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Showing papers by "Diederick E. Grobbee published in 2013"


Journal ArticleDOI
Giuseppe Mancia1, Robert Fagard, Krzysztof Narkiewicz, Josep Redon, Alberto Zanchetti, Michael Böhm, Thierry Christiaens, Renata Cifkova, Guy De Backer, Anna F. Dominiczak, Maurizio Galderisi, Diederick E. Grobbee, Tiny Jaarsma, Paulus Kirchhof, Sverre E. Kjeldsen, Stéphane Laurent, Athanasios J. Manolis, Peter M. Nilsson, Luis M. Ruilope, Roland E. Schmieder, Per Anton Sirnes, Peter Sleight, Margus Viigimaa, Bernard Waeber, Faiez Zannad, Michel Burnier, Ettore Ambrosioni, Mark Caufield, Antonio Coca, Michael H. Olsen, Costas Tsioufis, Philippe van de Borne, José Luis Zamorano, Stephan Achenbach, Helmut Baumgartner, Jeroen J. Bax, Héctor Bueno, Veronica Dean, Christi Deaton, Çetin Erol, Roberto Ferrari, David Hasdai, Arno W. Hoes, Juhani Knuuti, Philippe Kolh2, Patrizio Lancellotti, Aleš Linhart, Petros Nihoyannopoulos, Massimo F Piepoli, Piotr Ponikowski, Juan Tamargo, Michal Tendera, Adam Torbicki, William Wijns, Stephan Windecker, Denis Clement, Thierry C. Gillebert, Enrico Agabiti Rosei, Stefan D. Anker, Johann Bauersachs, Jana Brguljan Hitij, Mark J. Caulfield, Marc De Buyzere, Sabina De Geest, Geneviève Derumeaux, Serap Erdine, Csaba Farsang, Christian Funck-Brentano, Vjekoslav Gerc, Giuseppe Germanò, Stephan Gielen, Herman Haller, Jens Jordan, Thomas Kahan, Michel Komajda, Dragan Lovic, Heiko Mahrholdt, Jan Östergren, Gianfranco Parati, Joep Perk, Jorge Polónia, Bogdan A. Popescu, Zeljko Reiner, Lars Rydén, Yuriy Sirenko, Alice Stanton, Harry A.J. Struijker-Boudier, Charalambos Vlachopoulos, Massimo Volpe, David A. Wood 
TL;DR: In this article, a randomized controlled trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly people was presented. But the authors did not discuss the effect of the combination therapy in patients living with systolic hypertension.
Abstract: ABCD : Appropriate Blood pressure Control in Diabetes ABI : ankle–brachial index ABPM : ambulatory blood pressure monitoring ACCESS : Acute Candesartan Cilexetil Therapy in Stroke Survival ACCOMPLISH : Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension ACCORD : Action to Control Cardiovascular Risk in Diabetes ACE : angiotensin-converting enzyme ACTIVE I : Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events ADVANCE : Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation AHEAD : Action for HEAlth in Diabetes ALLHAT : Antihypertensive and Lipid-Lowering Treatment to Prevent Heart ATtack ALTITUDE : ALiskiren Trial In Type 2 Diabetes Using Cardio-renal Endpoints ANTIPAF : ANgioTensin II Antagonist In Paroxysmal Atrial Fibrillation APOLLO : A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People ARB : angiotensin receptor blocker ARIC : Atherosclerosis Risk In Communities ARR : aldosterone renin ratio ASCOT : Anglo-Scandinavian Cardiac Outcomes Trial ASCOT-LLA : Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm ASTRAL : Angioplasty and STenting for Renal Artery Lesions A-V : atrioventricular BB : beta-blocker BMI : body mass index BP : blood pressure BSA : body surface area CA : calcium antagonist CABG : coronary artery bypass graft CAPPP : CAPtopril Prevention Project CAPRAF : CAndesartan in the Prevention of Relapsing Atrial Fibrillation CHD : coronary heart disease CHHIPS : Controlling Hypertension and Hypertension Immediately Post-Stroke CKD : chronic kidney disease CKD-EPI : Chronic Kidney Disease—EPIdemiology collaboration CONVINCE : Controlled ONset Verapamil INvestigation of CV Endpoints CT : computed tomography CV : cardiovascular CVD : cardiovascular disease D : diuretic DASH : Dietary Approaches to Stop Hypertension DBP : diastolic blood pressure DCCT : Diabetes Control and Complications Study DIRECT : DIabetic REtinopathy Candesartan Trials DM : diabetes mellitus DPP-4 : dipeptidyl peptidase 4 EAS : European Atherosclerosis Society EASD : European Association for the Study of Diabetes ECG : electrocardiogram EF : ejection fraction eGFR : estimated glomerular filtration rate ELSA : European Lacidipine Study on Atherosclerosis ESC : European Society of Cardiology ESH : European Society of Hypertension ESRD : end-stage renal disease EXPLOR : Amlodipine–Valsartan Combination Decreases Central Systolic Blood Pressure more Effectively than the Amlodipine–Atenolol Combination FDA : U.S. Food and Drug Administration FEVER : Felodipine EVent Reduction study GISSI-AF : Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Atrial Fibrillation HbA1c : glycated haemoglobin HBPM : home blood pressure monitoring HOPE : Heart Outcomes Prevention Evaluation HOT : Hypertension Optimal Treatment HRT : hormone replacement therapy HT : hypertension HYVET : HYpertension in the Very Elderly Trial IMT : intima-media thickness I-PRESERVE : Irbesartan in Heart Failure with Preserved Systolic Function INTERHEART : Effect of Potentially Modifiable Risk Factors associated with Myocardial Infarction in 52 Countries INVEST : INternational VErapamil SR/T Trandolapril ISH : Isolated systolic hypertension JNC : Joint National Committee JUPITER : Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin LAVi : left atrial volume index LIFE : Losartan Intervention For Endpoint Reduction in Hypertensives LV : left ventricle/left ventricular LVH : left ventricular hypertrophy LVM : left ventricular mass MDRD : Modification of Diet in Renal Disease MRFIT : Multiple Risk Factor Intervention Trial MRI : magnetic resonance imaging NORDIL : The Nordic Diltiazem Intervention study OC : oral contraceptive OD : organ damage ONTARGET : ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial PAD : peripheral artery disease PATHS : Prevention And Treatment of Hypertension Study PCI : percutaneous coronary intervention PPAR : peroxisome proliferator-activated receptor PREVEND : Prevention of REnal and Vascular ENdstage Disease PROFESS : Prevention Regimen for Effectively Avoiding Secondary Strokes PROGRESS : Perindopril Protection Against Recurrent Stroke Study PWV : pulse wave velocity QALY : Quality adjusted life years RAA : renin-angiotensin-aldosterone RAS : renin-angiotensin system RCT : randomized controlled trials RF : risk factor ROADMAP : Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention SBP : systolic blood pressure SCAST : Angiotensin-Receptor Blocker Candesartan for Treatment of Acute STroke SCOPE : Study on COgnition and Prognosis in the Elderly SCORE : Systematic COronary Risk Evaluation SHEP : Systolic Hypertension in the Elderly Program STOP : Swedish Trials in Old Patients with Hypertension STOP-2 : The second Swedish Trial in Old Patients with Hypertension SYSTCHINA : SYSTolic Hypertension in the Elderly: Chinese trial SYSTEUR : SYSTolic Hypertension in Europe TIA : transient ischaemic attack TOHP : Trials Of Hypertension Prevention TRANSCEND : Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease UKPDS : United Kingdom Prospective Diabetes Study VADT : Veterans' Affairs Diabetes Trial VALUE : Valsartan Antihypertensive Long-term Use Evaluation WHO : World Health Organization ### 1.1 Principles The 2013 guidelines on hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology …

