Patient Compliance with Antihypertensive and Lipid-Lowering Meds
Patient Compliance with Antihypertensive and Lipid-Lowering Meds
The MEDLINE database was searched from 1972 to June 2002 to identify studies of interventions designed to improve compliance with antihypertensive or lipid-lowering medications. Studies were required to employ a controlled design, follow patients for ≥6 months and measure compliance by a method other than patient self-report. The literature review yielded 62 studies describing 79 interventions. Overall, 56% of interventions were reported to improve patient compliance. When only those studies meeting minimum criteria for methodological quality were considered, 22 interventions remained and 12 were recommended, because they demonstrated a significant improvement in compliance. Recommended interventions included fixed-dose combination drugs, once-daily or once-weekly dosing schedules, unit-dose packaging, educational counselling by telephone, case management by pharmacists, treatment in pharmacist- or nurse-operated disease management clinics, mailed refill reminders, self-monitoring, dose-tailoring, rewards and various combination strategies. Personalised, patient-focused programs that involved frequent contact with health professionals or a combination of interventions were the most effective at improving compliance. Less-intensive strategies, such as prescribing products that simplify the medication regimen or sending refill reminders, achieved smaller improvements in compliance but may be cost-effective due to their low cost.
Cardiovascular disease (CVD) accounts for 927,448 deaths annually in the United States and costs an estimated $393.5 billion annually in direct medical costs and lost productivity. Numerous clinical trials and meta-analyses have concluded that antihypertensive and lipid-lowering medications substantially reduce the risk of coronary heart disease, stroke and death in patients with cardiovascular (CV) risk factors. The duration of treatment required to achieve significant risk reductions is debatable, but studies suggest that long-term therapy for 5 or more years yields the greatest benefit. Recently, significant benefits in the outcome of major CV events have been observed after only 3 years.
In actual practice, however, long-term compliance and persistence are rare. Fourteen percent of all written prescriptions are never filled; another 13% of prescriptions are filled but never taken. Among patients who actually begin therapy with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins), observational studies have reported 1-year discontinuation rates of 15–60% and 5-year persistence rates of only 52%. Only 26% of patients are both persistent and compliant 5 years after initiating statin therapy. Similar trends have been observed with antihypertensive medications. During the first year of treatment, the average patient has antihypertensive medications on hand less than 50% of the time. Twenty-one percent of patients never obtain a refill after starting antihypertensive therapy, and only one patient in five has sufficiently high compliance during the first year of therapy to receive the benefits observed in clinical trials.
Improving compliance with CV medications is key to approximating the magnitude of benefits demonstrated in clinical trials. Compliance-enhancing interventions have been evaluated by many researchers and by authorities such as the National Cholesterol Education Program, which recommended that state-of-the-art interventions to improve adherence with lipid-lowering medications be targeted to patients, clinicians and health delivery systems. Although the data supporting specific interventions are frequently weak and/or equivocal, many managed care organisations and providers have already implemented such programs to improve treatment outcomes.
The aim of this study was to assist those healthcare providers and organisations who seek to identify and implement evidence-based compliance interventions for antihypertensive and lipid-lowering therapy. We reviewed the medical and social science literature to determine which interventions can be recommended for implementation based on available evidence.
We searched the MEDLINE database for original studies of compliance interventions for lipid-lowering and antihypertensive medications that were published between 1972 and June 2002. Additional studies were identified by searching the reference lists of published articles. Because antihypertensive and lipid-lowering therapies are both used to treat chronic, asymptomatic CV risk factors and both classes of drugs are generally well tolerated, interventions were not stratified by drug class. The studies were abstracted to identify individual interventions, the patient population in which they were studied, target medications, study design characteristics (experimental design, sample size, duration of follow-up and compliance metric) and outcomes. Because of the substantial between-study differences, quantitative meta-analysis was determined to be inappropriate. Instead, we determined whether each intervention significantly improved compliance, health status and healthcare costs based on the reported results and conclusions.
Previous reviews of this literature have been very selective, including only interventions that were evaluated using the most rigorous methods. From a practical perspective, this approach results in only a few interventions and may exclude potentially useful strategies. We therefore sought to describe the breadth of interventions that have been evaluated and recommend those whose effectiveness has been demonstrated with a reasonable level of scientific rigor. Interventions were only eligible to be 'recommended' if they were evaluated in a study which met the following 4 criteria: (i) the study must have evaluated at least one generalisable intervention designed to improve compliance with lipid-lowering or antihypertensive therapy; (ii) the study had to compare subjects who received the intervention to a control group (non-randomised designs were permitted); (iii) compliance had to be measured by a method other than self report, which relies on patient recall, because this method overestimates compliance and (iv) because of the chronic duration of these medications, studies must have followed subjects for at least 6 months.
Interventions determined by their investigators to significantly increase patient compliance and whose studies met these criteria were recommended. For these interventions, details about the practical aspects of implementation were abstracted and reported.
