectrum of aetiology. PATIENTS AND METHODS: In all, 315 patients from five countries were randomized to receive treatment with placebo (156 men) or sildenafil (159 men). Significant concomitant medical conditions were hypertension (20%), a history of pelvic surgery (19%), diabetes mellitus (15%), and ischaemic heart disease (10%). Patients randomized to treatment received a starting dose of 25 mg of sildenafil or matching placebo, which could be increased to 50 mg and then to 100 mg of sildenafil, based on efficacy and tolerability. Assessments of efficacy comprised the 15-item International Index of Erectile Function (IIEF), including question three (ability to achieve an erection) and question four (ability to maintain an erection), a partner questionnaire, an overall efficacy question, and event-log data. RESULTS: After 12 weeks of treatment, 26%, 32% and 42% of patients were taking 25, 50 and 100 mg of sildenafil, respectively. A similar distribution of doses was reported after 26 weeks of treatment. Treatment with sildenafil significantly improved the patients' abilities to achieve and maintain an erection compared with treatment with placebo (P < 0.001). Scores for four of the five sexual function domains of the IIEF (erectile function, orgasmic function, intercourse satisfaction and overall satisfaction) also improved significantly (P < 0.001). There was a significant improvement in the mean score for the erectile function domain, regardless of the aetiology of erectile dysfunction (P < 0.001). After 12 weeks and 26 weeks of treatment, 82% and 79% of patients receiving sildenafil reported improved erections, compared with 24% and 23% of patients receiving placebo, respectively (P < 0.001). Treatment-related adverse events were mild to moderate and occurred in 27% of patients receiving sildenafil, compared with 8% of patients receiving placebo. CONCLUSION: Sildenafil is an effective and well-tolerated treatment for men with erectile dysfunction of a broad spectrum of aetiology.
Managing menopause.
Many women will spend one third of their lifetime after menopause. A growing number of options are available for the treatment of menopausal symptoms like vasomotor instability and vaginal atrophy, as well as the long-term health risks such as cardiovascular disease and osteoporosis that are associated with menopause. Currently, hormone replacement therapy (estrogen with or without progestin) is the primary treatment for the symptoms and long-term risks associated with menopause. However, recent evidence calls into question the protective effect of estrogen on cardiovascular disease risk. The association of risk for breast cancer with estrogen replacement therapy also has not been fully clarified. In addition, many women cannot or choose not to take hormones. For treatment of osteoporosis and heart disease, pharmacologic choices include antiresorptive agents such as bisphosphonates and calcitonin, and estrogens or selective estrogen receptor modulators such as raloxifene. In addition, complementary options that include vitamins, herbal treatments, exercise and other lifestyle adaptations are gaining increased interest. The growing number of choices and questions in this area emphasizes the need to individualize a treatment plan for each woman to meet her specific needs.
Intracavernous Alprostadil Alfadex--an effective and well tolerated treatment for erectile dysfunction. Results of a long-term European study.
Long-term efficacy and safety of Alprostadil-Alfadex (EDEX/VIRIDAL) in intracavernous self-injection therapy for chronical erectile failure was investigated in a four year running multicenter European trial. Of the 16,886 protocolled injections 93% (15,713) resulted in rigid erections followed by successful sexual intercourse. Reported side effects by patients were prolonged erections > 6 h only occurring during the first year in 1.2% (2 out of 162), painful erections in 29% (47 out of 162) during the first year and decreasing to 12.1% by year 4, hematomas, neither requiring therapeutic measures nor impeding sexual performance in 33.3% (54 out of 162) in year 1 with a decrease to 12.1% by year 4, fibrotic penile alterations such as nodules, plaques or deviations in 11.7% (19 out of 162) with spontaneous healing in 48% (9 out of 19). Of the 162 patients involved in this trial 54 completed the 4 y. Of the 54 completers 91.4% considered the tolerability good or very good and were satisfied or very satisfied with self-injection therapy with Alprostadil-Alfadex. The respective rates of the female partners were 51.7% very satisfied and 39.7% satisfied. These data of the world-wide longest running prospective trial with a vasoactive drug in self-injection therapy provided impressive proof that Alprostadil-Alfadex represents a very effective and safe treatment for erectile dysfunction of both psychogenic and organogenic origin.