14,173 citations


Journal ArticleDOI
TL;DR: The 2013 European Society of Hypertension/European Society of Cardiology (ESH/ESC) guidelines continue to adhere to some fundamental principles that inspired the 2003 and 2007 guidelines, namely to base recommendations on properly conducted studies identified from an ext
Abstract: 1. INTRODUCTION1.1 PrinciplesThe 2013 European Society of Hypertension/European Society of Cardiology (ESH/ESC) guidelines continue to adhere to some fundamental principles that inspired the 2003 and 2007 guidelines, namely to base recommendations on properly conducted studies identified from an ext

1,139 citations


Journal ArticleDOI
04 Sep 2013-JAMA
TL;DR: There was consistency of effects across predefined subgroups, and evidence existed of larger benefits in patients with lower adherence at baseline, which resulted in significantly improved medication adherence at the end of the study.
Abstract: Importance Most patients with cardiovascular disease (CVD) do not take recommended medications long-term. The use of fixed-dose combinations (FDCs) improves adherence in several clinical areas. Previous trials of cardiovascular FDCs have assessed short-term effects compared with placebo or no treatment. Objective To assess whether FDC delivery of aspirin, statin, and 2 blood pressure–lowering agents vs usual care improves long-term adherence to indicated therapy and 2 major CVD risk factors, systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-C). Design, Setting, and Participants The UMPIRE trial, a randomized, open-label, blinded-end-point trial among 2004 participants with established CVD or at risk of CVD enrolled July 2010–July 2011 in India and Europe. The trial follow-up concluded in July 2012. Interventions Participants were randomly assigned (1:1) to an FDC-based strategy (n=1002) containing either (1) 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and 50 mg atenolol or (2) 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and 12.5 mg hydrochlorothiazide or to usual care (n=1002). Main Outcomes and Measures Adherence to medication (defined as self-reported use of antiplatelet, statin, and ≥2 BP-lowering medications) and changes in SBP and LDL-C from baseline. Results At baseline, mean BP was 137/78 mm Hg, LDL-C was 91.5 mg/dL, and 1233 (61.5%) of 2004 participants reported use of antiplatelet, statin, and 2 or more BP-lowering medications. Median follow-up was 15 months (interquartile range, 12-18 months). The FDC group had improved adherence vs usual care (86% vs 65%; relative risk [RR] of being adherent, 1.33; 95% CI, 1.26-1.41; P P P P P = .01 for interaction), and LDL-C was reduced by 6.7 mg/dL (95% CI, 10.5-2.8 mg/dL; P = .11 for interaction). There were no significant differences in serious adverse events or cardiovascular events (50 [5%] in the FDC group and 35 [3.5%] in the usual care group; RR, 1.45; 95% CI, 0.94-2.24; P =.09) between the groups. Conclusions and Relevance Among patients with or at high risk of CVD, use of an FDC strategy for blood pressure, cholesterol, and platelet control vs usual care resulted in significantly improved medication adherence at 15 months and statistically significant but small improvements in SBP and LDL-C. Trial Registration clinicaltrials.gov Identifier:NCT01057537

