Search

Introduction: Vibegron is a selective β3‐adrenergic receptor agonist that was approved by the US Food and Drug Administration in December 2020 for the treatment of overactive bladder in adults. This retrospective study assessed US pharmacy claims data to evaluate the real‐world adherence and persistence of vibegron compared with mirabegron and with anticholinergics. Materials and Methods: This analysis used the Optum Research Database to identify adults with ≥1 pharmacy claim for vibegron, mirabegron, or an anticholinergic from April 1, 2021, to August 31, 2022. Patients had ≥ 90 days of continuous commercial or Medicare medical and pharmacy coverage preindex and ≥ 60 days of continuous pharmacy coverage postindex. Two independent propensity‐score models matched patients treated with (1) vibegron versus mirabegron and (2) vibegron versus anticholinergics on key variables such as demographics and clinical characteristics, index copay, days' supply, and time of entry into analysis (index quarter). Adherence was measured by proportion of days covered (PDC) from index to the end of follow‐up and was defined as PDC ≥ 80%. Persistence was defined as days to discontinuation of index medication (first 30‐day gap) or end of follow‐up. Results: The matched vibegron and mirabegron cohorts included 4921 and 9842 patients, respectively, and the matched vibegron and anticholinergic cohorts included 4676 and 9352 patients, respectively. Patients receiving vibegron had greater mean PDC versus patients receiving mirabegron (0.67 vs. 0.64, respectively; p < 0.001) or anticholinergics (0.67 vs. 0.58; p < 0.001). A greater percentage of patients receiving vibegron were adherent versus those receiving mirabegron (49.0% vs. 45.1%, respectively; p < 0.001) or anticholinergics (49.1% vs. 38.5%; p < 0.001). Persistence was longer with vibegron compared with both mirabegron (median [95% CI], 171 [159–182] vs. 128 [122–137] days, respectively; p < 0.001) and anticholinergics (172 [159–183] vs. 91 [91] days; p < 0.001). Conclusion: In this retrospective analysis of pharmacy claims data, patients receiving vibegron exhibited significantly higher adherence and demonstrated longer persistence in comparison to matched patient cohorts receiving either mirabegron or anticholinergics. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Increasing anticholinergic burden (ACB), especially in older adults, may be associated with increased risk of adverse outcomes. This analysis quantified the contribution of overactive bladder (OAB) anticholinergic medications (ACHs) to total ACB and the association of time-varying ACB with 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. Patient's daily ACB was categorized as 0 (< 0.5), 1 (≥ 0.5, < 1.5), 2 (≥ 1.5, < 2.5), 3 (≥ 2.5, < 3.5), or ≥ 4 (> 3.5) points/day. The mean ratio of OAB ACB to total ACB over follow-up was calculated. Adverse health outcomes assessed were: urinary tract infection (UTI), incontinence-associated dermatitis, urinary retention, delirium/drowsiness, cognitive impairment, falls/fractures, cardiovascular events, and mortality. The association between postindex event risk and ACB was analyzed with a time-varying Cox proportional hazard model to account for varying ACB and patient characteristics. RESULTS: In total, 428,142 patients were identified. Mean age was 65.2 years, 66.7% were female, mean (SD) baseline ACB was 0.53 (1.44), and mean (SD) follow-up was 1096 (862) days. Overall, 61% of ACB was attributable to OAB medications. Adjusted hazard ratios (HR) for UTI, urinary retention, delirium/drowsiness, cognitive impairment, fall/fractures, and cardiovascular events were >1 for all ACB categories (vs 0 points/day) and increased with ACB. Cognitive impairment had the highest association with ACB (HR range, 1.182-1.551). CONCLUSION: This analysis shows an association between increased ACB and greater risk of adverse health outcomes. OAB ACHs are a major contributor to total ACB in patients treated with OAB ACHs. [ABSTRACT FROM AUTHOR]

"The Battle of Finnsburh," related to the "Finn Episode" in Beowulf, exists only in a seventeenth-century transcription and contains foay-eight lines. The original manuscript, believed to have been found in the Lambeth Palace Library, is thought to have been lost during the reordering and rebinding of manuscripts ha the late seventeenth century. It is known as the Finnsburh Fragment. There are numerous cruces found in the text, including line 34a, hwearflacra hrcer. Although many previous considerations have assumed the transcriber, George Hickes, was in error, it is proposed that Hickes was correct in his transcription. Hwearflacra is dealt with as a plural genitive kenning, while hrcer is viewed as a variation of hrcew. The proposed reading of line 34a also considers the influence of Germanic and Norse mythology on the text. The suggested interpretation demonstrates that harsh emendations to Hickes's transcription are not necessary to reach a comprehensible reading. [ABSTRACT FROM AUTHOR]

