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Biomedical subjects

H G Schrott

Publications and source records attributed to H G Schrott.

At least 19 recordsLinked to original sources
PubMed2000

Lipid-altering efficacy and safety of simvastatin 80 mg/day: long-term experience in a large group of patients with hypercholesterolemia. World Wide Expanded Dose Simvastatin Study Group.

BACKGROUND: Elevated levels of low-density lipoprotein (LDL) cholesterol promote the development of atherosclerosis and coronary heart disease. HYPOTHESIS: Simvastatin 80 mg/day will be more effective than simvastatin 40 mg/day at reducing LDL cholesterol and will be well tolerated. METHODS: Two similar, randomized, multicenter, controlled, double-blind, parallel-group, 48-week studies were performed to evaluate the long-term lipid-altering efficacy and safety of simvastatin 80 mg/day in patients with hypercholesterolemia. One study conducted in the US enrolled patients meeting the National Cholesterol Education Program (NCEP) LDL cholesterol criteria for pharmacologic treatment. In the other multinational study, patients with LDL cholesterol levels > or = 4.2 mmol/l were enrolled. At 20 centers in the US and 19 countries world-wide, 1,105 hypercholesterolemic patients, while on a lipid-lowering diet, were randomly assigned at a ratio of 2:3 to receive simvastatin 40 mg (n = 436) or 80 mg (n = 669) once daily for 24 weeks. Those patients completing an initial 24-week base study were enrolled in a 24-week blinded extension. Patients who had started on the 80 mg dose in the base study continued on the same dose in the extension, while those who had started on the 40 mg dose were rerandomized at a 1:1 ratio to simvastatin 40 or 80 mg in the extension. RESULTS: There was a significant advantage in the LDL cholesterol-lowering effect of the 80 mg dose compared with that of the 40 mg dose, which was maintained over the 48 weeks of treatment. The mean percentage reductions (95% confidence intervals) from baseline in LDL cholesterol for the 40 and 80 mg groups were 41% (42, 39) and 47% (48, 46), respectively, for the 24-week base study, and 41% (43, 39) and 46% (47, 45), respectively, after 48 weeks of treatment (p < 0.001 between groups). Larger reductions in total cholesterol and triglycerides were also observed with the 80 mg dose compared with the 40 mg dose at Weeks 24 and 48. Both doses were well tolerated, with close to 95% of patients enrolled completing the entire 48 weeks of treatment. Myopathy (muscle symptoms plus creatine kinase increase > 10 fold upper limit of normal) and clinically significant hepatic transaminase increases (> 3 times the upper limit of normal) occurred infrequently with both doses. There was no significant difference between the groups in the number of patients with such increases, although there were more cases for both with the 80 mg dose. CONCLUSIONS: Compared with the 40 mg dose, simvastatin 80 mg produced greater reductions in LDL cholesterol, total cholesterol, and triglycerides. Both doses were well tolerated.

Adult↗
PubMed2000

Effect of atorvastatin on blood lipid levels in the first 2 weeks of treatment: a randomized, placebo-controlled study.

BACKGROUND: The rate and degree of LDL cholesterol reduction, in the first 2 weeks of therapy, may relate to the early benefit of hydroxymethyl glutaryl coenzyme A reductase inhibitor therapy. In patients with similar baseline LDL cholesterol levels as in the Cholesterol and Recurrent Events (CARE) trial, we report the results of a 2-week placebo-controlled, double-blind investigation of 10 mg/day atorvastatin. METHODS AND RESULTS: The 22 participants were non-Hispanic whites younger than age 72 (average age 47 years) who were modestly overweight and had normal blood pressure. There were no significant baseline lipid and lipoprotein differences. By day 5, there were significant (P <.01) reductions in total cholesterol and LDL levels. The total cholesterol level fell by 25% (226 mg/dL to 169 mg/dL) and LDL cholesterol fell 35% by day 14 (P <.001). Triglyceride levels declined by 24% (from 137 mg/dL to 104 mg/dL) by day 14, but this was not statistically significant. There was no significant difference in HDL cholesterol. The total/HDL level dropped from 4.54 (day 0) to 3.32 (day 14), and the LDL/HDL level dropped from 2.92 to 1.88; both results were highly significant (P <. 001). CONCLUSION: The rapid lipid reduction observed with atorvastatin may benefit the vascular endothelium.

