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Clinical Q & A; on male pattern baldness
March 16, 1998
Q. What pharmacological agents are available for male pattern
baldness?
A. Male pattern baldness (MPB) is an extremely common condition.
Hair loss in males may begin in the late teens or early 20s, and, by the
age of 35 to 40, approximately 66% of male Caucasians will display some
degree of hair loss. It is a familial condition and has genetic and hormonal
etiologies. Typical presentation includes hair loss beginning in the lateral
frontal areas or over the vertex. It may be extensive, depending on the
person's age at the time of onset. It is now believed that hair loss can
be attributed to the action of dihydrotestosterone (DHT), a metabolite
of testosterone. This metabolic conversion, catalyzed by the enzyme 5-alpha
reductase, takes place in the scalp. The activity level of 5-alpha reductase
has been shown to adversely affect hair follicles and correlate with increased
hair loss.
In the United States, there are two drugs approved by the Food &
Drug Administration for the treatment of male pattern baldness: topical
minoxidil (Rogaine, Pharmacia & Upjohn), and oral finasteride (Propecia,
Merck & Co.). Minoxidil 2% solution has been available for almost 10
years, initially by Rx only and currently as an OTC item; in November 1997,
minoxidil 5% (Rogaine Extra Strength for Men) solution was approved by
the FDA for sale as an OTC item as well. Finasteride, under the trade name
Proscar, has been used in the United States for the treatment of benign
prostatic hypertrophy (BPH) since 1992.
Patients taking finasteride for BPH reported increased growth of scalp
hair, which led to investigation of the drug and its approval for the treatment
of MPB. The recommended dose of finasteride for MPB is 1 mg daily.
The mechanism of action of minoxidil on hair growth is not known, but
it is believed that the drug opens potassium channels, which could increase
blood flow to the scalp or even stimulate hair follicles directly; it does
not appear to have any antiandronergic effects. The 5% solution appears
superior to the 2% solution, as measured by hair regrowth and overall hair
density. Regrowth may occur as early as two months after initiation of
therapy with the 5% solution and after four months with the 2% solution.
After 48 weeks of treatment, users of the 5% solution displayed 46% greater
overall hair regrowth than did users of the 2% solution. There is no significant
difference between the two concentrations in terms of systemic side effects;
however, cardiovascular--but minor and localized--side effects such as
erythema, itchiness, and dryness are PAGE 10 Drug Topics March 16, 1998
more frequent with the 5% solution.
In contrast to minoxidil, the mechanism of action of finasteride is
well documented. The drug acts by blocking the enzyme 5-Alpha reductase.
The reduced activity of 5-alpha reductase results in a 66% decrease in
DHT concentration in the scalp. Clinical trials reported 83% of male patients
with mild to moderate hair loss kept their hair or had grown more hair
after one year of finasteride treatment. Compared with placebo, the frequency
of side effects associated with finasteride appear minimal, although statistically
significant. Reported side effects, caused by the drug's antiandronergic
properties, include difficulty achieving erection, a diminished desire
for sex, and/or a decreased amount of semen. The 5-mg dosage of finasteride
carries a warning against exposure of women to semen from men who are taking
the drug; the 1-mg dosage carries no such warning.
A literature search did not reveal any controlled clinical trials directly;
comparing minoxidil and finasteride. However, based on clinical trials
comparing either agent to placebo, it appears a similar number of subjects
(50%) reported an increase in hair growth for both drugs. Demographic data
and degree of hair loss may have varied at the start of the trials, so
a hue comparison of efficacy cannot be made.
One apparent advantage of minoxidil over finasteride is the approval
of the 2% solution for the treatment of some types of hair loss in women.
Finasteride is currently not marketed for women; safety and efficacy have
not been established. A drawback to minoxidil therapy, however, is its
twice-daily topical application regimen. The monthly cost of therapy of
MPB ranges from $ 12.00 to $ 47.00. (See table.)
Encouraging results were seen in a patient treated with topical minoxidil
in a tretinoin base in combination with oral finasteride. Tretinoin is
believed to enhance minoxidil absorption, follicle differentiation, and
dermal vessel formation, which may enhance the response to minoxidil. More
studies are needed to compare the available treatment options in order
to decide which agent--or, possibly, combination of agents--should be used.
Recently, researchers have identified the gene for alopecia universalis
(total loss of scalp and body hair). This discovery helps scientists understand
the molecular basis for inherited forms of baldness. This finding may be
useful in developing future treatment options.
RELATED ARTICLE: Cost comparison of agents used in treating male pattern
baldness
Recommended Monthly
dose cost(*)
minoxidil 2% solution 1 ml topically twice daily $ 12.00
Rogaine 2% solution 1 ml topically twice daily 19.40
Rogaine 5% solution 1 ml topically twice daily 21.64 PAGE 11 Drug Topics
March 16, 1998
Propecia 1 mg orally once daily 46.88
(*) Based on Average Wholesale Price (AWP), Red Book, January 1998
This column was prepared by the staff of the International Drug Information
Center, Arnold & Marie Schwartz College of Pharmacy & Health Sciences,
Long Island University, Brooklyn, N.Y.
Copyright 1998 Information Access Company, a Thomson Corporation Company;
ASAP Copyright 1998 Medical Economics Publishing Drug Topics
SECTION: No. 6, Vol. 142; Pg. 2; ISSN: 0012-6616
IAC-ACC-NO: 20443876
LENGTH: 989 words
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