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Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies.

ABSTRACT: To evaluate if new imiquimod formulations using a shorter treatment duration are safe and efficacious to treat anogenital warts.In two studies 534 women ?12 years of age (mean 33.4) with 2-30 warts (mean 7.9) and total wart area ?10 mm(2) (mean 166.3) were randomized (1:2:2) to placebo (106), imiquimod 2.5% (212) or 3.75% (216) creams applied once daily until complete clearance or a maximum of 8 weeks.For placebo, imiquimod 2.5% and 3.75%, respectively, complete clearance of all warts was achieved in 14.2%, 28.3%, and 36.6% of women (intent-to-treat, P = 0.008 imiquimod 2.5%, and P < 0.001 3.75% versus placebo). Mean changes in wart counts were -10.7%, -50.9%, and -63.5% (per-protocol, P < 0.001 each active versus placebo) and safety-related discontinuation rates 0.9%, 1.4%, and 2.3%.Imiquimod 3.75% applied daily for up to 8 weeks was well tolerated and superior to placebo in treating women with external anogenital warts.

SUBMITTER: Baker DA

PROVIDER: S-EPMC3162968 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies.

Baker David A DA Ferris Daron G DG Martens Mark G MG Fife Kenneth H KH Tyring Stephen K SK Edwards Libby L Nelson Anita A Ault Kevin K Trofatter Kenneth F KF Liu Tiepu T Levy Sharon S Wu Jason J

Infectious diseases in obstetrics and gynecology 20110824

<h4>Objective</h4>To evaluate if new imiquimod formulations using a shorter treatment duration are safe and efficacious to treat anogenital warts.<h4>Methods</h4>In two studies 534 women ≥12 years of age (mean 33.4) with 2-30 warts (mean 7.9) and total wart area ≥10 mm(2) (mean 166.3) were randomized (1:2:2) to placebo (106), imiquimod 2.5% (212) or 3.75% (216) creams applied once daily until complete clearance or a maximum of 8 weeks.<h4>Results</h4>For placebo, imiquimod 2.5% and 3.75%, respec ...[more]

PMID: 21876641

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Project description:BackgroundHuman papillomavirus (HPV), primarily genotypes 6 and 11, cause the majority of cases of anogenital warts (AGW). Although benign, AGW are associated with a substantial economic and psychosocial burden. Several vaccines have been developed to prevent HPV. The objective of this study was to describe the epidemiology and healthcare resource utilization of AGW in Morocco, as well as the associated costs of treatment from the public healthcare perspective.MethodsThis was a descriptive analysis of questionnaire data obtained via a Delphi panel. The panel consisted of 9 physicians practicing in public hospitals in Morocco (4 dermatologists and 5 obstetricians/gynecologists). The questionnaire collected data on physician and practice characteristics, diagnostic tests and procedures, treatments, and follow-up (including recurrence) of patients with AGW. Questionnaire items on which ≥ 70% of respondents agreed were considered as having consensus. Costs associated with diagnosis, treatment, and follow-up were calculated in Moroccan dirham (MAD) and converted to euros (€) based on official national price lists for public hospitals and the HCRU estimates from the questionnaire.ResultsThe physician-estimated prevalence of AGW in Morocco was 1.6%-2.6% in women and 2.0%-5.3% in men. A mean (median) of 6.4 (4) patients per month per physician sought medical attention for AGW. Simple observation was the most common diagnostic method for AGW in both men and women, and excision was the most prescribed therapy (75%), requiring a mean of 2 visits. Recurrence occurred in approximately 27% of patients. The cost per case of managing AGW, including recurrence, was estimated at 2182-2872 MAD (€207-272) for women and 2170-2450 MAD (€206-233) for men. The total annual cost of medical consultations for AGW in Morocco ranged from 3,271,877 MAD to 4,253,703 MAD (€310,828-404,102).ConclusionsExpert consensus indicates that AGW represent a significant burden to the Moroccan public healthcare system. These data can inform policy makers regarding this vaccine-preventable disease.

Project description:ObjectiveTo review published randomised controlled trials to assess the benefit and harm of imiquimod in the treatment of external genital warts.Data sourcesMEDLINE (1966 - December 2000), Cochrane Library (Issue 3, 2000) and PubMed (December 15, 2000), review articles and reference lists.Review methodsIncluded studies had to be randomised trials of imiquimod, to be full published papers, and to have a comparison group. Quality of trial reporting was assessed. Relative benefit and number needed to treat were calculated for the main outcomes of wart clearance at the end of therapy, of at least 50% reduction in wart area, and of complete clearance at the end of treatment and no recurrence of warts during a follow-up period, as well as for adverse effect withdrawal or lack of efficacy withdrawal.ResultsThere were six trials, all with quality scores of 3 (out of 5) or greater. In five trials with HIV-negative patients complete clearance of warts at the end of treatment occurred in 51% of patients treated with imiquimod 2% or 5% cream and 6% of placebo treated patients. The number needed to treat was 2.2 (95% confidence interval 2.0 to 2.6). In four trials at least 50% wart area reduction occurred with 72% of patients treated with imiquimod 5% cream and 20% of placebo treated patients. The number needed to treat was 1.9 (1.7 to 2.2). In three trials complete clearance of warts at the end of treatment plus no recurrence occurred in 37% of patients treated with imiquimod 5% cream and 4% of those treated with placebo. The number needed to treat was 3.0 (2.5 to 3.8). Adverse event withdrawal was rare and no more likely with imiquimod than with placebo. Imiquimod was not effective in one trial in HIV-positive patients.ConclusionThe evidence base for imiquimod in treating genital warts is of high quality and the necessary size from which to draw useful conclusions. Imiquimod is effective in home application, though not in patients with HIV infection with the evidence presently available.

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Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies.

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Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies.

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