Primary Information
The Purpose Of
Evaluate the effectiveness of sildenafil (Viagra, Pfizer, New York, NY) when the violation of erection.
The structure of the study
2 randomized, double-blind, placebo-control of the test; the duration of the observation - 24 weeks in the employment drug fixed dose and 12 weeks at the individual selection of the dose.
The clinical base
37 health centres, USA.
Participants
861 man (the average age of 58 years). Inclusion criteria: erectile dysfunction in the preceding і6 months and presence in this period of constant sexual relationship with one and the same woman. Exclusion criteria: anatomical defects of the penis, the existence of other sexual disorders, spinal cord injury, expressed mental disorders, poorly amenable to therapy, diabetes mellitus, peptic ulcer disease, a history of alcoholism or drug abuse, severe systemic disease, recently experienced a stroke or myocardial infarction, nitrate therapy. Until the end of the test with the application of fixed doses of the drug were observed 87% of the participants with an individual selection of doses of the drug - 93%.
Intervention
In a trial with the use of fixed-dose 216 participants received a placebo and the 316 - sildenafil the dose of 25, 50, or 100 mg. In a trial with an individual selection of doses 166 of the participants received a placebo and the 163 - sildenafil in the initial dose of 50 mg, which could increase or decrease twice at each of the control examination.
Evaluation criteria
The average total number of points obtained in response to the questions regarding the ability to enter the penis in the vagina and maintaining an erection (3-rd and 4-th points scale of the IIEF - International Index of Erectile Function); number of points on a scale IIEF in response to the questions relating to the erectile function, orgasm, sexual desire, satisfaction with intercourse and general satisfaction with sex life; the answer to the main question concerning the effectiveness of the treatment: "to Improve the use of the product your erection?"
The main results of the
Analyses were performed based on the assumption that all patients receive the prescribed treatment. In a trial with the use of fixed-dose ability to enter the penis in the vagina in those receiving sildenafil the dose of 25, 50, and 100 mg increased in comparison with the initial 60, 84, and 100% of resp.and in those receiving placebo - only on 5% (p<0.001). Ability to maintain an erection in those receiving sildenafil the dose of 25, 50, and 100 mg increased by 121, 133 and 130% respectively.and in those receiving placebo - by 24% (p<0.001). In a trial with an individual selection of doses of the total ability to enter the vagina and keep an erection in the receiving sildenafil increased in comparison with the original 95 and 140% respectively.and in those receiving placebo - on 10 and 13% respectively. (p<0.001). In a trial with the use of fixed-dose drug average number of points in the evaluation of erectile function increased with increasing dose of sildenafil (p<0.001) and was higher than in those receiving placebo in a trial with an individual selection of doses (p<0.001). In a trial with the use of fixed-dose efficacy of treatment in general positively evaluated 56, 77 and 84% of the participants who received 25, 50 and 100 mg of sildenafil resp.and only 25% of the participants receiving placebo (p<0.001), and in the test with an individual selection of doses - 74% of the participants from the group of sildenafil and 19% of the participants of the placebo group (p<0.001). Side effects associated with the intake of sildenafil were expressed insignificantly and included headache, tides blood to a person, indigestion and transient visual disturbances.
Conclusion
The use of sildenafil improves the erection and increase the frequency of successful sexual intercourse; the drug is well tolerated take it.
Source of financing: Pfizer.
Address for correspondence: Dr. I. Goldstein, Department of Urology, Boston University Medical Center, 720 Harrison Avenue, P (606), Boston, MA 02118, USA. FAX 617-638-8487.
Comment
Two clinical trials conducted I. Goldstein et al., have shown that taking viagra praised its impact on the quality of erection. The effectiveness of the product emphasizes the minimum response in the placebo, reported even when psychogenic violations of erection.
There is an impression that sildenafil is equally effective in the organic, psychogenic or mixed forms of erectile dysfunction, but the standardized measure of effectiveness was not applied, and the participants were heterogeneous. In order to clarify the effectiveness of the drug in the specific disorders, further research is needed.
Erectile dysfunction can be one of the manifestations of atherosclerosis and ischemic heart disease. The simultaneous use of sildenafil and nitrates may provoke the development of expressed arterial hypotension. The solution of this question seems simple enough - for patients who have already been appointed nitrates should be advised to refrain from the use of sildenafil. However, the real problem is just the opposite. If men receiving sildenafil, there is pain behind the breastbone (which is sometimes due to excessive sexual activity), doctor of the emergency can assign it nitrates, since usually these drugs are being used at once, even before the end of collecting the complete medical history. On the other hand, after a thorough collection of anamnesis doctor may fear of possible complications and refrains from the use of nitrates, which in other circumstances would have saved the patient's life. Only 10% of the participants of these two tests was previously diagnosed with ischemic heart disease, however, the latent form of it undoubtedly had a significantly larger number of participants. During the tests there were no serious side effects, but the period of observation in both cases was relatively short.
Thus, sildenafil is an effective drug that can help many men. However, the only time it will be possible to evaluate how often the random assignment of nitrates or, on the contrary, the rejection of their application in acute myocardial ischemia leads to the development of severe complications in men taking this drug.
