Karen A. Grace

Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER) 2 A Double-Blind, Placebo-Controlled Study of Extended-Release Niacin on Atherosclerosis Progression in Secondary Prevention Patients Treated With Statins

Background—Niacin reduces coronary heart disease morbidity and mortality when taken either alone or in combination with statins; however, the incremental impact of adding niacin to background statin therapy is unknown. Methods and Results—This was a double-blind randomized placebo-controlled study of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease and low levels of high-density lipoprotein cholesterol (HDL-C; <45 mg/dL). The primary end point was the change in common carotid intima-media thickness (CIMT) after 1 year. Baseline CIMT (0.884±0.234 mm), low-density lipoprotein cholesterol (89±20 mg/dL), and HDL-C (40±7 mg/dL) were comparable in the placebo and niacin groups. Adherence to niacin exceeded 90%, and 149 patients (89.2%) completed the study. HDL-C increased 21% (39 to 47 mg/dL) in the niacin group. After 12 months, mean CIMT increased significantly in the placebo group (0.044±0.100 mm; P<0.001) and was unchanged in the niacin group (0.014±0.104 mm; P=0.23). Although the overall difference in IMT progression between the niacin and placebo groups was not statistically significant (P=0.08), niacin significantly reduced the rate of IMT progression in subjects without insulin resistance (P=0.026). Clinical cardiovascular events occurred in 3 patients treated with niacin (3.8%) and 7 patients treated with placebo (9.6%; P=0.20). Conclusions—The addition of extended-release niacin to statin therapy slowed the progression of atherosclerosis among individuals with known coronary heart disease and moderately low HDL-C.

Lipid‐Lowering Efficacy, Safety, and Costs of a Large‐Scale Therapeutic Statin Formulary Conversion Program

Study Objective. To assess the lipid‐lowering efficacy, safety, and costs of a large‐scale statin formulary conversion program.

Ten lessons learned from conducting an adherence intervention trial

Clinical practice research provides a unique opportunity to care for a diverse patient population in various health care system settings. Federal study of Adherence to Medications in the Elderly (FAME) was the first prospective observational and randomized controlled trial to implement effective strategies to enhance medication adherence and health outcomes in older patients using polypharmacy. Ten lessons learned from conducting this adherence intervention trial are described: (1) Link the trial to existing clinical work, (2) Begin with a thorough understanding of medication adherence, (3) Ensure that trial highlights individualized intervention, (4) Tailor inclusion criteria and study duration to target population, (5) Employ a range of outcomes linked to meaningful clinical effects, (6) Win the support of the multidisciplinary team and the administration, (7) Promote team work, (8) Consider the potential limitations, (9) Seize the grant opportunities, and (10) Share the findings.

How Should We Measure Medication Adherence in Clinical Trials and Practice

Objective To determine if simple adherence measures, such as twenty-four hour recall and refill history, are accurate for routine use, compared to more time-consuming measures such as pill counts. Design Randomized, double-blind, placebo-controlled trial. Setting Walter Reed Army Medical Center, a tertiary medical center in Washington. Patients Men and women >30 years old with known coronary heart disease and taking a statin medication. Intervention Clinical pharmacists met with patients for adherence assessments. Main outcome measures Adherence was measured by pill counts, twenty-four hour recall by patient, and refill history per computer record. Temporal changes in these adherence measures were assessed using general linear models for repeated measures. Results Adherence was consistently greater for the experimental agent than for the statin therapy (n = 148). Mean pill count adherence for statin drug was 78.7 ± 25.2% compared to 93.5 ± 11.6% (P < 0.001) for the study agent. Refill history and twenty-four hour recall inaccurately measured adherence when compared to pill counts. Adherence, as determined by pill count, for both experimental (P = 0.029) and statin therapy (P = 0.015) showed significant variability across time in general linear models. Neither refill history nor twenty-four hour recall was sensitive to temporal changes. Conclusions Twenty-four hour recall and refill history inaccurately measure medication adherence for both clinical trial and clinical practice pharmacotherapies. Further, these measures are insensitive to changes in adherence. For a single or multiple assessments across time, pill count more accurately measures medication adherence. Pill count should be the standard for monitoring medication adherence for both clinical trials and clinical practice.

Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER) 2: a double-blind, placebo-controlled study of extended-release niacin on atherosclerosis progression in secondary prevention patients treated with statins

UNLABELLED This study demonstrates the efficacy of ambulatory blood pressure monitoring to measure anti hypertensive effect. Original Article: White WB, Giles T, Bakris GL, Neutel JM, Davidai G, Weber MA. Measuring the efficacy of antihypertensive therapy by ambulatory blood pressure monitoring in the primary care setting. Am Heart J. 2006;151(1):176-184. KEYWORDS anti hypertensive therapy; blood pressure; hypertension.PRACTICE PEARL This study demonstrates that adding extended-release niacin to statins favorably affects atherosclerotic lesions in the carotid arteries of atherosclerotic coronary heart disease (CHD) patients and moderately low high density lipoprotein cholesterol (HDL-C) levels.