Roundtable II: clinical implications of anticoagulation mediator replacement in sepsis and acute respiratory distress syndrome.
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Anticoagulants↗
Biomedical subjects
L Thijs
Publications and source records attributed to L Thijs.
Modern approaches to blood pressure measurement.
BACKGROUND: Blood pressure (BP) is usually measured by conventional sphygmomanometry. Although apparently simple, this procedure is fraught with many potential sources of error. This review focuses on two alternative techniques of BP measurement: ambulatory monitoring and self measurement. REVIEW: BP values obtained by ambulatory monitoring or self measurement are characterised by high reproducibility, are not subject to digit preference or observer bias, and minimise the transient rise of the blood pressure in response to the surroundings of the clinic or the presence of the observer, the so called white coat effect. For ambulatory monitoring, the upper limits of systolic/diastolic normotension in adults include 130/80 mm Hg for the 24 hour BP and 135/85 and 120/70 mm Hg for the daytime BP and night time BP, respectively. For the the self measured BP these thresholds include 135/85 mm Hg. Automated BP measurement is most useful to identify patients with white coat hypertension. Whether or not white coat hypertension predisposes to sustained hypertension remains debated. However, outcome is better correlated with the ambulatory BP than with the conventional BP. In patients with white coat hypertension, antihypertensive drugs lower the BP in the clinic, but not the ambulatory BP, and also do not improve prognosis. Ambulatory BP monitoring is also better than conventional BP measurement in assessing the effects of treatment. Ambulatory BP monitoring is necessary to diagnose nocturnal hypertension and is especially indicated in patients with borderline hypertension, elderly patients, pregnant women, patients with treatment resistant hypertension, and also in patients with symptoms suggestive of hypotension. CONCLUSIONS: The newer techniques of BP measurement are now well established in clinical research, for diagnosis in clinical practice, and will increasingly make their appearance in occupational and environmental medicine.
Blood Pressure↗
Development of diagnostic thresholds for automated self-measurement of blood pressure in adults. First International Consensus Conference on Blood Pressure Self-Measurement.
Blood pressure is usually measured by conventional sphygmomanometry, a procedure fraught with many potential sources of error. Automated techniques of measurement, such as ambulatory monitoring and self-measurement, reduce the limitations of conventional sphygmomanometry. However, the diagnostic thresholds applicable for conventional sphygmomanometry cannot be extrapolated to automated measurements. During the past 10 years criteria for normality have gradually been developed for ambulatory blood pressure monitoring. First, the distributions of the ambulatory blood pressure in normotensive subjects and in untreated hypertensive patients who had initially been classified on the basis of their conventional blood pressure were studied. Second, epidemiological studies were performed to investigate the distribution of the conventional and ambulatory blood pressures in the population at large. Third, authors of several studies have now validated the preliminary thresholds for ambulatory monitoring against left ventricular hypertrophy, other signs of target-organ damage and the incidence of cardiovascular complications. Finally, authors of clinical trials investigated whether it is beneficial to patients and cost-effective to diagnose and treat hypertension on the basis of ambulatory monitoring rather than under the sole guidance of conventional sphygmomanometry. For systolic/diastolic measurements, the upper limits of normotension include 130/80, 135/85 and 120/70 mmHg for the 24 h, daytime and night-time blood pressures, respectively. Whereas for ambulatory monitoring a large body of evidence currently supports the proposed diagnostic thresholds, for the self-recorded blood pressure, to a large extent, this evidence must still be collected. In pursuing this goal, the methods applied for ambulatory monitoring may serve as a template. On the basis of a meta-analysis of summary statistics of published articles and a meta-analysis of data from individual subjects, 135/85 mmHg is likely to be the upper limit of normality for the self-measured blood pressure. Obviously, this threshold is preliminary and must be further validated in prognostic studies. However, the present proposal could guide clinicians who wish to use self-measurement to refine the diagnosis and the management of hypertension based on conventional sphygmomanometry.
