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Objective: To assess the clinical effectiveness and tolerability of wax-matrix, controlled-release nicotinic acid (CNA) in persons with hypercholesterolemia., Design: Randomized, double-blind, placebo controlled, crossover trial., Setting: Ambulatory clinic at an academic cardiology center in Moscow, Russia., Patients: A volunteer sample of 135 men and women, aged 20 to 70 years, with hypercholesterolemia greater than 5.82 mmol/L (225 mg/dL) (70th-95th percentile for age and sex) who otherwise met study inclusion and exclusion criteria, were initially recruited into the study. Cholesterol levels were reduced to less than 5.82 mmol/L (225 mg/dL) in 46 subjects who participated in the initial diet intervention and were excluded from the drug intervention. Eighty-nine subjects were randomized into the clinical trial; 4 subjects (4.5%) dropped out of the study because of intolerance of CNA., Intervention: Eight weeks of diet alone (American Heart Association Step I Diet) was followed by randomization to 2 treatment groups (1500 mg/d CNA [ENDURACIN] or placebo) for 2 months followed by a crossover of treatments for 2 months, followed by all subjects taking 2000 mg/d of CNA for 2 months., Main Outcome Measures: Significant improvements in baseline measures for total serum cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) were observed after initial diet (TC, 6%; LDL-C, 6%; P < .001, t test), after 1500 mg/d CNA (TC, 14%; LDL-C, 18%; P < .001, t test), and after 2000 mg/d CNA (TC, 16%; LDL-C, 21%; P < .001, t test). Triglyceride, high-density lipoprotein cholesterol, and lipoprotein(a) levels also improved. No serious toxic reactions were encountered, and 4 subjects withdrew from the study because of intolerance of cutaneous and gastrointestinal adverse effects., Conclusion: Wax-matrix CNA is an effective and well-tolerated pharmacological treatment for hypercholesterolemia.

Objective: To more closely approximate the use of a nonsteroidal inhaled anti-inflammatory medication for asthma, nedocromil sodium, under actual ambulatory practice conditions., Design: Large, open-label trial., Patients: One thousand two hundred one patients from 286 primary care and specialty centers., Intervention: Four weeks of treatment with nedocromil sodium (4 mg delivered from the valve and 3.5 mg delivered from the mouthpiece of a metered inhalor [2 puffs, four times daily])., Main Outcome Measures: Asthma symptom scores, peak expiratory flow rate, a lifestyle assessment measures questionnaire, and mean number of days missed per month from work or school., Results: Statistically significant improvements were seen after 1 and 4 weeks of treatment for cough, daytime and nighttime asthma, morning tightness, peak expiratory flow rate, and all four measured lifestyle assessment factors (P < .001). An additional clinically relevant outcome measure, mean number of days missed per month from work or school, was reduced by 75% (P < .001). No serious adverse reactions were reported., Conclusion: This study reproduces the high level of efficacy and safety of nedocromil that was previously reported in placebo-controlled clinical studies.

Objectives: To determine the efficacy of the American Heart Association Step-One Diet for lowering blood lipid levels and to assess its nutritional adequacy in younger (< 50 years old) and older (> or = 50 years old) subgroups., Study Design: A prospective cohort study; 383 subjects were instructed in the American Heart Association Step-One Diet. Adherence to the diet was assessed at 6 weeks. Eighty-seven subjects continued the diet for an additional 12 weeks., Setting: General community participants: volunteers from community cholesterol screening programs and chart reviews at family practice clinics., Study Participants: Men and women, aged 20 to 70 years, with baseline low-density lipoprotein cholesterol levels between the 50th and 95th percentile, and excluded if receiving any medications that affect blood lipid levels or if there was a history of diabetes, gout, peptic ulcer, or liver disease., Intervention: Instruction by a registered dietitian and adherence to the American Heart Association Step-One Diet for 6 (n = 383) and 18 weeks (n = 87). This diet involves an intake of total fat not to exceed 30% of calories, saturated fatty acids not to exceed 10% of calories, and dietary cholesterol limited to 300 mg/d., Results: Subjects aged 50 to 70 years averaged a reduction in total cholesterol level and low-density lipoprotein cholesterol level of 4% after 6 weeks. At the end of 18 weeks, mean total cholesterol and low-density lipoprotein cholesterol levels in subjects younger than 50 years exceeded their baseline levels, and in those older than 50 years returned to baseline lipid levels. Inadequate intake of several micronutrients were reported, notably, zinc, calcium, and vitamins A, D, and E., Conclusions: When recommending the American Heart Association Step-One Diet to persons with hyperlipidemia, baseline dietary behavior should be assessed to determine whether that diet offers therapeutic advantage over the persons's self-selected diet. Follow-up should include monitoring of lipid response and nutritional adequacy. Special emphasis should be placed on selection of foods with appropriate micronutrient content.

Objectives: To test the a priori hypothesis that consumption of oats will lower the blood total cholesterol level and to assess modifiers and confounders of this association., Data Sources: A computerized literature (MEDLINE) search and the Quaker Oats Co identified published and unpublished trials as of March 1991. Raw data were requested for all trials., Study Selection: Trials were included in summary effect size estimates if they were randomized and controlled, if a formal assessment of diet and body weight changes occurred, and, if raw data were not received, if there was enough information in the published report to perform calculations., Data Synthesis: Twenty trials were identified. Using the methods of DerSimonian and Laird, a summary effect size for change in blood total cholesterol level of -0.13 mmol/L (-5.9 mg/dL) (95% confidence interval [CI], -0.19 to -0.017 mmol/L [-8.4 to -3.3 mg/dL]) was calculated for the 10 trials meeting the inclusion criteria. The summary effect size for trials using wheat control groups was -0.11 mmol/L (-4.4 mg/dL) (95% CI, -0.21 to -0.01 mmol/L [-8.3 to -0.38 mg/dL]). Calculation of Keys scores demonstrated that substituting carbohydrates for dietary fats and cholesterol did not account for the majority of blood cholesterol reduction. Larger reductions were seen in trials in which subjects had initially higher blood cholesterol levels (greater than or equal to 5.9 mmol/L [greater than or equal to 229 mg/dL]), particularly when a dose of 3 g or more of soluble fiber was employed., Conclusion: This analysis supports the hypothesis that incorporating oat products into the diet causes a modest reduction in blood cholesterol level.