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1.
Arch Gynecol Obstet ; 302(3): 763-777, 2020 09.
Article in English | MEDLINE | ID: mdl-32661753

ABSTRACT

This short version of the interdisciplinary S3 guideline "Peri- and Postmenopause-Diagnosis and Interventions" is intended as a decision-making instrument for physicians who counsel peri- and postmenopausal women. It is designed to assist daily practice. The present short version summarizes the full version of the guideline which contains detailed information on guideline methodology, particularly regarding the critical appraisal of the evidence and the assignment of evidence levels. The statements and recommendations of the full version of the guideline are quoted completely in the present short version including levels of evidence (LoE) and grades of recommendation. The classification system developed by the Centre for Evidence-based Medicine in Oxford was used in this guideline.


Subject(s)
Societies, Medical , Evidence-Based Medicine/methods , Female , Germany , Guidelines as Topic , Humans , Middle Aged , Perimenopause , Postmenopause
2.
J Nutr ; 148(2): 285-297, 2018 02 01.
Article in English | MEDLINE | ID: mdl-29490094

ABSTRACT

Background: Joint data analysis from multiple nutrition studies may improve the ability to answer complex questions regarding the role of nutritional status and diet in health and disease. Objective: The objective was to identify nutritional observational studies from partners participating in the European Nutritional Phenotype Assessment and Data Sharing Initiative (ENPADASI) Consortium, as well as minimal requirements for joint data analysis. Methods: A predefined template containing information on study design, exposure measurements (dietary intake, alcohol and tobacco consumption, physical activity, sedentary behavior, anthropometric measures, and sociodemographic and health status), main health-related outcomes, and laboratory measurements (traditional and omics biomarkers) was developed and circulated to those European research groups participating in the ENPADASI under the strategic research area of "diet-related chronic diseases." Information about raw data disposition and metadata sharing was requested. A set of minimal requirements was abstracted from the gathered information. Results: Studies (12 cohort, 12 cross-sectional, and 2 case-control) were identified. Two studies recruited children only and the rest recruited adults. All studies included dietary intake data. Twenty studies collected blood samples. Data on traditional biomarkers were available for 20 studies, of which 17 measured lipoproteins, glucose, and insulin and 13 measured inflammatory biomarkers. Metabolomics, proteomics, and genomics or transcriptomics data were available in 5, 3, and 12 studies, respectively. Although the study authors were willing to share metadata, most refused, were hesitant, or had legal or ethical issues related to sharing raw data. Forty-one descriptors of minimal requirements for the study data were identified to facilitate data integration. Conclusions: Combining study data sets will enable sufficiently powered, refined investigations to increase the knowledge and understanding of the relation between food, nutrition, and human health. Furthermore, the minimal requirements for study data may encourage more efficient secondary usage of existing data and provide sufficient information for researchers to draft future multicenter research proposals in nutrition.


Subject(s)
Diet , Epidemiology , Nutritional Status , Observational Studies as Topic , Adult , Biomarkers/blood , Blood Glucose/analysis , Case-Control Studies , Child , Chronic Disease , Cohort Studies , Cross-Sectional Studies , Europe , Genomics , Health Status , Humans , Inflammation/blood , Insulin/blood , Life Style , Lipoproteins/blood , Longitudinal Studies , Metabolomics , Statistics as Topic/methods
5.
Arch Gynecol Obstet ; 291(1): 213-7, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25322975

ABSTRACT

PURPOSE: Vascular disease is the leading cause of death in women. One-third of acute events affect women below age 60, when the prevalence of menopausal symptoms is high. This raises the question if hormone replacement therapy (HRT) may be an appropriate treatment for individual women although vascular disease is generally considered a contraindication. METHODS: Selective literature search was used for this study. RESULTS: In healthy women, HRT increases risks for venous thromboembolism and ischemic stroke, but for cardiovascular disease apparently only beyond 10 years after menopause or 60 years of age. Limited data in women with cardio or cerebrovascular disease have not demonstrated an increased risk for a vascular recurrent event, but for the first year after initiation. In HRT users affected by a cardiovascular event continuation of HRT has not been found to be associated with adverse outcome. Low dose estradiol--preferentially as transdermal patches, if necessary combined with metabolically neutral progestins--appears to convey lower risk. CONCLUSIONS: Safety data on HRT in survivors of cardiovascular events or ischemic stroke are limited, but exceptionally increased risk appears to be excluded. If off-label use of HRT is considered to be initiated or continued in women with cardio- or cerebrovascular disease, extensive counseling on the pros and cons of HRT is mandatory.


