There were 69 women and 25 men who completed the study with an average age of 57 ± 12 years. The youngest woman was 29 years old and the youngest man was 33. The oldest woman and man were 85 and 77 years, respectively.
describes the baseline patient characteristics. None of the differences in the distribution of patient characteristics was statistically significant.
Patient Characteristics Within Control and Intervention Groups*
describes the baseline health status of the patients that might be related to the study outcomes for the control and intervention groups. None of the entry measures of health status differed significantly between the intervention and control groups.
Patient Baseline Health Status Related to Treatment Goals Within Control and Intervention Groups*
The pharmacist made 186 recommendations over the 6-month study period. There were 17 recommendations for a change in dose, 59 for a change in medication, 95 for monitoring, and 15 for patient education by personnel other than the pharmacist or physician (e.g., a dietitian). Overall, physicians accepted 90% (167/186) of the pharmacist’s recommendations. All recommendations with regard to patient education, as well as 94% of recommendations to alter dosing and 93% of recommendations for patient monitoring were accepted by the intervention group physicians. As a result of the pharmacist recommendations, there were 27 medications started in the intervention group: 12 of pravastatin, 7 of nicotinic acid, 2 of premarin, 2 of cholestyramine, 3 of aspirin, and 1 of lovastatin. Twenty-one medications were discontinued at the pharmacist’s recommendation: 6 of lovastatin, 4 of cholestyramine, 4 of pravastatin, 3 of niacin, 1 of aspirin, 1 of premarin, 1 of gemfibrozil, and 1 of dyazide. There were 16 accepted recommendations for increases in medication dosages: 11 of niacin, 4 of pravastatin, and 1 of cholestyramine.
Physicians declined to accept 19% (11/59) of the pharmacist recommendations for a drug selection. The 11 refusals to accept a drug selection were nearly evenly divided between 2 of the 20 physicians who participated in the study. Of the refused recommendations, there were 3 to start premarin, 2 to start pravastatin, 1 to start nicotinic acid, 1 to start “a lipid-lowering agent” not further specified, 1 to increase lovastatin, 1 to discontinue a β blocker and start a calcium channel blocker instead, 1 to discontinue gemfibrozil, and 1 to discontinue lovastatin.
The percentage of patients who achieved the goal of lowering LDL cholesterol to levels described by NCEP guidelines is shown in . The success rate in the intervention group was double the rate in the control group (43% vs 21%, p < .05). Within the intervention group, patients for whom the physician declined the pharmacist’s recommendations fared worse than those for whom recommendations were accepted. Only 2 (17%) of 12 patients for whom recommendations were declined met their NCEP goals, compared with 18 (51%) of 35 patients for whom recommendations were accepted (p = .047).
FIGURE 1 Percentage of men and women who achieved the NCEP goal of lowering LDL cholesterol within intervention and control groups. For patients without coronary heart disease, the goal was to lower LDL cholesterol to under 160 mg/dL (4.1 mmol/L) in patients with (more ...)
The effect of the intervention in terms of meeting NCEP goals tended to be greater in women than in men. Women in the intervention group were more than twice as likely as women in the control group to meet NCEP goals (39% vs 16%). Although the number of men enrolled in the study was small, NCEP goals were achieved by half of the men in the intervention arm and by 44% in the control arm.
In contrast to meeting NCEP goals, the effect of the intervention on reducing total cholesterol concentrations from study entry to closure were similar in men and women (see ). For the intervention group, total cholesterol levels in men declined 57 ± 50 mg/dL (1.5 ± 1.3 mmol/L). In the control group, average levels of total cholesterol declined by 26 ± 28 mg/dL (0.7 ± 0.7 mmol/L). For women, the average decline in total cholesterol levels was 37 ± 45 mg/dL (1.0 ± 1.2 mmol/L) in the intervention group as compared with 9 ± 55 mg/dL (0.2 ± 1.4 mmol/L) in the control group (p < .05). Although there appeared to be a tendency for men to have a greater reduction in total cholesterol than women, the difference was not statistically significant (p = .18), even after adjustment for baseline levels of total cholesterol.
Average reduction in total cholesterol for men and women in the intervention and control groups.
The effect of the study intervention was most apparent in patients with the least favorable risk factor profiles. For patients with coronary heart disease or with two or more risk factors, 38% (13/34) of those in the intervention arm reached an NCEP goal as compared with 14% (5/36) in the control arm (p < .05). For patients without coronary heart disease and fewer than two risk factors, 54% (7/13) reached an NCEP goal in the intervention arm and 45% (5/11) in the control arm. The latter difference was not statistically significant.
In terms of absolute reductions in total cholesterol concentrations, confirms that the intervention had its greatest effect on patients with coronary heart disease (p < .01), followed by those without coronary heart disease but with two or more risk factors (p < .05). There was no significant effect on subjects without coronary heart disease and with fewer than two risk factors. Among patients in the intervention arm (see ), the average reduction in total cholesterol concentrations increased significantly as risk profiles became more adverse (p < .01). For patients in the control arm, reductions in total cholesterol levels were similar across risk factor strata.
Average reduction in total cholesterol for patients with and without coronary heart disease (CHD). For patients without CHD, average reductions are also reported by the number of baseline risk factors.
Age was not a factor in affecting the performance of the intervention. Although among patients aged 65 and older, significantly more of those in the intervention arm met their NCEP goal (7/12) as compared with those in the control arm (4/15, p < .05), similar benefits were observed in younger patients in the intervention arm (15/37) versus the control arm (7/32). Although the latter difference in the younger patients was not statistically significant, younger patients in the intervention group were able to lower their total cholesterol levels by significantly greater amounts (45 ± 47 mg/dL [1.2 ± 1.2 mmol/L]) than those in the control group (16 ± 58 mg/dL [0.4 ± 1.5 mmol/L], p < .05).
The last month’s mean medication charge dropped $11.40 per patient from the first month’s in the intervention group. There was a $3.82 increase in the control group. The difference in the changes in medication charges between the groups was not statistically significant.
In contrast, during the 6-month study period, there were 108 lipid profiles and 35 hepatic function panels ordered for the intervention group as compared with 67 lipid profiles and 9 hepatic function panels for the control group. There were no significant differences in the number of urinalyses, serum chemistry panels, complete blood counts, or blood glucose determinations. Frequencies of visits to the emergency department and referrals to a dietitian also did not differ significantly. Clinic visits were significantly more common in the intervention group (12 on average) than in the control group (9 on average, p < .05).