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Medication Discontinuation in the IMPROVE-IT Trial.

ABSTRACT: BACKGROUND:Although cholesterol-lowering medications can reduce the risk of recurrent cardiovascular events, premature discontinuation limits effectiveness. Discontinuation rates have not been systematically reported for lipid-lowering trials. METHODS AND RESULTS:We evaluated medication discontinuation in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial), which evaluated placebo+simvastatin versus ezetimibe+simvastatin in patients hospitalized with the acute coronary syndrome and followed longitudinally postdischarge. Reasons for discontinuation were evaluated from randomization through study end (median 71.9 [interquartile range 51.8-85.8] months). Kaplan-Meier (KM) discontinuation rates were evaluated at 30 days, 1 year, and through year 7, and compared by treatment arm and region, with Cox proportional hazards modeling used to evaluate predictors of discontinuation. Overall, 46.7% of subjects discontinued study medication (KM rate by study end 50.9% [95% CI, 50.1%-51.7%]). The risk of discontinuation was highest early in the trial but decreased with increasing time, with a terminal KM rate per 100 person-years of 8.4 (8.2-8.6) from years 1 to 7. Discontinuation was higher in the placebo+simvastatin versus ezetimibe+simvastatin arm (KM rate 52.0% versus 49.8%, P=0.049) and was highest in the United States (7-year KM rate 57.4%). In multivariable modeling, smoking, prior revascularization, hypertension, unstable angina, female sex, nonwhite race, and US location were associated with higher discontinuation rates. CONCLUSIONS:Although discontinuation was highest early and stabilized to 8% per year, because of prolonged follow-up, most discontinuation occurred after year 1. Adding ezetimibe to statin therapy did not increase discontinuation risk. Geographic differences and patient-level factors should be considered in trial design and analysis. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov . Unique identifier: NCT00202878.

SUBMITTER: Navar AM

PROVIDER: S-EPMC6541480 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Medication Discontinuation in the IMPROVE-IT Trial.

Navar Ann Marie AM Roe Matthew T MT White Jennifer A JA Cannon Christopher P CP Lokhnygina Yuliya Y Newby L Kristin LK Giugliano Robert P RP Tershakovec Andrew M AM Braunwald Eugene E Califf Robert M RM Blazing Michael A MA

Circulation. Cardiovascular quality and outcomes 20190101 1

<h4>Background</h4>Although cholesterol-lowering medications can reduce the risk of recurrent cardiovascular events, premature discontinuation limits effectiveness. Discontinuation rates have not been systematically reported for lipid-lowering trials.<h4>Methods and results</h4>We evaluated medication discontinuation in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial), which evaluated placebo+simvastatin versus ezetimibe+simvastatin in patients hospitalized with ...[more]

PMID: 30630361

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Project description:INTRODUCTION:The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. METHODS AND ANALYSIS:Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. ETHICS AND DISSEMINATION:Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. TRIAL REGISTRATION NUMBER:ACTRN12616000661471; Pre-results.

Project description:ObjectivesWhether unintended discontinuation of common, evidence-based, long-term medication occurs after hospitalisation; what factors are associated with unintended discontinuation; and whether the presence of documentation of medication at hospital discharge is associated with continuity of medication in general practice.DesignRetrospective cohort study between 2012 and 2015.SettingElectronic records and hospital supplied discharge notifications in 44 Irish general practices.Participants20?488 patients aged 65 years or more prescribed long-term medication for chronic conditions.Primary and secondary outcomesDiscontinuity of four evidence-based medication drug classes: antithrombotic, lipid-lowering, thyroid replacement drugs and respiratory inhalers in hospitalised versus non-hospitalised patients; patient and health system factors associated with discontinuity; impact of the presence of medication in the hospital discharge summary on continuity of medication in a patient's general practitioner (GP) prescribing record at 6?months follow-up.ResultsIn patients admitted to hospital, medication discontinuity ranged from 6%-11% in the 6?months posthospitalisation. Discontinuity of medication is significantly lower for hospitalised patients taking respiratory inhalers (adjusted OR (AOR) 0.63, 95% CI (0.49 to 0.80), p<0.001) and thyroid medications (AOR 0.62, 95%?CI (0.40 to 0.96), p=0.03). There is no association between discontinuity of medication and hospitalisation for antithrombotics (AOR 0.95, 95%?CI (0.81 to 1.11), p=0.49) or lipid lowering medications (AOR 0.92, 95%?CI (0.78 to 1.08), p=0.29). Older patients and those who paid to see their GP were more likely to experience increased odds of discontinuity in all four medicine groups. Less than half (39% to 47.4%) of patients had medication listed on their hospital discharge summary. Presence of medication on hospital discharge summary is significantly associated with continuity of medication in the GP prescribing record for lipid lowering medications (AOR 1.64, 95%?CI (1.15 to 2.36), p=0.01) and respiratory inhalers (AOR 2.97, 95%?CI (1.68 to 5.25), p<0.01).ConclusionDiscontinuity of evidence-based long-term medication is common. Increasing age and private medical care are independently associated with a higher risk of medication discontinuity. Hospitalisation is not associated with discontinuity but less than half of hospitalised patients have medication recorded on their hospital discharge summary.

