Effect of intervention through a pharmaceutical care program on patient adherence with prescribed once-daily atorvastatin. Failure of educational videotapes to improve medication compliance in a health maintenance organization. Impact of pharmacy counseling on compliance and effectiveness of combination lipid-lowering therapy in patients undergoing coronary artery revascularization: a randomized, controlled trial. [Therapy compliance in cases of hyperlipaemia, as measured through electronic monitors. Is a reminder calendar to avoid forgetfulness effective?]. [Efficacy of an intervention to improve treatment compliance in hyperlipidemias]. [Therapeutic compliance in dyslipidemias. A trial of the efficacy of health education]. Efficacy and compliance with cholestyramine bar versus powder in the treatment of hyperlipidemia. Moderate dose, three-drug therapy with niacin, lovastatin, and colestipol to reduce low-density lipoprotein cholesterol <100 mg/dl in patients with hyperlipidemia and coronary artery disease. Telephone contacts do not improve adherence to niacin or bile acid sequestrant therapy. The effects of postal and telephone reminders on compliance with pravastatin therapy in a national registry: results of the first myocardial infarction risk reduction program.
Correct execution of prescribed dosing regimen(s) is essential for patients to benefit from lipid lowering treatments. The objective of this study was to estimate the effect of a pharmaceutical care program on the adherence of once-daily atorvastatin treatment in patients with elevated cholesterol levels.
                In both linguistic regions of Belgium, two districts were randomized between usual care and a supportive intervention program. Eligible patients included hyperlipemic subjects taking atorvastatin for at least 3 months. 'Adherence' was defined as the proportion of days during which the electronic device record showed that the patient had taken the daily dose. 'Persistence' quantifies how long the treatment is executed.
                A total of 392 patients from 35 pharmacies were included in the intent-to-treat (ITT) analysis of the data (194 patients received intervention and 198 in the control group). The intervention resulted in a 6.5% increase in post-baseline adherence (p < 0.001) mainly driven by a 13% increase in persistence at 1 year (p = 0.002).
                A supportive pharmaceutical care program consisting of review by patient and pharmacist of each patient's electronically compiled dosing history, plus educational reminders, improves patient adherence to the once-daily atorvastatin dosing regimen, mainly by extending persistence.
                Copyright 2005 John Wiley & Sons, Ltd. The value of mailed educational videotapes as a means of enhancing compliance with drug therapy was studied. Members of a health maintenance organization with a pharmacy claim for benazepril, metoprolol, simvastatin, or transdermal estrogen were randomly assigned to a study group or a control group. Subjects in the study group were mailed one of four videotape programs giving information on the drug prescribed and the inferred disease state. Control subjects received no educational materials. Subjects were enrolled from July 1, 1993, through January 2, 1994. Refill data were collected from July 1, 1993, through April 1, 1994. The medication possession ratio (MPR) was calculated as the total number of days' supply of a drug obtained by a member divided by the number of days between the time of enrollment and April 1, 1994, or the date the member was terminated from the plan. A subject was deemed compliant if his or her MPR was > or = 0.80. There were no significant differences in mean MPRs between the study group (n = 1993) and the control group (n = 2253). None of the mean MPRs was > or = 0.80, although 44% of control subjects and 46% of study-group subjects were compliant. Of 97 respondents to a survey mailed to a randomly selected subset of the study group, almost 87% reported that they had viewed the videotapes, and of these subjects, about 88% said they found them very useful or somewhat useful. A one-time mailing of videotapes to patients, with no individual follow-up, did not increase compliance with the medications monitored. This randomized, controlled trial evaluated the impact of personalized follow-up on compliance rates in high-risk patients receiving combination lipid-lowering therapy over 2 years. A random sample of 30 patients 7-30 days after cardiac surgery had baseline fasting low-density lipoprotein levels higher than 130 mg/dl. All patients received lovastatin 20 mg/day and colestipol 5 g twice/day. Weekly telephone contact was made with each patient for 12 weeks. Short- and long-term compliance was assessed by pill and packet counts and refill records. Compliance and lipid profile results were significantly better in the intervention group (p<0.05) up to 2 years after the start of therapy than in the control group for all parameters except high-density lipoprotein. However, this effect was not apparent during the first 12 weeks of therapy. Short-term telephone follow-up favorably affected compliance and lipid profile results up to 2 years after start of therapy. To analyse the efficacy of the intervention with a calendar reminder of the medication taking in the treatment of the hyperlipidemias.
