Impact of fixed-dose combination drugs on adherence to prescription medications.
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ABSTRACT:
SUBMITTER: Pan F
PROVIDER: S-EPMC2324153 | biostudies-other | 2008 May
REPOSITORIES: biostudies-other
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Project description:BackgroundThe majority of people with hypertension require more than one medication to achieve blood pressure control. Many patients are prescribed multipill antihypertensive regimens rather than single-pill fixed-dose combination (FDC) treatment. Although FDC use may improve medication adherence, the impact on patient outcomes is unclear. We compared clinical outcomes and medication adherence with FDC therapy versus multipill combination therapy in a real-world setting using linked clinical and administrative databases.Methods and findingsWe conducted a population-based retrospective cohort study of 13,350 individuals 66 years and older in Ontario, Canada with up to 5 years of follow-up. We included individuals who were newly initiated on one angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II-receptor blocker (ARB) plus one thiazide diuretic. High-dimensional propensity score matching was used to compare individuals receiving FDC versus multipill therapy. The primary outcome was a composite of death or hospitalization for acute myocardial infarction (AMI), heart failure, or stroke. We conducted 2 analyses to examine the association between adherence and patient outcomes. First, we performed an on-treatment analysis to determine whether outcomes differed between groups while patients were on treatment, censoring patients when they first discontinued treatment, defined as not receiving medications within 150% of the previous days' supply. Second, we conducted an intention-to-treat analysis that followed individuals allowing for breaks in treatment to quantify the difference in drug adherence between groups and assess its impact on clinical outcomes. As expected, there was no significant difference in the primary outcome between groups in the on-treatment analysis (HR 1.06, 95% CI 0.86-1.31, P = 0.60). In the intention-to-treat analysis, the proportion of total follow-up days covered with medications was significantly greater in the FDC group (70%; IQR 19-98) than in the multipill group (42%, IQR 11-91, P < 0.01), and the primary outcome was less frequent in FDC recipients (3.4 versus 3.9 events per 100 person-years; HR 0.89, 95% CI 0.81-0.97, P < 0.01). The main limitations of this study were the lack of data regarding cause of death and blood pressure measurements and the possibility of residual confounding.ConclusionsAmong older adults initiating combination antihypertensive treatment, FDC therapy was associated with a significantly lower risk of composite clinical outcomes, which may be related to better medication adherence.
| S-EPMC5995349 | biostudies-literature
Project description:ImportanceThe adverse effects of prescription drug costs on medication adherence and health have been well described for individuals. Because many families share financial resources, high medication costs for one could lead to cost-related nonadherence in another; however, these family-level spillover effects have not been explored.ObjectiveTo evaluate whether the cost of a child's newly initiated medication was associated with changes in their parent's adherence to their own medications and whether that differed by likely duration of treatment.Design, setting, and participantsThis cohort study used interrupted time-series analysis with a propensity score-matched control group from a large national US health insurer database (2010-2020) and included children initiating medication and their linked presumed parents using long-term medications.ExposureThe cost of the child's initiated medication. Child medication cost was classified based on highest (≥90th) or lowest (<10th) decile from out-of-pocket medication spending, stratified by whether the medication was intended for short- or long-term use. Children initiating high-cost medications (based on the highest decile) were propensity-score matched with children initiating low-cost medications.Main outcome and measuresThe child's parent's adherence to long-term medication assessed by the widely used proportion of days covered metric in 30-day increments before and after the child's first fill date. Parent demographic characteristics, baseline adherence, and length of treatment, and family unit size and out-of-pocket medication spending were key subgroups.ResultsAcross 47 154 included pairs, the parents' mean (SD) age was 42.8 (7.7) years. Compared with a low-cost medication, initiating a high-cost, long-term medication was associated with an immediate 1.9% (95% CI, -3.8% to -0.9%) reduction in parental adherence sustained over time (0.2%; 95% CI, -0.1% to 0.4%). Similar results were observed for short-term medications (0.6% immediate change; 95% CI, -1.3% to -0.01%). Previously adherent parents, parents using treatment for longer periods, and families who spent more out-of-pocket on medications were more sensitive to high costs, with immediate adherence reductions of 2.8% (95% CI, -4.9% to -0.6%), 2.7% (95% CI, -4.7% to -0.7%), and -3.8% (95% CI, -7.2% to -0.5%), respectively, after long-term medication initiation.Conclusions and relevanceIn this cohort study small reductions in adherence across parents with higher child drug costs were observed. Health care systems should consider child-level or even household-level spending in adherence interventions or prescription policy design.
