Of 689 patients recruited, 338 were randomized to the control condition and 351 to the intervention condition. A total of 559 (81%) had complete pharmacy records and were included in the final analysis. There was no statistically significant difference between intervention and control subjects in the percentage of subjects with complete pharmacy records (80% versus 82%, P
= .50). Of the total patient population, 554/689 or 80.4% had a one-year LDL-C value available; 83.5% in intervention versus 77.2% in the control condition. This difference was due to a greater number of subjects in the control condition having triglycerides ≥400
mg/dl, precluding the calculation of LDL-C. In total, 65.5% of the participants had both pharmacy and LDL-C measures, with no significant difference between the conditions (66.4% versus 64.5% for intervention versus control, resp.). is a flowchart that outlines the recruitment, follow-up, and sample used for the analysis.
Study recruitment, follow-up, and sample used for the PACT analysis.
The mean age of participants was 60 years, with an average body mass index (BMI) of 30
. Sixty percent were male, 68% were married or lived with partner, and 90% were white. Forty-five percent had a high school or less education (). Participants in the UC condition were more likely to be smokers, but were not statistically different from the PI participants in any other characteristic, including demographics, BMI, and catheterization-assessed severity index [23
Demographics of participants, Pharmacist Assisted Compliance Trial, Worcester Massachusetts, 2000–2005 (n = 689).
presents the results of lipid measures. At 12 months, 65% achieved the goal LDL-C level of <100
mg/dl in the PI condition, and 60% achieved this in the UC condition (P
= .29). Average levels of total cholesterol, HDL-C, LDL-C, and triglycerides also were similar between the two conditions.
Cholesterol measure at one-year, Pharmacist Assisted Compliance Trial, Worcester Massachusetts, 2000–2005 (n = 689).
Three hundred and thirty-two subjects (48%) used statin therapy during the study. Of these 85% used atorvastatin, 13% simvastatin, 5% pravastatin, 2% fluvastatin, and 1% lovastatin. Seventy-four percent of statin refills were written for a 30-day supply. At one-year, only 53% and 56% of the participants in the UC and PI conditions, respectively, were using statin medication. Use of nonstatin lipid-lowering medication was infrequent, and these medications included fenofibrate (9 patients), gemfibrozil (7 patients), slow-release niacin (6 patients), colesevelam (4 patients), and cholestyramine (1 patient).
presents adherence with statin medications. The CMA for statin medication use was 0.88 (standard deviation (SD) = 0.3) in the PI condition (referring to the patient being 88% adherent to their statins medication), and 0.90 (SD = 0.3) in the UC condition (P = .51). The number of statin refills and total days on statins were similar in the two conditions.
Statins, Beta-Blockers, and ACE Inhibitor medication compliance at one-year, Pharmacist Assisted Compliance Trial, Worcester Massachusetts, 2000–2005 (n = 689).
Adherence to beta-blockers and ACE inhibitors is also noted in , showing no statistical differences in the use of these medications in the two conditions. The number of beta- blocker and ACE inhibitor refills was also similar in the two conditions, and, as was the case with statin therapy, very high (>90%) in all conditions.
Multivariate logistic regression model results predicting LDL-C <100
mg/dl included variables of study condition, gender, age, and CMA. Results indicated that females were less likely to reach the LDL-C goal (odd ratio = 0.62, 95% confidence interval: 0.39–0.97, P
= .04); and patients aged 61–70 were more likely to reach goal (odd ratio = 2.27, 95% confidence interval: 1.18–4.34, P
= .01, referent group: age < 51). Patients with greater statin CMA levels also had a higher likelihood of attaining the LDL-C goal (odd ratio for CMA > 1 = 2.23, 95% confidence interval: 1.17–4.24, P
= .01, referent group: CMA = 0). Study condition was not significantly associated with LDL-C goal attainment. We considered several other variables such as depression, however, they were not significantly predicting LDL goal, thus were not included in the final model.
Since a smaller proportion of females reached LDL goals, we examine differences in the measurements by gender. Compared to men, women were on average older, had higher BMI, had lower education level, were less likely to be married/live with a partner, and had a lower coronary disease severity score. Women were more likely to use a pillbox, took medication more often, and were more likely to believe that spirituality influences health.
We examined statin medication use and LDL-C outcome. The highest percentage of those who reached the LDL-C goal of <100
mg/dl were patients who used statins as opposed to subjects who did not use statins medications (67% versus 58%, P
= .05). They also had lower LDL-C levels at one-year (93
mg/dl for statins use versus 99
mg/dl for non-statins use, P
Completion rates for pharmacist counseling calls were high: 78% for 2 week calls; 80% for 1 month calls; 78% for 3 month calls; 72% for 6 month calls; 70% for 9 month calls. Forty-eight percent completed all 5 calls and 62% completed at least 4 calls. There was no apparent relationship between intervention dose (i.e., number of intervention calls, the total minutes of call time, and the average minutes of call time) and the study outcomes (i.e., adherence or LDL-C level).