Subject(s)
Cardiovascular Diseases/epidemiology , Estrogen Replacement Therapy/methods , Postmenopause , Venous Thromboembolism/epidemiology , Estradiol/administration & dosage , Estrogen Replacement Therapy/adverse effects , Female , Humans , Middle Aged , Progestins/administration & dosage , Risk , Stroke/epidemiology
6.
Maturitas ; 167: 60-65, 2023 01.
Article in English | MEDLINE | ID: mdl-36306668

ABSTRACT

Cardio- and cerebrovascular diseases are leading causes of death and morbidity in ageing populations. While numerous cohort studies show inverse associations of presumably healthy lifestyles and cardiovascular risk factors, the causal link to many modifiable behaviors is still insufficiently evidence-based. Because of bias of studies and heterogeneity of results, we performed a systematic review of meta-analyses of randomized controlled trials and observational studies on lifestyle patterns including nutrition, physical activity, smoking, and weight versus incidence and mortality of cardio- and cerebrovascular diseases. A search string retrieved 624 references in PubMed covering the last five years. Two researchers screened titles and abstracts independently but with equivalent results. Nineteen references met the inclusion criteria. Results affirm that high adherence to plant-based diets, including components such as fruits, vegetables, legumes, whole grains, low-fat dairy, olive oil, nuts, and low intake of sodium, sweetened beverages, alcohol, and red and processed meats, results in lower risk of vascular outcomes in a dose-dependent manner. Physical activity quantified as walking pace or cardiorespiratory fitness yielded an inverse effect on stroke. Health measures such as smoking status, BMI and increase in body weight are associated with substantial risk of the incidence of and mortality from cardio- and cerebrovascular diseases, while strong adherence to an overall prudent lifestyle lowered the risk of cardiovascular disease by 66 % and that stroke by 60 %. In summary, increasing numbers of and adherence to health behaviors may markedly lower the burden of cardio- and cerebrovascular diseases. However, future research should focus on randomized controlled trials to test for causal relationships.


Subject(s)
Cardiovascular Diseases , Cerebrovascular Disorders , Stroke , Humans , Cerebrovascular Disorders/epidemiology , Cerebrovascular Disorders/prevention & control , Life Style , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Vegetables , Stroke/epidemiology , Stroke/prevention & control
7.
Nutrients ; 15(4)2023 Feb 06.
Article in English | MEDLINE | ID: mdl-36839186

ABSTRACT

Phytosterols (PSs) have been proposed as dietary means to lower plasma LDL-C. However, concerns are raised that PSs may exert atherogenic effects, which would offset this benefit. Phytosterolemia was thought to mimic increased plasma PSs observed after the consumption of PS-enriched foods. This expert statement examines the possibility of specific atherogenicity of PSs based on sterol metabolism, experimental, animal, and human data. Observational studies show no evidence that plasma PS concentrations would be associated with an increased risk of atherosclerosis or cardiovascular (CV) events. Since variants of the ABCG5/8 transporter affect the absorption of cholesterol and non-cholesterol sterols, Mendelian randomization studies examining the effects of ABCG5/8 polymorphisms cannot support or refute the potential atherogenic effects of PSs due to pleiotropy. In homozygous patients with phytosterolemia, total PS concentrations are ~4000% higher than under physiological conditions. The prevalence of atherosclerosis in these individuals is variable and may mainly relate to concomitant elevated LDL-C. Consuming PS-enriched foods increases PS concentrations by ~35%. Hence, PSs, on a molar basis, would need to have 20-40 times higher atherogenicity than cholesterol to offset their cholesterol reduction benefit. Based on their LDL-C lowering and absence of adverse safety signals, PSs offer a dietary approach to cholesterol management. However, their clinical benefits have not been established in long-term CV endpoint studies.


