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[1376] EFFICACY AND SAFETY OF APOMORPHINE SL
VS PLACEBO FOR ERECTILE DYSFUNCTION
IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA (BPH).
Ronald Lewis, Susan Buttler, Dustin Ruff, Karl Agre Augusta,
GA; Deerfield, IL
INTRODUCTION AND OBJECTIVES: Benign Prostatic Hyperplasia
(BPH) has been associated with erectile dysfunction (ED). The dopaminergic
agent apomorphine has known erectogenic properties. Here we examine the
use of a sublingual formulation of apomorphine (apomorphine HCL tablets,
sublingual) as a treatment for ED in patients with BPH.
METHODS: In three multicenter, double-blind studies, 1,472
patients with ED were randomized to one of four arms-each a separate crossover
comparing either 2 mg, 4 mg, 5 mg, or 6 mg apomophine to placebo. Out
of these patients, 229 (15.6%) had BPH as evidenced by a documented prior
medical history of BPH. The primary endpoint for these studies was the
percentage of attempts resulting in an erection firm enough for intercourse.
RESULTS: For the patients (mean age=61) with BPH, the percentage
of attempts resulting in erections firm enough for intercourse were significantly
larger for the apomorphine dosing group than for placebo; 58% vs. 38%
for 2 mg compared to placebo (p<.001), 52% vs. 29% for 4 mg compared to
placebo (p<.001), 55% vs. 29% for 5 mg compared to placebo (p<.001), 46%
vs. 17% for 6 mg compared to placebo (p=.001). The most common adverse
event reported for these patients was nausea with 4%, 25%, 39%, and 41%
of patients reporting related nausea when taking 2 mg, 4 mg, 5 mg, and
6 mg apomorphine, respectively versus up to 4% while on placebo.
CONCLUSIONS: Apomorphine HCl tablets, sublingual is an efficacious
and safe treatment for ED in patients with a history of benign prostatic
hyperplasia.
---Supported by: TAP Holdings, Inc.
[889] EFFICACY AND SAFETY OF APOMORPHINE SL
VS PLACEBO FOR ERECTILE DYSFUNCTION
IN PATIENTS WITH CORONARY ARTERY DISEASE.
Eugene Dula, Susan Buttler, Renee Perdok, Karl Agre,
Van Nuys, CA; Deerfield, IL
INTRODUCTION AND OBJECTIVES: Coronary artery disease (CAD)
has been associated with erectile dysfunction (ED). The dopaminergic agent
apomorphine is a known central initiator of erections. Here we examine
the use of a sublingual formulation of apomorphine (apomorphine HCL tablets,
sublingual) as a treatment for ED in patients with CAD.
METHODS: In three multi-center, double-blind studies, 1,472
patients with ED were randomized to one of four arms-each a separate crossover
comparing either 2 mg, 4 mg, 5 mg, or 6 mg apomophine to placebo. Out
of these patients, 224 (15%) had CAD as evidenced by a history of angina,
coronary artery bypass surgery, angioplasty or myocardial infarction.
The primary endpoint for these studies was the percentage of attempts
resulting in an erection firm enough for intercourse.
RESULTS: For the patients (mean age=59) with CAD, the percentage
of attempts resulting in erections firm enough for intercourse were significantly
larger for the apomorphine dosing group than for placebo; 41% vs. 26%
for 2 mg compared to placebo (p=.003), 54% vs. 25% for 4 mg compared to
placebo (p<.001), 48% vs. 26% for 5 mg compared to placebo (p=.011), 61%
vs. 41% for 6 mg compared to placebo (p=.039). The most common adverse
event reported for these patients was nausea with 2%, 19%, 32%, and 34%
of patients reporting related nausea when taking 2 mg, 4 mg, 5 mg, and
6 mg apomorphine, respectively versus up to 4% while on placebo.
CONCLUSIONS: Apomorphine HCl tablets, sublingual is an efficacious
and safe treatment for ED in patients with coronary artery disease.
---Supported by: TAP Holdings, Inc.
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