361 citations


Journal ArticleDOI
TL;DR: This study establishes the favourable outcome of exercise-related out-of-hospital cardiac arrest (OHCA) and should have direct implications for public health programs to prevent exercised sudden death.
Abstract: Aims Although regular physical activity has beneficial cardiovascular effects, exercise can trigger an acute cardiac event. We aimed to determine the incidence and prognosis of exercise-related out-of-hospital cardiac arrest (OHCA) in the general population. Methods and results We prospectively collected all OHCAs in persons aged 10–90 years from January 2006 to January 2009 in the Dutch province North Holland. The relation between exercise during or within 1 h before OHCA and outcome was analysed using multivariable logistic regression, adjusted for age, gender, location, bystander witness, bystander cardiopulmonary resuscitation (CPR), automated external defibrillator (AED) use, initial rhythm, and Emergency Medical System response time. Of 2524 OHCAs, 143 (5.7%) were exercise related (7 ≤35 years, 93% men). Exercise-related OHCA incidence was 2.1 per 100 000 person-years overall and 0.3 per 100 000 person-years in those ≤35 years. Survival after exercise-related OHCA was distinctly better than after non-exercise related OHCA (46.2 vs. 17.2%) [unadjusted odds ratio (OR) 4.12; 95%CI 2.92–5.82; P < 0.001], even after adjustment for abovementioned variables (OR 2.63; 95%CI, 1.23–5.54; P = 0.01). In the 69 victims aged ≤35 years, exercise was not associated with better survival: 14.3 vs. 17.7% in non-exercise-related OHCA (OR 0.77; 95%CI 0.08–7.08; P = 0.82). Conclusion Exercise-related OHCA has a low incidence, particularly in the young. Cardiac arrests occurring during or shortly after exercise carry a markedly better prognosis than non-exercise-related arrests in persons >35 years. This study establishes the favourable outcome of exercise-related OHCA and should have direct implications for public health programs to prevent exercise-related sudden death.

126 citations


Journal ArticleDOI
TL;DR: The socioeconomic distribution of diet, smoking and alcohol consumption largely explained the inequalities in CHD and stroke in the Netherlands and need to be considered when developing policies to reduce socioeconomic inequalities in cardiovascular diseases.

106 citations


Journal ArticleDOI
TL;DR: Women with a history of early-onset preeclampsia have a high prevalence of several major cardiovascular disease risk factors, and cardiovascular Disease risk is expected to increase rapidly with increasing age.

84 citations


Journal ArticleDOI
01 Sep 2013-Stroke
TL;DR: The Post-stroke Depression Prediction Scale is a clinical prediction model for the early identification of stroke patients at increased risk for post-stroke depression and enables clinicians to estimate the degree of the depression risk for an individual patient within the first week after stroke.
Abstract: Background and Purpose—The timely detection of post-stroke depression is complicated by a decreasing length of hospital stay. Therefore, the Post-stroke Depression Prediction Scale was developed and validated. The Post-stroke Depression Prediction Scale is a clinical prediction model for the early identification of stroke patients at increased risk for post-stroke depression. Methods—The study included 410 consecutive stroke patients who were able to communicate adequately. Predictors were collected within the first week after stroke. Between 6 to 8 weeks after stroke, major depressive disorder was diagnosed using the Composite International Diagnostic Interview. Multivariable logistic regression models were fitted. A bootstrap-backward selection process resulted in a reduced model. Performance of the model was expressed by discrimination, calibration, and accuracy. Results—The model included a medical history of depression or other psychiatric disorders, hypertension, angina pectoris, and the Barthel Ind...

72 citations


Journal ArticleDOI
TL;DR: There is no improvement in risk prediction in individuals with diabetes when measurement of the mean common CIMT is added to the Framingham risk score, and this measurement is not recommended for improving individual cardiovascular risk stratification in Individuals with diabetes.
Abstract: Aims/hypothesis The aim of this work was to investigate whether measurement of the mean common carotid intima-media thickness (CIMT) improves cardiovascular risk prediction in individuals with diabetes.

60 citations


Journal ArticleDOI
TL;DR: The results of this study support supposed benefits from combination therapy, but the effect of fixed-dose combination pill on clinical outcome needs to be demonstrated in randomized clinical trials.