| S-EPMC10580109 | biostudies-literature
Project description:Highlights: - Despite clinical evidence of its effectiveness in secondary prevention of cardiovascular disease, uptake of fixed dose combination therapy (FDCs) for CVD has been poor.- A symposium was held bringing together stakeholders on this issue, including from academia, government and NGOs.- The conclusion made was that what is now needed to improve implementation of FDCs is country-specific health systems analyses to design appropriate implementation strategies.- Implementation strategies must look beyond listing on the WHO Essential Medicines List to consider approaches to improving FDC availability, accessibility, affordability, and adherence.- Strategies might include incorporation of FDCs into the WHO HEARTS technical package, simplified treatment and monitoring algorithms, decentralisation of medicine dispensing and task-sharing for treatment management.
| S-EPMC7442173 | biostudies-literature
Project description:BACKGROUND:Many patients with hypertension require more than one drug to achieve blood pressure control. They are prescribed with fixed-dose combination (FDC) antihypertensive therapy rather than monotherapies. Although it is commonly admitted that the use of FDC may improve compliance to treatment, adherence rates in patients receiving FDCs have not been documented. Therefore, the aim of this study was to assess the adherence to treatment in patients receiving FDCs of antihypertensive medications in a real-world setting in Egypt. RESULTS:We conducted a multi-center cross-sectional study over a period of 1 year from Jan 2017 to Jan 2018. We included patients above 21 years old with essential hypertension who were already prescribed with an FDC of antihypertensive treatment for at least 3-month duration. We assessed the adherence to treatment by patient self-assessment using the Morisky 8-Item Medication Adherence Scale (MMAS 8). This study enrolled 2000 hypertensive Egyptian patients. The mean age of enrolled patients was 55.8 ± 10.9 years. Male to female ratio was 1.08. The mean MMAS score was 6.5 ± 1.9. Our analysis showed that 825 (41.3%) patients reached high adherence score, 523 (26.2%) medium adherence, and 652 (32.6%) low adherence. Furthermore, Male patients showed higher adherence rate than females (56.4% versus 43.6%, p < 0.001). Out of 746 patients with controlled blood pressure (< 140/90), 387 (51.9%) patients were highly adherent to treatment. Higher level of education was significantly associated with high adherence rate; 559 (67.8%) patients were university graduates, 232 (28.1%) had primary/secondary school education, and 34 (4.1%) were illiterate (p < 0.001). Moreover, once daily (99.2%) fixed-dose combination was associated with higher adherence rate than twice regimen daily (0.8%), p = 0.03. Multivariate logistic regression analysis showed that patients with high level of education, employed patients, and patients with controlled blood pressure have high adherence rate to medication. CONCLUSIONS:Higher adherence to medication is associated with high level of education and employment, and it can lead to better blood pressure control. Thus, patient education programs may increase patients' adherence to their medication.
| S-EPMC7058724 | biostudies-literature
Project description:BackgroundSuboptimal patient adherence to pharmacological therapy of type 2 diabetes may be due in part to pill burden. One way to reduce pill burden in patients who need multiple medications is to use fixed-dose combinations. Our study aimed to compare the effects of fixed-dose combination versus loose-dose combination therapy on medication adherence and persistence, health care utilization, therapeutic safety, morbidities, and treatment modification in patients with type 2 diabetes over three years.MethodsUsing administrative data, we conducted a retrospective controlled cohort study comparing type 2 diabetes patients who switched from monotherapy to either a fixed-dose combination or a loose-dose combination. Adherence was assessed as the primary endpoint and calculated as the proportion of days covered with medication. After using entropy balancing to eliminate differences in observable baseline characteristics between the two groups, we applied difference-in-difference estimators for each outcome to account for time-invariant unobservable heterogeneity.ResultsOf the 990 type 2 diabetes patients included in our analysis, 756 were taking a fixed-dose combination and 234 were taking a loose-dose combination. We observed a statistically significantly higher change in adherence (year one: 0.22, p<0.001, year two: 0.25, p<0.001, and year three: 0.29, p<0.001) as well as higher persistence and a smaller change in the number of drug prescriptions in each of the three years in the fixed-dose combination group compared to the loose-dose combination group. The differences were most pronounced in patients who were poorly adherent, had a high pill burden, or did not have a severe concomitant disease.ConclusionOur results indicate that taking a fixed-dose combination can lead to a significant improvement in adherence to pharmacological therapy of type 2 diabetes compared to a loose-dose combination. In particular, these findings suggest that reducing pill burden may improve disease management among patients with more complex medication demand and patients who have demonstrated poor medication adherence.