The MEDLINE database was searched from 1972 to June 2002 to identify studies of interventions designed to improve compliance with antihypertensive or lipid-lowering medications. Studies were required to employ a controlled design, follow patients for ≥6 months and measure compliance by a method other than patient self-report. The literature review yielded 62 studies describing 79 interventions. Overall, 56% of interventions were reported to improve patient compliance. When only those studies meeting minimum criteria for methodological quality were considered, 22 interventions remained and 12 were recommended, because they demonstrated a significant improvement in compliance. Recommended interventions included fixed-dose combination drugs, once-daily or once-weekly dosing schedules, unit-dose packaging, educational counselling by telephone, case management by pharmacists, treatment in pharmacist- or nurse-operated disease management clinics, mailed refill reminders, self-monitoring, dose-tailoring, rewards and various combination strategies. Personalised, patient-focused programs that involved frequent contact with health professionals or a combination of interventions were the most effective at improving compliance. Less-intensive strategies, such as prescribing products that simplify the medication regimen or sending refill reminders, achieved smaller improvements in compliance but may be cost-effective due to their low cost.
Cardiovascular disease (CVD) accounts for 927,448 deaths annually in the United States and costs an estimated $393.5 billion annually in direct medical costs and lost productivity. Numerous clinical trials and meta-analyses have concluded that antihypertensive and lipid-lowering medications substantially reduce the risk of coronary heart disease, stroke and death in patients with cardiovascular (CV) risk factors. The duration of treatment required to achieve significant risk reductions is debatable, but studies suggest that long-term therapy for 5 or more years yields the greatest benefit. Recently, significant benefits in the outcome of major CV events have been observed after only 3 years.
In actual practice, however, long-term compliance and persistence are rare. Fourteen percent of all written prescriptions are never filled; another 13% of prescriptions are filled but never taken. Among patients who actually begin therapy with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins), observational studies have reported 1-year discontinuation rates of 15–60% and 5-year persistence rates of only 52%. Only 26% of patients are both persistent and compliant 5 years after initiating statin therapy. Similar trends have been observed with antihypertensive medications. During the first year of treatment, the average patient has antihypertensive medications on hand less than 50% of the time. Twenty-one percent of patients never obtain a refill after starting antihypertensive therapy, and only one patient in five has sufficiently high compliance during the first year of therapy to receive the benefits observed in clinical trials.
Improving compliance with CV medications is key to approximating the magnitude of benefits demonstrated in clinical trials. Compliance-enhancing interventions have been evaluated by many researchers and by authorities such as the National Cholesterol Education Program, which recommended that state-of-the-art interventions to improve adherence with lipid-lowering medications be targeted to patients, clinicians and health delivery systems. Although the data supporting specific interventions are frequently weak and/or equivocal, many managed care organisations and providers have already implemented such programs to improve treatment outcomes.
The aim of this study was to assist those healthcare providers and organisations who seek to identify and implement evidence-based compliance interventions for antihypertensive and lipid-lowering therapy. We reviewed the medical and social science literature to determine which interventions can be recommended for implementation based on available evidence.
We searched the MEDLINE database for original studies of compliance interventions for lipid-lowering and antihypertensive medications that were published between 1972 and June 2002. Additional studies were identified by searching the reference lists of published articles. Because antihypertensive and lipid-lowering therapies are both used to treat chronic, asymptomatic CV risk factors and both classes of drugs are generally well tolerated, interventions were not stratified by drug class. The studies were abstracted to identify individual interventions, the patient population in which they were studied, target medications, study design characteristics (experimental design, sample size, duration of follow-up and compliance metric) and outcomes. Because of the substantial between-study differences, quantitative meta-analysis was determined to be inappropriate. Instead, we determined whether each intervention significantly improved compliance, health status and healthcare costs based on the reported results and conclusions.
Previous reviews of this literature have been very selective, including only interventions that were evaluated using the most rigorous methods. From a practical perspective, this approach results in only a few interventions and may exclude potentially useful strategies. We therefore sought to describe the breadth of interventions that have been evaluated and recommend those whose effectiveness has been demonstrated with a reasonable level of scientific rigor. Interventions were only eligible to be 'recommended' if they were evaluated in a study which met the following 4 criteria: (i) the study must have evaluated at least one generalisable intervention designed to improve compliance with lipid-lowering or antihypertensive therapy; (ii) the study had to compare subjects who received the intervention to a control group (non-randomised designs were permitted); (iii) compliance had to be measured by a method other than self report, which relies on patient recall, because this method overestimates compliance and (iv) because of the chronic duration of these medications, studies must have followed subjects for at least 6 months.
Interventions determined by their investigators to significantly increase patient compliance and whose studies met these criteria were recommended. For these interventions, details about the practical aspects of implementation were abstracted and reported.
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