Characteristics and long-term follow-up of participants with peripheral arterial disease during ALLHAT.

BACKGROUND: Hypertension is a major risk factor for peripheral artery disease (PAD). Little is known about relative efficacy of antihypertensive treatments for preventing PAD. OBJECTIVES: To compare, by randomized treatment groups, hospitalized or revascularized PAD rates and subsequent morbidity and mortality among participants in the Antihypertensive and Lipid-Lower Treatment to Prevent Heart Attack Trial (ALLHAT). DESIGN: Randomized, double-blind, active-control trial in high-risk hypertensive participants. PARTICIPANTS: Eight hundred thirty participants with specified secondary outcome of lower extremity PAD events during the randomized phase of ALLHAT. INTERVENTIONS/EVENTS: In-trial PAD events were reported during ALLHAT (1994-2002). Post-trial mortality data through 2006 were obtained from administrative databases. Mean follow-up was 8.8 years. MAIN MEASURES: Baseline characteristics and intermediate outcomes in three treatment groups, using the Kaplan-Meier method to calculate cumulative event rates and post-PAD mortality rates, Cox proportional hazards regression model for hazard ratios and 95 % confidence intervals, and multivariate Cox regression models to examine risk differences among treatment groups. KEY RESULTS: Following adjustment for baseline characteristics, neither participants assigned to the calcium-channel antagonist amlodipine nor to the ACE-inhibitor lisinopril showed a difference in risk of clinically advanced PAD compared with those in the chlorthalidone arm (HR, 0.86; 95 % CI, 0.72-1.03 and HR, 0.98; 95 % CI, 0.83-1.17, respectively). Of the 830 participants with in-trial PAD events, 63 % died compared to 34 % of those without PAD; there were no significant treatment group differences for subsequent nonfatal myocardial infarction, coronary revascularizations, strokes, heart failure, or mortality. CONCLUSIONS: Neither amlodipine nor lisinopril showed superiority over chlorthalidone in reducing clinically advanced PAD risk. These findings reinforce the compelling need for comparative outcome trials examining treatment of PAD in high-risk hypertensive patients. Once PAD develops, cardiovascular event and mortality risk is high, regardless of type of antihypertensive treatment.

Randomized trial of pharmacist interventions to improve depression care and outcomes in primary care.

PURPOSE: The impact of pharmacist interventions on the care and outcomes of patients with depression in a primary care setting was evaluated. METHODS: Patients diagnosed with a new episode of depression and started on anti-depressant medications were randomized to enhanced care (EC) or usual care (UC) for one year. EC consisted of a pharmacist collaborating with primary care providers to facilitate patient education, the initiation and adjustment of antidepressant dosages, the monitoring of patient adherence to the regimen, the management of adverse reactions, and the prevention of relapse. The patients in the UC group served as controls. Outcomes were measured by the Hopkins Symptom Checklist, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for major depression, health-related quality of life, medication adherence, patient satisfaction, and use of depression-related health care services. An intent-to-treat analysis was used. RESULTS: Seventy-four patients were randomized to EC or UC. At baseline, the EC group included more patients diagnosed with major depression than did the UC group (p = 0.04). All analyses were adjusted for this difference. In both groups, mean scores significantly improved from baseline for symptoms of depression and quality of life at three months and were maintained for one year. There were no statistically significant differences between treatment groups in depression symptoms, quality of life, medication adherence, provider visits, or patient satisfaction. CONCLUSION: Frequent telephone contacts and interventions by pharmacists and UC in a primary care setting resulted in similar rates of adherence to antidepressant regimens and improvements in the outcomes of depression at one year.

Collaborative care model to improve outcomes in major depression.

OBJECTIVE: To develop a pharmacist intervention to improve depression care and outcomes within a primary care setting. METHODS: Pragmatic, randomized trial of a clinical pharmacist collaborative care intervention versus usual care in a busy, academic family practice clinic. RESULTS: Seventy-four patients diagnosed with a new episode of major depression and started on antidepressant medications were randomized to enhanced care (EC) or usual care (UC) groups. EC consists of a clinical pharmacist collaborating with primary care providers (PCPs) to facilitate education, initiation, and titration of acute-phase antidepressant treatment to monitor treatment adherence and to prevent relapse. Control patients receive UC by their PCP. The main end point is reduction of depression symptoms over time as measured by the Hopkins Symptom Checklist (SCL-20). Other outcomes include the Diagnostic and Statistical Manual of Mental Disorders, (DSM-IV) criteria for major depression, health-related quality of life measured by the Medical Outcomes Study Short Form 12 (SF-12), medication adherence, patient satisfaction, and healthcare utilization. The main end point and the cost of treating major depression will be used to estimate the cost-effectiveness of the collaborative care model. CONCLUSIONS: The study is a unique, ongoing trial that may have important implications for the treatment of depression in primary care settings as well as new roles for clinical pharmacists.