L.M. Ruilope

European Society of Hypertension practice guidelines for home blood pressure monitoring.

Self-monitoring of blood pressure by patients at home (home blood pressure monitoring (HBPM)) is being increasingly used in many countries and is well accepted by hypertensive patients. Current hypertension guidelines have endorsed the use of HBPM in clinical practice as a useful adjunct to conventional office measurements. Recently, a detailed consensus document on HBPM was published by the European Society of Hypertension Working Group on Blood Pressure Monitoring. However, in daily practice, briefer documents summarizing the essential recommendations are needed. It is also accepted that the successful implementation of clinical guidelines in routine patient care is dependent on their acceptance by involvement of practising physicians. The present document, which provides concise and updated guidelines on the use of HBPM for practising physicians, was therefore prepared by including the comments and feedback of general practitioners.

Study on COgnition and Prognosis in the Elderly (SCOPE)

The Study on COgnition and Prognosis in the Elderly (SCOPE) is a multicentre, prospective, randomized, double-blind, parallel-group study designed to compare the effects of candesartan cilexetil and placebo in elderly patients with mild hypertension. The primary objective of the study is to assess the effect of candesartan cilexetil on major cardiovascular events. The secondary objectives of the study are to assess the effect of candesartan cilexetil on cognitive function and on total mortality, cardiovascular mortality, myocardial infarction, stroke, renal function, hospitalization, quality of life and health economics. Male and female patients aged between 70 and 89 years, with a sitting systolic blood pressure (SBP) of 160-179 mmHg and/or diastolic blood pressure (DBP) of 90-99 mmHg, and a Mini-Mental State Examination (MMSE) score of 24 or above, are eligible for the study. The overall target study population is 4000 patients, at least 1000 of whom are also to be assessed for quality of life and health economics data. After an open run-in period lasting 1-3 months, during which patients are assessed for eligibility and those who are already on antihypertensive therapy at enrolment are switched to hydrochlorothiazide 12.5 mg o.d., patients are randomized to receive either candesartan cilexetil 8 mg once daily (o.d.) or matching placebo o.d. At subsequent study visits, if SBP remains >160 mmHg, or has decreased by <10 mmHg since the randomization visit, or DBP is >85 mmHg, study treatment is doubled to candesartan cilexetil 16 mg o.d. or two placebo tablets o.d. Recruitment was completed in January 1999. At that time 4964 patients had been randomized. All randomized patients will be followed for an additional 2 years. If the event rate is lower than anticipated, the follow-up will be prolonged.

Principal results from the International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT)

Background We compared the effects of a long-acting calcium-channel blocker with a thiazide-amiloride combination on cardiovascular mortality and morbidity in patients with additional cardiovascular risk factors. The primary objective was to demonstrate 25% superiority of nifedipine GITS. A secondary objective was to establish non-inferiority compared with co-amilozide. Methods A prospective, randomized, double-masked trial was carried out in Europe and Israel, involving 6321 patients of 55–80 years of age with hypertension (blood pressure \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \({\geq}\ {150}/{95}\) \end{document} mmHg or systolic ≥ 160 mmHg). Patients were also required to have at least one out of ten additional cardiovascular risk factors, such as diabetes or hypercholesterolaemia. Patients were assigned randomly to initial treatment with either nifedipine GITS (N), 30 mg, or co-amilozide (C) (hydrochlorothiazide, 25 mg, and amiloride, 2·5 mg), so that similar numbers of patients with each risk factor could be compared between the two drugs. Dose titration was principally by dose doubling, and addition of atenolol, 25–50 mg, or enalapril, 5–10 mg. Patients were followed for a mean period of 3 years. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, heart failure or stroke, Secondary outcome variables included death from any cause. Superiority analysis was of time to first event, by intention-to-treat. Non-inferiority analysis required the difference (Δ) in event-rate, and the 95% CI around Δ, to be <2% in patients remaining on randomized treatment. Findings Mean blood pressure was decreased similarly in both treatment groups, from \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \({173}/{99}\ ({14}/{8})\) \end{document} mmHg to \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \({138}/{82}\) \end{document} (\batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \({12}/{7}\) \end{document}) mmHg; 72% of patients were controlled on monotherapy. There were more withdrawals from the N group than from the C group, because of peripheral oedema in 8% and because of more serious adverse events (880 vs 776, \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \(P\ =\ 0{\cdot}02\) \end{document}) in the C group. A primary end-point occurred in 200 (6·3%) of 3157 patients in the N group (18·2 events per 1000 patient-years) and in 182 (5·8%) of 3164 patients in the C group (16·5 events per 1000 patient-years; relative risk 1·1 [95% CI 0·90-1·3], \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \(P=0{\cdot}35\) \end{document}). Adding secondary variables, there were end-points in 383 (12·1%) of the N group (35·1 per 1000 patient-years), and 397 (12·7%) of the C group (36·5 per 1000 patient-years; relative risk 0·97 [95% CI 0·84-1·11], \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \(P=0{\cdot}32\) \end{document}). Deaths were predominantly non-vascular (N, 176 vs C, 172; \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \(P=0{\cdot}81\) \end{document}). Interpretation The INSIGHT treatment regimens achieve optimal blood pressure control in most high-risk patients. This appears to be more important than choice of individual drugs in determining outcome in hypertension. Against a previous ‘gold standard’, nifedipine GITS was found to be effective in preventing cardiovascular or cerebrovascular complications, and may be regarded as appropriate first-line therapy in hypertension.

