Efficacy and safety of controlled-release niacin in dyslipoproteinemic veterans.

OBJECTIVE: To evaluate the safety and efficacy of controlled-release niacin in patients with hyperlipoproteinemia. DESIGN: A retrospective cohort study. SETTING: A Department of Veterans Affairs Medical Center. PATIENTS: A consecutive sample of 969 predominantly elderly male veterans treated for dyslipoproteinemia with controlled-release niacin between October 1988 and October 1991. MAIN OUTCOME MEASURES: Primary outcomes were lipid levels and lipoprotein cholesterol response, alternations in levels of hepatic enzymes and blood chemistry test results, and characterization of niacin-induced hepatotoxicity abstracted from the patient's medical, laboratory, and pharmacy records. RESULTS: 93% (896 of 969) of the cohort was evaluable. Patients (age, 61.7 years [9.4 years], mean [SD]) were treated for 1 to 36 months (13.0 months [9.7 months]) with an average maintenance dose of 1.67 g/d (0.8 g/d). Niacin was discontinued in 48.5% (435 of 896) of the patients primarily because of adverse effects. Poor glycemic control led to discontinuation in 40.6% (43 of 106) of the patients with diabetes mellitus. The lipoprotein response was dose-related and favorable (levels of total cholesterol, -19.1%; low-density lipoprotein cholesterol, -24.0%; high-density lipoprotein cholesterol, +5.7%; and triglycerides, -32.5%). Statistically but not clinically meaningful dose-related increases were seen in levels of liver enzymes and serum glucose (aspartate aminotransferase, +29%; alanine aminotransferase, +23%; alkaline phosphatase, +25%; and glucose, +7%; P = 0.0001). Twenty of 896 (2.2%) and 42 of 896 (4.7%) patients met biochemical criteria for probable and for possible or probable niacin-induced hepatotoxicity, respectively. Predisposing factors included high dose, alcohol use, preexisting liver disease, and concurrent oral sulfonylurea therapy. CONCLUSIONS: Controlled-release niacin is effective in treating dyslipoproteinemia in selected middle-aged and elderly veterans, but approximately one half of patients discontinued the drug because of adverse effects or other causes including noncompliance. Niacin should be avoided in patients with hepatic dysfunction or a history of liver disease, patients with diabetes mellitus, and patients who abuse alcohol. Because controlled-release niacin seems to be more potent than crystalline niacin, product substitution without dose adjustment should be avoided.

Workload measurement of a clinical pharmacy residency program.

The types of activities performed by four clinical pharmacy residents and the amount of time spent on each activity were studied using a workload measurement system. A workload measurement system was developed to record all activities performed by pharmacy residents. The system included 50 activities that were grouped under 11 general headings; residents' time was divided among 10 major areas of service. The following data were collected and analyzed each month during the six-month study period: units of work, weighted units of work, total productive hours, total service hours, and productivity. The residents participated in 39 of 50 clinical pharmacy activities. Activities performed most frequently included nursing-home-care-unit drug reviews, drug monitoring, and rounds. The most time-consuming activities were clinical education, administration, and drug-use review. Productivity ranged from 80 to 115% and was influenced by residents' assigned rotations. A workload measurement system for quantifying the time spent by residents performing various clinical pharmacy activities provided objective data that were used to restructure a clinical pharmacy residency program.

Cost-justification of a clinical pharmacist-managed anticoagulation clinic.

A cost-benefit evaluation of a clinical pharmacist-managed anticoagulation clinic (AC) was performed. Outpatient and hospital records were examined for 26 patients in the treatment group with an AC clinic and 26 patients in the control group. Therapeutic prothrombin times were maintained within the treatment group to a significantly greater extent than within the control group (p less than 0.001). The AC was successful in preventing hospitalizations resulting from hemorrhage or thromboembolism (p less than 0.01). The abnormal prothrombin times on admission in the control group correlated with hemorrhagic and thromboembolic admissions (p less than 0.05, p less than 0.005, respectively). Patients were hospitalized 3.22 days and .048 days per patient-treatment-year in the control and treatment groups, respectively. The net savings in reduced hospitalization costs per year in the treatment group was $211776. The benefit:cost ratio (B:C) was 6.55, suggesting the program is socially valuable. This clinical pharmacist-managed AC was effective in maintaining therapeutic prothrombin times, and reducing the incidence of hospitalization resulting from anticoagulation complications, and can be cost-justified based on a cost-benefit analysis.

Centrally acting antihypertensive agents: a comparison of lofexidine with clonidine.

Lofexidine, a new centrally acting antihypertensive agent, was compared in a double-blind study with clonidine in the treatment of mild (standing diastolic blood pressure 95-104 mm Hg) or moderate (105-129 mm Hg) essential hypertension. In dialy dosages of 0.2 or 0.4 mg, monotherapy with lofexidine produced significant decreases in blood pressure and heart rate that were not different from those with clonidine. Blood pressure and heart rate were not different from those with clonidine. Blood pressure control (supine and standing diastolic pressure less than 90 mm Hg) occurred in seven of eight mild hypertensives treated with lofexidine and in seven of ten treated with clonidine. In moderate hypertension, three of 11 and seven of ten, ten of the 14 responders to clonidine required dosages of 0.4 mg daily or less. The maximum dosage tested was 1.6 mg daily. Concomitant hydrochlorothiazide therapy was given to eight of the lofexidine responders and 12 of the clonidine responders. For both drugs, drowsiness and dry mouth were the chief complaints. Neither agent changed standard clinical biochemistries except for decreased potassium and increased bicarbonate concentrations due to concurrent diuretic therapy. Lofexidine to have clinical characteristics similar to those of clonidine. Each of these agents is best used in lower doses, which are frequently effective and less likely to produce symptomatic complaints.