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Browsing by Subject "Discontinuation"

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    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 Medicine
    Aims: 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.
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    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 Medicine
    Purpose: 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.
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    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 Medicine
    Introduction: 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.
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