Estimating the glomerular filtration rate in the Spanish working population: chronic kidney disease prevalence and its association with risk factors.

Objective: This study aims to investigate the influence of estimated glomerular filtration rate (eGFR) with two equations (and by one or two separate measurements), on the prevalence of chronic kidney disease (CKD) and its association with blood pressure, and cardiovascular and metabolic risk factors. Methods: Between January 2010 and October 2011, the Ibermutuamur CArdiovascular RIsk Assessment project included 128 588 workers (77.2% men, mean age 39.3 years, range 16–75), who underwent two consecutive yearly medical check-ups and had information for eGFR according to the MDRD-IDMS and CKD-EPI equations (serum creatinine was measured by a isotope-dilution mass spectrometry traceable method in a single central laboratory). CKD was defined by an eGFR less than 60 ml/min per 1.73 m2. Subclinical (occult) renal disease was defined as an eGFR less than 60 ml/min per 1.73 m2 in patients with serum creatinine below 1.3 mg/dl and below 1.2 mg/dl in men and women, respectively. Results: In this working population, prevalence of CKD was very low, but two to six times lower when two separate eGFRs below 60 ml/min per 1.73 m2 were used. The prevalence of CKD was significantly lower with the CKD-EPI compared to the MDRD-IDMS equation. The same applies to occult CKD. In male workers, occult CKD was practically nonexistent. Multivariate analyses show that blood pressure, total serum cholesterol, and serum glucose (positively), and high-density lipoprotein and low-density lipoprotein (negatively) were associated with CKD, with both equations. Another metabolic factor (waist circumference) was only associated (positively) with CKD defined by the CKD-EPI equation, which appears to be associated with most components of the metabolic syndrome. Conclusions: The CKD-EPI formula, calculated on the basis of two reported blood samples, may provide the most specific definition of CKD.

APPLICATION OF AN EXPERT SYSTEM TO IMPROVE CARDIOVASCULAR RISK IN THE WORKPLACE

Objective: The aim of this study was to design, develop and test an expert system to help professionals in clinical decision-making as providing an assessment of the health of workers at very high CVR. Design and method: lt was designed and developed an operational web-expert system in ASP Ianguage, which gathers information on risk factors and returns an output with recommendations for management of risk factors based on the 2012 European Guidelines on Cardiovascular Disease Prevention criteria. In the case of needing an intervention or modification of drug treatment, the expert system helps to plan them. The CVR was stratified by the European SCORE system for low-risk countries. A test was conducted with a pilot program providing workers with very high CVR (SCORE >  = 10). The adherence to the Mediterranean diet was assessed by a 14-item questionnaire and physical activity by the International Physical Activity Questionnaire (IPAQ). Results: This pilot study included 148 patients (mean age: 64.5 ± 8.3 years). All the participants were men, 73.6% and 55.2% had hypertension and dyslipidaemia, but only 50.7% and 34.3% of them were receiving anti-hypertensive treatment and lipid-lowering therapy at baseline, respectively. The participants were mostly manual workers (63.5%). 91.8% of them knew they had cardiovascular risk factors. 73.0% were smokers, of which 34.3% expressed their intention to give up smoking in the coming months. The mean BMI was 28.5 kg/m2 and the mean waist circumference was 100.5 cm. After 1-year follow-up, the percentage of patients who met the therapeutic objective for total cholesterol levels (<175 mg/dl) significantly increased (p = 0.03). The percentage of subjects with moderate-to-high adherence to the Mediterranean diet increased form 77.0% to 88.7% (p < 0.001). The percentage of subjects with sufficient-to-high physical activity also increased but not significantly (p = 0.547). Conclusions: Our preliminary results suggest that there is a high potential for improvement in Iifestyle and CVR control among patients at very high cardiovascular risk. The availability of an expert system could facilitate decision-making when providing medical advice. An expert system could be a value-added service in order to standardize health care and to promote the best clinical practice