Adult↗
Predicting cardiovascular risk using conventional vs ambulatory blood pressure in older patients with systolic hypertension. Systolic Hypertension in Europe Trial Investigators.
CONTEXT: The clinical use of ambulatory blood pressure (BP) monitoring requires further validation in prospective outcome studies. OBJECTIVE: To compare the prognostic significance of conventional and ambulatory BP measurement in older patients with isolated systolic hypertension. DESIGN: Substudy to the double-blind placebo-controlled Systolic Hypertension in Europe (Syst-Eur) Trial, started in October 1988 with follow up to February 1999. The conventional BP at randomization was the mean of 6 readings (2 measurements in the sitting position at 3 visits 1 month apart). The baseline ambulatory BP was recorded with a noninvasive intermittent technique. SETTING: Family practices and outpatient clinics at primary and secondary referral hospitals. PARTICIPANTS: A total of 808 older (aged > or =60 years) patients whose untreated BP level on conventional measurement at baseline was 160 to 219 mm Hg systolic and less than 95 mm Hg diastolic. INTERVENTIONS: For the overall study, patients were randomized to nitrendipine (n = 415; 10-40 mg/d) with the possible addition of enalapril (5-20 mg/d) and/or hydrochlorothiazide (12.5-25.0 mg/d) or to matching placebos (n = 393). MAIN OUTCOME MEASURES: Total and cardiovascular mortality, all cardiovascular end points, fatal and nonfatal stroke, and fatal and nonfatal cardiac end points. RESULTS: After adjusting for sex, age, previous cardiovascular complications, smoking, and residence in western Europe, a 10-mm Hg higher conventional systolic BP at randomization was not associated with a worse prognosis, whereas in the placebo group, a 10-mm Hg higher 24-hour BP was associated with an increased relative hazard rate (HR) of most outcome measures (eg, HR, 1.23 [95% confidence interval [CI], 1.00-1.50] for total mortality and 1.34 [95% CI, 1.03-1.75] for cardiovascular mortality). In the placebo group, the nighttime systolic BP (12 AM-6 AM) more accurately predicted end points than the daytime level. Cardiovascular risk increased with a higher night-to-day ratio of systolic BP independent of the 24-hour BP (10% increase in night-to-day ratio; HR for all cardiovascular end points, 1.41; 95% CI, 1.03-1.94). At randomization, the cardiovascular risk conferred by a conventional systolic BP of 160 mm Hg was similar to that associated with a 24-hour daytime or nighttime systolic BP of 142 mm Hg (95% CI, 128-156 mm Hg), 145 mm Hg (95% CI, 126-164 mm Hg) or 132 mm Hg (95% CI, 120-145 mm Hg), respectively. In the active treatment group, systolic BP at randomization did not significantly predict cardiovascular risk, regardless of the technique of BP measurement. CONCLUSIONS: In untreated older patients with isolated systolic hypertension, ambulatory systolic BP was a significant predictor of cardiovascular risk over and above conventional BP.
Aged↗
Environmental exposure to cadmium, forearm bone density, and risk of fractures: prospective population study. Public Health and Environmental Exposure to Cadmium (PheeCad) Study Group.