                Controlled, randomised clinical trial.
                Twelve clinics at 5 primary care centres, Spain.
                Two hundred and twenty people diagnosed with hypercholesterolaemia according to Spanish Consensus criteria were chosen.
                Two groups were formed. The control group (CG) of 110 patients, who received the doctor's normal treatment; and the Intervention group (IG) of 110 patients, who received in addition a calendar remider of medication taking.
                Meausured of compliance was performed by moniotrs electronic (MEMS) and cholesterol, triglycerides, HDL-C, and LDL-C determined at the start, and at the third and sixth months. Percentages of patients complying (80%-110%), the mean compliance percentage and the degree of control were compared. The reduction of absolute and relative risk (RAR and RRR) and the mean number of people that required an intervention in order to avoid non-compliance (NI) were calculated.
                One hundred and eighty eight people (85.45%) completed the survey, 96 in the IG and 92 in the CG; 26.55% were non compliers with the therapy (CI, +/-6.3%) (IG, 10.5%, CI, +/-4.6%; CG, 42.6%, CI, +/-10.1% [P<.0001]). Mean compliance ran at 88,1% (IC, +/-4.6%) overall, at 92% (CI, +/-5.4%) in the IG and at 84% (CI, +/-7.4%) in the IG (P<.05). The RAR was 32.1%, the RRR 75.35%, and the NI was 3.1 patients. The patients with cholesterol controlled ran at 66.7% (CI, +/-9.4%) in the IG and 41.2% in the CG (P<.001).
                The calendar reminder intervention is an efficacious way of improving the percentage of patients complying with lipaemia treatment. To analyse the efficacy of the intervention through a telephone call about patients' compliance with lipaemia therapy.
                Controlled, randomised clinical trial.
                Ten clinics at 6 primary care centres.
                126 people diagnosed with hypercholesterolaemia according to Spanish Consensus criteria were chosen.
                Two groups were formed. The control group (CG) of 63 patients, who received the doctor's normal treatment; and the Intervention group (IG) of 63 patients, who received in addition a telephone call at 2 weeks, 2 months and 4 months.
                Pills were counted and cholesterol, triglycerides, HDL-C and LDL-C determined at the start, and at the third and sixth months. Percentages of patients complying (80%-110%), the mean compliance percentage and the degree of control were compared. The reduction of absolute and relative risk (RAR and RRR) and the mean number of people that required an intervention in order to avoid non-compliance (NI) were calculated.
                115 people (91.26%) completed the survey, 56 in the IG and 59 in the CG. 77.1% complied with the therapy (CI, 68.4-85.8), (CG=64.4%, CI, 55.3-73.5; IG=93.5%, CI, 88.8-98 [P<.001]). Mean compliance ran at 88.7 +/- 10.2 overall, at 84.4 +/- 12.8 in the CG and at 93 +/- 8.2 in the IG (P<.001). The RAR was 29.1%, the RRR 81%, and the NI was 3.43 patients. The patients controlled ran at 43.9% in the IG (CI, 34.9-52.9) and 23.1% in the CG (CI, 15.4-30.8) (P<.005).
                The telephone intervention is an efficacious way of improving the percentage of patients complying with lipaemia treatment. To analyse the efficacy of health education (HE) through group session with postal back-up in furthering compliance with therapy for Lipaemia.
                Controlled clinical trial, with random distribution.
                Primary care.
                110 patients with Hypercholesterolaemia, with new diagnoses or not in treatment, in which medical treatment with statins was indicated as a start or change in medication.