52 citations


Journal ArticleDOI
13 Feb 2013-PLOS ONE
TL;DR: Supporting frontline worker clinical decision making for maternal and newborn services is an important but neglected aspect of improved quality of care towards attainment of MDG 4 & 5.
Abstract: Objectives: To explore the “how” and “why” of care decision making by frontline providers of maternal and newborn services in the Greater Accra region of Ghana and determine appropriate interventions needed to support its quality and related maternal and neonatal outcomes. Methods: A cross sectional and descriptive mixed method study involving a desk review of maternal and newborn care protocols and guidelines availability focus group discussions and administration of a structured questionnaire and observational checklist to frontline providers of maternal and newborn care. Results: Tacit knowledge or ‘mind lines’ was an important primary approach to care decision making. When available protocols and guidelines were used as decision making aids especially when they were simple handy tools and in situations where providers were not sure what their next step in management had to be. Expert opinion and peer consultation were also used through face to face discussions phone calls text messages and occasional emails depending on the urgency and communication medium access. Health system constraints such as availability of staff essential medicines supplies and equipment; management issues (including leadership and interpersonal relations among staff) and barriers to referral were important influences in decision making. Frontline health providers welcomed the idea of interventions to support clinical decision making and made several proposals towards the development of such an intervention. They felt such an intervention ought to be multi-faceted to impact the multiple influences simultaneously. Effective interventions would also need to address immediate challenges as well as more long-term challenges influencing decision-making. Conclusion: Supporting frontline worker clinical decision making for maternal and newborn services is an important but neglected aspect of improved quality of care towards attainment of MDG 4 & 5. A multi-faceted intervention is probably the best way to make a difference given the multiple inter-related issues.

48 citations


Journal ArticleDOI
TL;DR: A high score on a pattern high in soft drinks, fries and snacks and low in fruit and vegetables was associated with higher risk of type 2 diabetes in overweight and obese subjects especially among physically less active individuals.
Abstract: Although overweight is an important determinant of diabetes risk, it remains unclear whether food choices can still influence the risk for type 2 diabetes in overweight persons. In this paper, we aim to clarify the role of dietary patterns in the development of type 2 diabetes in overweight and obese individuals. We studied 20,835 overweight and obese participants in the Dutch part of the European Investigation into Cancer and Nutrition (EPIC-NL) study. Dietary intake was measured using a validated food frequency questionnaire, and dietary patterns were generated using factor analysis. Incident type 2 diabetes was verified against medical records. Cox proportional hazards models were used to assess the association between the dietary patterns (factor scores categorized in quartiles) and incident type 2 diabetes. Scoring on Pattern 1, characterized by fish, wine, chicken, raw vegetables and fruit juices, was not associated with type 2 diabetes risk after confounder adjustment. A high score on Pattern 2, characterized by soft drinks, fries and snacks, was associated with higher risk of type 2 diabetes (HR Q4 vs. Q1 (95 % CI): 1.70 (1.31; 2.20), p trend ≤ 0.0001), particularly among less active individuals [less active: HR Q4 vs. Q1 (95 % CI): 2.14 (1.48; 3.09), p trend = 0.00004, more active: HR Q4 vs. Q1 (95 % CI): 1.35 (0.93; 1.97), p trend = 0.01; p interaction = 0.02]. A high score on a pattern high in soft drinks, fries and snacks and low in fruit and vegetables was associated with higher risk of type 2 diabetes in overweight and obese subjects especially among physically less active individuals.

Journal ArticleDOI
TL;DR: Excess early postnatal weight gain leads to vascular changes already in early childhood, characterized by thicker arterial walls, which supports the view that cardiovascular disease risk is associated with growth pattern early in life.
Abstract: Background: Although early life growth pattern is associated with cardiovascular disease later in life, it is unknown whether vascular changes associated with excess early weight gain already occur in early childhood. Methods: In the Wheezing-Illnesses-Study-Leidsche-Rijn (WHISTLER) birth cohort, weight and height from birth to 3 months of age were used to calculate Z-scores of individual weight and length gain rates. In the first 333 children who turned 5 years old, intima-media thickness, distensibility, and elastic modulus of the carotid artery were measured ultrasonographically. The association between weight gain rate for length gain rate (WLG), as a measure of excess weight gain, and vascular characteristics was assessed by generalized linear modeling. Interaction between birth size and WLG was tested. Results: Per 1 SD increase in WLG, carotid intima-media thickness was 5.1 μm (95% confidence interval, 1.0–9.2; P value = .01) higher (adjusted for age, gender, current height, and observer). The thin...


