Tolerability and efficacy of carvedilol in patients with New York Heart Association class IV heart failure.

OBJECTIVES: The purpose of this study was to assess the tolerability and efficacy of carvedilol in patients with New York Heart Association (NYHA) functional class IV symptoms. BACKGROUND: Carvedilol, a nonselective beta-adrenergic blocking drug with alpha-adrenergic blocking and antioxidant properties, has been shown to improve left ventricular function and clinical outcome in patients with mild to moderate chronic heart failure. METHODS: We retrospectively analyzed the outcomes of 230 patients with heart failure treated with carvedilol who were stratified according to baseline functional class: 63 patients were NYHA class IV and 167 were NYHA class I, II or III. Carvedilol was commenced at 3.125 mg b.i.d. and titrated to 25 mg b.i.d. as tolerated. Patients with class IV symptoms were older (p = 0.03), had lower left ventricular fractional shortening (p < 0.001), had lower six-min walk distance (p < 0.001) and were receiving more heart failure medications at baseline compared with less symptomatic patients. RESULTS: Nonfatal adverse events while taking carvedilol occurred more frequently in class IV patients (43% vs. 24%, p < 0.0001), and more often resulted in permanent withdrawal of the drug (25% vs. 13%, p < 0.01). Thirty-seven (59%) patients who were NYHA class IV at baseline had improved by one or more functional class at 3 months, 8 (13%) were unchanged and 18 (29%) had deteriorated or died. Among the less symptomatic group, 62 (37%) patients had improved their NYHA status at 3 months, 73 (44%) were unchanged and 32 (19%) had deteriorated or died. The differences in symptomatic outcome at three months between the two groups were statistically significant (p = 0.001, chi-square analysis). Both groups demonstrated similar significant improvements in left ventricular dimensions and systolic function. CONCLUSIONS: Patients with chronic NYHA class IV heart failure are more likely to develop adverse events during initiation and dose titration when compared with less symptomatic patients but are more likely to show symptomatic improvement in the long term. We conclude that carvedilol is a useful adjunctive therapy for patients with NYHA class IV heart failure; however, they require close observation during initiation and titration of the drug.

A national survey of the home visiting practice and attitudes of family physicians and internists.

BACKGROUND: Over the past decade, while physician home visiting has continued to decline, the home care industry has been experiencing dramatic growth. In response, several major physician organizations have been encouraging increased physician education and involvement in home care and urging related health policy changes. This study provides the first in-depth, nationally representative descriptive data on the current home visiting practice and related attitudes of physicians. METHODS: Data were gathered through a structured 15-minute telephone survey, consisting of 141 items covering physician's general practice, personal home visiting practice, interaction with other home care providers, and attitudes regarding home care issues. Subjects were a nationally representative, randomly selected sample of 2200 family practice physicians (FPs) and internal medicine physicians (IMs) currently in active practice with at least 10 hours per week of professional time spent in ambulatory care. RESULTS: Sixty-five percent of eligible participants completed the survey. Of all physicians surveyed, 65% of FPs and 44% of IMs reported that they may make house calls (P less than .001). Mean number of visits per year was 21.2 (median, 10) for FPs, and it was 15.7 (median, 6) for IMs. Physicians in rural practice were more likely to make home visits (P less than .001). Physician attitudes related to home care reflect a strong dissatisfaction with reimbursement, but positive opinions about the use of other home care professionals and the importance of home visits for selected patients. Logistic regression analysis comparing home-visiting physicians with non-visiting physicians allowed for prediction of the correct classification 73% of the time, and it revealed six variables that were significant predictors of home visiting. The strongest of these predictors were the physician's positive attitude regarding the importance of home visits for selected patients and his or her perception of having time available for home visits. Other significant variables predictive of home visiting were family practice specialty, rural location of practice, greater numbers of referrals to home care agencies, and, interestingly, dissatisfaction with reimbursement. CONCLUSIONS: Although the great majority (over 75%) of FPs and IMs still regard the physician home visit as important for the care of selected patients, only about half report making one or more home visits within a 12-month period. Family physicians generally report a greater involvement in home care than do IMs. Physician reimbursement for home visits is perceived to be inadequate, and almost half (45%) indicate that they would do more home visits if reimbursement were increased. Most physicians (over 80%) have the opinion that home care agencies should be used more.

Optimization of left ventricular function with carvedilol before high-risk cardiac surgery.

Patients with severe left ventricular dysfunction and symptomatic heart failure caused by ischemic or valvular heart disease face a high morbidity and mortality risk from cardiac surgery. We present data showing that excellent surgical outcome can be achieved after pre-treatment of such patients with carvedilol.

A clinical trial of the American Heart Association step one diet for treatment of hypercholesterolemia.