                They were distributed in two groups at random, with observation four months after being included in the study and appointments after one, two and four months. 1. Control group (CG): 55 patients who received HE from their family doctor. 2. Intervention group (IG): 55 patients whose HE was monitored: a) a group HE session and b) back-up by letter sent to their homes.
                Patients whose consumption was between 80 and 110% of the amount prescribed were defined as compliant. The pill count was recorded. The percentages of compliant patients and mean compliance (chi squared, Student's t) were analysed. 108 individuals, 41 men and 67 women, completed the trial. There was no difference between the two groups as to age, sex, evolution time, number of diseases and dosage of medicines consumed. 71.3% were compliant (CI, 62.8-79.8%), CG = 61.8% and IG 81.1% (p < 0.05). The mean percentage of compliance was 86.1 +/- 14.3 overall, with CG = 83.8 +/- 14 and IG 88.5 +/- 14 (p = NS).
                The HE intervention with a group session and postal back-up is an effective way of improving therapeutic compliance in cases of hypercholesterolaemia. The purpose of the study was to compare the powder and the bar forms of cholestyramine to determine efficacy and patient compliance.
                A prospective, randomized trial was conducted that included 83 healthy men and women with hyperlipidemia greater than the 90th percentile for low-density lipoprotein (LDL) or total cholesterol. Patients were randomly assigned to receive either cholestyramine powder, two packets (8 g), twice daily, or cholestyramine confectionery bar, in maple or mint flavors, two bars (8 g), twice daily. Fasting serum total cholesterol, LDL cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides were measured at baseline, after 6 to 8 weeks of following the American Heart Association Step I diet alone, and after 8 weeks of taking either the cholestyramine bar or powder.
                Total cholesterol decreased significantly (p less than 0.01) by 16% in the bar group and 17% in the powder group. LDL cholesterol decreased by 28% and 29% in the bar and powder groups, respectively (p less than 0.01). There was no significant change in HDL cholesterol. Triglycerides increased in both groups, by 29% in the bar group and by 25% in the powder group. There was no difference between bar and powder in the effect on blood lipids. The majority of the lipid-lowering effect was seen within 14 days. Mean patient endpoint compliance with the therapy was 91.8 +/- 3.6% in the bar group and 94.8 +/- 2.1% in the powder group. There was no difference between groups.
                The cholestyramine confectionery bar is as effective as cholestyramine powder in the treatment of hyperlipidemia. The majority of the lipid-lowering effect is seen within 14 days of therapy. Although patient compliance is comparable between the two forms, gastrointestinal side effects were slightly greater with the bar form. Therefore, although the bar offers an alternative form of therapy, there appears to be no advantage with regard to patient compliance or palatability. The efficacy, safety, and tolerability of a moderate dose, 3-drug lipid-lowering regimen were evaluated among 29 male patients with hyperlipidemia and coronary artery disease. In an initial 12-month phase, regular niacin, 500 mg qid, lovastatin, 20 mg bid, and colestipol, 10 g/bid, were given with dose adjustment for lipid targets and side effects. This was followed by 2 random sequence crossover phases (8 months each) alternating regular niacin with a polygel controlled-release formulation of niacin for use in this regimen. Lipid, lipoprotein, apoprotein, and clinical chemistry determinations were obtained at baseline, during the initial phase, at the 2 crossover phases, and at 6 weeks after therapy. A final questionnaire queried specific side effects and overall preferences. Low-/high-density lipoprotein (LDL/HDL) changed from means of 215/46 mg/dl at baseline, to 94/59 mg/dl after run-in, to 85/52 mg/dl after 8 months of controlled-release niacin, and to 98/56 mg/dl after 8 months of regular niacin (regular niacin vs controlled-release niacin, p <0.005/<0.05). The target of LDL < or = 100 mg/dl was achieved at 8 months by 83% of these patients with controlled-release niacin and by 52% with regular niacin (p <0.01). Compliance was 95% with controlled-release niacin versus 85% with regular niacin (p <0.001). The controlled-release niacin and regular niacin regimens did not differ in terms of uric acid, glucose, insulin, or asparate aminotransferase levels. Overall, 21% of patients called the 3 drugs "very easy" and 72% "fairly easy" to take. The controlled-release niacin-containing regimen was preferred by 21 patients and the regular niacin by 4. In conclusion, these regimens achieve striking lipid changes among hyperlipidemic patients. Controlled release is the preferred niacin preparation in terms of LDL reduction, compliance, patient preference, and achieving the National Cholesterol Education Program guideline of LDL < or = 100 mg/dl. The 2 niacin preparations did not differ in evidence of toxicity. Noxious adverse effects frequently limit patient acceptance of niacin and bile acid sequestrants (BAS), first-line agents in the management of hypercholesterolemia. The purpose of this study was to determine whether telephone contacts from a healthcare professional could improve drug adherence and tolerance in patients prescribed these medications.
