In addition, patients treated with RAPAFLO(R) 4 mg showed significantly better results relative to placebo on the physical component of another widely accepted evaluation tool, the 12-Item Short Form Health Survey (SF-12) developed to study patients with chronic conditions (4.2 +/- 8.1 vs 1.7 +/- 9.0; P=.049). In a global response assessment (GRA), 56 percent of patients treated with RAPAFLO(R) 4 mg versus 29 percent of patients receiving placebo reported moderate or marked improvement (P= 0.0069). An increase in dose to 8 mg resulted in no incremental increased effect.
Overall, one in three (33.1%) of men in the study experienced a treatment-related adverse event (AE). The incidences of drug-related AEs were similar for RAPAFLO(R) 4 mg and placebo, and included: dizziness (1.9%, 4 mg; 8.9%, 8 mg; 7.4%, placebo); headache (0, 4 mg; 4.4%, 8 mg; 1.9%, placebo); nasal congestion (3.8%, 4 mg; 6.7%, 8 mg; 0, placebo); and decreased libido (1.9%, 4 mg; 2.2%, 8 mg; 1.9%, placebo). The most common adverse event was retrograde ejaculation. More men treated with RAPAFLO(R) versus placebo experienced retrograde ejaculation (26.9%, 4 mg; 40%, 8 mg; 1.9%, placebo). Retrograde ejaculation, or an orgasm with reduced semen, is an expected and reversible effect of selective alpha blockers and thought to be a direct reflection of the product's selective binding properties. Discontinuation rates due to a drug-related adverse event were 5.8 percent f
|SOURCE Watson Pharmaceuticals, Inc.|
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