BACKGROUND: Although diet therapy is the primary treatment for hypercholesterolemia, a trial to determine the effectiveness of the new American Heart Association Step One Diet (AHA diet) in lowering cholesterol has to our knowledge never been carried out. METHODS: A clinical trial was conducted to assess the plasma lipids response and adherence to the AHA diet in 120 men and women with hypercholesterolemia. All subjects were advised to follow the AHA diet for 18 weeks. RESULTS: After 6 weeks of the AHA diet intervention, there were modest but significant reductions in plasma total cholesterol (-2.6%) and low-density lipoprotein (LDL) cholesterol (-3.5%), but no further significant reductions were observed thereafter. Rather, there was a tendency to return to and even exceed baseline levels of total cholesterol and LDL cholesterol over the subsequent 12 weeks, in spite of the subjects' reported continued adherence to the AHA diet and maintenance of weight loss throughout the entire study period. Nevertheless, 51% of the subjects had experienced improvement (-0.2% to -26.3%) in their plasma LDL cholesterol levels by the end of the study. CONCLUSIONS: A probable reason for the limited response of the diet was low baseline levels in intake of saturated fat and cholesterol by participants. The subjects who were older and had higher levels of plasma LDL cholesterol and total fat intake at baseline experienced better plasma LDL cholesterol response to the AHA diet. Thus, practicing physicians should consider assessing the baseline dietary fat and cholesterol intake of patients with hypercholesterolemia before starting the AHA diet, since patients may already be following a relatively prudent self-selected diet. Additional dietary gains in lipid management might well require a more severe restriction of dietary fats and cholesterol. Long-term efficacy of the AHA diet should also be evaluated clinically with periodic lipid profiles.

A clinical trial of oat bran and niacin in the treatment of hyperlipidemia.

BACKGROUND: Previous studies have demonstrated the lipid-lowering potential of wax-matrix controlled-release forms of nicotinic acid, but questions have been raised about the risks associated with long-term use. This report describes a 38-week trial that was designed as a follow-up to a shorter 16-week clinical trial of wax-matrix controlled-release niacin. The present study also tested the hypothesis that niacin (1500 mg/d) and oat bran (56 g/d [2 oz/day]) may have a synergistic effect on improving serum lipid levels. METHODS: Ninety-eight subjects began the following protocol: oat bran alone (6 weeks), oat bran plus niacin (6 weeks), and niacin alone (32 weeks). Blood lipids, blood chemistries, nutritional variables, and side-effect profiles were monitored throughout the study. Sixty-nine (70%) subjects completed the trial taking the full dose of niacin (1500 mg/d); 8 subjects completed the trial taking a reduced dose of niacin (average 906 mg/d); 11 discontinued taking any niacin because of either intolerable side effects (n = 7) or liver enzyme abnormalities (n = 4). RESULTS: Generally, oat bran-niacin synergism was not found. Only 10% of subjects who completed the study showed greater than expected lipid improvement on combination therapy. From baseline to the end of the final phase, significant reductions (P less than .05) occurred for total cholesterol (-10%) and low-density lipoprotein cholesterol (-16%). High-density lipoprotein cholesterol rose significantly at the end of the oat bran plus niacin phase, but returned to near baseline by the end of the study. The liver enzymes alkaline phosphatase, lactate dehydrogenase, and aspartate aminotransferase all showed a tendency to rise throughout the study. CONCLUSIONS: The results of this 38-week trial suggest that the relatively inexpensive wax-matrix form of niacin is effective and reasonably well tolerated. Approximately 8% of subjects were unable to continue taking niacin because of side effects, and 4% discontinued taking niacin because of liver enzyme elevations. A small group of subjects (10%) experienced greater than expected lipid improvements (synergism) on combined oat-bran and niacin therapy. Liver function monitoring with long-term use of niacin is warranted.

Sale of tobacco products in pharmacies: results and implications of an empirical study.

OBJECTIVE: To provide national-level data concerning the percentage of pharmacies selling tobacco products, examine relationships between selling practices and pharmacy characteristic variables, and explore perceptions of conflicts between tobacco-selling activity and professional and personal values and the potential effects of such conflicts. DESIGN, SETTING, PARTICIPANTS: Data were collected from a geographically stratified systematic random sample of 899 pharmacies. Multiple mailings were sent to the attention of the pharmacy manager. A random sample of nonrespondents was also contacted by telephone, urging participation. MAIN OUTCOME MEASURES: Whether the pharmacy currently sold cigarettes and/or smokeless tobacco products, and if so, whether these practices differed from what respondents' personal or professional values tell them to do. Scales designed to measure job satisfaction, job-induced tension, and propensity to leave were also included. RESULTS: Slightly more than half (50.5%) of the pharmacies sold cigarettes and 35.4% sold smokeless tobacco products. Independents were less likely than chain pharmacies to sell tobacco products. For those respondents working in pharmacies where tobacco products were sold, 47.6% responded that this practice differs from what their personal values tell them to do and 63.9% replied that this practice differs from what their professional values tell them to do. Even when controlling for pharmacy type, respondents working in pharmacies that sold tobacco products had significantly lower levels of global job satisfaction, higher levels of job-induced tension, and a higher propensity to leave than did respondents working in pharmacies that did not. CONCLUSION: Decision makers in pharmacies where tobacco products are still sold should take a serious look at the justification for the continued availability of tobacco products in an environment that has a goal of promoting health.

Plasma lipid response and nutritional adequacy in hypercholesterolemic subjects on the American Heart Association Step-One Diet.

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.