BACKGROUND: Chronic low-level exposure to cadmium may promote calcium loss via urinary excretion. We undertook a prospective population study to investigate whether environmental exposure to cadmium lowers bone density and increases risk of fractures. METHODS: We measured urinary cadmium excretion, a biomarker of lifetime exposure, in people from ten districts of Belgium, of which six districts bordered on three zinc smelters. We also measured cadmium in soil and in vegetables from the districts, and collected data on incidence of fractures and height loss. Bone density was measured at the forearm just above the wrist by single photon absorptiometry, and calculated as the mean of six proximal and four distal scans. FINDINGS: Mean cadmium excretion at baseline was 8.7 nmol daily. Across the ten districts, mean cadmium concentration in soil ranged from 0.8 to 14.7 mg/kg, and from 0.1 to 4.0 mg/kg dry weight in vegetables. Median follow-up was 6.6 years. Mean forearm bone density in proximal and distal scans was 0.54 g/cm2 and 0.43 g/cm2 in men, and 0.44 g/cm2 and 0.34 g/cm2 in women. In postmenopausal women, a twofold increase in urinary cadmium correlated with 0.01 g/cm2 decrease in bone density (p<0.02). The relative risks associated with doubled urinary cadmium were 1.73 (95% CI 1.16-2.57; p=0.007) for fractures in women and 1.60 (0.94-2.72, p=0.08) for height loss in men. Cadmium excretion in districts near smelters was 22.8% higher (p=0.001) than in other districts, with fracture rates of 16.0 and 10.3 cases per 1000 person-years, respectively, and a population-attributable risk of 35.0%. INTERPRETATION: Even at a low degree of environmental exposure, cadmium may promote skeletal demineralisation, which may lead to increased bone fragility and raised risk of fractures.
Absorptiometry, Photon↗
Effects of calcium-channel blockade in older patients with diabetes and systolic hypertension. Systolic Hypertension in Europe Trial Investigators.
BACKGROUND: Recent reports suggest that calcium-channel blockers may be harmful in patients with diabetes and hypertension. We previously reported that antihypertensive treatment with the calcium-channel blocker nitrendipine reduced the risk of cardiovascular events. In this post hoc analysis, we compared the outcome of treatment with nitrendipine in diabetic and nondiabetic patients. METHODS: After stratification according to center, sex, and presence or absence of previous cardiovascular complications, 4695 patients (age, > or =60 years) with systolic blood pressure of 160 to 219 mm Hg and diastolic pressure below 95 mm Hg were randomly assigned to receive active treatment or placebo. Active treatment consisted of nitrendipine (10 to 40 mg per day) with the possible addition or substitution of enalapril (5 to 20 mg per day) or hydrochlorothiazide (12.5 to 25 mg per day) or both, titrated to reduce the systolic blood pressure by at least 20 mm Hg and to less than 150 mm Hg. In the control group, matching placebo tablets were administered similarly. RESULTS: At randomization, 492 patients (10.5 percent) had diabetes. After a median follow-up of two years, the systolic and diastolic blood pressures in the placebo and active-treatment groups differed by 8.6 and 3.9 mm Hg, respectively, among the diabetic patients. Among the 4203 patients without diabetes, systolic and diastolic pressures differed by 10.3 and 4.5 mm Hg, respectively, in the two groups. After adjustment for possible confounders, active treatment was found to have reduced overall mortality by 55 percent (from 45.1 deaths per 1000 patients to 26.4 deaths per 1000 patients), mortality from cardiovascular disease by 76 percent, all cardiovascular events combined by 69 percent, fatal and nonfatal strokes by 73 percent, and all cardiac events combined by 63 percent in the group of patients with diabetes. Among the nondiabetic patients, active treatment decreased all cardiovascular events combined by 26 percent and fatal and nonfatal strokes by 38 percent. In the group of patients receiving active treatment, reductions in overall mortality, mortality from cardiovascular disease, and all cardiovascular events were significantly larger among the diabetic patients than among the nondiabetic patients (P=0.04, P=0.02, and P=0.01, respectively). CONCLUSIONS: Nitrendipine-based antihypertensive therapy is particularly beneficial in older patients with diabetes and isolated systolic hypertension. Thus, our findings do not support the hypothesis that the use of long-acting calcium-channel blockers may be harmful in diabetic patients.
Aged↗
The use of maximum SOFA score to quantify organ dysfunction/failure in intensive care. Results of a prospective, multicentre study. Working Group on Sepsis related Problems of the ESICM.
