Predicted 10-year risk of cardiovascular mortality in the 40 to 69 year old general population without cardiovascular diseases in Germany.

AIMS: To estimate the 10-year risk of fatal cardiovascular disease (CVD) in the 40 to 69 year old general population in Germany stratified by sex and to analyze differences between socio-economic status (SES), region and community size in individuals without CVD. The analysis is based on the newly recalibrated SCORE Deutschland risk charts and considered other comorbidities for the classification of the high CVD risk group according to the guidelines of the European Society of Cardiology. METHODS AND RESULTS: In 3,498 participants (40-69 years) from the German Health Examination Survey for Adults 2008-2011 (DEGS1) without a history of CVD (myocardial infarction, coronary heart disease, heart failure, stroke) we estimated the proportion with a low (SCORE <1%), moderate (SCORE 1-<5%) and high 10-year CVD mortality risk (SCORE ≥5% or diabetes, renal insufficiency, SBP/DPB ≥180/110 mmHg or cholesterol >8 mmol/l). The prevalence of low, moderate and high risk was 42.8%, 38.5% and 18.8% in men and 73.7%, 18.1% and 8.2% in women. The prevalence of high risk was significantly lower in women with a high compared to a low SES (3.3% vs. 11.2%) and in communities with ≥100.000 inhabitants compared to <20.000 inhabitants (5.4% vs.10.9%). There were no significant associations between predicted CVD mortality risk and SES or community size in men and regions in men and women. Among the high risk group, 58.2% of men and 9.8% of women had SCORE ≥5%, leaving the majority of women (60.1%) classified as high risks due to diabetes and SCORE <5%. CONCLUSION: Our results suggest the persistence of socioeconomic disparities in predicted cardiovascular mortality in women and support the need of large-scale prevention efforts beyond individual lifestyle modification or treatment. Furthermore, the importance of additional comorbidities for the high risk group classification is highlighted.

Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

OBJECTIVES:  To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. DESIGN:  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. SETTING:  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. MAIN OUTCOME MEASURES:  Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. RESULTS:  Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. CONCLUSIONS:  Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor. High remuneration and strict confidentiality clauses in these studies could influence the physicians' reporting behaviours of adverse drug reactions.

Regular exercise behaviour and intention and symptoms of anxiety and depression in coronary heart disease patients across Europe: Results from the EUROASPIRE III survey.

BACKGROUND: Regular exercise lowers the risk of cardiovascular death in coronary heart disease (CHD) patients. We aimed to investigate regular exercise behaviour and intention in relation to symptoms of anxiety and depression in CHD patients across Europe. DESIGN: This study was based on a multicentre cross-sectional survey. METHODS: In the EUROpean Action on Secondary and Primary Prevention through Intervention to Reduce Events (EUROASPIRE) III survey, 8966 CHD patients <80 years of age from 22 European countries were interviewed on average 15 months after hospitalisation. Whether patients exercised or intended to exercise regularly was assessed using the Stages of Change questionnaire in 8330 patients. Symptoms of anxiety and depression were evaluated using the Hospital Anxiety and Depression Scale. Total physical activity was measured by the International Physical Activity Questionnaire in patients from a subset of 14 countries. RESULTS: Overall, 50.3% of patients were not intending to exercise regularly, 15.9% were intending to exercise regularly, and 33.8% were exercising regularly. Patients with severe symptoms of depression less frequently exercised regularly than patients with symptoms in the normal range (20.2%, 95% confidence interval (CI) 14.8-26.8 vs 36.7%, 95% CI 29.8-44.2). Among patients not exercising regularly, patients with severe symptoms of depression were less likely to have an intention to exercise regularly (odds ratio 0.62, 95% CI 0.46-0.85). Symptoms of anxiety did not affect regular exercise intention. In sensitivity analysis, results were consistent when adjusting for total physical activity. CONCLUSIONS: Lower frequency of regular exercise and decreased likelihood of exercise intention were observed in CHD patients with severe depressive symptoms. Severe symptoms of depression may preclude CHD patients from performing regular exercise.

Predicting 10-Year Risk of Fatal Cardiovascular Disease in Germany: An Update Based on the SCORE-Deutschland Risk Charts.