Subject(s)
Atherosclerosis , Cardiovascular Diseases , Hypercholesterolemia , Phytosterols , Animals , Humans , Cholesterol, LDL , Cardiovascular Diseases/chemically induced , Risk Factors , Phytosterols/pharmacology , Cholesterol , Heart Disease Risk Factors , Atherosclerosis/chemically induced
8.
Public Health Nutr ; 15(5): 860-7, 2012 May.
Article in English | MEDLINE | ID: mdl-22014407

ABSTRACT

OBJECTIVE: To investigate the impact of eating behaviour traits on central obesity, prediabetes and associated major dietary food patterns. DESIGN: Assessment of eating behaviour was based on the revised German version of the Three-Eating Factor Questionnaire using cross-sectional and longitudinal data of a feasibility study in employees. Data on lifestyle and nutrition were obtained by validated self-administered questionnaires. Baseline characteristics were analysed by the univariate χ2 test or the Mann-Whitney test. To quantify correlations linear regression analysis was used. SETTING: The Delay of Impaired Glucose Tolerance by a Healthy Lifestyle Trial (DELIGHT), which investigated measures to prevent type 2 diabetes mellitus in 2004-2008. SUBJECTS: Employees (21-64 years, 127 men, 157 women) with elevated waist circumference (men ≥ 94 cm, women ≥ 80 cm) of five medium-sized companies in northern Germany. RESULTS: At baseline (T0), BMI but particularly waist circumference showed a strong inverse correlation with flexible control (P < 0.0001) and a positive correlation with disinhibition (P < 0.0001) and rigid control (P = 0.063). Flexible control was also significantly inversely related to fasting plasma glucose (P = 0.040), energy intake (P < 0.0001), intake of meat and meat products (P = 0.0001), and positively associated with intake of fruit and vegetables (P < 0.0001) at baseline (T0). Changes in flexible control within the first year of intervention (T1 v. T0) predicted changes in central obesity (P < 0.0001) and fasting plasma glucose (P = 0.025). CONCLUSIONS: DELIGHT shows that flexible control characterizes individuals with a higher dietary quality, a lower waist circumference and a lower glucose level. Enhancing flexible control more than rigid control, and decreasing disinhibition, seems beneficial in terms of central adiposity and glucose levels.


Subject(s)
Blood Glucose/metabolism , Body Mass Index , Diet/psychology , Feeding Behavior/psychology , Obesity, Abdominal/psychology , Prediabetic State/psychology , Adult , Cross-Sectional Studies , Diabetes Mellitus, Type 2/prevention & control , Energy Intake , Feasibility Studies , Female , Germany/epidemiology , Glucose Tolerance Test , Humans , Life Style , Longitudinal Studies , Male , Middle Aged , Obesity, Abdominal/epidemiology , Prediabetic State/epidemiology , Surveys and Questionnaires , Waist Circumference , Young Adult
9.
Atherosclerosis ; 341: 1-6, 2022 01.
Article in English | MEDLINE | ID: mdl-34922192

ABSTRACT

BACKGROUND AND AIMS: Dietary approaches to lowering cholesterol appear to be common knowledge. However, the marketing of phytosterol-enriched products and their recommendation by guidelines for individuals at increased risk of cardiovascular disease have given rise to concern, since phytosterols may be atherogenic and inappropriately used by healthy individuals of higher social status at low cardiovascular risk. Hence, we have investigated awareness of cholesterol lowering lifestyle measures and attitudes towards consumption of phytosterol-enriched foods. METHODS: Data from validated questionnaires supplemented by queries on cholesterol lowering and phytosterol-enriched products were analyzed using data of 7223 participants of the Hamburg City Health Study, an ongoing cohort study of the general population aged 45-74 years. RESULTS: 95.9% of the participants agreed that lifestyle may lower cholesterol and 76.6% claimed knowledge of measures that lower plasma cholesterol. As to effective approaches, 80.2% suggested physical activity, 67.8% reducing dietary fat, followed by sugar-sweetened beverages or stress, increasing water consumption, or dietary fiber and only 16.2% stated statins and 9.3% phytosterol-enriched products. Compared to nonusers, the 2.0% female and 2.8% male individuals regularly using phytosterol-enriched products had a lower educational status, higher cardiovascular risk, but no difference in income and were characterized by adverse dietary habits. The study has been registered in ClinicalTrial.gov (NCT03934957). CONCLUSIONS: In the general population awareness of hypercholesterolemia is high but knowledge on how to lower plasma cholesterol does not necessarily follow scientific evidence. There is a trend towards the use of phytosterol-enriched products by individuals at increased cardiovascular risk independent of income.