OBJECTIVE: To evaluate the performance of total maximum sequential organ failure assessment (SOFA) score and a derived measure, delta SOFA (total maximum SOFA score minus admission total SOFA) as a descriptor of multiple organ dysfunction/failure in intensive care. DESIGN: Prospective, multicentre and multinational study. SETTING: Forty intensive care units (ICUs) from Australia, Europe, North and South America. PATIENTS: Data on 1,449 patients, evaluated at admission and then consecutively every 24 h until ICU discharge (11,417 records) during May 1995. Excluded from data collection were all patients with a length of stay in the ICU less than 2 days following uncomplicated scheduled surgery. MAIN OUTCOME MEASURE: Survival status at ICU discharge. INTERVENTIONS: The collection of raw data necessary for the computation of a SOFA score on admission and then every 24 h, and basic demographic and clinical statistics. MEASUREMENTS AND MAIN RESULTS: Mean total maximum SOFA score presented a very good correlation to ICU outcome, with mortality rates ranging from 3.2% in patients without organ failure to 91.3% in patients with failure of all the six organs analysed. A maximum score was reached 1.1 +/- 0.2 days after admission for all the organ systems analysed. The total maximum SOFA score presented an area under the ROC curve of 0.847 (SE 0.012), which was significantly higher than any of its individual components. The cardiovascular score (odds ratio 1.68) was associated with the highest relative contribution to outcome. No independent contribution could be demonstrated for the hepatic score. No significant interactions were found. Principal components analysis demonstrated the existence of a two-factor structure that became clearer when analysis was limited to the presence or absence of organ failure (SOFA score > or = 3 points) during the ICU stay. The first factor comprises respiratory, cardiovascular and neurological systems and the second coagulation, hepatic and renal systems. Delta SOFA also presented a good correlation to outcome. The area under the receiver operating characteristic (ROC) curve was 0.742 (SE 0.017) for delta SOFA, lower than the total maximum SOFA score or admission total SOFA score. The impact of delta SOFA on prognosis remained significant after correction for admission total SOFA. CONCLUSIONS: The results show that total maximum SOFA score and delta SOFA can be used to quantify the degree of dysfunction/failure already present on ICU admission, the degree of dysfunction/failure that appears during the ICU stay and the cumulative insult suffered by the patient. These properties make it a good instrument to be used in the evaluation of organ dysfunction/failure.
Adolescent↗
Systolic Hypertension in Europe (Syst-Eur) trial phase 2: objectives, protocol, and initial progress. Systolic Hypertension in Europe Investigators.
The Systolic Hypertension in Europe (Syst-Eur) trial proved that blood pressure (BP) lowering therapy starting with nitrendipine reduces the risk of cardiovascular complications in older (> or = 60 years) patients with isolated systolic hypertension (systolic BP > or = 160 mm Hg and diastolic BP < 95 mm Hg). After the completion of the Syst-Eur trial on 14 February 1997, 3506 consenting patients (93.0% of those eligible) were enrolled in phase 2 of the Syst-Eur trial. This open follow-up study aims to confirm the safety of long-term antihypertensive therapy based on a dihydropyridine. To lower the sitting systolic BP below 150 mm Hg (target BP), the first-line agent nitrendipine (10-40 mg/day) may be associated with enalapril (5-20 mg/day), hydrochlorothiazide (12.5-25 mg/day), both add-on study drugs, or if required any other antihypertensive agent. On 1 November 1998, 3248 patients were still being followed, 86 patients had proceeded to non-supervised follow-up, and 43 had died. The median follow-up in Syst-Eur 2 was 14.3 months. At the last available visit, systolic/diastolic BP in the patients formerly randomised to placebo (n = 1682) or active treatment (n = 1824), had decreased by 13.2/5.2 mm Hg and by 4.6/1.6 mm Hg, respectively, so that the between-group BP difference was 1.7 mm Hg systolic (95% Ci: 0.8 to 2.6 mm Hg; P < 0.001) and 0.9 mm Hg diastolic (95% Cl: 0.4 to 1.5 mm mm Hg; P < 0.001). At the beginning of Syst-Eur 2, the goal BP was reached by 25.4% and 50.6% of the former placebo and active-treatment groups; at the last visit these proportions were 55.9% and 63.1%, respectively. At that moment, 45.9% of the patients were on monotherapy with nitrendipine, 29.3% took nitrendipine in combination with other study drugs. Until the end of 2001, BP control of the Syst-Eur 2 patients will be further improved. Cardiovascular complications and adverse events, such as cancer or gastro-intestinal bleeding, will be monitored and validated by blinded experts.