Project description:BackgroundSimple nudges such as reminders and feedback reports to either a patient or a partner may facilitate improved medication adherence.ObjectiveTo test the impact of a pill bottle used to monitor adherence, deliver a daily alarm, and generate weekly medication adherence feedback reports on statin adherence.DesignThree-month, three-arm randomized clinical trial (ClinicalTrials.gov identifier: NCT02480530).ParticipantsOne hundred and twenty-six veterans with known coronary artery disease and poor adherence (medication possession ratio <80 %).InterventionPatients were randomized to one of three groups: (1) a control group (n = 36) that received a pill-monitoring device with no alarms or feedback; (2) an individual feedback group (n = 36) that received a daily alarm and a weekly medication adherence feedback report; and (3) a partner feedback group (n = 54) that received an alarm and a weekly feedback report that was shared with a friend, family member, or a peer. The intervention continued for 3 months, and participants were followed for an additional 3 months after the intervention period.Main measuresAdherence as measured by pill bottle. Secondary outcomes included change in LDL (mg/dl), patient activation, and social support.Key resultsDuring the 3-month intervention period, medication adherence was higher in both feedback arms than in the control arm (individual feedback group 89 %, partner feedback group 86 %, control group 67 %; p < 0.001 and = 0.001). At 6 months, there was no difference in medication adherence between either of the feedback groups and the control (individual feedback 60 %, partner feedback 52 %, control group 54 %; p = 0.75 and 0.97).ConclusionsDaily alarms combined with individual or partner feedback reports improved statin medication adherence. While neither an individual feedback nor partner feedback strategy created a sustainable medication adherence habit, the intervention itself is relatively easy to implement and low cost.

Project description:Low adherence to bisphosphonate therapy is associated with increased fracture risk. Factors associated with discontinuation of osteoporosis medications have not been studied in-depth. This study assessed medication discontinuation and switching patterns among Medicare beneficiaries who were new users of bisphosphonates and evaluated factors possibly associated with discontinuation.We identified patients initiating bisphosphonate treatment using a 5% random sample of Medicare beneficiaries with at least 24 months of traditional fee-for-service and part D drug coverage from 2006 through 2009. We classified medication status at the end of follow-up as: continued original bisphosphonate, discontinued without switching or restarting, restarted the same drug after a treatment gap (? 90 days), or switched to another anti-osteoporosis medication. We conducted logistic regression analyses to identify baseline characteristics associated with discontinuation and a case-crossover analysis to identify factors that precipitate discontinuation.Of 21,452 new users followed respectively for 12 months, 44% continued their original therapy, 36% discontinued without switching or restarting, 8% restarted the same drug after a gap greater than 90 days, and 11% switched to another anti-osteoporosis medication. Factors assessed during the 12-month period before initiation were weakly associated with discontinuation. Several Factors measured during follow-up were associated with discontinuation, including more physician visits, hospitalization, having a dual-energy X-ray absorptiometry test, higher Charlson comorbidity index scores, higher out-of-pocket drug payments, and upper gastrointestinal problems. Patterns were similar for 4,738 new users followed for 30 months.Among new bisphosphonates users, switching within and across drug classes and extended treatment gaps are common. Robust definitions and time-varying considerations should be considered to characterize medication discontinuation more accurately.

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Medication Discontinuation in the IMPROVE-IT Trial.

Publications

Medication Discontinuation in the IMPROVE-IT Trial.

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