Subject(s)
Phytosterols , Cholesterol , Cohort Studies , Female , Food, Fortified , Humans , Male , Social Status
10.
Clin Nutr ; 41(1): 49-70, 2022 01.
Article in English | MEDLINE | ID: mdl-34864455

ABSTRACT

BACKGROUND & AIMS: This systematic review sought to identify and summarize existing evidence for the impact of nutrition on the development, progression, and outcomes of peripheral artery disease (PAD). METHODS: We performed a systematic literature search of available studies published between January 1974 and December 2019. Randomized controlled trials (RCT), observational studies, and cross-sectional studies reporting either the primary or secondary prevention of PAD with nutritional intake were included. The quality assessment was performed for the RCTs, without pooling a meta-risk estimate. RESULTS: Among a total of 8502 records screened, 186 full texts were assessed for eligibility, and 82 studies (30% RCT) were analyzed. The nutrients were structured in fruits, vegetables and antioxidants, fats and oils, dietary fiber, meat, proteins, vitamins and trace elements, and diets and lifestyle. The findings of the current systematic review indicate that the Mediterranean diet, nuts, and polyunsaturated fat are associated with a lower incidence of PAD and saturated fat, cholesterol, and processed meat were associated with higher rates of cardiovascular events in patients suffering from PAD. CONCLUSIONS: The current review found evidence of a beneficial impact of the Mediterranean diet including nuts in this target population. More RCTs and high-quality registries are needed that focus on nutritional habits among patients with PAD to design appropriate preventive programs.


Subject(s)
Diet, Mediterranean , Diet/adverse effects , Peripheral Arterial Disease/etiology , Peripheral Arterial Disease/prevention & control , Adult , Aged , Cross-Sectional Studies , Disease Progression , Female , Humans , Incidence , Male , Middle Aged , Nutritional Status , Peripheral Arterial Disease/epidemiology , Randomized Controlled Trials as Topic
11.
Arch Gynecol Obstet ; 284(2): 343-55, 2011 Aug.
Article in English | MEDLINE | ID: mdl-21431845

ABSTRACT

This short version of the interdisciplinary S3 guideline on hormone therapy in peri- and postmenopause (HT) is intended as a decision-making instrument for physicians and women considering HT. It is designed to assist daily practice. This short version summarises the long version that contains detailed information about the development of the guideline, particularly about establishing the evidence levels. The statements and recommendations, quoted completely, are marked with the relevant levels of evidence (LoE) and grades of recommendation. The classification system from the Centre for Evidence-based Medicine in Oxford was used in this guideline (see "Attachment").


Subject(s)
Hormone Replacement Therapy/standards , Perimenopause , Postmenopause , Female , Humans
12.
Ultrasound J ; 13(1): 17, 2021 Mar 11.
Article in English | MEDLINE | ID: mdl-33704610