Adult↗
PubMed2000

Improving prevention systems in primary care practices: the Health Education and Research Trial (HEART)

BACKGROUND: The Health Education and Research Trial (HEART) was a multicenter clinical trial designed to test methods to improve primary care practice systems for heart disease prevention services. We present the trial methodology, the practices' use of medical record tools, and changes in documentation of cardiovascular risk factor screening and management. METHODS: Primary care practices were recruited from 4 Midwestern states. The factorial design resulted in 4 study groups: conference only, conference and quality improvement consultations, conference and prevention coordinator, and all interventions combined. Medical record audits and physician, staff, and patient surveys assessed practice change in cardiovascular disease risk factor documentation. RESULTS: Practices participated fully in this project, set goals to improve preventive services, and implemented recommended medical record tools. The number of goals set and the increase in the use of medical record tools were greatest in the combined intervention group, with improvements noted in all groups. The use of patient history questionnaires, problem lists, and flow sheets was significantly higher in the combined intervention group when compared with the conference-only group. Documentation of risk factor screening in a recommended-medical record location improved in all intervention groups, with significant sustained improvements in the practices that received the combined intervention. Documented risk factor management significantly improved in all intervention groups compared with the conference-only control. CONCLUSION: Primary care practices are interested in improving prevention systems and can change these systems in response to supportive external interventions. Promoting organizational change to produce sustained improvement in preventive service clinical outcomes is a complex process that requires further research.

Adult↗
PubMed2000

Lipid-altering efficacy and safety of simvastatin 80 mg/day: worldwide long-term experience in patients with hypercholesterolemia.

BACKGROUND AND AIM: Clinical data suggesting that larger decreases in low density lipoprotein cholesterol (LDL-C) result in greater reductions in coronary heart disease events have led to the establishment of aggressive LDL-C targets for the treatment of hypercholesterolemia. In view of this, the efficacy and safety of a new maximum dose of simvastatin, 80 mg, were evaluated in 9 studies involving 2819 hypercholesterolemic patients. This report focuses on the combined results from the 4 main or Pivotal studies in which a total of 1936 patients received simvastatin 40 or 80 mg for 36 to 48 weeks. METHODS AND RESULTS: The Pivotal studies had similar randomized, multicenter, controlled, double-blind, parallel-group designs. Their combined results demonstrated a significant advantage in the LDL-C-lowering effect for the 80 mg dose. At week 24, the mean percentage reductions (95% confidence intervals) from baseline in LDL-C for the 40 and 80 mg groups were -39.8% (-40.9, -38.7) and -45.7% (-46.5, -45.0) respectively (p < 0.001, between groups), and larger reductions in total cholesterol and triglycerides were also observed in the 80 mg group. Both doses were well tolerated. No new or unexpected adverse events were observed and the overall clinical event profiles were similar in the two groups. Clinically significant hepatic transaminase increases (> 3 times the upper limit of normal/ULN) and myopathy (muscle symptoms plus creatine kinase increase > 10 times ULN) occurred infrequently with both doses. Simvastatin 80 mg had a comparable efficacy and safety profile in women and men as well as in non-elderly and elderly patients. CONCLUSIONS: Simvastatin 80 mg provides additional LDL-C and triglyceride reductions compared to the 40 mg dose and has an excellent safety and tolerability profile.

Adolescent↗
PubMed1999

Effect of hormone replacement therapy on the validity of the Friedewald equation in postmenopausal women: the postmenopausal estrogen/progestins interventions (PEPI) trial.

