Depression and Anxiety Relative Risks in Women Newly Diagnosed with Vulvovaginal Atrophy and Dyspareunia

Transcription

1 Depression and Anxiety Relative Risks in Women Newly Diagnosed with Vulvovaginal Atrophy and Dyspareunia Moyneur, Erick MA 1, Dea, Katherine MSc 1, Derogatis, Len PhD 2, Labrie, Fernand MD, PhD 3 1 StatLog Econometrics Inc., Quebec, QC, Canada. 2 Johns Hopkins University School of Medicine, Baltimore, MD, USA. 3 Endoceutics Inc., Quebec, QC, Canada. Date

2 Introduction Vulvovaginal atrophy (VVA) is a highly prevalent, underreported, and mostly untreated condition in women of postmenopausal age. The main symptoms include dyspareunia (DYSP) or pain at sexual activity, as well as vaginal dryness, and irritation/itching. In addition to these symptoms, it is hypothesised that VVA is also associated with an increased risk of depression and anxiety. Living with these is well known to have a significant impact on relationship, including reduced sexual activity and even divorce.

3 Objective The objective of this study was to estimate the prevalence and relative risk of 1. Overall Depression, 2. Major depressive disorder (MDD), and 3. Anxiety among women newly diagnosed with VVA compared to a control group of women.

4 Data A retrospective cohort analysis of individual-level healthcare claims data from Truven Health MarketScan Commercial and Medicare Supplemental Databases was conducted with data from 01/2010 to 06/2015.

5 Sample Selection VVA Cohort: At least two (2) VVA/DYSP diagnoses (ICD9: 627.3, 625.0) on separate visits. At least 365 days of continuous insurance coverage before and after the first VVA/DYSP diagnosis, allowing enrollment gaps less than 45 days. (index date). Non-VVA Cohort Non-VVA controls were identified from women without a diagnosis of VVA/DYSP anytime in their history. Because control women didn t have a VVA diagnosis, their index date was a randomly selected outpatient visit with at least 365 days of continuous insurance coverage before and after.

6 Matching All VVA Age Calendar Year Health Plan Type US Region All Non - VVA Age Calendar Year Health Plan Type US Region Match 1:3 Final Matched VVA Final Matched Non - VVA Women in both groups were required to be at least 45 years old at the index date.

7 Outcomes Outcomes: MDD and anxiety outcomes were defined as including at least two (2) separate visits with the indicated diagnoses. The overall depression outcome was defined as including at least (2) separate visits with a depression diagnosis or one visit with a depression diagnosis and at least 1 dispensing of an antidepressant.

8 Outcomes The observation period for the outcomes was the year before and the year after the index date. The relative risk of an outcome was defined as the ratio of the proportions of VVA/non-VVA women diagnosed with at least one outcome during the observation period.

9 Design Index Date 1 Baseline Window (Minimum 365 Days of Data Prior to Index Date) Follow-up Window (Minimum 365 Days of Data Post Index Date) 1-Yr Pre-Index Period 1-Yr Post-Index Period Overall Depression Study Period Notes: VVA: Vulvovaginal atrophy; Yr: Year [1] For women with VVA, the index date was defined as the first VVA diagnosis. For women without VVA, the index date was imputed based on a randomly selected outpatient visit.

10 Patient Disposition Women with both Medical and Pharmacy Coverage N=5,570,955 2 VVA Claims Recorded on Separate Dates N=284,726 No VVA Claim N=4,620,233 Continuously Enrolled 365 Days before and after Index Date N=105,430 Continuously Enrolled 365 Days before and after Index Date N=1,328,253 Age 45 at Index Date N= 89,553 Age 45 at Index Date N=1,097,426 VVA Matched Cohort N= 79,595 No VVA Matched Cohort N= 217,296

11 Baseline Demographics VVA (N=79,595) Non-VVA (N=217,296) Standardized Difference Age, Mean (SD) 60.9 (9.2) 60.9 (9.3) 0.20% ,418 (25.7%) 56,038 (25.8%) 0.30% ,569 (45.9%) 99,552 (45.8%) 0.30% ,784 (18.6%) 40,270 (18.5%) 0.10% 75+ 7,824 (9.8%) 21,436 (9.9%) 0.10% Region Northeast 20,532 (25.8%) 54,819 (25.2%) 1.30% South 26,853 (33.7%) 73,446 (33.8%) 0.10% West 18,471 (23.2%) 51,570 (23.7%) 1.20% North Central 13,588 (17.1%) 37,099 (17.1%) 0.00% Unknown 151 (0.2%) 362 (0.2%) 0.50% Notes: VVA: Vulvovaginal atrophy [1] The baseline period was defined as the one-year period preceding the index date.

12 Baseline Demographics Insurance Plan Type, N (%) VVA (N=79,595) Non-VVA (N=217,296) Standardized Difference PPO 46,526 (58.5%) 125,611 (57.8%) 1.30% HMO 10,079 (12.7%) 28,576 (13.2%) 1.50% Comprehensive 9,476 (11.9%) 26,199 (12.1%) 0.50% POS 5,166 (6.5%) 13,939 (6.4%) 0.30% CDHP 3,149 (4.0%) 8,563 (3.9%) 0.10% Other/Unknown 5,199 (6.5%) 14,408 (6.6%) 0.40% Notes: VVA: Vulvovaginal atrophy [1] The baseline period was defined as the one-year period preceding the index date.