ABSTRACT

BACKGROUND: Assessment of cardiovascular risk by scores lacks sensitivity and leaves the majority of future cardiovascular patients unidentified particularly individuals at low cardiovascular risk. The present analysis investigates into the correlation of carotid intima-media thickness (CIMT) and cardiovascular risk factors and derived scores as to the potential of improved cardiovascular risk prediction by combining the two. METHODS: The Stress, Atherosclerosis and ECG Study (STRATEGY) is a cross-sectional study of selectively healthy 107 women and 106 men without diagnosed and treated cardiovascular risk factors evenly distributed between 30 and 70 years. CIMT was determined by evaluating B-mode ultrasonograms offline according to a standardized protocol. The unpaired t-test was used to compare normal-distributed continuous variables, the Chi-squared test for normal-distributed categorical variables and the Mann-Whitney U test for non-normal distributed continuous variables. The association between risk prediction scores and CIMT was calculated by the Spearman rank correlation coefficient. Pearson correlation coefficient was used for the correlation between cardiovascular risk factors and CIMT. A multiple linear regression analysis was executed for the association of cardiovascular risk factors and CIMT. RESULTS: Age, systolic blood pressure, fasting glucose, total, LDL- and non-HDL-cholesterol and waist circumference were significantly associated with CIMT (each P ≤ 0.03). The Framingham Risk Score, the Prospective Cardiovascular Münster Study Score and the European Society of Cardiology Score correlated significantly but only moderately with CIMT. The Framingham Risk Score considering BMI correlated most strongly and predicted 27% of the CIMT variance in men and 20% in women. CONCLUSION: In individuals without overt cardiovascular risk factors and thus at low cardiovascular risk, CIMT and cardiovascular risk factors correlated only partially suggesting that combining CIMT and conventional risk factors or common derived scores may improve risk prediction in individuals at low cardiovascular risk. The clinical benefit as to cardiovascular events of such combined risk prediction needs to be explored in large prospective cohorts of still healthy low-risk volunteers. DRKS ID DRKS00015209 07/02/2019 retrospectively registered https://www.drks.de/drks_web/navigate.do?navigationId=resultsExt.

13.
Geburtshilfe Frauenheilkd ; 81(6): 612-636, 2021 Jun.
Article in English | MEDLINE | ID: mdl-34168377

ABSTRACT

Aim The aim of the interdisciplinary S3-guideline Perimenopause and Postmenopause - Diagnosis and Interventions is to provide help to physicians as they inform women about the physiological changes which occur at this stage of life and the treatment options. The guideline should serve as a basis for decisions taken during routine medical care. This short version lists the statements and recommendations given in the long version of the guideline together with the evidence levels, the level of recommendation, and the strength of consensus. Methods The statements and recommendations are largely based on methodologically high-quality publications. The literature was evaluated by experts and mandate holders using evidence-based medicine (EbM) criteria. The search for evidence was carried out by the Essen Research Institute for Medical Management (EsFoMed). To some extent, this guideline also draws on an evaluation of the evidence used in the NICE guideline on Menopause and the S3-guidelines of the AWMF and has adapted parts of these guidelines. Recommendations Recommendations are given for the following subjects: diagnosis and therapeutic interventions for perimenopausal and postmenopausal women, urogynecology, cardiovascular disease, osteoporosis, dementia, depression, mood swings, hormone therapy and cancer risk, as well as primary ovarian insufficiency.

14.
J Public Health (Oxf) ; 32(3): 387-94, 2010 Sep.
Article in English | MEDLINE | ID: mdl-20208067

ABSTRACT

BACKGROUND: To determine the accuracy of patient self-reports of specific cardiovascular diagnoses and to identify individual patient characteristics that influence the accuracy. METHODS: This investigation was conducted as a part of the randomized controlled ORBITAL study. Patients with hypercholesterolemia were enrolled in 1961 primary-care centers all over Germany. Self-reported questionnaire data of 7640 patients were compared with patients' case report forms (CRFs) and medical records on cardiovascular diseases, using kappa statistics and binomial logit models. RESULTS: kappa values ranged from 0.89 for diabetes to 0.04 for angina. The percentage of overreporting varied from 1% for diabetes to 17% for angina, whereas the percentage of underreporting varied from 8.0% for myocardial infarction to 57% for heart failure. Individual characteristics such as choice of individual general practitioner, male gender and age were associated with the accuracy of self-report data. CONCLUSION: Since the agreement between patient self-report and CRFs/medical records varies with specific cardiovascular diagnoses in patients with hypercholesterolemia, the adequacy of this tool seems to be limited. However, the authors recommend additional data validation for certain patient groups and consideration of individual patient characteristics associated with over- and underreporting.


