Health Outcomes Risk by Incremental Anticholinergic Burden in Overactive Bladder

Thursday, October 24, 2024

4:38 PM – 4:42 PM EDT

Location: Independence Ballroom A-D (Meeting Level 4)

Table. Risk of Adverse Health Outcomes With A 1-Point/Day Increase in Anticholinergic Burden by Anticholinergic Burden Category

Table.docx

Objectives: Increasing anticholinergic medication (ACH) burden (ACB), especially in older adults may be associated with increased risk of adverse outcomes. ACHs for overactive bladder (OAB) contribute approximately 1 point per day to overall ACB. This analysis quantified the impact of an incremental 1 point/day increase of time-varying total ACB on health outcomes in patients with OAB.

Methods: This retrospective study used medical and pharmacy claims from the Optum Research Database to identify adults with ≥1 pharmacy claim for ≥1 of 6 OAB ACHs from January 2010–November 2021. Patients had continuous enrollment in a commercial or Medicare Advantage plan with pharmacy and medical benefits for ≥6 months preindex (baseline) and postindex and were followed until disenrollment or 31 May 2022. Each ACH was assigned a burden score per established burden values and quantity received. Each patient’s daily ACB was calculated for each day of follow-up as the average burden value over the previous 180 days rounded to the nearest integer. New onset of adverse health outcomes were identified, specifically urinary tract infection (UTI), incontinence-associated dermatitis (IAD), urinary retention, delirium/drowsiness, cognitive impairment, falls/fractures, cardiovascular (CV) events, and mortality. The effect of a 1-point/day change in ACB on the risk of an event was examined within ACB categories 0–3 (0, < 3.5), 4–8 (≥3.5, < 8.5), or ≥9 (≥8.5) points/day using Cox Proportional Hazards regression with piecewise linear time-varying ACB to account for varying ACB and patient characteristics.

Results: In total, 428,142 patients were identified. Mean age was 65.2 years, and 66.7% were female. Mean (SD) follow-up was 1096 (862) days. Most patients (97.3%) were classified as having ACB of 0–3 points/day at baseline. During follow-up, patients added 0.69 to 0.99 ACB points/day from OAB treatment; for patients with 0 points/day at baseline, OAB ACHs accounted for 73% of their total ACB at follow-up. Among the 0–3 points/day category, a 1-point/day increase in ACB was associated with a 2.4%–11.5% greater risk of UTI, urinary retention, delirium/drowsiness, cognitive impairment, falls/fractures, CV events, and mortality (Table). Among the 4–8 points/day category, a 1-point/day increase in ACB was associated with a 1.0%–2.8% greater risk of UTI, urinary retention, delirium/drowsiness, cognitive impairment, falls/fractures, and CV events. A 1-point/day increase in ACB was associated with a 5.3% reduction in the risk of mortality for the 4–8 points/day category. For ACB category ≥9, a 1-point/day increase was not associated with greater risk of adverse health outcomes.

Conclusions: Use of OAB ACHs is a major contributor to patient total ACB. This analysis shows an association between an increase in ACB by 1 point/day and greater risk of adverse health outcomes for patients with ACB of ≤8 points/day. ACH assessment should be performed by providers treating patients with OAB.

Disclosure(s):

Holly E. Richter, PhD, MD: No relevant disclosure to display

Benjamin Chastek, MS: Optum: Employee (Ongoing)

Adam Carrera, PharmD: Sumitomo Pharma America: Employee (Ongoing)

Christina Landis, MPH: Optum: Consultant/Advisory Board (Ongoing), I am an employee of Optum, who was hired by Sumitomo for this project (Ongoing)

Daniel Snyder, PhD: Sumitomo Pharma America: Employee (Terminated, March 31, 2024)

Laleh Abedinzadeh, MD. MBA: Sumitomo Pharma America Inc.: Employee (Ongoing)

tim Bancroft, phd: optum: Employee (Ongoing), I am an employee of Optum. Optum was paid by Urovant to do this work. My employment at Optum is not contingent upon this work. (Ongoing)

Jeffrey R. Nesheim, PharmD, MS: No relevant disclosure to display

Roger R. Dmochowski, MD, MA. MMHC, FACS: Blue wind medical: Consultant/Advisory Board (Ongoing); Sumitomo: Advisory Board (Ongoing)

Adonis Hijaz, MD: No relevant disclosure to display

jeffrey M. Frankel, MD: No relevant disclosure to display

Presenting Author(s)

Holly E. Richter, PhD, MD

Professor
University of Alabama at Birmingham
Birmingham, Alabama, United States

Disclosure(s): No relevant disclosure to display

Co-Author(s)

BC

Benjamin Chastek, MS (he/him/his)

Director
Optum
Eden Prairie, Minnesota, United States

Disclosure(s): Optum: Employee (Ongoing)
AC

Adam Carrera, PharmD (he/him/his)

Director, Medical Managed Markets, HEOR, & RWE
Sumitomo Pharma America
Apex, North Carolina, United States

Disclosure(s): Sumitomo Pharma America: Employee (Ongoing)
CL

Christina Landis, MPH (she/her/hers)

Research Analyst
Optum
Eden Prairie, Minnesota, United States

Disclosure(s): Optum: Consultant/Advisory Board (Ongoing), I am an employee of Optum, who was hired by Sumitomo for this project (Ongoing)
DS

Daniel Snyder, PhD

Senior Vice President, Head of Medical Affairs, Biopharma & Women's Health
Sumitomo Pharma America
Bridgewater, New Jersey, United States

Disclosure(s): Sumitomo Pharma America: Employee (Terminated, March 31, 2024)
LA

Laleh Abedinzadeh, MD. MBA

Senior Director
Sumitomo Pharma America Inc.
Laguna Niguel, California, United States

Disclosure(s): Sumitomo Pharma America Inc.: Employee (Ongoing)
tB

tim Bancroft, phd

analyst
optum
eden prairie, Minnesota, United States

Disclosure(s): optum: Employee (Ongoing), I am an employee of Optum. Optum was paid by Urovant to do this work. My employment at Optum is not contingent upon this work. (Ongoing)
JN

Jeffrey R. Nesheim, PharmD, MS (he/him/his)

Director Medical Managed Markets, HEOR, RWE
SMPA
Littleton, Colorado, United States

Disclosure(s): No relevant disclosure to display
RD

Roger R. Dmochowski, MD, MA. MMHC, FACS

Professor Urology, Surgery and Gynecology
Vanderbilt MEdical Center
Nashville, Tennessee, United States

Disclosure(s): Blue wind medical: Consultant/Advisory Board (Ongoing); Sumitomo: Advisory Board (Ongoing)
AH

Adonis Hijaz, MD

Vice Chairman of academics and research
University Hospitals Cleveland Medical Center
cleveland, Ohio, United States

Disclosure(s): No relevant disclosure to display
jF

jeffrey M. Frankel, MD (he/him/his)

Medical Director
Seattle Urology Research Center
MERCER ISLAND, Washington, United States

Disclosure(s): No relevant disclosure to display