Aged↗
Overview of the outcome trials in older patients with isolated systolic hypertension.
AIMS: Isolated systolic hypertension affects over 8 to 15% of all subjects older than 60 years. In the elderly, systolic hypertension is the major modifiable cardiovascular risk factor. Three placebo-controlled outcome trials on antihypertensive drug treatment of this disorder have been published. The aim of this article was to shortly review each of these three trials and to present the pooled estimates of benefit of antihypertensive drug treatment in isolated systolic hypertension in the elderly. METHODS AND RESULTS: The Systolic Hypertension in the Elderly Program (SHEP) in the United States, the Systolic Hypertension in Europe (Syst-Eur) trial and the Systolic Hypertension in China (Syst-China) trial published their main findings in 1991, 1997 and 1998, respectively. The outcome results of these trials were pooled by calculating the common odds ratio for active versus placebo treatment for five major end-points. Zelen's exact test for homogeneity did not reach statistical significance for any of the end-points considered. Thus, the hypothesis of a common underlying treatment effect across the three trials was not rejected. Overall, active treatment compared with placebo, reduced all-cause mortality by 17%, cardiovascular mortality by 25%, all cardiovascular end-points by 32%, total stroke by 37% and myocardial infarction including sudden death by 25%. CONCLUSIONS: The pooled results of the outcome trials in older patients with isolated systolic hypertension prove that antihypertensive drug treatment must be prescribed, if on repeated measurement systolic blood pressure is 160 mm Hg or higher.
Aged↗
Symptoms reported by elderly patients with isolated systolic hypertension: baseline data from the SYST-EUR trial. Systolic Hypertension in Europe.
OBJECTIVES: To determine the symptomatic well-being of elderly persons with isolated systolic hypertension. DESIGN AND SETTING: Well-being determined during the placebo run-in period prior to entry to the Systolic Hypertension in Europe (SYST-EUR) trial. SUBJECTS: 641 People, 60 years or older with an average sitting blood pressure of 173/86 mm Hg. OUTCOME MEASURES: 33 Symptomatic complaints determined by a standard interview. RESULTS: The 437 women complained of 25% of the symptoms and the 204 men 21% (P<0.001). A markedly higher prevalence was observed in women compared with men for: pain in the joints of the hands (35% of women complained of this against 22% of men); 'racing heart' (33% against 17%); dry eyes (16% against 6%); blurring of vision (35% against 23%); cramps in the legs (43% against 31%); and a sore throat (15% against 7%). Nocturia was the most frequent complaint (68% in both sexes). Eight symptoms increased with age and one (rash) tended to decline. With increasing systolic pressure women also reported more headaches, unsteadiness, blurring of vision, irregular heart beat and 'racing heart' but, of these, only headaches increased with diastolic pressure. These observations were made after adjusting for age, blood sugar and body mass index (BMI) and were not observed in men. Higher blood sugars were associated with mouth ulcers, 'racing heart', blurring of vision and cramps in the legs. A higher BMI was associated with six symptoms, and a lower age of leaving education with eight. In men, alcohol consumption was related to 'racing heart', and smoking to wheezing and having a dry cough. CONCLUSIONS: A high level of complaint was associated with female gender, increasing age, blood sugar and BMI and a low age of leaving education.
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Task force VI: Self-monitoring of the blood pressure.