Subject(s)
Cardiovascular Diseases/diagnosis , Health Status , Hypercholesterolemia , Self Disclosure , Surveys and Questionnaires , Aged , Female , Germany , Humans , Male , Medical Records , Middle Aged , Physicians, Family , Reproducibility of Results
15.
Eur J Cardiovasc Prev Rehabil ; 16(1): 1-9, 2009 Feb.
Article in English | MEDLINE | ID: mdl-19237992

ABSTRACT

Several recent meta-analyses of numerous lipid-lowering outcome trials confirm the direct relationship between low-density lipoprotein-cholesterol (LDL-C) lowering and cardiovascular risk reduction. As a consequence, LDL-C goals are continuously being set lower. To achieve lipid lowering, several efficient drugs are available, however, the current pharmacopoeia remains limited for some critical patient situations. Colesevelam hydrochloride is a specifically engineered bile acid sequestrant that features a more favourable tolerability and drug interaction profile than traditional bile acid sequestrants, because of a better affinity and binding capacity to bile acids. In addition, colesevelam retains the nonsystemic mode of action of bile acid sequestrants. Moreover, colesevelam lowers LDL-C by 15-19% and 10-16%, respectively, in monotherapy and in combination to various lipid-lowering drugs, such as statins, ezetimibe and fenofibrates. Along with an efficient and sustainable effect on lipid profiles, colesevelam - as other bile acid sequestrants - has been shown to lower the glycosylated haemoglobin HbA1c by 0.5% on average in patients with type 2 diabetes. Overall, colesevelam represents an interesting add-on treatment to be used in high-risk patients with hypercholesterolaemia for whom standard lipid-lowering therapies are not enough or not well tolerated.


Subject(s)
Allylamine/analogs & derivatives , Anticholesteremic Agents/pharmacology , Cholesterol, LDL/blood , Hypercholesterolemia/drug therapy , Allylamine/pharmacology , Allylamine/therapeutic use , Anticholesteremic Agents/therapeutic use , Colesevelam Hydrochloride , Drug Interactions , Humans
16.
Eur J Cardiovasc Prev Rehabil ; 16(2): 180-7, 2009 Apr.
Article in English | MEDLINE | ID: mdl-19174696

ABSTRACT

AIM: To determine whether a compliance-enhancing program could increase the level of lipid control in patients treated with rosuvastatin. METHODS AND RESULTS: A total of 8108 patients (56% men, mean age 59 years; 44% women, mean age 63 years) with low-density lipoprotein cholesterol (LDL-C) >or=115 mg/dl if statin-naive or else >or=125 mg/dl were randomized to rosuvastatin 10 mg daily either with or without a compliance-enhancing program for 12 months. Patients not achieving the goal after 3 months were uptitrated to rosuvastatin 20 mg daily thereafter. At 3, 6, and 12 months, rosuvastatin plus compliance initiatives were similarly effective to rosuvastatin alone in terms of 1998 European LDL-C goal of less than 115 mg/dl achievement (72 vs. 70%, 71 vs. 69%, 68 vs. 68%) and changes in the lipid profile. Significant differences were observed in the subgroup of statin-naive patients at 3 and 6 months (80 vs. 76% and 78 vs. 73%, P<0.01). The frequency of adverse events and relevant changes in laboratory data were consistent with the known safety profile of rosuvastatin. CONCLUSION: Rosuvastatin 10/20 mg daily enables the majority of patients to achieve LDL-C less than 115 mg/dl within 3 months. The compliance-enhancing program was only effective in statin-naive patients at early time points, but had no overall effect over 12 months.


Subject(s)
Cholesterol, LDL/blood , Fluorobenzenes/therapeutic use , Health Knowledge, Attitudes, Practice , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Hypercholesterolemia/drug therapy , Medication Adherence , Patient Education as Topic , Pyrimidines/therapeutic use , Sulfonamides/therapeutic use , Aged , Biomarkers/blood , Europe , Female , Fluorobenzenes/adverse effects , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Hypercholesterolemia/blood , Male , Middle Aged , Program Evaluation , Pyrimidines/adverse effects , Rosuvastatin Calcium , Sulfonamides/adverse effects , Time Factors , Treatment Outcome
17.
Am J Cardiol ; 101(4): 490-6, 2008 Feb 15.
Article in English | MEDLINE | ID: mdl-18312764

