Atrophic vaginitis 5-17-06.pmd

A Systematic Review of Atrophic Vaginitis Treatment, Duration of Therapy, and Healthcare Costs
Sanjeev Balu, PhD1; Ashish V. Joshi, MS, PhD2; David Cobden, MSc, MPH2; Won Chan Lee, PhD1; Chris L. Pashos, PhD1
1HERQuLES, Abt Associates Inc., Bethesda, MD, USA; 2Novo Nordisk Inc., Princeton, NJ, USA
KEY FINDINGS
Abstract
Table 1: Duration of Hormonal Therapy
• Studies have shown that AV is a common problem occurring in OBJECTIVES: A systematic review of the prevalence of atrophic
• A systematic literature search (1990 to 2005) was performed to postmenopausal women.1-4 More specifically, AV can occur in 10%- vaginitis, treatments involved, therapy duration, and associated identify articles with qualitative and quantitative data on AV 40% of postmenopausal women, up to 15% of pre-menopausal Duration of
Objective
Outcome Measures
healthcare costs was undertaken to identify studies with clinical and treatments, treatment duration, and the economic impact of women, and 10%-25% of women on systemic hormone therapy.5 Weisberg E, et al. 2005
economic relevance and gaps in literature.
• Patients with AV tend to be under-diagnosed. Less than 25% METHODS: A systematic literature search using an exhaustive list
• Electronic MEDLINE®/PubMed® searches along with manual review discuss the condition with their healthcare providers or try to seek Palacios S, et al. 2005
of relevant search terms (1990-2004) was performed to identify articles with qualitative and quantitative data on atrophic vaginitis • A comprehensive list of key search words was used, including, • Hormone replacement therapy (HRT) is the most common Raymundo N, et al. 2004
treatments, treatment duration, and economic impact of treatment treatment for AV since decreased estrogen level is a major risk duration. Electronic Medline® and PubMed® searches along with - “atrophic vaginitis”, “urogenital atrophy”, “vaginitis” AND manual review of bibliographies were conducted in different phases “epidemiology”, “prevalence”, “incidence”, “compliance”, • Vaginal estrogen preparations have been shown to be more Marx P, et al. 2004
“costs”, “economics”, “cost-sharing”, and “co-payments” efficacious and easier to use than systemic estrogen RESULTS: Out of 35 retrieved studies, 6 were on epidemiology, 14
• All search terms were limited to Medical Subjects Headings on treatment patterns, 8 on treatment duration, and 7 studies [MESH] terms, English–language abstracts, human subjects, and - Advantages of locally administered estrogen preparations Akrivis Ch, et al. 2003
showed comparisons between vaginal tablets and other vaginal Evaluate the clinical efficacy and safety year 1990 to 2005, except for the articles on epidemiology which over systemic preparations include: 1) convenience and preparations. Overall, studies examining prevalence showed that were limited from year 2000 to 2005.
avoidance of systemic adverse effects; 2) prevention of atrophic vaginitis was commonly occurring among postmenopausal hepatic metabolism and increased response of vaginal Notelovitz M, et al. 2002
• We supplemented our search with several additional resources women (10-40%), and affecting as many as 15% of pre-meno- tissues to locally applied estrogen; 3) rapid and efficient including E-medicine® and internet searches pausal women and 10-25% of women on systemic hormone therapy.
absorption into the systemic circulation through vaginal Diagnosis of this condition was low with less than 25% discussing Rioux JE, et al. 2000
the condition with their healthcare providers and only 20-25% • The overall duration of treatment for atrophic vaginitis ranges seeking medical attention. Treatment duration was found to be in from 2 to 12 months (weighted average of 4.1 months).10-17 the range of 2-12 months (weighted average of 4.1 months).
Studies on long-term safety and efficacy of treatment are lacking.
SEARCH RESULTS
• Clinical trials have evaluated safety and efficacy outcomes, Vaginal tablets were preferred over vaginal creams due to conve- Dugal R, et al. 2000
• Of 235 possible publications identified electronically, 27 were including cytological changes and changes in pH.10-17 deemed appropriate for analysis. The distribution of these clinical • The major side effect of HRT is increased systemic estrogen CONCLUSIONS: No data exist that mirror treatment duration in a
concentrations. Some of the above clinical trials showed that “real-world” setting. There is a complete lack of studies correlating • A manual review of bibliographies yielded 8 more unique articles vaginal estrogen preparations, especially the low-dose vaginal treatment duration with overall healthcare costs both at an indi- tablets, resulted in low absorption of estrogen without the vidual and national level. Health economic studies examining systemic effects often associated with HRT.11,15,16 Also, vaginal resource utilization patterns, cost drivers and economic burden of • Overall, 35 relevant studies were identified and analyzed in the tablets were found to be a better alternative to other local Conclusions
this condition on individuals and society at large were not found.
estrogen preparations due to higher safety and better conve- Future research needs to examine relationships between treatment - Of these 35 studies, 6 (17%) were epidemiological, 22 duration, choice of medication, adherence, incidence of adverse (63%) were on treatment patterns or treatment duration, • AV is typically under-diagnosed and those diagnosed
• However, no studies were identified that quantify levels of with AV rarely seek treatment.
and 7 studies (20%) compared vaginal tablets and other adherence (i.e., treatment duration and treatment intensity) to current treatment regimens in a “real world” setting.