Journal ArticleDOI
TL;DR: Off-pump coronary artery bypass grafting patients had a similar or perhaps even better cognitive performance compared with percutaneous coronary intervention patients at 7.5 years follow-up.


Journal ArticleDOI
TL;DR: Observations may be used to promote high‐intensity activities before participating in sports for moderate and mild haemophilia A patients, to reduce bleeding risk.
Abstract: Increase of factor VIII activity (FVIII) after physical exercise has been reported in healthy subjects and small-scale studies in patients with coagulopathies. The aim was to study whether moderate and mild haemophilia A patients are able to increase their endogenous FVIII activity levels by physical activity. We studied changes in FVIII activity levels after high-intensity exercise in 15 haemophilia A patients, 20-39 years, eight with moderate, seven with mild haemophilia. Patients cycled until volitional exhaustion, blood samples were drawn before and 10 min after the exercise test. FVIII activity increased 2.5 times (range 1.8-7.0 times), for both severities. Absolute increases were markedly different: median 7 IU dL(-1) (range 3-9 IU dL(-1) ) in patients with moderate, compared to 15 IU dL(-1) (range 6-62 IU dL(-1) ) in mild haemophilia patients. VWF and VWFpp increased independently of severity; median 50% (range 8-123%) and median 165% (range 48-350%), respectively, reflecting acute release of VWF. These observations may be used to promote high-intensity activities before participating in sports for moderate and mild haemophilia A patients, to reduce bleeding risk. Further studies are warranted to fully appreciate the clinical significance of exercise on different levels of intensity in patients with mild and moderate haemophilia A.

Journal ArticleDOI
TL;DR: Comparative performance of the HAMD(17) and various subscales strongly depends on type of antidepressant, but it will be beneficial to pro-actively include subscales as additional endpoints to successfully establish treatment effects of new antidepressants.

Journal ArticleDOI
TL;DR: A CIMT trial positioned before an M&M trial may considerably improve the efficiency of the evaluation of new drug therapies on atherosclerosis and cardiovascular disease risk and should be seen as a decision tool to support or refute the start of a large-scale M &M trial on drugs targeting atheros sclerosis.
Abstract: Background—Trials with carotid intima-media thickness (CIMT) as primary end point may improve the efficiency of the evaluation of new therapies targeting atherosclerosis considerably, and the results of CIMT trials may be used as a decision tool to help in the choice to launch or not to launch a large-scale morbidity and mortality (MM6:20-25.)

Journal ArticleDOI
TL;DR: Planning of prolonged breastfeeding has little to do with maternal age, education, or number of pregnancies, however, mothers who work, who had previously breastfed for a short period, and who are not well informed about breastfeeding tend to plan shorter breastfeeding.
Abstract: Objectives: This study investigated factors involved in breastfeeding planning of pregnant Asian women. Subjects and Methods: A cross-sectional study was conducted on 207 pregnant women visiting the Budi Kemuliaan Hospital, Jakarta, Indonesia, between June and August 2011. The planned breastfeeding duration and determinants were sought using a standardized self-reported questionnaire. Results: Most subjects had low income (84.1%) and education (79.7%). Women who had been informed about breastfeeding had a higher likelihood to plan longer (≥6 months) breastfeeding (odds ratio [OR] 1.97; 95% confidence interval [CI] 1.04–3.75; p=0.04), whereas women who had breastfed previous children over a shorter period had a lower likelihood (OR 0.26; 95% CI 0.11–0.59; p=0.001). Age, low education level, first pregnancy, and low income had no association with breastfeeding plans. Working mothers who had to return to work before 6 months and worked for >8 hours/day were less likely to plan longer breastfeeding (...

Journal ArticleDOI
23 Dec 2013-PLOS ONE
TL;DR: Investigating whether acute undernutrition in childhood or young adulthood increases the risk of later hospitalization for obstructive airways disease, chronic obstructive pulmonary disease (COPD), or asthma found that it does.
Abstract: Background Undernutrition during critical periods of growth and development may permanently affect lung physiology and function.

