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Introduction: During clinical trials, mirabegron, a β3-adrenoreceptor agonist, was associated with increased vital signs vs placebo in patients with overactive bladder.Objective: The purpose of this study was to compare incidence rates of adverse cardiovascular (CV) outcomes following mirabegron or antimuscarinic use.Methods: We conducted an observational post-marketing safety study utilising real-world data. The study population was identified within five sources: Danish and Swedish National Registers, Clinical Practice Research Datalink (UK), Optum (USA) and Humana (USA). Episodes of time when patients were new users of mirabegron or antimuscarinics (October 2012-December 2018) were sourced from prescriptions and matched on propensity scores. Occurrences of major adverse cardiovascular events (MACE), acute myocardial infarction (AMI), stroke, CV mortality and all-cause mortality were identified. Outcome incidence rates and hazard ratios from Cox models were estimated.Results: Overall, 152,026 mirabegron and 152,026 antimuscarinic episodes were matched. The population consisted of 63.1% women and 72.6% were ≥ 65 years old. There were no appreciable differences in the incidence rates of MACE, AMI or stroke between users of mirabegron and antimuscarinics. Incidence rates of CV mortality (hazard ratio 0.83, 95% confidence interval 0.73-0.95) and all-cause mortality (hazard ratio 0.80, 95% confidence interval 0.76-0.84) were no higher with mirabegron vs antimuscarinics. Results restricted to episodes at high risk for CV events or stratified by age (< 65 years, ≥ 65 years) or prior overactive bladder medication use were consistent with overall findings.Conclusions: This large, multinational study found no higher risk of MACE, AMI, stroke, CV mortality or all-cause mortality among users of mirabegron relative to users of antimuscarinics. [ABSTRACT FROM AUTHOR]

Aims: To understand differences in patient reported outcomes (PRO) between patients initiating mirabegron or an antimuscarinic using a validated PRO instrument, OAB‐Satisfaction (OAB‐S). Methods: This prospective observational study used real‐time prescription claims from Humana to identify Medicare patients initiating mirabegron or an antimuscarinic to participate in a series of three phone surveys over ninety days. Results: A total of 1897 mirabegron and 2444 randomly selected antimuscarinic initiators were identified; 174 mirabegron and 193 antimuscarinic initiators completed all three surveys. Among responders, mirabegron initiators were slightly older (76 vs 75 years, P = 0.032), included more males (32% vs 23%, P = 0.044), more likely to have prior OAB treatment (21% vs 13%, P = 0.048), and had greater medication burden (number of unique medications: 10.0 vs 8.7, P = 0.014). There were no between‐group differences at any time or on any OAB‐S scale. There were significant within‐group differences at follow‐up compared to baseline for OAB‐S scales: “impact on daily living,” with improvement over the 90‐day survey period for both mirabegron (P = 0.008) and antimuscarinic (P < 0.001); “interruption of day‐to‐day life,” with improvement for both mirabegron (P < 0.001) and antimuscarinic (P < 0.001); and improvement in “OAB control” for mirabegron (P < 0.001) and antimuscarinic (P < 0.001). Conclusions: Mirabegron initiators tended to be older, had a greater number of unique medications and previously tried prescriptions to treat OAB; nonetheless, mirabegron, and antimuscarinic initiators reported similar trends in improvement in PROs over the first 90 days of treatment. Significant improvement in daily impact of OAB was observed after treatment initiation; however, no significant differences between groups were observed. [ABSTRACT FROM AUTHOR]