Estimation of absolute risk of cardiovascular disease (CVD), preferably with population-specific risk charts, has become a cornerstone of CVD primary prevention. Regular recalibration of risk charts may be necessary due to decreasing CVD rates and CVD risk factor levels. The SCORE risk charts for fatal CVD risk assessment were first calibrated for Germany with 1998 risk factor level data and 1999 mortality statistics. We present an update of these risk charts based on the SCORE methodology including estimates of relative risks from SCORE, risk factor levels from the German Health Interview and Examination Survey for Adults 2008-11 (DEGS1) and official mortality statistics from 2012. Competing risks methods were applied and estimates were independently validated. Updated risk charts were calculated based on cholesterol, smoking, systolic blood pressure risk factor levels, sex and 5-year age-groups. The absolute 10-year risk estimates of fatal CVD were lower according to the updated risk charts compared to the first calibration for Germany. In a nationwide sample of 3062 adults aged 40-65 years free of major CVD from DEGS1, the mean 10-year risk of fatal CVD estimated by the updated charts was lower by 29% and the estimated proportion of high risk people (10-year risk > = 5%) by 50% compared to the older risk charts. This recalibration shows a need for regular updates of risk charts according to changes in mortality and risk factor levels in order to sustain the identification of people with a high CVD risk.

Changes in life expectancy 1950-2010: contributions from age- and disease-specific mortality in selected countries.

BACKGROUND: Changes of life expectancy over time serve as an interesting public health indicator for medical, social and economic developments within populations. The aim of this study was to quantify changes of life expectancy between 1950 and 2010 and relate these to main causes of death. METHODS: Pollard's actuarial method of decomposing life expectancy was applied to compare the contributions of different age- and disease-groups on life expectancy in 5-year intervals. RESULTS: From the 1960 to 70s on, declines in cardiovascular disease (CVD) mortality play an increasing role in improving life expectancy in many developed countries. During the past decades gains in life expectancy in these countries were mainly observed in age groups ≥65 years. A further consistent pattern was that life expectancy increases were stronger in men than in women, although life expectancy is still higher in women. In Japan, an accelerated epidemiologic transition in causes of death was found, with the highest increases between 1950 and 1955. Short-term declines and subsequent gains in life expectancy were observed in Eastern Europe and the former states of the Union of Soviet Socialist Republics (USSR), reflecting the changes of the political system. CONCLUSIONS: Changes of life years estimated with the decomposing method can be directly interpreted and may therefore be useful in public health communication. The development within specific countries is highly sensitive to changes in the political, social and public health environment.

Control of main risk factors after ischaemic stroke across Europe: data from the stroke-specific module of the EUROASPIRE III survey.

BACKGROUND: Previous cross-sectional surveys in different European countries within the EUROASPIRE programme demonstrated a high prevalence of modifiable risk factors, unhealthy lifestyles and inadequate drug treatment in coronary heart disease patients. Comparable data for ischaemic stroke patients is lacking. METHODS: A stroke-specific study module was added to the EUROASPIRE III core survey. This cross-sectional multicentre survey included consecutive patients with first-ever ischaemic stroke from four European countries. Data were obtained from medical records, patient interviews and patient examinations within 6-36 months after the stroke event. Control of modifiable risk factors after stroke was evaluated against contemporary European guidelines. RESULTS: A total of 881 patients was recruited. Median age was 66 years, 37.5% were female; average time from the stroke event to interview was 550 days. At the time of the interview, 17.6% of stroke patients smoked cigarettes, 35.5% had a body mass index ≥30 kg/m(2), 62.4% showed elevated blood pressure and 75.7% exhibited elevated LDL cholesterol levels. Antiplatelet drugs or oral anticoagulants were used by 87.2%, antihypertensive medication by 84.4% and statins by 56.8% of stroke patients. Among patients using antihypertensive drugs and lipid-lowering medication at the time of the interview, 34.3% and 34.4%, respectively, achieved target blood pressure and total cholesterol values according to current European guidelines. CONCLUSION: The EUROASPIRE III stroke-specific module shows that secondary prevention and risk factor control in patients after ischaemic stroke need to be improved in four European centres at the time of the study since about half of patients are not achieving risk factor targets defined in European guidelines.

Readiness for smoking cessation in coronary heart disease patients across Europe: Results from the EUROASPIRE III survey.

BACKGROUND: Readiness for smoking cessation is an important predictor of quit attempts and cessation success. We aimed to investigate the prevalence and correlates of readiness for smoking cessation in coronary heart disease (CHD) patients. DESIGN: The EUROpean Action on Secondary and Primary Prevention by Intervention to Reduce Events III (EUROASPIRE III) survey is a cross-sectional study conducted in 2006-2007 among CHD patients <80 years of age from 22 European regions. METHODS: Patients were interviewed on average 15 months after hospital admission for an acute coronary event or procedure. Readiness for smoking cessation was assessed using the smoking stages of change (SSC) short form questionnaire. Breath carbon monoxide was measured to validate self-reported non-smoking. RESULTS: Among 2585 patients who were smoking prior to hospital admission, 25.6%, 16.8%, 8.1%, 5.6% and 44.0% were in the precontemplation (no intention to quit), contemplation (thinking of quitting), preparation (planning to quit), action (having quit within six months) and maintenance (having quit more than six months ago) stages, respectively. Significant multivariable correlates of advancement in SSC showed positive associations of older age and attended cardiac rehabilitation and negative associations of severe depressive symptoms, longer smoking duration and environmental tobacco smoke (ETS) exposure. CONCLUSIONS: One-quarter of CHD patients across Europe who were smoking prior to hospitalisation have no intention to quit, and an additional quarter is thinking of quitting or planning to quit. Patients who are younger, do not attend cardiac rehabilitation, have severe depressive symptoms, have been smoking for longer periods of time and are exposed to ETS may need to be specifically targeted in cessation interventions.