Journal ArticleDOI
TL;DR: A high proportion of patients with established cardiovascular diseases already uses a combination of pharmacological agents and introduction of a polypill in high-risk patients might be feasible to reduce prescription gaps and increase adherence to indicated therapy.
Abstract: Aim:Based on guidelines, patients with established cardiovascular disease are likely to already receive a combination of aspirin, a statin, and blood pressure (BP)-lowering agents. Combining these pharmacological agents into a cardiovascular polypill could be considered in these patients to reduce prescription gaps and non-adherence. We aimed to assess the prevalence of the combined use of aspirin, statin, and BP-lowering agents in patients with established cardiovascular diseases or type 2 diabetes mellitus (DM2) in the period 1996–2009.Methods:In total, 5702 patients with coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral arterial occlusive disease (PAOD), abdominal aortic aneurysm (AAA) or, DM2 were included in the period 1996–2009.Results:The overall use of combination therapy with aspirin, statin, and ≥1 BP-lowering agent increased substantially from 9% in 1996 to 66% in 2009 and ≥2 BP-lowering agents increased from 1% to 47%. In 2009, combination therapy with ≥1 BP-lowering age...

Journal ArticleDOI
TL;DR: Evaluation of the potential impact of CRP measurement in cardiovascular risk management will require studies designed to quantify the effect of additional CRP assessment on medical decision-making, patient outcomes, and cost-effectiveness.
Abstract: Adding C-reactive protein (CRP) level to conventional cardiovascular risk models has been suggested to improve risk prediction for cardiovascular events. However, evaluation of the potential impact of CRP measurement in cardiovascular risk management will require studies designed to quantify the effect of additional CRP assessment on medical decision-making, patient outcomes, and cost-effectiveness.


01 Jan 2013
TL;DR: In this paper, the effect of coronary artery bypass graft (CABG) surgery without use of cardiopulmonary bypass (off-pump procedures) on cognitive function was compared with CABG surgery with and without (on-Pump) CARB procedures.
Abstract: Context Coronary artery bypass graft (CABG) surgery is associated with a decline in cognitive function, which has largely been attributed to the use of cardiopulmonary bypass (on-pump procedures). Cardiac stabilizers facilitate CABG surgery without use of cardiopulmonary bypass (off-pump procedures) and should reduce the cognitive decline associated with on-pump procedures. Objective To compare the effect of CABG surgery with (on-pump) and without (off- pump) cardiopulmonary bypass on cognitive outcome. Design and Setting Randomized controlled trial conducted in the Netherlands of CABG surgery patients enrolled from March 1998 through August 2000, with 3- and 12-month follow-up. Participants and Intervention Patients scheduled for their first CABG surgery (mean age, 61 years; n=281) were randomly assigned to off-pump surgery (n=142) or on- pump surgery (n=139). Main Outcome Measures Cognitive outcome at 3 and 12 months, which was de- termined by psychologists (blinded for randomization) who administered 10 neuro- psychological tests before and after surgery. Quality of life, stroke rate, and all-cause mortality at 3 and 12 months were secondary outcome measures. Results Cognitive outcome could be determined at 3 months in 248 patients. Cog- nitive decline occurred in 21% in the off-pump group and 29% in the on-pump group (relative risk (RR), 0.65; 95% confidence interval (CI), 0.36-1.16; P=.15). The overall standardized change score (ie, improvement of cognitive performance) was 0.19 in the off-pump vs 0.13 in the on-pump group (P=.03). At 12 months, cognitive decline occurred in 30.8% in the off-pump group and 33.6% in the on-pump group (RR, 0.88; 95% CI, 0.52-1.49; P=.69). The overall standardized change score was 0.19 in the off-pump vs 0.12 in the on-pump group (P=.09). No statistically significant differ- ences were observed between the on-pump and off-pump groups in quality of life, stroke rate, or all-cause mortality at 3 and 12 months.