Background: Alpha-1 antitrypsin deficiency (AATD) testing rates and associated clinical and economic outcomes data in the US Medicare population are limited. Objective: To characterize individuals with AATD, describe clinical outcomes/healthcare research utilization (HCRU) among individuals with chronic obstructive pulmonary disease (COPD) with or without AATD, and identify AATD testing rates among individuals newly diagnosed with COPD. Methods: This retrospective, observational analysis of claims data included individuals from the Humana Research Database (aged 18-89 years) enrolled in Medicare Advantage Prescription Drug plans. Three cohorts included individuals with evidence of AATD; individuals with COPD + AATD matched to individuals with COPD; and individuals with newly diagnosed COPD. AATD health-related outcomes, such as pulmonary and extrapulmonary conditions or events, and economic outcomes, including inpatient admissions, emergency department visits, and physician visits, were examined independently during the pre-index and post-index periods and compared between those with ATTD and without AATD. Results: We identified 1103 individuals with AATD (aged 67.2 ± 10.0 years, 56.3% women, 94.5% White); overall, 22.2% had exacerbations, respiratory distress, and respiratory failure. Individuals with COPD and AATD (n = 742) were matched to individuals with COPD (n = 7420), based on age (68 ± 9 years), sex (55.0% women), and race (97.2% White). The AATD group had a higher proportion of emphysema (47.4% vs 18.7%), COPD exacerbations (40.6% vs 24.7%), and cirrhosis (4.0% vs 1.3%) than the non-AATD group. All-cause inpatient admissions (31.7% vs 27.3%), COPD-specific inpatient admissions (7.4% vs 4.3%), and COPD-specific emergency department visits (19.5% vs 10.8%) were higher in individuals who had ATTD than in those without AATD. AATD testing rates among individuals with newly diagnosed COPD increased slightly over time (2015: 1.07%; 2020: 1.49%). Individuals with COPD and AATD had more comorbidities and higher HCRU. Testing rates increased slightly but remained low. Discussion: Further research is needed to assess the impact of improved AATD testing on those with COPD. Conclusion: Increased awareness, earlier testing, and treatment may reduce the healthcare burden of AATD in the US Medicare population., Competing Interests: N.K., J.H., and M.S. are employees of Takeda Pharmaceuticals USA, Inc., and are Takeda shareholders. S.H. was an employee of Takeda Pharmaceuticals USA, Inc. at the time of this study, and is a Takeda shareholder. T.N. was an employee of Takeda Pharmaceuticals USA, Inc. at the time of this study. A.D. is an employee of Humana Healthcare Research, Inc. B.T.S. and Y.X. are employees of Humana Healthcare Research, Inc. and are Humana shareholders. J.M.W. is an employee of the University of Alabama at Birmingham, received research support/grants from NIH/NHLBI, ARCUS-Med, Mereo BioPharma, Medscape, Verona Pharma, Grifols, Alpha-1 Foundation, Inhibrx, Department of Veterans Affairs, has patents issued or pending with Mereo BioPharma, has participated on Data Safety Monitoring Board or Advisory Board for AstraZeneca, Takeda, GSK, Bavarian Nordic, has stock options with Alveolus Bio, and has received equipment, materials, drugs, medical writing, gifts, or other services from Takeda, GSK, and Verona Pharma.

Background: Varenicline, a nicotinic acetylcholine receptor partial agonist, is a pharmacotherapy indicated for smoking cessation treatment. To date, no research has examined the relationship between out-of-pocket (OOP) expense and varenicline adherence among Medicare beneficiaries., Objectives: To (a) characterize medication utilization patterns of varenicline among Medicare members newly initiated on varenicline and (b) examine the relationship between member OOP expense and varenicline medication adherence., Methods: In this retrospective cohort study, pharmacy claims data were used to identify Medicare Advantage Prescription Drug Plan (MAPD) members newly initiated on varenicline. Demographic and clinical characteristics, varenicline medication utilization patterns, and pharmacy costs (total and varenicline-specific) were determined for members included in the study. Varenicline adherence was measured by calculating the proportion of days covered (PDC) over a period of 84 days (12 weeks) after initiation. Multiple regression analysis was used to examine the relationship between varenicline OOP cost and varenicline medication utilization, while controlling for sociodemographic characteristics, clinical factors, and nonvarenicline pharmacy costs., Results: A total of 15,452 MAPD members were included in the analysis. Mean (SD) subject age was 62.6 (10.0) years; 21.1% (n = 3,256) were dual eligible; and 33.0% (n = 5,106) received a low-income subsidy. Mean (SD) initial varenicline treatment episode duration was 50.8 (37.8) days, with a mean (SD) varenicline days' supply of 47.8 (32.6) obtained by members during the initial treatment episode. Mean (SD) PDC was 0.51 (0.24), and 14.9% (n = 2,302) of members were classified as adherent to treatment (PDC  ≥  0.80). Greater varenicline OOP expense was significantly associated with lower PDC (regression coefficient = -0.058, P  less than  0.001) and significantly associated with lower odds of receiving a refill for varenicline (odds ratio 0.594, 95% CI: 0.540-0.655, P  less than  0.001)., Conclusions: Among Medicare beneficiaries newly initiated on varenicline, medication adherence was suboptimal, and greater OOP cost was associated with lower adherence and lower odds of refilling varenicline.

Objective: To develop a multiattribute decision model (MADM) to aid in the selection of preferred medications for the treatment of bipolar disorder., Study Design: Data were obtained via a self-administered online survey among psychiatric pharmacist specialists. These survey data were used to construct a MADM based on multiattribute utility technology., Methods: Anticonvulsant mood stabilizers, atypical antipsychotics, olanzapine-fluoxetine combination, and lithium carbonate were evaluated using a MADM. Attributes included in the model were effectiveness, safety and tolerability, cost, monitoring burden, and dosing frequency. A survey instrument was developed to score the relative importance of each attribute and the factor scores for each medication. Four iterations of the model were performed to ascertain the medication with the highest total utility score when the effectiveness factors were weighted to consider the following: overall effectiveness, effectiveness in acute mania, effectiveness in acute bipolar depression, and effectiveness in maintenance treatment. Sensitivity analyses were performed to evaluate the stability of the MADM results., Results: When overall effectiveness, effectiveness in acute mania, or effectiveness in maintenance treatment was considered, lithium carbonate had the highest total utility score. When effectiveness in acute bipolar depression was considered, lamotrigine had the highest total utility score. When considering only atypical antipsychotics, aripiprazole was associated with the highest total utility score for all iterations of the MADM., Conclusion: The use of a MADM may be a beneficial tool to assist in making formulary or preferred therapeutic agent decisions.