| S-EPMC8096115 | biostudies-literature
Project description:Often considered to be a symptomless condition, hypertension can be associated with a significant emotional burden. To analyze changes of health-related quality of life as well as the emotional burden questions regarding the impact of hypertension were incorporated into the noninterventional SeviTarget study. Comparisons were made between baseline and follow-up findings, and between patients with treatment target achievement and those without. A total of 5831 patients were recruited. At baseline, only 33.3% of patients described their current state of health as good or excellent, while at follow-up this value had risen to 75.8%. Responses regarding symptoms and limitations in activities and mental factors such as anxiety associated with treatment all improved during antihypertensive treatment. Changes to more optimistic responses were more likely for patients who achieved a target BP of <140/90 mm Hg. The study demonstrates that improvements in quality of life and the perceived emotional burden related to hypertension can be achieved with effective management of hypertension.
| S-EPMC8031145 | biostudies-literature
Project description:To compare the safety and efficacy of fixed-dose tafluprost/timolol combination (Taf/T-FDC) with those of fixed-dose latanoprost/timolol combination (Lat/T-FDC) by measuring the intraocular pressure (IOP)-lowering effect, ocular pharmacokinetics, and ocular surface toxicity.The IOP-lowering effect of Taf/T-FDC and Lat/T-FDC in ocular normotensive monkeys was evaluated at 4 and 8 h after instillation in study A, at 12, 14, 16, and 18 h after instillation in study B, and at 24, 26, 28, and 30 h after instillation in study C. Drug penetration into the eye was evaluated by measuring the concentrations of timolol, tafluprost acid (active metabolic form of tafluprost), and latanoprost acid (active metabolic form of latanoprost) using liquid chromatography coupled with tandem mass spectrometry after single instillation of Taf/T-FDC or Lat/T-FDC to Sprague Dawley rats. Cytotoxicity following 1-30 min exposure of SV40-transformed human corneal epithelial cells to Taf/T-FDC or Lat/T-FDC was analyzed using 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium assays. Undiluted and 10-fold diluted solutions of each FDC were evaluated.The IOP-lowering effect of Taf/T-FDC was almost equivalent to that of Lat/T-FDC at 4-8 h after instillation. The peak IOP reduction of Taf/T-FDC and Lat/T-FDC was observed at 8 h after instillation, and there is no difference between the two. The difference between them was observed at 24-30 h after instillation, and Taf/T-FDC demonstrated a significantly greater IOP-lowering effect than Lat/T-FDC at 24-30 h after instillation. The IOP-lowering effect of Taf/T-FDC was sustained up to 30 h after instillation, while that of Lat/T-FDC had almost disappeared at 28 h after instillation. Timolol concentrations in aqueous humor after Taf/T-FDC instillation were higher than those after Lat/T-FDC instillation (Cmax, 3870 ng/mL vs 1330 ng/mL; AUCinf, 3970 ng·h/mL vs 1250 ng·h/mL). The concentrations of tafluprost acid and latanoprost acid in aqueous humor after instillation of Taf/T-FDC and Lat/T-FDC, respectively, were similar to those after instillation of mono-preparations of tafluprost and latanoprost, respectively. The cytotoxic effect of Taf/T-FDC to the human corneal epithelial cells was significantly lower than that of Lat/T-FDC at all evaluated time points in both undiluted and 10-fold diluted FDCs.Taf/T-FDC provides increased IOP-lowering effect duration and lower potential ocular surface toxicity than Lat/T-FDC.
