Safety studies with finasteride in men

18.6.1 Effects on bone

The effects of finasteride, both at a 5 mg and 1 mg daily dose, on bone have been evaluated in several studies. In men with BPH, finasteride 5 mg was shown to have no deleterious effects on markers of bone formation compared to placebo over one year or on bone mineral density compared to placebo over four years. In young men with AGA, finasteride had no deleterious effects on markers of bone formation or bone mineral density compared to placebo in a 48-week study. Taken together, these data demonstrate that finasteride has no deleterious effects on bone integrity in men. Recent evidence supports the hypothesis that estrogen is the primary mediator of bone integrity in both men and women, based on findings in male subjects with aromatase deficiency.

18.6.2 Effects on semen

Three separate studies evaluated the effects of finasteride 5 mg and 1 mg on semen production in young men. In two placebo-controlled studies evaluating the effects of finasteride at a daily dose of 5 mg, small (25%) reductions in ejaculate volume that were reversible upon discontinuation of drug were observed, while sperm concentration was not altered. This transient effect of finasteride 5 mg on ejaculate volume is believed to be due to reduction in the prostatic contribution to the ejaculate (US Product Circulars for Propecia® 2002 and Proscar® 1999). In a subsequent placebo-controlled study evaluating the effects of finasteride at a daily dose of 1 mg, no significant differences in ejaculate volume, sperm concentration, total sperm per ejaculate, percent motile sperm or percent sperm with normal morphology were observed (Overstreet etal. 1999). These findings support the concept of a dose-dependent effect of finasteride on ejaculate volume through an effect on the prostatic contribution to the ejaculate. This dose-dependence of effect of finasteride on prostatic function is consistent with similar findings ofa dose dependence between 1 mg and 5 mg daily doses of finasteride, such as has been reported for serum DHT (Gormley et al. 1992), intraprostatic DHT suppression (Norman etal. 1993), and clinical benefit in men with BPH (Finasteride Study Group 1993; Gormley etal. 1992).

18.6.3 Effects on lipids

Finasteride treatment does not affect the fasting lipid profile (total cholesterol, LDL-cholesterol or triglycerides). In some studies, a small (~10%) increase in plasma HDL-cholesterol level has been observed with finasteride (1 mg or 5 mg per day) compared to placebo, but this effect has not been consistently demonstrated.

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