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Item A comprehensive assessment of statin discontinuation among patients who concurrently initiate statins and CYP3A4-inhibitor drugs; a multistate transition model(Wiley, 2023) Donneyong, Macarius M.; Zhu, Yuxi; Zhang, Pengyue; Li, Yiting; Hunold, Katherine M.; Chiang, ChienWei; Unroe, Kathleen; Caterino, Jeffrey M.; Li, Lang; Medicine, School of MedicineAims: The aim of this study was to describe the 1-year direct and indirect transition probabilities to premature discontinuation of statin therapy after concurrently initiating statins and CYP3A4-inhibitor drugs. Methods: A retrospective new-user cohort study design was used to identify (N = 160 828) patients who concurrently initiated CYP3A4 inhibitors (diltiazem, ketoconazole, clarithromycin, others) and CYP3A4-metabolized statins (statin DDI exposed, n = 104 774) vs. other statins (unexposed to statin DDI, n = 56 054) from the MarketScan commercial claims database (2012-2017). The statin DDI exposed and unexposed groups were matched (2:1) through propensity score matching techniques. We applied a multistate transition model to compare the 1-year transition probabilities involving four distinct states (start, adverse drug events [ADEs], discontinuation of CYP3A4-inhibitor drugs, and discontinuation of statin therapy) between those exposed to statin DDIs vs. those unexposed. Statistically significant differences were assessed by comparing the 95% confidence intervals (CIs) of probabilities. Results: After concurrently starting stains and CYP3A, patients exposed to statin DDIs, vs. unexposed, were significantly less likely to discontinue statin therapy (71.4% [95% CI: 71.1, 71.6] vs. 73.3% [95% CI: 72.9, 73.6]) but more likely to experience an ADE (3.4% [95% CI: 3.3, 3.5] vs. 3.2% [95% CI: 3.1, 3.3]) and discontinue with CYP3A4-inhibitor therapy (21.0% [95% CI: 20.8, 21.3] vs. 19.5% [95% CI: 19.2, 19.8]). ADEs did not change these associations because those exposed to statin DDIs, vs. unexposed, were still less likely to discontinue statin therapy but more likely to discontinue CYP3A4-inhibitor therapy after experiencing an ADE. Conclusion: We did not observe any meaningful clinical differences in the probability of premature statin discontinuation between statin users exposed to statin DDIs and those unexposed.Item An Exploratory Analysis of Associations Between Eating Disordered Symptoms, Perceived Weight Changes and Oral Contraceptive Discontinuation Among Young Minority Women(Elsevier, 2013) Stidham Hall, Kelli; O’Connell White, Katharine; Rickert, Vaughn I.; Reame, Nancy K.; Westhoff, Carolyn L.; Pediatrics, School of MedicinePurpose: To explore associations between eating-disordered (ED) symptoms, perceived oral contraceptive (OC)-related weight changes, and OC discontinuation among young minority women. Methods: We conducted a prospective substudy of a randomized controlled trial evaluating the impact of a pill pack supply (3 vs. 7 months) on OC continuation among young urban women presenting to a university-affiliated community-based family planning clinic for OC management. Participants (n = 354) were adolescent (n = 173) and young adult (n = 181) women aged 13-24 years, predominantly underinsured and largely Hispanic (92%). We conducted a structured baseline interview that included an ED screening instrument. At the 6-month follow-up, we conducted a telephone interview to determine OC continuation and dimensions of perceived OC-related weight changes during the study period. Results: At baseline, 24% of the subjects fulfilled the moderate/severe ED symptom screen criteria (n = 60). By 6 months, 57% of the subjects (n = 200) reported weight changes and 62% (n = 218) had discontinued OC use. Unadjusted discontinuation rates were similar across age- and ED symptom groups. In multivariate analysis, both ED symptoms (odds ratio = .49, 95% confidence interval = .25-.96, p = .04) and perceived weight changes (odds ratio = .60, 95% confidence interval = .38-.94, p = .03) were negatively associated with OC continuation. Conclusions: ED symptoms and perceived weight changes were associated with an increased likelihood of OC discontinuation among these young women. Reproductive health practitioners should consider psychological symptoms when managing OC.Item Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies(Sage, 2024-12-24) Shah, Viral N.; Agesen, Rikke M.; Bardtrum, Lars; Christiansen, Erik; Snaith, Jennifer; Greenfield, Jerry R.; Medicine, School of MedicineIntroduction: Two phase 3 randomized controlled studies (ADJUNCT ONE (Clinicaltrials.gov: NCT01836523), ADJUNCT TWO (Clinicaltrials.gov: NCT02098395)) evaluated liraglutide (1.8, 1.2 or 0.6 mg) vs placebo in participants with type 1 diabetes (T1D) as an adjunct to insulin therapy. This paper aims to improve our understanding of the potential mechanisms leading to premature discontinuation of this treatment regimen. Methods: Post hoc comparisons were conducted on baseline characteristics and adverse event (AE) rates of participants completing and not completing the ADJUNCT studies due to AEs/lack of tolerance using summary tables and variance analysis. Results: Non-completers (liraglutide and placebo combined) had lower baseline body mass index (BMI) (ADJUNCT ONE: 27.8 kg/m2 vs 29.8 kg/m2, P < .0001; ADJUNCT TWO: 26.3 kg/m2 vs 29.2 kg/m2, P < .0001), longer duration of T1D (25.8 years vs 21.0 years, P < .0001; 24.1 years vs 21.0 years, P = .04), lower daily insulin doses by continuous infusion (46.4 U vs 57.3 U, P = .01; 40.9 U vs 57.4 U, P = .12) or multiple injections (58.4 U vs 68.5 U, P = .006; 56.0 U vs 65.8 U, P =.03) and a higher proportion of participants with undetectable C-peptide (91.5% vs 81.3%; 87.0% vs 84.9%) compared to completers. When analyzed by treatment group, only duration of T1D and C-peptide differed between completers and non-completers among liraglutide (and not placebo) participants. The AE rates were higher for non-completers. Conclusion: Individuals with longer-standing T1D and low levels of C-peptide at baseline were more likely to discontinue adjunctive liraglutide treatment due to AEs/lack of tolerance than individuals with residual insulin production. Lower BMI predicted a greater likelihood of non-completion for the included participants, regardless of treatment. These new findings may be relevant for clinical practice.