| S-EPMC4934872 | biostudies-literature
Project description:Many patients do not adhere to treatment because they cannot afford their prescription medications, putting them at increased risk of adverse health outcomes. We determined the prevalence of cost-related nonadherence and investigated its associated characteristics, including whether a person has drug insurance.Using data from the 2007 Canada Community Health Survey, we analyzed the responses of 5732 people who answered questions about cost-related nonadherence to treatment. We determined the national prevalence of cost-related nonadherence and used logistic regression to evaluate the association between cost-related nonadherence and a series of demographic and socioeconomic variables, including province of residence, age, sex, household income, health status and having drug insurance.Cost-related nonadherence was reported by 9.6% (95% confidence interval [CI] 8.5%-10.6%) of Canadians who had received a prescription in the past year. In our adjusted model, we found that people in poor health (odds ratio [OR] 2.64, 95% CI 1.77-3.94), those with lower income (OR 3.29, 95% CI 2.03-5.33), those without drug insurance (OR 4.52, 95% CI 3.29-6.20) and those who live in British Columbia (OR 2.56, 95% CI 1.49-4.42) were more likely to report cost-related nonadherence. Predicted rates of cost-related nonadherence ranged from 3.6% (95% CI 2.4-4.5) among people with insurance and high household incomes to 35.6% (95% CI 26.1%-44.9%) among people with no insurance and low household incomes.About 1 in 10 Canadians who receive a prescription report cost-related nonadherence. The variability in insurance coverage for prescription medications appears to be a key reason behind this phenomenon.
| S-EPMC3281154 | biostudies-literature
Project description:This paper describes a planned process evaluation of the Use of a Multidrug Pill In Reducing Cardiovascular Events (UMPIRE) trial, one of several randomised clinical trials taking place globally to assess the potential of cardiovascular drugs as a fixed-dose combination (polypill) in cardiovascular disease prevention. A fixed-dose combination may be a promising strategy for promoting adherence to medication; alleviating pill burden through simplifying regimens and reducing cost. This process evaluation will complement the UMPIRE trial by using qualitative research methods to inform understanding of the complex interplay of factors that underpin trial outcomes.A series of semistructured, in-depth interviews with local health professionals and UMPIRE trial participants in India and the UK will be undertaken. The aim is to understand their views and experiences of the trial context and of day-to-day use of medications more generally. The grounded theory approach will be used to analyse data and help inform the processes of the UMPIRE trial.The study has received ethical approval for all sites in the UK and India where trial participant interviews will be undertaken. The process evaluation will help inform and enhance the understanding of the UMPIRE trial results and its applicability to clinical practice as well as shaping policy regarding strategies for improving cardiovascular medication adherence.
| S-EPMC3664347 | biostudies-other
Project description:ObjectivesThis pre-post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting.SettingTwo Médecins sans Frontières (MSF) primary care clinics serving Syrian refugee and host populations in north Lebanon.ParticipantsConsenting patients ≥18 years with existing ASCVD requiring secondary prevention medication were eligible for study enrolment. Those with FDC contraindication(s) or planning to move were excluded. Of 521 enrolled patients, 460 (88.3%) were retained at 6 months, and 418 (80.2%) switched to FDC. Of these, 84% remained on FDC (n=351), 8.1% (n=34) discontinued and 7.9% (n=33) were lost to follow-up by month 12.InterventionsEligible patients, enrolled February-May 2019, were switched to Trinomia FDC (atorvastatin 20 mg, aspirin 100 mg, ramipril 2.5/5/10 mg) after 6 months' usual care. During the study, the COVID-19 pandemic, an economic crisis and clinic closures occurred.Outcome measuresDescriptive and regression analyses compared key outcomes at 6 and 12 months: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) and systolic blood pressure (SBP) control. We performed per-protocol, intention-to-treat and secondary analyses of non-switchers.ResultsAmong 385 switchers remaining at 12 months, total adherence improved 23%, from 63% (95% CI 58 to 68) at month 6, to 86% (95% CI 82 to 90) at month 12; mean non-HDL-C levels dropped 0.28 mmol/L (95% CI -0.38 to -0.18; p<0.0001), from 2.39 (95% CI 2.26 to 2.51) to 2.11 mmol/L (95% CI 2.00 to 2.22); mean SBP dropped 2.89 mm Hg (95% CI -4.49 to -1.28; p=0.0005) from 132.7 (95% CI 130.8 to 134.6) to 129.7 mm Hg (95% CI 127.9 to 131.5). Non-switchers had smaller improvements in adherence and clinical outcomes.ConclusionImplementing an ASCVD secondary prevention FDC improved adherence and CVD risk factors in MSF clinics in Lebanon, with potential for wider implementation by humanitarian actors and host health systems.
| S-EPMC9884866 | biostudies-literature