BACKGROUND: Self-monitoring of the blood pressure by patients at home or in other nonclinical settings has become increasingly common in recent years. This phenomenon has been fueled in part by the increase in availability of automatic sphygmomanometers, which are now both affordable and easy for patients to use. BENEFITS OF SELF-MONITORING: Self-monitoring of the blood pressure can be an important adjunct to management of hypertension. The technique allows patients to participate more in their care. Self-measured values of blood pressure are more likely to be representative of the average daily blood pressure than is a clinic measurement and may be better related to hypertensive involvement of target organs and cardiovascular morbidity than is the clinic blood pressure. Finally, the self-monitoring of blood pressure has the potential to reduce the costs of hypertension-related care. LIMITATIONS OF SELF-MONITORING: There are several issues that prevent the more widespread use of self-monitoring of the blood pressure in clinical practice. First, devices marketed for use by patients have advanced technically during the 1990s, but many have not been subjected to rigorous clinical validation for precision and reliability (e.g. in terms of Association for the Advancement of Medical Instrumentation and British Hypertension Society guidelines). It is recommended that devices for measuring blood pressure used by patients at home be subjected to the same validation processes as those that are applied to ambulatory recordings. Second, although the upper limits of normal for self-monitored blood pressure of a general population can be defined statistically (it is approximately 135/85 mmHg), it is not yet possible to determine the normal self-monitored blood pressure because these values must be linked to classical clinical cardiovascular endpoints or outcomes. Third, the relationships among self-monitored, clinic, and ambulatory blood pressures are defined for some populations but their behaviors according to age, sex, ethnicity, and treatment status require further study. Fourth, several different schedules for self-monitoring of the blood pressure by patients have been used in clinical research and practice. It will be necessary to determine the optimal schedule and number of recordings required when patients perform self-monitoring of the blood pressure. Fifth, self-monitoring of the blood pressure in clinical trials of antihypertensive therapies is certainly feasible but has typically not been included in their design, either by investigators or by the pharmaceutical sponsors. Sixth, there have been data suggesting that self-monitoring of the blood pressure reduces the comprehensive costs associated with hypertension care on an annual basis. However, since most work on the economic impact of self-monitoring of the blood pressure has been performed in managed-care environments in the USA, it is not known whether this reduction in health-care costs would be applicable to other types of practice environments on a worldwide basis. CONCLUSIONS: Self-monitoring of the blood pressure is at present useful as an adjunct measurement for the management of hypertensive patients and might provide benefits in clinical trials of antihypertensive therapy. Nevertheless, the available data on self-monitoring of the blood pressure are inadequate as grounds for clinicians to make primary diagnostic or therapeutic decisions and should not override the blood pressure obtained by clinical measurement or via ambulatory monitoring.
Blood Pressure↗
Update on the systolic hypertension in Europe (Syst-Eur) trial. The Syst-Eur Investigators.
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Antihypertensive Agents↗
The international database of self-recorded blood pressures in normotensive and untreated hypertensive subjects.
OBJECTIVES: To pool data from individual subjects in an attempt to determine an operational threshold for making clinical decisions based on the self-recorded blood pressure (SRBP) and to examine how many hypertensive subjects, diagnosed by conventional blood pressure (CBP) measurement, would have a self-recorded blood pressure within the normotensive range if the proposed thresholds were applied. DATA SOURCES: Thirteen research groups studied 4668 untreated subjects. RESULTS: In total 2401 subjects were normotensive, 494 were borderline hypertensive and 1773 were definitely hypertensive. Hypertension had been diagnosed from the mean of 1-6 (median 3) CBP measurements obtained during 1-3 (median 1) visits. The reference values for SRBP measurements determined from the 95th percentiles of the distributions for normotensive subjects were 137 mmHg systolic and 85 mmHg diastolic. Of the subjects with systolic hypertension, 16% had systolic SRBP </= 137 mmHg. Similarly, 25% of those with diastolic hypertension had diastolic SRBP </= 85 mmHg. The probability that hypertensive subjects had SRBP below these thresholds was 34% (diastolic) to 62% (systolic) greater for women than it was for men, was 2-3 times greater if fewer than three CBP measurements had been averaged for establishing the diagnosis of hypertension, and increased by 50% (diastolic) to 126% (systolic) when SRBP had been measured on more than 3 days. In contrast, for each 10 mmHg increment in systolic CBP, this probability decreased by 35% for systolic SRBP and by 11% for diastolic SRBP; for each 5 mmHg increment in diastolic CBP it decreased by 36% for diastolic SRBP. In addition, for systolic blood pressure, the probability decreased by 31% for each 10-year increment in age. CONCLUSIONS: Until the relationship between SRBP and the incidence of cardiovascular morbidity and mortality has been clarified further by prospective studies, a mean self-recorded blood pressure above 137 mmHg systolic or 85 mmHg diastolic may be considered hypertensive. Among the hypertensive patients 16-31% had SRBP below these thresholds, but this proportion decreased if the hypertensive subjects had higher CBP.