The Friedewald equation is often used to estimate low-density lipoprotein cholesterol (LDL-C). Hormone therapy is known to raise triglyceride (TG) and high-density lipoprotein cholesterol (HDL-C) and alter lipid contents of lipoproteins. We compared Friedewald estimated LDL-C to measured LDL-C in PEPI participants on placebo or four different hormone treatment groups. At baseline, the 0.2 coefficient for triglyceride (TG) was accurate for all five treatment groups. Among women who took >80% of their pills and whose TG was <4.5 mmol/l (400 mg/dl), LDL-C was underestimated for 69-82% of the participants in the active treatment groups, compared to 50% in the placebo group. After 3 years of therapy, the TG coefficient that offered a better fit of the Friedewald equation in the active treatment groups was 0.39 for the equation in mmol/l (0.17 for the equation in mg/dl). Using this coefficient is clearly warranted for greater accuracy in research studies.

Algorithms↗
PubMed1998

Primary care practice adherence to National Cholesterol Education Program guidelines for patients with coronary heart disease.

BACKGROUND: Clinical trials demonstrate significant benefit from cholesterol management for patients with cardiovascular disease (CVD). National guidelines recommending goals for screening and treatment were published in 1993 and widely disseminated. This study examines cholesterol screening and management by primary care physicians after the guidelines were released. METHODS: Medical records and patient surveys provided data for 603 patients with CVD, aged 27 to 70 years, from 45 practices in 4 states during 1993 to 1995. Physician surveys measured estimated performance and other variables. Physician and patient factors associated with adherence, or lack of adherence, to national guidelines were examined using univariate and multivariate analyses. RESULTS: A total of 199 patients (33%) with CVD were not screened with lipid panels, 271 patients (45%) were not receiving dietary counseling, and 404 (67%) were not receiving cholesterol medication. Only 84 patients (14%) with CVD had achieved the recommended low-density lipoprotein level of less than 2.58 mmol/L (100 mg/dL) and 302 (50%) had triglyceride levels lower than 2.26 mmol/L (200 mg/dL). Patients with a revascularization history and higher low-density lipoprotein and/or triglyceride levels were more likely to receive treatment, but other patient factors, including CVD risk factors, did not predict treatment. Physician specialty was not associated with differences in treatment, but physicians in practice for fewer years ordered more lipid panels. CONCLUSIONS: Most patients with CVD in primary care were not receiving cholesterol screening and management as recommended by the National Cholesterol Education Program guidelines in the 2 years after their release. Increasing cholesterol screening and treatment should be a priority for practice quality improvement and could result in significant reductions in CVD events for high-risk patients.

Adult↗
PubMed1998

Comparison of the Heart and Estrogen/Progestin Replacement Study (HERS) cohort with women with coronary disease from the National Health and Nutrition Examination Survey III (NHANES III)

BACKGROUND: The Heart and Estrogen/Progestin Replacement Study (HERS) is the first large clinical trial designed to test the efficacy of postmenopausal estrogen/progestin therapy for secondary prevention of coronary heart disease (CHD). To examine the representativeness of the HERS cohort to the general population of postmenopausal women with CHD, we compared the baseline cardiovascular risk factor data from HERS with similar data from women presumed to have CHD from the National Health and Nutrition Examination Survey (NHANES) III. METHODS: Age, race, and cardiovascular disease risk factors were compared in the 2763 postmenopausal women younger than 80 years old, with a uterus, and with documented CHD in HERS versus 145 similarly aged women with clinical or electrocardiographic evidence of CHD from phase I of NHANES III. RESULTS: There were fewer current smokers in HERS (13%) than in the NHANES cohort (21.7%, p = 0.05). Similarly, a history of hypertension was less prevalent in HERS (58.6%) than in the NHANES cohort (69.3%, p = 0.03). Women with fasting triglyceride levels >3.39 mmol/L or fasting glucose levels >16.6 mmol/L were excluded from HERS, resulting in fewer diabetics (22.9% vs 29.5%, p = 0.26) and lower serum triglyceride levels (1.88 mmol/L vs 2.25 mmol/L, p = 0.19) in HERS versus the NHANES cohort. Systolic and diastolic blood pressure, body mass index, physical activity, and total LDL and HDL cholesterol were not significantly different between the two groups. CONCLUSIONS: The HERS cohort had fewer CHD risk factors than women with myocardial infarction or angina in NHANES III, although comparison is hindered by differences in selection criteria. The many women with diabetes and hypertriglyceridemia in the NHANES cohort emphasizes the importance of testing strategies for secondary prevention of CHD in this high-risk subgroup.