Journal ArticleDOI
TL;DR: This study compared sample size requirements for fixed parallel group, group sequential, and adaptive selection designs with equal overall power and control of the family‐wise type I error rate to find the most efficient two‐stage clinical trial designs.
Abstract: Two-stage clinical trial designs may be efficient in pharmacogenetics research when there is some but inconclusive evidence of effect modification by a genomic marker. Two-stage designs allow to stop early for efficacy or futility and can offer the additional opportunity to enrich the study population to a specific patient subgroup after an interim analysis. This study compared sample size requirements for fixed parallel group, group sequential, and adaptive selection designs with equal overall power and control of the family-wise type I error rate. The designs were evaluated across scenarios that defined the effect sizes in the marker positive and marker negative subgroups and the prevalence of marker positive patients in the overall study population. Effect sizes were chosen to reflect realistic planning scenarios, where at least some effect is present in the marker negative subgroup. In addition, scenarios were considered in which the assumed ‘true’ subgroup effects (i.e., the postulated effects) differed from those hypothesized at the planning stage. As expected, both two-stage designs generally required fewer patients than a fixed parallel group design, and the advantage increased as the difference between subgroups increased. The adaptive selection design added little further reduction in sample size, as compared with the group sequential design, when the postulated effect sizes were equal to those hypothesized at the planning stage. However, when the postulated effects deviated strongly in favor of enrichment, the comparative advantage of the adaptive selection design increased, which precisely reflects the adaptive nature of the design. Copyright © 2013 John Wiley & Sons, Ltd.

Journal ArticleDOI
19 Jun 2013-PLOS ONE
TL;DR: Cardioselective β-blockers, but also calcium channel blockers and statins may reduce mortality, possibly as a result of cardiovascular protective properties.
Abstract: Background Recent observational studies suggest that β-blockers may improve long-term prognosis in patients with chronic obstructive pulmonary disease (COPD). We assessed whether β-blocker use improves all-cause mortality in patients with episodes of acute bronchitis.

Journal ArticleDOI
TL;DR: Adaptive marketing authorization approaches may, in some instances, replace traditional binary regulatory decisions on drug approval with progressive reduction of uncertainty about the benefit–risk profile of a drug through iterative evidence gathering and evaluation.
Abstract: Adaptive marketing authorization approaches may, in some instances, replace traditional binary regulatory decisions on drug approval with progressive reduction of uncertainty about the benefit–risk profile of a drug through iterative evidence gathering and evaluation. How should the nature of such evidence be determined?


Journal ArticleDOI
TL;DR: In the heterogeneous population of PPI users for GORD in primary care, no clinically useful, easily obtainable combination of patient characteristics was able to adequately predict eligibility for therapy reduction.
Abstract: Background: Proton pump inhibitor (PPI) therapy reduction after long-term daily treatment for gastro-oesophageal reflux disease (GORD) symptomatology proves difficult in primary care practice. We aimed to identify patient and/or disease characteristics in long-term daily PPI users predicting a successful switch to less than daily therapy. Methods: GORD patients who after long-term continuous treatment were able to use less than a daily PPI dose in a placebo-controlled trial were compared to patients who persisted in a daily dosage with respect to general, lifestyle and quality of life characteristics (SF-36 Health Survey) as well as psychological factors (Symptom Check List 90), symptom control on daily PPI (Quality of Life in Reflux and Dyspepsia questionnaire), disease and medication history. Results: Adequate symptom control on daily PPI use and female gender were determinants of successful therapy reduction. A prediction rule including the Quality of Life in Reflux and Dyspepsia vitality dimension and gender correctly predicted 64% of patients to both less than daily and sustained daily treatment (area under the receiver operating characteristic curve = 0.69). Conclusion: In the heterogeneous population of PPI users for GORD in primary care, no clinically useful, easily obtainable combination of patient characteristics was able to adequately predict eligibility for therapy reduction. Switching to less than daily therapy remains a process of trial and error in which motivation of the patient and support by the physician will be important factors for success.