Adolescent↗
Diagnostic thresholds for the clinical use of ambulatory blood pressure monitoring.
The technique of noninvasive ambulatory blood pressure monitoring is now well established as an instrument in clinical research and as a diagnostic tool in clinical practice. Diagnostic thresholds for ambulatory monitoring were derived by averaging the 95th percentiles of the ambulatory blood pressure measurements in the normotensive subjects enrolled in various large-scale studies. Subjects normotensive on conventional sphygmomanometry, in the absence of other risk factors, have a low cardiovascular risk profile in comparison with their hypertensive counterparts. The evidence from prospective outcome studies also supports the proposed thresholds. More outcome studies are still ongoing. However, their results are unlikely to change the proposed thresholds, which are in line with the recommendations of the JNC VI (the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) and those of many other national expert committees.
Blood Pressure↗
Treatment of isolated systolic hypertension in the elderly: further evidence from the systolic hypertension in Europe (Syst-Eur) trial.
The Systolic Hypertension in Europe (Syst-Eur) study investigated whether antihypertensive treatment could decrease the risk of cardiovascular complications in elderly patients with isolated systolic hypertension. Patients > or = 60 years were randomly assigned to treatment with the dihydropyridine calcium antagonist nitrendipine (n = 2,398), with the addition of enalapril and hydrochlorothiazide if needed, or to matching placebo (n = 2,297). In the intent-to-treat analysis, the between-group difference in blood pressure was 10.1/4.5 mm Hg (p < 0.001). Active treatment decreased the total incidence of stroke (the primary endpoint) by 42% (p = 0.003), of all cardiac endpoints by 26% (p = 0.03), and of all cardiovascular endpoints combined by 31% (p < 0.001). Cardiovascular mortality was somewhat lower with active treatment (-27%, p = 0.07); all-cause mortality was not significantly different (-14%; p = 0.22). For total (p = 0.009) and cardiovascular (p = 0.09) mortality, the benefit of antihypertensive treatment weakened with advancing age and for total mortality it decreased with lower systolic blood pressure at entry (p = 0.05). The benefits of active treatment were not independently related to gender or to the presence of cardiovascular complications at entry. Antihypertensive therapy was at least as effective in patients with diabetes as in those without diabetes at entry. Further analyses suggested benefit in patients who were taking nitrendipine as monotherapy. Per-protocol analysis largely confirmed the intent-to-treat results. Active treatment decreased all strokes by 44% (p = 0.004), all cardiac endpoints by 26% (p = 0.05), and all cardiovascular endpoints by 32% (p < 0.001). Total mortality was decreased by 26% (p = 0.05), but the similar reduction in cardiovascular mortality did not reach significance in this analysis. It is concluded that stepwise antihypertensive drug treatment starting with nitrendipine improves prognosis in elderly patients with isolated systolic hypertension.
Adult↗
Prevention of dementia in randomised double-blind placebo-controlled Systolic Hypertension in Europe (Syst-Eur) trial.