PREDICTIVE PERFORMANCE AND CLINICAL UTILITY OF A NEW PREDICTIVE MODEL OF CARDIOVASCULAR RISK FOR YOUNG AND MIDDLE-AGED WORKING POPULATION

Objective: Identifying people at high cardiovascular risk is challenging, especially at young age. The main objective of the IberScore study was to derive a mathematical model for risk prediction of fatal and non-fatal cardiovascular events from a relatively young and healthy working population. Design and method: A predictive function for fatal and non-fatal CV events was derived from a cohort of 774,404 workers (70.4% of the target population), free of CV disease at entry, who were followed during 10 years. Workers ages ranged 16–65 years (mean 35.7, SD 10.7). 71.7% were men, which represented the real proportion in the target population. Cardiovascular ageing was estimated (independently by genders) based on the effects of well-known cardiovascular risk factors as: smoking; cholesterol; blood glucose; HDL; systolic blood pressure (SBP); obesity; history of dyslipidemia, diabetes and hypertension. Results: Along the 10-year follow-up we found 3,762 first cardiovascular events (6‰) in derivation cohort. Most of them (80.3%) were non-fatal ischemic events. We derived a logistic flexible parametric model to predict 10-year cardiovascular risk. 82% of those who suffered a cardiovascular event during the follow-up span had been previously classified as “high risk” or “very high risk” using our model, whereas only 12% of them were classified in the same groups using SCORE. The latter also showed a weak discrimination power for risk stratification while IberScore clearly distinguished the four risk categories. IberScore was well calibrated and showed outstanding predictive performance and clinical utility even at young and middle-age workers. Cut-off points were fixed taking on account their discriminatory capacity and the balance between costs and benefits of the treatments that will be prescribed based on them. Conclusions: IberScore worked much better to estimate cardiovascular risk in a relatively young and healthy Spanish working population when compared to other models. Cardiovascular aging, as the result of the effects of risk factors, should be at the core of CV risk estimation. Cut-off points should be set considering the benefit we seek with the treatments we have in mind.

[OP.LB01.06] EFFECTIVENESS OF A COMPREHENSIVE HEALTH PROMOTION STRATEGY IN WORKERS WITH HIGH CARDIOVASCULAR RISK.

Objective: To assess the impact of the implementation of a comprehensive health promotion strategy in controlling cardiovascular risk factors (CVRF), among workers at high risk of cardiovascular disease (CVD). Design and method: CVRF were assessed in an occupational cohort of 8,975 workers with high CVR (SCORE > = 5%) from the ICARIA Study. CVRF and CVR were assessed again after a 1-year follow-up (365 ± 90 days). All workers were informed about their CVR, were given recommendations regarding CVRF control and changes in their lifestyle while they participated in a Comprehensive Health Promotion Strategy provided by their Mutual Insurance Company. Joint European Societies’ guidelines on cardiovascular disease prevention were followed in order to evaluate CVRF control. McNemars test for paired data was used to compare differences in CVRF between baseline and follow-up. Results: 89.3% of participants were men (mean age 51.1 ± 32.3 years-old). The percentage of patients with prior CVD was 8.2%. After a 1-year follow-up, 46.4% of workers at high CVR and no prior CVD decreased their CVR to less than 5%. Improvements in CVRF control were observed: increasing percentage of non-smokers (+3.9%; p < 0.001), of workers with blood pressure < 140/90 mmHg (+13.0%; p < 0.001), total-cholesterol < 190 mg/dl (+5.9%; p < 0.001), LDL-cholesterol <100 mg/dl [high CVR] / <70 mg/dl [very high CVR] (+3.9%; p < 0.001), and triglycerides <150 mg/dl (+2.6%; p < 0.001). In contrast, a decrease in the percentage of workers with HDL-cholesterol >40 mg/dl [men] / >45 mg/dl [women] (-2.1%; p < 0.001) was observed. No significant differences were detected in the percentage of workers with glycaemia <126 mg/dl (p = 0.537), body mass index <25 Kg/m2 (p = 0.967), or waist circumference <102 cm [men] / <88 cm [women] (p = 0.232). Conclusions: A comprehensive health promotion strategy at the workplace is effective in improving control of CVRF in workers at high risk of cardiovascular disease. This achievement could complement the work done by general practitioners and nurses in their consultation visits. Further efforts are necessary to improve weight reduction.