ABSTRACT

Although statin treatment is generally well tolerated, it is estimated that 5% to 10% of patients develop muscle-related side effects (MRSEs), resulting in less effective nonstatin alternatives or cessation of lipid-lowering therapy completely. This study was designed to assess the efficacy and tolerability of extended-release fluvastatin (fluvastatin XL) and ezetimibe alone or in combination in patients with previous MRSEs with other statins. This was a double-blinded, double-dummy trial of 199 mostly moderate- or high-risk dyslipidemic patients randomized to fluvastatin XL 80 mg/day (n = 69), ezetimibe 10 mg/day (n = 66), or fluvastatin XL 80 mg/day plus ezetimibe 10 mg/day (n = 64) for 12 weeks. Fluvastatin XL lowered low-density lipoprotein (LDL) cholesterol by 32.8% compared with 15.6% with ezetimibe (between-group difference -17.1%, 95% confidence interval -23.6 to -10.7, p <0.0001); the fluvastatin XL/ezetimibe combination lowered LDL cholesterol by 46.1% (between-group difference vs ezetimibe -30.4%, 95% confidence interval -37.0 to -23.8, p <0.0001). Proportions of patients achieving their National Cholesterol Education Program Adult Treatment Panel III target LDL cholesterol were 84% with the fluvastatin XL/ezetimibe combination, 59% with fluvastatin XL, and 29% with ezetimibe (p <0.001 for fluvastatin XL monotherapy or combination therapy vs ezetimibe monotherapy). Incidences of MRSEs were 24% in the ezetimibe group, 17% in the fluvastatin XL group, and 14% in the combination group. There were no instances of creatine kinase increases >or=10 times upper limit of normal. In conclusion, in patients with a history of statin-associated MRSEs, fluvastatin XL alone or in combination with ezetimibe offers an effective and well-tolerated lipid-lowering option.


Subject(s)
Anticholesteremic Agents/administration & dosage , Azetidines/administration & dosage , Dyslipidemias/drug therapy , Fatty Acids, Monounsaturated/administration & dosage , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Indoles/administration & dosage , Cholesterol/blood , Delayed-Action Preparations , Double-Blind Method , Drug Therapy, Combination , Ezetimibe , Female , Fluvastatin , Humans , Lipoproteins/blood , Male , Middle Aged , Muscular Diseases/chemically induced , Treatment Outcome , Triglycerides/blood
18.
Cardiology ; 111(4): 219-28, 2008.
Article in English | MEDLINE | ID: mdl-18434729

ABSTRACT

BACKGROUND: Patients at high risk of cardiovascular disease frequently fail to reach recommended low-density lipoprotein cholesterol (LDL-C) goals, partly because statin doses are not titrated to optimal effect. The ECLIPSE study was designed to compare the efficacy and safety of force-titrated treatment with rosuvastatin (10-40 mg) with that of atorvastatin (10-80 mg) in high-risk patients with hypercholesterolemia. METHODS: In this 24-week, open-label, randomized, multinational, parallel-group study, 1,036 patients were randomized to rosuvastatin (n = 522) or atorvastatin (n = 514). RESULTS: At all time points, a significantly greater percentage of patients on rosuvastatin treatment achieved the NCEP ATP III LDL-C goal of <100 mg/dl (2.5 mmol/l), the 2003 European LDL-C target of <2.5 or 3.0 mmol/l (100 or 115 mg/dl) and the LDL-C goal of <70 mg/dl (1.8 mmol/l), a goal suggested for very high-risk patients (p < 0.001 for all). Rosuvastatin also achieved significantly greater improvements in components of the atherogenic lipid profile versus atorvastatin. Both treatments were well tolerated. CONCLUSION: Rosuvastatin titrated across its recommended dose range provides a more favorable effect on lipoprotein variables than atorvastatin, enabling more high-risk patients to achieve recommended LDL-C goals.