Aged↗
PubMed1998

The cost of reaching National Cholesterol Education Program (NCEP) goals in hypercholesterolaemic patients. A comparison of atorvastatin, simvastatin, lovastatin and fluvastatin.

OBJECTIVE: Recognising the importance of treating hyperlipidaemia, the National Cholesterol Education Program (NCEP) has established widely accepted treatment goals for low density lipoprotein cholesterol (LDL-C). Medications used most commonly to achieve these LDL-C goals are HMG-CoA reductase inhibitors. The relative resource utilisation and cost associated with the use of reductase inhibitors of different LDL-C lowering efficacy are unknown, but are major health and economic concerns. The objective of this study was to determine the mean total cost of care to reach NCEP goals with various reductase inhibitors. DESIGN: In a randomised, 54-week, 30-centre controlled trial we compared resources used and costs associated with treating patients to achieve NCEP goals using 4 reductase inhibitors: atorvastatin, simvastatin, lovastatin and fluvastatin. PATIENTS AND PARTICIPANTS: The trial studied 662 patients; 318 had known atherosclerotic disease. INTERVENTIONS: Reductase inhibitor therapy was initiated at recommended starting doses and increased according to NCEP guidelines and package insert information. For patients who did not reach the goal at the highest recommended dose of each reductase inhibitor, the resin colestipol was added. MAIN OUTCOME MEASURES AND RESULTS: Patients treated with atorvastatin, compared-with other reductase inhibitors, were more likely to reach NCEP goals during treatment (p < 0.05), required fewer office visits (p < 0.001) and less adjuvant colestipol therapy (p = 0.001). Consequently, the mean total cost of care (1996 values) to reach NCEP goals was lower with atorvastatin [$US1064; 95% confidence interval (CI): $US953 to $US1176] compared with simvastatin ($US1471, 95% CI: $US1304 to $US1648), lovastatin ($US1972; 95% CI: $US1758 to $US2186) and fluvastatin ($US1542; 95% CI: $US1384 to $US1710). Results were similar for patients with or without known atherosclerotic disease. CONCLUSIONS: In patients requiring drug therapy for hypercholesterolaemia, NCEP LDL-C goals are achieved significantly more often using fewer resources with atorvastatin compared with simvastatin, lovastatin or fluvastatin.

Aged↗
PubMed1996

Factors associated with glucose and insulin levels in healthy postmenopausal women.

OBJECTIVE: Little is known about the covariates of hyperglycemia and hyperinsulinemia. We examined candidate factors in postmenopausal women. RESEARCH DESIGN AND METHODS: We determined the cross-sectional associations of sociodemographic, body-size, lifestyle, reproductive, and menopausal factors with pretrial fasting and postchallenge glucose and insulin levels in 869 postmenopausal women aged 45-65 years. Women were participants in the Postmenopausal Estrogen/Progestin Interventions study who were not taking estrogen or insulin. RESULTS: Plasma glucose levels increased significantly with age; serum insulin levels did not. BMI and waist-to-hip ratio (WHR) each showed graded positive and independent associations with glucose and insulin levels. Alcohol intake, cigarette smoking, physical activity, parity, education, and income were also associated with insulin or glucose in age-adjusted models. In multivariable models, BMI and WHR explained 18% of the variability in fasting glucose, 16% in postchallenge glucose, 28% in fasting insulin, and 17% in postchallenge insulin. Age and all other factors combined accounted for < 6% of the variance in glucose or insulin. In multiply adjusted models, African-American and Hispanic women had higher fasting and 2-h insulin levels than non-Hispanic white women. CONCLUSIONS: Most of the variance in glycemia and insulin is unexplained. Measures of obesity and fat distribution account for nearly all the explained variance.

Aged↗
PubMed1995

Enhanced low-density lipoprotein cholesterol reduction and cost-effectiveness by low-dose colestipol plus lovastatin combination therapy.