Michael J. Barry
Massachusetts General Hospital
Boston, Massachusetts, USA
Evaluate the effectiveness of sildenafil (Viagra, Pfizer, New York, NY) when the violation of erection.
The structure of the study
2 randomized, double-blind, placebo-control of the test; the duration of the observation - 24 weeks in the employment drug fixed dose and 12 weeks at the individual selection of the dose.
The clinical base
37 health centres, USA.
Participants
861 man (the average age of 58 years). Inclusion criteria: erectile dysfunction in the preceding і6 months and presence in this period of constant sexual relationship with one and the same woman. Exclusion criteria: anatomical defects of the penis, the existence of other sexual disorders, spinal cord injury, expressed mental disorders, poorly amenable to therapy, diabetes mellitus, peptic ulcer disease, a history of alcoholism or drug abuse, severe systemic disease, recently experienced a stroke or myocardial infarction, nitrate therapy. Until the end of the test with the application of fixed doses of the drug were observed 87% of the participants with an individual selection of doses of the drug - 93%.
Intervention
In a trial with the use of fixed-dose 216 participants received a placebo and the 316 - sildenafil the dose of 25, 50, or 100 mg. In a trial with an individual selection of doses 166 of the participants received a placebo and the 163 - sildenafil in the initial dose of 50 mg, which could increase or decrease twice at each of the control examination.
Evaluation criteria
The average total number of points obtained in response to the questions regarding the ability to enter the penis in the vagina and maintaining an erection (3-rd and 4-th points scale of the IIEF - International Index of Erectile Function); number of points on a scale IIEF in response to the questions relating to the erectile function, orgasm, sexual desire, satisfaction with intercourse and general satisfaction with sex life; the answer to the main question concerning the effectiveness of the treatment: "to Improve the use of the product your erection?"
The main results of the
Analyses were performed based on the assumption that all patients receive the prescribed treatment. In a trial with the use of fixed-dose ability to enter the penis in the vagina in those receiving sildenafil the dose of 25, 50, and 100 mg increased in comparison with the initial 60, 84, and 100% of resp.and in those receiving placebo - only on 5% (p<0.001). Ability to maintain an erection in those receiving sildenafil the dose of 25, 50, and 100 mg increased by 121, 133 and 130% respectively.and in those receiving placebo - by 24% (p<0.001). In a trial with an individual selection of doses of the total ability to enter the vagina and keep an erection in the receiving sildenafil increased in comparison with the original 95 and 140% respectively.and in those receiving placebo - on 10 and 13% respectively. (p<0.001). In a trial with the use of fixed-dose drug average number of points in the evaluation of erectile function increased with increasing dose of sildenafil (p<0.001) and was higher than in those receiving placebo in a trial with an individual selection of doses (p<0.001). In a trial with the use of fixed-dose efficacy of treatment in general positively evaluated 56, 77 and 84% of the participants who received 25, 50 and 100 mg of sildenafil resp.and only 25% of the participants receiving placebo (p<0.001), and in the test with an individual selection of doses - 74% of the participants from the group of sildenafil and 19% of the participants of the placebo group (p<0.001). Side effects associated with the intake of sildenafil were expressed insignificantly and included headache, tides blood to a person, indigestion and transient visual disturbances.
Conclusion
The use of sildenafil improves the erection and increase the frequency of successful sexual intercourse; the drug is well tolerated take it.
Source of financing: Pfizer.
Address for correspondence: Dr. I. Goldstein, Department of Urology, Boston University Medical Center, 720 Harrison Avenue, P (606), Boston, MA 02118, USA. FAX 617-638-8487.
Comment
Two clinical trials conducted I. Goldstein et al., have shown that taking viagra praised its impact on the quality of erection. The effectiveness of the product emphasizes the minimum response in the placebo, reported even when psychogenic violations of erection.
There is an impression that sildenafil is equally effective in the organic, psychogenic or mixed forms of erectile dysfunction, but the standardized measure of effectiveness was not applied, and the participants were heterogeneous. In order to clarify the effectiveness of the drug in the specific disorders, further research is needed.
Erectile dysfunction can be one of the manifestations of atherosclerosis and ischemic heart disease. The simultaneous use of sildenafil and nitrates may provoke the development of expressed arterial hypotension. The solution of this question seems simple enough - for patients who have already been appointed nitrates should be advised to refrain from the use of sildenafil. However, the real problem is just the opposite. If men receiving sildenafil, there is pain behind the breastbone (which is sometimes due to excessive sexual activity), doctor of the emergency can assign it nitrates, since usually these drugs are being used at once, even before the end of collecting the complete medical history. On the other hand, after a thorough collection of anamnesis doctor may fear of possible complications and refrains from the use of nitrates, which in other circumstances would have saved the patient's life. Only 10% of the participants of these two tests was previously diagnosed with ischemic heart disease, however, the latent form of it undoubtedly had a significantly larger number of participants. During the tests there were no serious side effects, but the period of observation in both cases was relatively short.
Thus, sildenafil is an effective drug that can help many men. However, the only time it will be possible to evaluate how often the random assignment of nitrates or, on the contrary, the rejection of their application in acute myocardial ischemia leads to the development of severe complications in men taking this drug.
Michael J. Barry
Massachusetts General Hospital
Boston, Massachusetts, USA