BACKGROUND: Systolic hypertension increases the risk of dementia in elderly people. The vascular dementia project, set up in the framework of the double-blind placebo-controlled Systolic Hypertension in Europe (Syst-Eur) trial, investigated whether antihypertensive drug treatment could reduce the incidence of dementia. METHODS: Eligible patients had no dementia, were at least 60 years old, and had a blood pressure when seated of 160-219 mm Hg systolic and below 95 mm Hg diastolic. Active treatment consisted of nitrendipine (10-40 mg/day) with the possible addition of enalapril (5-20 mg/day), hydrochlorothiazide (12.5-25 mg/day), or both drugs, titrated or combined to reduce the systolic blood pressure by at least 20 mm Hg to reach a value below 150 mm Hg. Cognitive function was assessed by the mini mental state examination (MMSE). If the MMSE score was 23 or less, diagnostic tests for dementia were done (DSM-III-R criteria). The cause of dementia was established by the modified ischaemic score with brain imaging or the Hachinski score. FINDINGS: Median follow-up by intention to treat was 2.0 years. Compared with placebo (n=1180), active treatment (n=1238) reduced the incidence of dementia by 50% from 7.7 to 3.8 cases per 1000 patient-years (21 vs 11 patients, p=0.05). The median MMSE score at randomisation was 29 in both treatment groups. At the last available assessment, systolic and diastolic blood pressure were, respectively, 8.3 mm Hg and 3.8 mm Hg lower (p<0.001) in the active-treatment group, but on average the MMSE scores did not change in either group. In the control patients, however, the MMSE decreased (p=0.04) with decreasing diastolic blood pressure, whereas in the active-treatment group MMSE scores improved slightly (p=0.01) with greater reduction in diastolic blood pressure (p=0.002 for between-group difference). INTERPRETATION: In elderly people with isolated systolic hypertension, antihypertensive treatment was associated with a lower incidence of dementia. If 1000 hypertensive patients were treated with antihypertensive drugs for 5 years 19 cases of dementia might be prevented.
Aged↗
Reference values for self-recorded blood pressure: a meta-analysis of summary data.
BACKGROUND: The widespread clinical use of self-recorded blood pressure measurement is limited by the lack of generally accepted reference values. The purpose of this study was therefore to perform a meta-analysis of summary data in an attempt to determine an operational threshold for self-recorded blood pressures. STUDIES AND METHODS: Seventeen studies, including a total of 5422 subjects, were reviewed. Eight of these 17 studies included both normotensive and untreated hypertensive subjects, while the other 9 reports included normotensive subjects only. Within each study an operational cutoff point between normotension and hypertension was derived by means of the mean+2 SDs and the 95th percentiles of the self-recorded blood pressure in normotensive subjects. These 2 methods were contrasted with 2 other techniques that have been applied in the literature to calculate (1) the self-recorded pressures equivalent to a conventional pressure of 140 mm Hg systolic and 90 mm Hg diastolic by means of regression analysis and (2) the self-recorded blood pressures at the percentiles corresponding to a conventional pressure of 140/90 mm Hg. The latter 2 methods were applied in untreated subjects not selected on the basis of their blood pressure. RESULTS: With weighting for the number of subjects included in the various studies, the self-recorded blood pressure averaged 115/71 mm Hg in normotensive persons and 119/74 mm Hg in untreated subjects not selected on the basis of their blood pressure. The reference values for self-recorded blood pressures determined by the mean+2 SDs (137/89 mm Hg) or the 95th percentile (135/86 mm Hg) of the distribution in normotensive subjects were concordant within 2/3 mm Hg, whereas the cutoff points derived with the regression and percentile methods were considerably lower, ie, 125/79 and 129/84 mm Hg, respectively. CONCLUSIONS: Until the relationship between self-recorded pressure and the incidence of cardiovascular morbidity and mortality is further clarified by prospective studies, a mean self-recorded blood pressure above 135 mm Hg systolic or 85 mm Hg diastolic may be considered hypertensive.
Blood Pressure Determination↗
A clinician's guide to the use of quality terminology. Working Group on Quality Improvement of the European Society of Intensive Care Medicine.
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Communication Barriers↗