Introduction: Overactive bladder (OAB) management with pharmacotherapy is limited by low real-world adherence and persistence. This analysis compared real-world adherence and persistence of patients initiating vibegron, a 3-adrenergic receptor agonist approved in December 2020 for OAB, with mirabegron and anticholinergics. Methods: This retrospective study used pharmacy claims data from the Optum Research Database. Study criteria included patients ≥18 years old with ≥1 pharmacy claim for vibegron, mirabegron, or anticholinergic from April 1, 2021--December 31, 2021; continuous enrollment in a health plan with pharmacy and medical benefits for 3 months preindex (baseline) and ≥2 months postindex (follow-up); and no index medication during baseline. Two independent propensity-score models were used to match patients treated with (1) vibegron vs mirabegron and (2) vibegron vs anticholinergics. Adherence was measured by proportion of days covered (PDC) from index to end of follow-up and defined as PDC ≥80%. Persistence was defined as days to discontinuation of index medication or end of follow-up. Adherence and persistence were analyzed descriptively and by Kaplan-Meier analysis, respectively. Results: The matched vibegron and mirabegron cohorts included 1655 and 3310 patients, respectively; the matched vibegron and anticholinergic cohorts included 1595 and 3190 patients. Patients receiving vibegron had greater adherence vs patients receiving mirabegron (PDC=0.71 vs 0.68, respectively; P=0.004) or anticholinergics (0.71 vs 0.61; P<0.001). A greater percentage of patients receiving vibegron were adherent (ie, PDC ≥80%) vs those receiving mirabegron (53.4% vs 49.2%, respectively; P=0.005) or anticholinergics (53.7% vs 43.2%; P<0.001). Persistence was longer with vibegron vs mirabegron (median [95% CI]; 205 [162-246] vs 148 [126-162] days, respectively; P<0.001) and anticholinergics (207 [167-246] vs 91 [91- 95] days; P<0.001). Conclusions: In this retrospective analysis, real-world adherence and persistence was higher in patients initiating vibegron compared with patients initiating mirabegron or anticholinergic when matched on baseline characteristics. [ABSTRACT FROM AUTHOR]

BACKGROUND: Muscular dystrophies (MDs) comprise a heterogenous group of genetically inherited conditions characterized by progressive muscle weakness and increasing disability. The lack of separate diagnosis codes for Duchenne MD (DMD) and Becker MD, 2 of the most common forms of MD, has limited the conduct of DMD-specific real-world studies. OBJECTIVE: To develop and validate administrative claims-based algorithms for identifying patients with DMD and capturing their nonambulatory and ventilation-dependent status. METHODS: This was a retrospective cohort study using the statistically deidentified Optum Market Clarity Database (including patient claims linked with electronic health records [EHRs] data) to develop and validate the following algorithms: DMD diagnosis, nonambulatory status, and ventilation-dependent status. The initial study sample consisted of US patients in the database who had a diagnosis code for Duchenne/Becker MD (DBMD) between October 1, 2018, and September 30, 2020, who were male, aged 40 years or younger on their first DBMD diagnosis, and met continuous enrollment and 1-day minimal clinical activities requirement in a 12-month measurement period between October 1, 2017, and September 30, 2020. The algorithms, developed by a cross-functional team of DMD specialists (including patient advocates), were based on administrative claims data with International Classification of Diseases, Tenth Revision, Clinical Modifications coding, using information of diagnosis codes for DBMD, sex, age, treatment, and disease severity (eg, evidence of ambulation assistance/support and/or evidence of ventilation support or dependence). Patients who met each algorithm and had EHR notes available were then validated against structured fields and unstructured provider notes from their own linked EHR to confirm patients' DMD diagnoses, nonambulatory status, and ventilation-dependent status. Algorithm performance was assessed by positive predictive value with 95% CIs. RESULTS: A total of 1,300 patients were included in the initial study sample. Of these, EHR were available and reviewed for 303 patients. The mean age of the 303 patients was 14.8 years, with 61.7% being non-Hispanic White. A majority had a Charlson comorbidity index score of 0 (59.4%) or 1-2 (27.7%). Positive predictive value (95% CI) was 91.6% (85.8%-95.6%) for the DMD diagnosis algorithm, 88.4% (80.2%-94.1%) for the nonambulatory status algorithm, and 77.8% (62.9%-88.8%) for the ventilation-dependent status algorithm. CONCLUSIONS: This work provides the means to more accurately identify patients with DMD from administrative claims data without a specific diagnosis code. The algorithms validated in this study can be applied to assess treatment effectiveness and other outcomes among patients with DMD treated in clinical practice. DISCLOSURES: This study was funded by Pfizer, which contracted with Optum to perform the study and provide medical writing assistance. Ms Schrader reports being an employee of Parent Project Muscular Dystrophy. Mr Posner reports being an employee and stockholder of Pfizer and receiving support from Pfizer for attending conferences not related to this manuscript. Dr Dorling reports being an employee and stockholder of Pfizer at the time the study was conducted and is a current employee of Chiesi USA, Inc. Ms Senerchia reports being an employee of Optum and owning stock in Pfizer and UnitedHealth Group, the parent company of Optum. Dr Chen reports being an employee and stockholder of Pfizer. Ms Beaverson reports being an employee of Pfizer and owning stock in Pfizer and Amicus Therapeutics. Dr Seare reports being an employee of Optum at the time the study was conducted. Dr Garnier and Ms Merla report being employees of Pfizer. Ms Walker reports being an employee of Optum. Dr Alvir reports being an employee and stockholder of Pfizer. Dr Mahn reports being an employee and stockholder of Pfizer. Dr Zhang reports being an employee of Optum. Ms Landis reports being an employee of Optum. Ms Buikema reports being an employee of Optum and holding stock in UnitedHealth Group, the parent company of Optum.