Subject(s)
Fluorobenzenes/administration & dosage , Fluorobenzenes/adverse effects , Heptanoic Acids/administration & dosage , Heptanoic Acids/adverse effects , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Hypercholesterolemia/drug therapy , Pyrimidines/administration & dosage , Pyrimidines/adverse effects , Pyrroles/administration & dosage , Pyrroles/adverse effects , Sulfonamides/administration & dosage , Sulfonamides/adverse effects , Aged , Atorvastatin , Canada , Cholesterol, LDL/blood , Coronary Disease/prevention & control , European Union , Female , Humans , Hypercholesterolemia/blood , Male , Middle Aged , Risk Assessment , Risk Factors , Rosuvastatin Calcium
19.
Eur J Clin Nutr ; 72(12): 1673-1681, 2018 12.
Article in English | MEDLINE | ID: mdl-29500458

ABSTRACT

BACKGROUND/OBJECTIVES: Smoking is a strong risk factor for coronary heart disease particularly in women. The risk may be aggravated by dietary habits, though. SUBJECTS/METHODS: The Coronary Risk for Atherosclerosis Study (CORA) compares dietary, lifestyle, biochemical, and clinical factors in 200 consecutive pre- and postmenopausal women with incident coronary heart disease to those of 255 age-matched population-based controls. A mixed logistic regression model was used to assess the possible interactions between smoking habits and dietary patterns. RESULTS: Each increase of 100 kcal energy intake per day was positively associated with coronary risk (OR 1.10, 95% CI 1.03-1.17; p = 0.006). Doubling the intake of alcohol and vegetables was negatively related with coronary risk (alcohol: OR 0.61, 95% CI 0.50-0.73; p < 0.001; vegetables: OR 0.50, 95% CI 0.032-0.080; p = 0.003). In contrast, doubling the intake of meat was associated with an increase of coronary risk, but only in smoking women (OR 2.61, 95%CI 1.58-4.29; p < 0.001). In smoking women a high meat-over-vegetable-ratio indicated an even higher risk (ratio of 2.0: OR 5.77, 95% CI 2.13-15.67; p < 0.001), while a low meat-over-vegetable-ratio did not have a significant impact on coronary risk (ratio of 0.5: OR 1.28, 95% CI 0,78-2.09). CONCLUSIONS: This explorative analysis of the CORA-study indicates that a high intake of meat is significantly associated with an increase in coronary risk particularly in smoking women, and may account for part of the unadjusted risk of smoking.


Subject(s)
Coronary Disease/etiology , Diet/adverse effects , Feeding Behavior , Smoking/adverse effects , Adult , Case-Control Studies , Coronary Disease/epidemiology , Energy Intake , Female , Humans , Incidence , Life Style , Logistic Models , Meat , Middle Aged , Odds Ratio , Postmenopause , Premenopause , Risk Factors , Vegetables
20.
Diab Vasc Dis Res ; 4(2): 136-42, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17654448

ABSTRACT

In most developed and developing countries, the proportion of the population aged 60 years or more is growing faster than any other age group. Given that the vast majority of cardiovascular events occur in older individuals, new thinking is needed to reduce their risk. Epidemiological studies have shown an increasing prevalence of the metabolic syndrome with age, driven by nutrition inappropriate for a modern sedentary lifestyle. A low level of high-density lipoprotein (HDL)-cholesterol, a component of the atherogenic dyslipidaemia of the metabolic syndrome, has been shown to be an important determinant of coronary risk, which rises in prevalence with increasing age. Thus, raising HDLcholesterol, in addition to lowering the level of low-density lipoprotein (LDL)-cholesterol, seems a plausible approach to reduce cardiovascular risk in an ageing population. Clinical studies have shown that adding nicotinic acid, which raises HDL-cholesterol by 20-25%, to a statin enhances the reduction in progression of atherosclerosis. Results of the ongoing Atherothrombosis Intervention in Metabolic syndrome with low HDL/High triglyceride and Impact on Global Health Outcomes (AIM-HIGH) study are awaited with interest to see whether such theoretical benefit translates into clinical outcome.


Subject(s)
Aging/blood , Cardiovascular Diseases/etiology , Cholesterol, HDL/blood , Dyslipidemias/blood , Hypolipidemic Agents/therapeutic use , Age Factors , Aged , Cardiovascular Diseases/blood , Cardiovascular Diseases/prevention & control , Cholesterol, LDL/blood , Drug Therapy, Combination , Dyslipidemias/complications , Dyslipidemias/drug therapy , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Middle Aged , Niacin/therapeutic use , Risk Assessment , Risk Factors , Treatment Outcome , Triglycerides/blood
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