A total of 96 patients with moderate elevations of low-density lipoprotein (LDL) cholesterol were randomly assigned to 4 different double-blind treatment regimens: placebo; colestipol 5 g and lovastatin 20 mg/day (C5 + L20); colestipol 10 g and lovastatin 20 mg/day (C10 + L20); and lovastatin 40 mg/day (L40). During 12 weeks of therapy, C10 + L20 achieved the greatest reduction in total cholesterol (-32%) and LDL cholesterol (-48%) levels from baseline. This combination also exhibited significantly greater reductions in LDL cholesterol levels than the C5 + L20 and L40 groups (p < 0.01). The differences in total and LDL cholesterol reduction between the C5 + L20 and L40 groups were not significant. Similar changes and differences between treatments were seen in apolipoprotein B levels. Whereas mean total apolipoprotein A-I levels increased with all treatments (p < 0.05), lipoprotein particles A-I were significantly increased in the C10 + L20 group (p < 0.01) only. Results demonstrate that the combination of low-dose lovastatin (20 mg/day) with low-dose colestipol (5 or 10 g/day) produces LDL cholesterol reductions equal to or greater than higher doses of lovastatin (40 mg/day). In addition, low-dose combinations are > 25% more cost-effective than high-dose monotherapy.

Apolipoproteins↗
PubMed1990

Efficacy and safety of pravastatin in patients with primary hypercholesterolemia. II. Once-daily versus twice-daily dosing.

This 8-week multicenter, placebo-controlled trial compared the efficacy and safety of the HMG-CoA reductase inhibitor, pravastatin, when administered either as single doses of 40 mg in the morning (AM) or evening (PM) or 20 mg twice daily (bid) in 196 diet-stabilized outpatients with primary type II hypercholesterolemia. Mean reductions in total and low-density lipoprotein (LDL) cholesterol concentrations were observed in all pravastatin groups after 1 week and were sustained throughout the study (P less than or equal to 0.001 versus baseline and placebo). At week 8, mean reductions from baseline in the pravastatin treatment groups were 23-27% for total cholesterol and 30-34% for LDL cholesterol. LDL cholesterol was reduced greater than or equal to 15% by pravastatin in all patients in the group treated with 40 mg PM and in 88 and 96% in those receiving 20 mg bid and 40 mg AM, respectively. High density lipoprotein cholesterol was elevated (up to 8%) and triglycerides were reduced (up to 25%) by all pravastatin regimens (P less than or equal to 0.05). Pravastatin was well tolerated and was associated with a low incidence of adverse events. No patient withdrew from the study due to a pravastatin-related adverse event. Once-daily pravastatin is a safe and effective treatment for patients with primary hypercholesterolemia and has a favorable safety profile.

Adult↗
PubMed1989

Managing lipid disorders.

We have reviewed the importance of treating hypercholesterolemia and hypertriglyceridemia. Unfortunately, most physicians are not experienced in prescribing diets to lower blood cholesterol; the use of cholesterol lowering drugs, especially resins and niacin, is not within the experience of most doctors. Although promising medications are on the horizon, the long-term safety of these drugs is not determined.

Combined Modality Therapy↗
PubMed1986

Aggregation of blood pressure in the families of children with labile high systolic blood pressure. The Muscatine Study.

The aggregation of systolic blood pressure, diastolic blood pressure, and heart rate is compared among the relatives of three groups of index children: children with low systolic blood pressure (less than the 5th percentile), middle range systolic blood pressure (between the 5th and 95th percentiles), or labile high blood pressure (above the 95th percentile when first sampled but below the 95th percentile when resampled four to six months later). Both systolic and diastolic blood pressures aggregate more strongly in the families of children with labile high systolic blood pressure than in the families of children with middle or low range systolic blood pressure. The degree of aggregation of heart rate does not differ among the three groups. Since blood pressures aggregate so strongly in families of children with labile high systolic blood pressure, study of these children and their families may yield important information about the etiology of hypertension.

Adolescent↗
PubMed1983

Effect of spouse support and health beliefs on medication adherence.

