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Executive Summary

MERCK's PROSCAR IN NEJM: BPH PATIENTS WITH MODERATE-TO-SEVERE SYMPTOMS may be the best target population for the alpha-reductase inhibitor finasteride, according to an editorial in the Oct. 22 New England Journal of Medicine authored by Paul Lange, MD, University of Washington School of Medicine. Commenting on what he called the "small gains" in symptom relief seen in the Finasteride Group study, which appears in the same issue, Lange suggested that Proscar treatment "might help a little in a small number of men with moderate-to-severe symptoms who are not in serious trouble." As examples of patient subgroups that might benefit from Proscar treatment, Lange suggested benign prostatic hyperplasia patients "with a very weak urinary stream, socially embarrassing hesitancy, or nocturia that interferes seriously with sleep." The study reported in NEJM is the pivotal trial used to gain FDA approval and is the same trial discussed at FDA's Endocrinologic and Metabolic Drugs Advisory Committee meeting in February ("The Pink Sheet" Feb. 10, p. 9). The 12-month, three- armed trial in 895 men with prostatic hyperplasia looked at 1 mg and 5 mg daily Proscar doses versus placebo and found that the 5 mg dose demonstrated a significant decrease in total urinary- symptom scores, a 22% increase in maximal urinary flow-rate and a 19% decrease in prostatic volume. Lange suggested that the "long-term cost" of Proscar and "the tedium of daily drug administration must be compared with manipulative procedures for the treatment" of BPH. He maintained that transurethral resection of prostate [TURP] is quicker, more effective, less costly, and safe." Citing newer procedures and technology, Lange said that "these outpatient procedures... promise a good and relatively permanent functional result in some patients, with advantages in cost, safety, and comfort as compared" with TURP. Lange concluded that "short-term finasteride therapy has very limited benefits in small numbers of men." He pointed out that Proscar "is an option for men with patience and moderate symptoms or men with more severe symptoms who are willing to forgo quicker and more reliable, albeit invasive, therapy." Merck introduced Proscar to much fanfare in late June and early July with a large-scale sampling and coupon program designed to support a patient communication effort called the Proscar Patient Support Program ("The Pink Sheet" June 29, p. 6). The drug was approved in June after a 14-month review. In comments to analysts, Merck has reported that it plans to target primary care physicians in its marketing of the product. The company said it will go after patients with diagnosed symptomatic BPH who are not currently receiving treatment ("The Pink Sheet" Aug. 10, T&G-6). Merck expects that patients with bothersome symptoms will be the most likely group to receive the drug initially but that over time patients with earlier-stage BPH will provide the bulk of prescriptions. Merck has acknowledged that the Proscar launch will entail a fairly steep educational curve for both physicians and patients given that the drug must be taken for several months before patients begin to see symptomatic improvement. The company is considering direct-to-consumer ads to support its patient education program for Proscar and company representatives recently met with FDA to discuss the content of an ad campaign.

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