HERE IS A STINKING STUDY....
Abstracts - February 1998
A Randomized, Placebo-Controlled Comparison of Oral
Valacyclovir and Acyclovir in Immunocompetent Patients
With Recurrent Genital Herpes Infections
Stephen K. Tyring, MD, PhD; John M. Douglas, Jr, MD; Lawrence
Corey, MD; Spotswood L. Spruance, MD; Jorgen Esmann, MD; for the
Valaciclovir International Study Group
Objective: To compare valacyclovir hydrochloride with acyclovir in the
treatment of recurrent genital herpes infection.
Design: A multicenter, double-blind, placebo-controlled, randomized,
parallel-design study.
Setting: University clinics (dermatology, gynecology, and infectious
diseases) and private practices.
Patients: One thousand two hundred patients with recurrent genital herpes
simplex infections.
Interventions: Patients self-initiated oral therapy with 1000 mg of
valacyclovir hydrochloride twice daily, 200 mg of acyclovir 5 times daily, or
placebo for 5 days.
Main Outcome Measures: Resolution of all signs and symptoms of
recurrent genital herpes infection.
Results: Both drugs were significantly more effective than placebo in
speeding resolution of herpetic episodes (median duration, 4.8, 4.8, and 5.9
days, respectively); the hazards ratios for valacyclovir and acyclovir vs
placebo were 1.66 (95% confidence interval [CI], 1.38-2.01) and 1.71
(95% CI, 1.41-2.06) (both P<.001). Similarly, valacyclovir and acyclovir
significantly hastened lesion healing (hazards ratios vs placebo were 1.88
[95% CI, 1.53-2.32] and 1.90 [95% CI, 1.55-2.34], respectively;
P<.001). Pain duration was shorter in valacyclovir- and acyclovir-treated
patients (median, 2 vs 3 days). Viral shedding stopped 2.55 times faster in
patients treated with valacyclovir and 2.24 times faster in patients treated
with acyclovir than in patients treated with placebo. Aborted episodes, in
which lesions did not progress beyond the macule or papule stage, tended to
occur in more patients treated with valacyclovir (25.9%) or acyclovir
(24.8%) than in patients treated with placebo (19.8%). Valacyclovir and
acyclovir did not differ significantly with regard to their respective effects on
any of the above efficacy parameters. The nature, severity, and frequency of
adverse events did not differ among the 3 treatment groups.
Conclusions: Twice-daily valacyclovir was as effective and well tolerated in
the treatment of recurrent genital herpes simplex virus infection as
5-times-daily acyclovir. Therefore, valacyclovir could prove a useful
alternative to acyclovir when convenience of dosing or compliance issues are
the prime considerations in treatment.
Arch Dermatol. 1998;134:185-191
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