13 Baseline Characteristics VVA (N=79,595) Non-VVA (N=217,296) Standardized Difference Gynecological examination 21,582 (27.1%) 55,820 (25.7%) 3.2% Symptomatic menopausal or female climacteric state 7,937 (10.0%) 11,109 (5.1%) 18.4% Osteoporosis 7,551 (9.5%) 12,443 (5.7%) 14.2% Vaginitis and vulvovaginitis 6,747 (8.5%) 4,294 (2.0%) 29.2% Dysuria 6,035 (7.6%) 4,937 (2.3%) 24.5% Unspecified symptom associated with female genital organs 5,045 (6.3%) 3,884 (1.8%) 23.1% Stress incontinence 2,868 (3.6%) 1,941 (0.9%) 18.3% Postmenopausal bleeding 2,321 (2.9%) 2,919 (1.3%) 10.9% Notes: VVA: Vulvovaginal atrophy [1] The baseline period was defined as the one-year period preceding the index date.

14 Prevalence Prevalence (%) of Depression and Anxiety in Women Newly Diagnosed with VVA versus not Diagnosed with VVA Age Groups Overall VVA Non-VVA (N) MDD 1 Only Overall Depression 2 Anxiety 3 79, , , , , , , , , , Notes: [1] MDD Only was defined as at least two diagnoses of major depressive disorder (a subset of depression outcome) [2] Overall Depression was defined as at least two diagnoses of depression OR at least one diagnosis of depression plus at least one prescription fill for depression. [3] Anxiety was defined as at least two diagnoses of anxiety

15 Relative Risks Relative Risks (95% CI) of Depression and Anxiety in Women Newly Diagnosed with VVA versus not Diagnosed with VVA Age Groups VVA Non-VVA (N) MDD Only 1 Overall Depression 2 Anxiety 3 Overall , ,296 20,418 56,038 36,569 99,552 14,784 40,270 7,824 21, (1.40,1.50) 1.33 (1.31,1.35) 1.62 (1.59,1.66) 1.54 (1.44,1.64) 1.48 (1.44,1.53) 1.74 (1.67,1.82) 1.46 (1.39,1.54) 1.32 (1.29,1.36) 1.61 (1.55,1.66) 1.31 (1.20,1.44) 1.19 (1.14,1.24) 1.50 (1.41,1.59) 1.27 (1.11,1.46) 1.16 (1.09,1.23) 1.54 (1.42,1.67) Notes: [1] MDD Only was defined as at least two diagnoses of major depressive disorder (a subset of depression outcome) [2] Overall Depression was defined as at least two diagnoses of depression OR at least one diagnosis of depression plus at least one prescription fill for depression. [3] Anxiety was defined as at least two diagnoses of anxiety

16 Results: MDD Notes: [1] MDD Only was defined as at least two diagnoses of major depressive disorder (a subset of depression outcome) [2] Overall Depression was defined as at least two diagnoses of depression OR at least one diagnosis of depression plus at least one prescription fill for depression. [3] Anxiety was defined as at least two diagnoses of anxiety

17 Results: Overall Depression Notes: [1] MDD Only was defined as at least two diagnoses of major depressive disorder (a subset of depression outcome) [2] Overall Depression was defined as at least two diagnoses of depression OR at least one diagnosis of depression plus at least one prescription fill for depression. [3] Anxiety was defined as at least two diagnoses of anxiety

18 Results: Anxiety Notes: [1] MDD Only was defined as at least two diagnoses of major depressive disorder (a subset of depression outcome) [2] Overall Depression was defined as at least two diagnoses of depression OR at least one diagnosis of depression plus at least one prescription fill for depression. [3] Anxiety was defined as at least two diagnoses of anxiety

19 Results: One Year Before and After VVA Prevalence (%) and Relative Risks of Depression and Anxiety in Women Newly Diagnosed with VVA Before and After the VVA Diagnosis versus No Diagnosis of VVA MDD Overall Depression Anxiety Number of Women (N=) 1-Yr Pre-Index Period 2 1-Yr Post-Index Period 3 Overall Study Period 4 Non-VVA 217, % 3.2% 4.00% VVA 79, % 4.6% 5.79% Risk Ratio - RR (95% CI) 1.49 (1.43,1.55) 1.43 (1.37,1.48) 1.45 (1.40,1.50) P-Value <.0001 <.0001 <.0001 Non-VVA 217, % 15.4% 16.62% VVA 79, % 20.1% 22.06% Risk Ratio - RR (95% CI) 1.33 (1.31,1.36) 1.31 (1.29,1.33) 1.33 (1.31,1.35) P-Value <.0001 <.0001 <.0001 Non-VVA 217, % 6.2% 7.91% VVA 79, % 9.9% 12.85% Risk Ratio - RR (95% CI) 1.67 (1.63,1.72) 1.60 (1.56,1.64) 1.62 (1.59,1.66) P-Value <.0001 <.0001 <.0001 Notes: [1] MDD Only was defined as at least two diagnoses of major depressive disorder (a subset of depression outcome) [2] Overall Depression was defined as at least two diagnoses of depression OR at least one diagnosis of depression plus at least one prescription fill for depression. [3] Anxiety was defined as at least two diagnoses of anxiety

20 Conclusions This study used claims data to identify the diagnoses of Depression, MDD, and Anxiety which reflect real world practice. Women diagnosed with VVA had a higher risk of depression and anxiety compared to controls. Since VVA is highly underdiagnosed, many women in the control group are also likely to suffer from these conditions and their associated symptoms, thus decreasing the observed differences between VVA and no VVA. Accordingly, the reported relative risks are likely to be significant underestimates of the true relative risks of depression and anxiety among women with VVA compared to no VVA.

21 Funding This study was funded by Endoceutics Inc., Quebec City, QC, Canada

22 The North American Menopause Society Annual Meeting (NAMS) Philadelphia October 11-14, Date