Early Blood Pressure Control By The Nifedipine Gits/telmisartan Combination: Ht.1.01

Background: Guidelines recommend combination treatment to be used as initial step in hypertensive patients at high cardiovascular(CV) risk because in this condition the earlier blood pressure (BP) control (and CV protection) achievable by two vs. one antihypertensive drug administration may be desirable. Goals: To determine whether initial treatment with telmisartan plus nifedipine GITS provides an earlier office and ambulatory BP control compared to initial treatment with the combination components in monotherapy and to verify whether initiating treatment with a combination allows a better long-term BP control, compared to use of combination treatment after initial monotherapy. Methods: 405 subjects with office systolic BP at inclusion ≥ 135 mmHg and with a high CV risk because of diabetes, metabolic syndrome and/or organ damage were randomized to initial administration of telmisartan plus nifedipine GITS (80 mg and 20 mg daily, respectively), to telmisartan alone or nifedipine GITS alone in a 2:1:1 ratio. Treatment was continued for 24 weeks shifting the monotherapy groups to combination treatment after 8 weeks. Office and ambulatory blood pressure were measured respectively after 2, 8, 16 and 24 and after 8, 16 and 24 weeks of treatment. Results: The main results for the per-protocol population (N = 327) are shown in the Table.Table. Systolic (S) and diastolic (D) office and ambulatory BP (least square means±SE; mmHg) in the three study groups: Telmisartan 80 mg (N = 74), Nifedipine GITS 20 mg (N = 89); their combination (N = 164). All subjects were on combination therapy starting from week 8. No significant differences were found between groups at baseline. Conclusion: Combination and monotherapy treatments all lowered systolic and diastolic BP substantially, the 24 h data showing that the effect was long lasting. Compared to the monotherapy, initiating treatment with the calcium antagonist/angiotensin receptor blocker combination allowed BP reduction and control to be achieved earlier, this being the case both for office and for ambulatory BP. Longer term BP control, on the other hand, was similar irrespective of the initial (combination or monotherapy) treatment strategy. Figure 1. No caption available.

D032 Study population and treatment titration in the International Nifedipine GITS Study Intervention as a goal in hypertension treatment (INSIGHT)

OBJECTIVES To ascertain the baseline characteristics of the high-risk hypertensive patients entering the International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT). To determine the success of single and combination therapy in achieving target blood pressures in such a population. DESIGN INSIGHT is a double-blind, prospective outcome trial comparing the efficacy of the calcium channel blocker, nifedipine GITS, and the thiazide, co-amilozide, in preventing myocardial infarction and stroke. We recruited 2996 men and 3454 women, aged 55-80 years, with blood pressure during placebo run-in >150/95 mmHg or isolated systolic blood pressure >160 mmHg from nine countries. Treatment allocation to nifedipine GITS 30 mg daily or co-amilozide (hydrochlorothiazide 25 mg/amiloride 5 mg) once daily was performed by minimization rather than randomization to balance additional risk factors. This was followed by four optional increases in treatment: dose-doubling of the primary drug, addition of atenolol 25/50 mg or enalapril 5/10 mg, and then any other hypotensive drug excluding calcium blockers or diuretics. Target blood pressure was 140/90 mmHg or a fall > or = 20/10 mmHg. RESULTS Blood pressure at randomization was 172+/-15 / 99+/-9 mmHg. Thirteen per cent of the patients were previously untreated. The proportions of each additional risk factors were: smoking > 10/day, 29%; cholesterol > 6.43 mmol/l, 52%; family history of premature myocardial infarction or stroke, 21%; diabetes mellitus 20%; left ventricular hypertrophy, 10%; previous myocardial infarction, other presentations of coronary heart disease, and peripheral vascular disease, each 6%; proteinuria, 3%. Fifty-five per cent of patients had one additional risk factor, whereas 33%, 9% and 3% had two, three or more additional risk factors, respectively. The blood pressure (and falls in blood pressure) at the end of titration and at 1 year after minimization was 139+/-12 / 82+/-7 mmHg (33+/-15 / 17+/-9) in the 5226 patients still on randomized treatment The numbers requiring the four treatment increments were, respectively, 1591, 780, 597 and 294, meaning that almost 70% of patients on randomized treatment in INSIGHT are receiving only the primary drug. At one year, 69% of patients had a blood pressure < or = 140/90 mmHg. CONCLUSION INSIGHT is one of the first double-blind comparisons of active antihypertensive treatments, requiring high-risk patients to achieve sufficient power. Despite this requirement, it is possible to achieve good blood pressure control in most patients without the addition of multiple additional treatments that may dilute any differences between the primary agents.