• Economic/outcome studies of patients with AV are
Introduction
lacking in the literature, and no studies pertainng to
Figure 1: Distribution of Retrieved Articles Based
• Health economic studies examining resource utilization patterns, medication adherance were found.
• Vaginitis is an inflammation of the vagina that can cause dis- cost drivers and economic burden of this condition on individuals on Study Methods
• Future studies need to examine the associations between
charge, itching, or pain. The most common types of vaginitis are and society at large were not found.
treatment duration, medication adherence, and economic
bacterial vaginitis, yeast infections, trichomoniasis, and atrophic • Studies on long-term safety and efficacy of AV treatment are also outcomes.
• AV, also known as urogenital atrophy, is inflammation of the vagina due to thinning and shrinking tissues and decreased Discussion
References
lubrication of the vaginal walls caused by a lack of estrogen National Library of Medicine. Medical encyclopedia: atrophic vaginitis. Available at: http:// • Successful management of AV depends, in part, on patient • Despite the high prevalence of AV, vaginal estrogen therapy www.nlm.nih.gov/medlineplus/ency/article/000892.htm. Accessed 5/8/06.
Nothnagle M, Taylor S. Vaginal estrogen preparations for relief of atrophic vaginitis. Am Fam Physician.
(VET) was underutilized. The magnitude of this underutilization of Bachmann GA, Nevadunsky NS. Diagnosis and treatment of atrophic vaginitis. Am Fam Physician. treatment should be investigated in the future.
• Better adherence is associated with symptom alleviation and Willhite LA, et al. Urogenital atrophy: prevention and treatment. Pharmacotherapy. 2001;21(4):464-480.
Notelovitz M. Urogenital atrophy and low-dose vaginal estrogen therapy (editorial). Menopause.
• Convenience and the mode of administration are perceived key Bachmann GA. Influence of menopause on sexuality. Int J Fertil. 1995;40:16-22.
• Little is known about the extent to which “real world” patients advantages of vaginal tablets compared with other local dosage Berman JR, Goldstein I. Female sexual dysfunction. Urol Clin N Am. 2001;28:405-416.
Freedman MA. Quality of life and menopause: the role of estrogen. J Womens Health. 2002;11:703-718.
with AV adhere to current available treatment regimens.
forms (e.g., vaginal creams). In light of the hypothesis that these Bellantoni MF, et al. Transdermal estradiol with oral progestin: biological and clinical effects in younger and advantages are likely to increase patient adherence to treatment older postmenopausal women. J Gerontol. 1991;46:M216-222.
Weisberg E, et al. Endometrial and vaginal effects of low-dose estradiol delivered by vaginal ring or vaginal tablet. Climacteric. 2005;8:83-92.
OBJECTIVES
regimens, thereby resulting in improved clinical outcomes, the Palacios S, et al. Low-dose, vaginally administered estrogens may enhance local benefits of systemic therapy in the treatment of urogenital atrophy in postmenopausal women on hormone therapy. Maturitas.
1) To describe levels of adherence and their relationship with level of adherence (i.e., treatment duration and intensity of Raymundo N, et al. Treatment of atrophic vaginitis with topical conjugated equine estrogens in treatment duration with healthcare resource utilization and medication use) of vaginal tablets compared to other local postmenopausal Asian women. Climacteric. 2004;7(3):312-318.
Marx P, et al. Low-dose (0.3 mg) synthetic conjugated estrogens A is effective for managing atrophic vaginitis. Maturitas. 2004;47(1):47-54.
Akrivis Ch, et al. Action of 25 microg 17beta-oestradiol vaginal tablets in the treatment of vaginal atrophy 2) To synthesize measurements of treatment duration observed in • Because AV is not a chronic medical condition, appropriate in Greek postmenopausal women; clinical study. Clin Exp Obstet Gynecol. 2003;30(4):229-234.
Notelovitz M, et al. Estradiol absorption from vaginal tablets in postmenopausal women. Obstet Gynecol. Presented at the 11th Annual ISPOR Meeting
measures of adherence should be carefully selected.
Rioux JE, et al. 17beta-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve 3) To identify adherence-related issues and directions for future May 20-24, 2006; Philadelphia, PA
menopausal atrophic vaginitis. Menopause. 2000;7(3):140-142 Dugal R, et al. Comparison of usefulness of estradiol vaginal tablets and estriol vagitories for treatment of vaginal atrophy. Acta Obstet Gynecol Scand. 2000;79(4):293-297.

Source: http://www.abtassoc.us/posters/BaluS_poster_ISPOR2006.pdf