                This was a randomized, single-blind trial of telephone contacts vs. no intervention in patients with hyperlipidemia who were prescribed either niacin or BAS in a large, Veterans Affairs, lipid clinic. Patients randomized to telephone contact (n = 81) received weekly calls from a trained healthcare professional during the first month of drug therapy. Counseling regarding adverse effects, and prescriptions to overcome minor adverse effects, were provided as needed to patients during the telephone contact.
                Significant differences were not observed between groups in the drug discontinuance rate, adherence assessed by two independent methods, or in the final dosage of medication ingested.
                Telephone contacts do not improve either adherence or tolerance to niacin or BAS. Alternative approaches to enhance acceptance of these medications requires further evaluation. Noncompliance with cardiovascular therapy and prevention initiatives is well documented.
                The purpose of the First Myocardial Infarction (MI) Risk Reduction Program, an open-label drug registry involving mainly primary-care patients at increased risk of a first MI, was to examine the effects of postal and telephone reminders, as well as demographic and other baseline characteristics, on patient self-reported compliance with pravastatin treatment. A second objective was to determine whether regimen adherence was associated with the adoption of other lifestyle modifications recommended to decrease the risk of coronary artery disease.
                Patients with risk scores of > or = 4 on a scale of -1 to +16 for men and -1 to +17 for women on the First Heart Attack Risk Test were considered to be at increased risk of a first MI and eligible for enrollment in the registry program. An elevated total cholesterol level despite dietary interventions was an additional inclusion criterion. Patients were prospectively randomized (4:1) to either an intervention involving postal and telephone reminders (about coronary risk reduction and medication compliance), which were sent during the first 2 months of pravastatin treatment, or usual care. Both groups received reminder postcards at 4 and 5 months, in addition to counseling by physicians about coronary risk reduction. At 3 and 6 months (or study discontinuation), patients completed and mailed to the program-coordinating center questionnaires concerning compliance with care, including current use of prescribed pravastatin, as well as self-reported adoption of other lifestyle modifications, such as changing eating habits, losing weight, increasing physical activity, and/or quitting smoking. Compliance with pravastatin therapy and with these coronary risk-reducing behaviors was also assessed by physicians at the 3-month follow-up visit.
                A total of 10,335 patients were in the intervention group, and 2765 received usual care. The 2 groups were well balanced at baseline with respect to age, race, and total cholesterol values. Neither early reminders nor baseline patient characteristics were significantly associated with reported pravastatin compliance rates, which were approximately 79% overall. However, according to self-reports at 6 months, regimen compliance was associated with the adoption of other coronary risk-reducing behaviors.
                The results of this study suggest that early telephone and postal reminders do not improve compliance with drug treatment or with recommended coronary risk-reducing behaviors.
At this stage, reminding patients seems the most promising intervention to increase adherence to lipid lowering drugs. The lack of a gold standard method of measuring adherence is one major barrier in adherence research. More reliable data might be achieved by newer methods of measurement, more consistency in adherence assessment and longer duration of follow up. More recent studies have started using more reliable methods for data collection but follow-up periods remain too short. Increased patient-centredness with emphasis on the patient's perspective and shared decision-making might lead to more conclusive answers when searching for tools to encourage patients to take lipid lowering medication.