Older participant perspectives on permanent study drug discontinuation in an ongoing primary prevention trial of statins

Zhou, Zhen; Jose, Kim; Curtis, Andrea J.; Kost, Alissia; Breslin, Monique; Zoungas, Sophia; Nelson, Mark

doi:10.1007/s00228-020-03073-x

Cited by 4 publications

(2 citation statements)

References 28 publications

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“…It can be concluded that discontinuations related to pre-PCI medication nonadherence, financial difficulties, routine disruption, and emotional distress are more likely to be transient and less difficult to intervene with, and tailored interventions may be appropriate ( Xu et al, 2020 ). In contrast, discontinuation due to lack of medication necessity ( West et al, 2020 ), living in a nonmetropolitan area ( Pietrzykowski et al, 2020 ; Simon et al, 2021 ), and side effects ( Zhou et al, 2021 ; Golder et al, 2022 ; Redfors et al, 2022 ; Yamamoto et al, 2023 ) may be more likely to be permanent and more difficult to intervene with, and an integrative consideration of patient perceptions, healthcare resources, medication characteristics, and therapeutic guidelines is needed to maximize benefit ( Simon et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

Temporal characteristics and associated factors of discontinuation and outcomes after percutaneous coronary intervention

Xu,

Zheng,

Tan

et al. 2024

Front. Pharmacol.

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Background: Medication adherence in patients after percutaneous coronary intervention (PCI) is suboptimal, and discontinuation is common. Information on the temporal characteristics and associated factors of discontinuation and outcomes after PCI is insufficient to improve medication adherence interventions.Methods: We conducted a single-center retrospective study of post-PCI patients by telephone survey and medical record extraction. Temporal characteristics and associated factors of discontinuation and outcomes were examined by survival curve analysis, Cox regression, or time-dependent Cox regression.Results: Discontinuation and major adverse cardiovascular events (MACE) after PCI had similar temporal characteristics, with the highest incidence in the first year, followed by a decline. Temporary discontinuation was associated with pre-PCI medication nonadherence (HR 1.63; 95% CI: 1.09–2.43), lack of medication necessity (HR 2.33; 95% CI: 1.44–3.78), economic difficulties (HR 2.09; 95% CI: 1.26–3.47), routine disruption (HR 2.09; 95% CI: 1.10–3.99), and emotional distress (HR 2.76; 95% CI: 1.50–5.09). Permanent discontinuation was associated with residence in rural areas (HR 4.18; 95% CI: 1.84–9.46) or small to medium-sized cities (HR 4.21; 95% CI: 1.82–9.73), lack of medication necessity (HR 10.60; 95% CI: 6.45–17.41), and side effects (HR 3.30; 95% CI: 1.94–5.62). The MACE after PCI was associated with pre-PCI hypertension (HR 1.42; 95% CI: 1.04–1.96), two coronary stents (HR 1.42; 95% CI: 1.01–1.99) or three coronary stents (HR 1.66; 95% CI: 1.11–2.49) compared to one coronary stent up to this PCI, and temporary discontinuation (≤60 months HR 2.18; 95% CI: 1.47–3.25; >60 months HR 8.82; 95% CI: 3.65–21.28).Conclusion: Discontinuation and MACE after PCI have similar temporal characteristics, temporary discontinuation and permanent discontinuation have different associated factors, and the former is associated with MACE. These findings may provide guidance for medication adherence interventions.

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Section: Discussionmentioning

confidence: 99%

Temporal characteristics and associated factors of discontinuation and outcomes after percutaneous coronary intervention

Xu,

Zheng,

Tan

et al. 2024

Front. Pharmacol.

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“…Clinical trials, such as the Statins in Reducing Events in the Elderly (STAREE) 39 and Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults (PREVENTABLE) 40 trials, will begin to address the question of statins for primary prevention specifically for older adults with CKD as well as in specific CKD stages. More research is also needed to explore the implications of our results in the prespecified subgroups that remained consistent when stratifying by age, sex, race and ethnicity, diabetes, frailty, or dialysis.…”

Section: Discussionmentioning

confidence: 99%

Statins, Mortality, and Major Adverse Cardiovascular Events Among US Veterans With Chronic Kidney Disease

Barayev,

Hawley,

Wellman

et al. 2023

JAMA Netw Open

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ImportanceThere are limited data for the utility of statins for primary prevention of atherosclerotic cardiovascular disease (ASCVD) and death in adults with chronic kidney disease (CKD).ObjectiveTo evaluate the association of statin use with all-cause mortality and major adverse cardiovascular events (MACE) among US veterans older than 65 years with CKD stages 3 to 4.Design, Setting, and ParticipantsThis cohort study used a target trial emulation design for statin initiation among veterans with moderate CKD (stages 3 or 4) using nested trials with a propensity weighting approach. Linked Veterans Affairs (VA) Healthcare System, Medicare, and Medicaid data were used. This study considered veterans newly diagnosed with moderate CKD between 2005 and 2015 in the VA, with follow-up through December 31, 2017. Veterans were older than 65 years, within 5 years of CKD diagnosis, had no prior ASCVD or statin use, and had at least 1 clinical visit in the year prior to trial baseline. Eligibility criteria were assessed for each nested trial, and Cox proportional hazards models with bootstrapping were run. Analysis was conducted from July 2021 to October 2023.ExposureStatin initiation vs none.Main Outcomes and MeasuresPrimary outcome was all-cause mortality; secondary outcome was time to first MACE (myocardial infarction, transient ischemic attack, stroke, revascularization, or mortality).ResultsIncluded in the analysis were 14 828 veterans. Mean (SD) age at CKD diagnosis was 76.9 (8.2) years, 14 616 (99%) were men, 10 539 (72%) White, and 2568 (17%) Black. After expanding to person-trials and assessing eligibility at each baseline, there were 151 243 person-trials (14 685 individuals) of nonstatin initiators and 2924 person-trials (2924 individuals) of statin initiators included. Propensity score adjustment via overlap weighting with nonparametric bootstrapping resulted in covariate balance, with mean (SD) follow-up of 3.6 (2.7) years. The hazard ratio for all-cause mortality was 0.91 (95% CI, 0.85-0.97) comparing statin initiators to noninitiators. The hazard ratio for MACE was 0.96 (95% CI, 0.91-1.02). Results remained consistent in prespecified subgroup analyses.Conclusions and RelevanceIn this target trial emulation of statin initiation in US veterans older than 65 years with CKD stages 3 to 4 and no prior ASCVD, statin initiation was significantly associated with a lower risk of all-cause mortality but not MACE. Results should be confirmed in a randomized clinical trial.

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Dyslipidemia

Jacobsen,

Whelton,

Blumenthal

et al. 2024

Hypertension

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Older participant perspectives on permanent study drug discontinuation in an ongoing primary prevention trial of statins

Cited by 4 publications

References 28 publications

Temporal characteristics and associated factors of discontinuation and outcomes after percutaneous coronary intervention

Temporal characteristics and associated factors of discontinuation and outcomes after percutaneous coronary intervention

Statins, Mortality, and Major Adverse Cardiovascular Events Among US Veterans With Chronic Kidney Disease

Dyslipidemia

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