German nationwide data on current trends and management of acute myocardial infarction: discrepancies between trials and real-life.

AIMS: Recent guidelines on acute myocardial infarction (AMI) are based on randomized clinical trials (RCTs) and registries with selected patients, and may therefore not represent 'real-life'. This analysis shows for the first time nationwide trends in AMI from Germany. METHODS AND RESULTS: We were provided with data on all in-patient hospitalizations by the Federal Statistical Office. All hospitalized cases with AMI (onset of symptoms <28 days) from the years 2005, 2007, and 2009 were analysed regarding morbidity, in-hospital mortality, treatments, and costs. Analysis of a total of 16.1, 16.6, and 17.2 million hospitalizations showed the proportion of coded AMI to remain relatively constant (1276, 1272, and 1181 per 100 000 hospitalizations in 2005, 2007, and 2009). The proportion of ST-elevation AMI decreased over time (STEMI; 631, 546, and 454 per 100 000 hospitalizations),while non-ST-elevation AMI increased (NSTEMI; 645, 726, and 727 per 100 000 hospitalizations). The proportion of older patients >75 years (+4.6%), of comorbidities such as hypertension (+5.8%), diabetes (+17.7%), left ventricular failure (+19.8%), peripheral artery disease (+13.3%), and chronic kidney disease (+165.4%) increased as well. In-hospital mortality remained relatively stable during this period in AMI cases overall (11.1, 10.7, 10.8%) but changed slightly in STEMI (11.2, 11.9, 12.2%) and NSTEMI (11.0, 9.9, 9.9%). Causing about 1.2% of hospitalizations, AMI accounted for 2.5% (1.2 billion €) of in-hospital health expenses. CONCLUSION: This hospitalization-based analysis revealed a marked increase of NSTEMI among constant AMI frequency. Despite all current efforts, in-hospital mortality was stagnating on a high level compared with data of RCTs.

Passive smoking and smoking cessation among patients with coronary heart disease across Europe: results from the EUROASPIRE III survey.

AIMS: Passive smoking is the inhalation of environmental tobacco smoke (ETS) and is a risk factor for coronary heart disease (CHD). We aimed to describe the frequency of passive smoking among patients with CHD and to investigate the association between ETS exposure and smoking cessation. METHODS AND RESULTS: The EUROASPIRE III survey was conducted in 2006-07 among CHD patients up to 80 years of age from 22 European regions. Patients were interviewed and examined on average 15 months after hospital admission for CHD. Information was obtained on smoking prior to hospital admission, smoking at interview, and ETS exposure at home, at work, and at other locations. Breath carbon monoxide was measured to validate self-reported non-smoking. Among 8729 patients, 6060 (69.4%) were non-smokers prior to hospital admission, of whom 10.3% reported ETS exposure at home, 7.2% at work, and 13.8% at other locations. Overall, 24.2% of non-smokers were exposed to ETS at any place. Among the 2669 patients who were smoking prior to hospital admission, the likelihood of cessation at interview was lower in those with ETS exposure at home than in those without [25.3 vs. 58.1%; adjusted odds ratio (OR) 0.26, 95% confidence interval (CI) 0.20-0.33]. This finding applied also to ETS exposure at work (32.2 vs. 52.7%; adjusted OR 0.56, 95% CI 0.42-0.76) and at other locations (38.0 vs. 52.8%; adjusted OR 0.63, 95% CI 0.48-0.84). CONCLUSION: A noteworthy proportion of non-smokers with CHD are exposed to ETS. Passive smoking may jeopardize smoking cessation among CHD patients.

Extended cancer mortality follow-up of a German rubber industry cohort.

OBJECTIVE: We extended follow-up of a cohort of German rubber industry workers (active or retired in 1981) by 9 years (1992 to 2000) to reassess previously observed cancer mortality risks. METHODS: We calculated standardized mortality ratios and stratified results by work area, duration of employment, and year of hire. RESULTS: The cohort includes 11,632 men and 1863 women from five tire or general rubber goods producing factories. Among men we observed significantly elevated standardized mortality ratios for cancers of the lung and the pleura in the full cohort and in specific strata. Among women we observed a significantly elevated standardized mortality ratio for cancer of the lung. CONCLUSIONS: We observed excess risk for several cancer sites among men and women. Further cancer risk analysis of workers in the rubber industry should focus on differences in work areas and associated exposures.

