Placebo effect is NOTabout 24% in all ED studies.
Here is one from Vivus website 1511 patients
over-all placebo 18.6%
non-diabetics with chronic ED Placebo effect only 17%!!!
THESE ARE THE REAL ED pts that VIVUS will hold for the long term treatment that they will require!
Abstract Presented by Dr. Paul C. Norwood
at the American Diabetes Association Meeting
President's Poster Session
June 9, 1996
MULTICENTER DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF TRANSURETHRAL
ALPROSTADIL IN DIABETIC AND NONDIABETIC MEN WITH CHRONIC ERECTILE
DYSFUNCTION (IMPOTENCE). Paul C. Norwood, Marshall B. Block, Stephen
Bookin, G. Stephen Decherney, Scott A. Heatley, Kenneth S. Hershon, Fran
E. Kaiser, Sidney Rosenblatt, Julio Rosenstock, Neil Gesundheit, Alfred
P. Spivack, Darby E. Stephens, Peter Y. Tam, Virgil A. Place and the
VIVUS-MUSE Study Group, Menlo Park, Ca.
Erectile dysfunction is a common problem in diabetic men. Previous
short-term studies have shown that alprostadil delivered by a
transurethral system produces erections and restores sexual intercourse.
We have now studied the clinical safety and efficacy of transurethral
alprostadil delivered by this system over a 3-month period in diabetic
and nondiabetic men.
1511 patients (age: 30-84; mean 62) with organic erectile dysfunction
(mean duration: 4 yrs) were enrolled in a prospective, double-blind,
placebo-controlled trial at 58 centers. Patients self-administered
transurethral alprostadil (125, 250, 500, and 1000 æg) in the clinic;
those achieving an erection sufficient for intercourse (996 patients)
were randomized to home therapy with either active drug or placebo.
Diabetes was present in 240 patients (39 insulin-dependent; 196
non-insulin-dependent; 5 unspecified).
Key results are shown in the table below. In patients who responded at
home, approximately 7 of 10 active drug systems resulted in sexual
intercourse. Adverse effects, other than penile pain, were uncommon in
the group as a whole. 88% of patients completed the 3 months of home
treatment.
% Reporting Intercourse on:p-value
Active Placebo
Overall 64.9 18.6 < 0.001
Diabetic 64.3 21.1 < 0.001
Nondiabetic 65.0 17.7 < 0.001
Transurethral alprostadil is well tolerated and can restore erections
and sexual intercourse in both diabetic and nondiabetic men with chronic
erectile dysfunction.
For more information, contact VIVUS at: product@vivus.com. For medical
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