This study addressed the issue of social support for patients' adherence to medical regimens. Social support of wives was assessed by structured interview of 150 male participants in the Coronary Primary Prevention Trial, their wives, and medical staff. In addition, wives were interviewed about their beliefs related to their husbands' health and participation in the trial. Unobtrusive packet counts were used as the measure of adherence. The participants were classified as having high spouse support if wife support scores were in the top one third of the distribution and as having low spouse support if scores were in the bottom one third as measured from inquiry of the participant, the spouse, and the staff. The adherence of men having low support averaged 70 percent, significantly lower than the high-support group, which averaged 96 percent. The correlations between spouses' health beliefs and their level of support were significant for three of four health belief variables. In particular, highly adhering men had wives who believed more strongly in the benefits of the Coronary Primary Prevention Trial.

Adult↗
PubMed1983

Multivariate models for human genetic analysis: aggregation, coaggregation, and tracking of systolic blood pressure and weight.

A multivariate path model parameterizing the sources of familial aggregation and coaggregation of systolic blood pressure and weight, as well as their tracking across time, is applied to longitudinal data collected in Muscatine, Iowa. Genetic, common household, and individual environmental effects, pleiotropy, and a direct regression effect of blood pressure on weight are parameterized. The sample consisted of 998 individuals distributed in 261 families of whom 601 were measured on four successive occasions. The data were divided with times 1 and 2 forming group 1, and times 3 and 4, group 2. Model fitting and estimation was performed using group 1, followed by testing the model and estimates using the data in group 2. Heritability estimates for systolic blood pressure and weight were .15 and .54, respectively. The genetic correlation between these traits was nonsignificant, but there was a significant direct regression effect. The results indicate that 30% of the full-sib correlation for systolic blood pressure is attributable to the aggregation of weight. In terms of tracking, 59% and 60% of the predicted systolic blood pressure and weight correlations, respectively, were attributable to genetic effects. Testing the model from group 1 in group 2 indicates that the qualitative relationships between blood pressure and weight are stable with time.

Adolescent↗
PubMed1982

The Muscatine Cholesterol Family Study: familial aggregation of blood lipids and relationship of lipid levels to age, sex and hormone use.

The Muscatine Cholesterol Family Study includes data on first, second and third-degree relatives of school children who have the following cholesterol levels: above the 95th percentile in two consecutive school screens, N = 53; below the 5th percentile twice, N = 45; and a random sample between the 5th and 95th percentiles twice, N = 44. For males and females not taking estrogen the relationship of cholesterol to age was the same in high, middle, and low groups, although the overall level differed. For females taking estrogen, cholesterol levels rose more quickly with age in the high group as compared to the middle and low groups. The triglyceride levels of females taking estrogen is higher at younger ages and shows no significant change with increasing age. Among first degree relatives, the cholesterol correlations are between 0.25 and 0.30. Correlations in relatives of the middle group probands are higher than those in relatives of high or low group probands, but not significantly so. Correction for ascertainment increases the correlations in the high and low groups. Among second degree relatives cholesterol correlations in all three groups are approximately 0.20. There is negligible cholesterol correlation between spouses in the high and low groups, while the middle group spouse correlation is significantly greater than zero. Categorical analysis suggests the effect of the proband's cholesterol level is seen most upon the cholesterol level of parents, with siblings and second-degree relatives being less similarly affected.

Adolescent↗
PubMed1982

The Muscatine Cholesterol Family Study: distribution of cholesterol levels within families of probands with high, low and middle cholesterol levels.

The Muscatine Cholesterol Family Study includes the relatives of three groups of schoolchildren: those with cholesterol levels above the 95th percentiles in two consecutive school screens, those with cholesterol levels below the 5th percentile twice, and random sample of those with cholesterol levels between the 5th and 95th percentiles twice. This paper examines the cholesterol distribution within and among these families for evidence of major gene effects. Three screening techniques are used: admixture analysis using maximum likelihood, comparison of within-sibship variances among groups, and regression of within-sibships variance on within-sibship mean. The results of the three techniques are consistent and indicate the existence of a major gene in a subset of the families with a proband above the the 95th percentile, but not in the other two groups of families. We estimate that 15% of schoolchildren with a cholesterol level above the 95th percentile twice, or 3 per thousand in the general population, have a dominant gene as a cause of the cholesterol elevation.

Adolescent↗