Effects of smoking on arterial distensibility, central aortic pressures and left ventricular mass.

BACKGROUND: The effects of smoking on central aortic pressures and the age-related increase in left ventricular mass (LVM) are largely unknown. We studied the relationship between smoking, arterial distensibility, central aortic pressures and left ventricular mass in two population-based studies. METHODS: Data was obtained from two German population-based studies (KORA and SHIP, participants' ages 25-84 years). We identified 114 normotensive current smokers and 185 normotensive all-time non-smokers in KORA as well as 400 and 588 such individuals in SHIP. Echocardiographic LVM was obtained at baseline (T0) and follow-up after ten years (T1) in KORA and at follow-up (T1) in SHIP. Additionally, pulse-wave analysis-based central aortic pressure and augmentation index (AIx) were measured at T1 in KORA. RESULTS: Cross-sectional analysis, using KORA T0 and SHIP T1, revealed in both studies a higher covariate-adjusted LVM and left ventricular mass index (LVMI) in smokers as compared with non-smokers. Moreover, in the KORA T1 examination, the smokers demonstrated a more pronounced increase, relative to baseline, of LVM (+13.5%) and LVMI (+13.4%) compared to non-smokers (+8.59% and +8.65%; p=0.036 and 0.042, respectively). Additionally, at KORA T1 smokers had a higher central systolic blood pressure and higher AIx than non-smokers (p=0.012 and p=0.001, respectively). CONCLUSIONS: The difference in central aortic pressure due to enhanced and more prolonged wave reflection may explain our finding of a further pronounced increase in left ventricular wall thickness and mass over time in smokers.

Do fast foods cause asthma, rhinoconjunctivitis and eczema? Global findings from the International Study of Asthma and Allergies in Childhood (ISAAC) phase three.

BACKGROUND: Certain foods may increase or decrease the risk of developing asthma, rhinoconjunctivitis and eczema. We explored the impact of the intake of types of food on these diseases in Phase Three of the International Study of Asthma and Allergies in Childhood. METHODS: Written questionnaires on the symptom prevalence of asthma, rhinoconjunctivitis and eczema and types and frequency of food intake over the past 12 months were completed by 13-14-year-old adolescents and by the parents/guardians of 6-7-year-old children. Prevalence ORs were estimated using logistic regression, adjusting for confounders, and using a random (mixed) effects model. RESULTS: For adolescents and children, a potential protective effect on severe asthma was associated with consumption of fruit ≥3 times per week (OR 0.89, 95% CI 0.82 to 0.97; OR 0.86, 95% CI 0.76 to 0.97, respectively). An increased risk of severe asthma in adolescents and children was associated with the consumption of fast food ≥3 times per week (OR 1.39, 95% CI 1.30 to 1.49; OR 1.27, 95% CI 1.13 to 1.42, respectively), as well as an increased risk of severe rhinoconjunctivitis and severe eczema. Similar patterns for both ages were observed for regional analyses, and were consistent with gender and affluence categories and with current symptoms of all three conditions. CONCLUSIONS: If the association between fast foods and the symptom prevalence of asthma, rhinoconjunctivitis and eczema is causal, then the findings have major public health significance owing to the rising consumption of fast foods globally.

Residual risk of cardiovascular mortality in patients with coronary heart disease: the EUROASPIRE risk categories.

BACKGROUND: The EUROASPIRE I, II and III surveys revealed high prevalences of modifiable risk factors in the high priority group of coronary patients all over Europe. The potential to further reduce coronary heart disease (CHD) morbidity and mortality rates is still considerable. We report here on the relative risk of cardiovascular disease (CVD) death associated with common modifiable risk factor levels based on the mortality follow-up of patients participating in the first two EUROASPIRE surveys. We also present a novel simple risk classification system (ERC) that can be used in the management of patients with existing CHD. METHODS: The study cohort consisted of a consecutive sample of CHD patients aged ≤ 70 years from 12 European countries. Baseline data gathered in 1995-2000 through standardized methods, were linked to cardiovascular mortality in 5216 patients according to an accelerated failure time model. RESULTS: During 28,143 person-years of follow-up, 332 patients died from cardiovascular disease denoting a CVD mortality risk of 12.3 per 1000 person-years in men and 10.2 per 1000 person-years in women. In multivariate analysis, fasting glucose, total cholesterol and smoking emerged as the strongest independent modifiable predictors of cardiovascular mortality. CONCLUSIONS: The results of the mortality follow-up of the EUROASPIRE I and II CHD patients emphasize the continuing risk from elevated glucose and total cholesterol levels and underline the importance of smoking cessation in secondary prevention. The ERC risk tool that we developed may prove helpful to obtain these goals in the setting of secondary prevention.