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Finasteride not associated with long-term adverse effects
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Finasteride did not appear associated with long-term adverse effects in men who used the drug for cancer prevention, hair growth or to relieve benign prostatic hyperplasia, according to study results.
Joseph M. Unger, PhD, MS, of the SWOG Statistical Center at Fred Hutchinson Cancer Research Center, and colleagues used Medicare claims records to assess the long-term effects of finasteride use in 13,935 men who participated in the Prostate Cancer Prevention Trial. In that trial, men were randomly assigned to finasteride or placebo for 7 years.
“The most common adverse events observed in the finasteride arm … were sexual dysfunction and gynecomastia. In contrast, patients receiving finasteride had a lower incidence of urinary obstructive symptoms and complications because of benign prostatic hyperplasia,” Unger and colleagues wrote. “Long-term consequences extending beyond the study period have not been well studied.”
Unger and colleagues used a cumulative incidence and Cox regression analysis to examine time to events, including cardiac, endocrine, sexual dysfunction, depression, diabetes and benign prostate hyperplasia–related events.
The median Medicare follow-up assessment time was 16 years from trial registration.
Researchers reported no differences in important baseline factors or Medicare follow-up assessment time between those assigned finasteride or placebo.
Men assigned finasteride demonstrated a 10% greater risk for new claims of depression (HR = 1.1; 95% CI, 1.01-1.19) and a 6% lower risk for procedures for benign prostatic hyperplasia–related events, particularly lower urinary tract symptoms (HR = 0.94; 95% CI, 0.89-1).
Researchers reported no other differences with regard to long-term consequences of intervention between the two treatment groups.
“Few men take finasteride today for the prevention of prostate cancer, despite its availability as a low-cost generic drug. Our findings show that finasteride reduces long-term symptoms of benign prostatic hyperplasia with almost no adverse consequences,” Unger and colleagues wrote. “Therefore, there is little need to worry about long-term noncancer consequences of finasteride use in those who use it for treatment of symptomatic benign prostatic hyperplasia, hair growth or prevention of cancer.” – by Andy Polhamus
Disclosure: The researchers report no relevant financial disclosures.
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