Ambulatory blood pressure in normotensive and hypertensive subjects: Results from an international database

Objective: To delineate more precisely an operational threshold for making clinical decisions based on ambulatory blood pressure (ABP) measurement by studying the ABP in subjects who were diagnosed as either normotensive or hypertensive by conventional blood pressure (CBP) measurement. Subjects: Twenty-four research groups recruited 7069 subjects. Of these, 4577 were normotensive (CBP 160 mmHg) and 1310 had diastolic hypertension (diastolic CBP >95 mmHg). Combined systolic and diastolic hypertension was present in 861 subjects. Hypertension had been diagnosed from the mean of two to nine (median two) CBP measurements obtained at one to three (median two) visits. Results: The 95th centiles of the ABP distributions in the normotensive subjects were (systolic and diastolic, respectively) 133 and 82 mmHg for 24-h ABP, 140 and 88 mmHg for daytime ABP and 125 and 76 mmHg for night-time ABP, respectively. Of the subjects with systolic hypertension, 24% had 24-h systolic ABP <133 mmHg. Similarly, 30% of those with diastolic hypertension had 24-h diastolic ABP <82 mmHg. The probability that hypertensive subjects had 24-h ABP below these thresholds tended to increase with age and was two- to fourfold greater if the CBP of the subject had been measured at only one visit and if fewer than three CBP measurements had been averaged for establishing the diagnosis of hypertension. By contrast, for each 10-mmHg increment in systolic CBP, this probability decreased by 54% for 24-h systolic ABP and by 26% for 24-h diastolic ABP, and for each 5-mmHg increment in diastolic CBP it decreased by 6 and 9%, respectively. In comparison with 24-h ABP, the overlap in the daytime and night-time ABP between normotensive and hypertensive subjects was of similar magnitude and was influenced by the same factors. Conclusions: The ABP distributions of the normotensive subjects included in the present international database were not materially different from those in previous reports in the literature. One-fifth to more than one-third of hypertensive subjects had an ABP which was below the 95th centile of the ABP of normotensive subjects, but this proportion decreased if the hypertensive subjects had shown a higher CBP upon repeated measurement. The prognostic implications of elevated CBP in the presence of normal ABP remain to be determined. © Current Science Ltd.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Short report: Ambulatory blood pressure in normotensive compared with hypertensive subjects

Objective: To delineate more precisely an operational threshold for making clinical decisions based on ambulatory blood pressure (ABP) measurement by studying the ABP in subjects who were diagnosed as either normotensive or hypertensive by conventional blood pressure (CBP) measurement. Subjects: Twenty-four research groups recruited 7069 subjects. Of these, 4577 were normotensive (CBP ≤140/90 mmHg), 719 were borderline hypertensive (systolic CBP 141-159 mmHg or diastolic CBP 91-94 mmHg) and 1773 were definitely hypertensive. Of the subjects in the last of these categories, 1324 had systolic hypertension (systolic CBP ≥160 mmHg) and 1310 had diastolic hypertension (diastolic CBP ≥95 mmHg). Hypertension had been diagnosed from the mean of two to nine (median two) CBP measurements obtained at one to three (median two) visits. Results: The 95th centiles of the 24-h ABP distributions in the normotensive subjects were (systolic and diastolic, respectively) 133 and 82 mmHg. Of the subjects with systolic hypertension, 24% had 24-h systolic ABP ≤133 mmHg. Similarly, 30% of those with diastolic hypertension had 24-h diastolic ABP <82 mmHg. The probability that hypertensive subjects had 24-h ABP below these thresholds tended to increase with age and was two- to fourfold greater if the CBP of the subject had been measured at only one visit and if fewer than three CBP measurements had been averaged for establishing the diagnosis of hypertension. By contrast, for each 10-mmHg increment in systolic CBP, this probability decreased by 54% for 24-h systolic ABP and by 26% for 24-h diastolic ABP, and for each 5-mmHg increment in diastolic CBP it decreased by 6 and 9%, respectively. Conclusions: The ABP distributions of the normotensive subjects included in the present international database were not materially different from those in previous reports in the literature. One-fifth to more than one-third of hypertensive subjects had an ABP which was below the 95th centile of the ABP of normotensive subjects, but this proportion decreased if the hypertensive subjects had shown a higher CBP upon repeated measurement. The prognostic implications of elevated CBP in the presence of normal ABP remain to be determined. © Current Science Ltd.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

The ambulatory blood pressure in normotensive and hypertensive subjects: results from an international database

Objective: To delineate more precisely an operational threshold for making clinical decisions based on ambulatory blood pressure (ABP) measurement by studying the ABP in subjects who were diagnosed as either normotensive or hypertensive by conventional blood pressure (CBP) measurement. Subjects: Twenty-four research groups recruited 7069 subjects. Of these, 4577 were normotensive (systolic CBP ≤ 140 mmHg and diastolic CBP ≤ 90 mmHg) and 1773 were hypertensive (systolic CBP ≥ 160 mmHg and/or diastolic CBP ≥ 90 mmHg). Of the latter, 1324 had systolic and 1310 had diastolic hypertension. Results: Ninety-five percent of the normotensive subjects had a 24-h ABP below (systolic and diastolic, respectively) 133 and 82 mmHg. Of the patients with systolic hypertension, 24% had a 24-h systolic ABP of < 133 mmHg. Similarly, 30% of those with diastolic hypertension had a 24-h diastolic ABP of < 82 mmHg. The probability that hypertensive patients had a 24-h ABP below these thresholds was higher in women than in men, increased with age and was 2- to 4-fold greater if the CBP of the patient had been measured at only one visit and if fewer than 3 CBP measurements had been averaged to establish the diagnosis of hypertension. By contrast, for each 10-mmHg increment in systolic CBP, this probability decreased by 54% for the 24-h systolic ABP and by 25% for the 24-h diastolic ABP, and for each 5 mmHg increment in diastolic CBP it increased by 6 and 9%, respectively. Conclusion: The ABP distributions of the normotensive subjects included in the present international database were not materially different from those in previous reports in the literature. One-fifth to more than one-third of the hypertensive patients had an ABP which was below the 95th centile of the ABP in normotensive subjects, but this proportion decreased if the hypertensive patients had shown a higher CBP upon repeated measurement. The prognostic implications of elevated CBP in the presence of normal ABP remain to be determined. © 1995.SCOPUS: re.jinfo:eu-repo/semantics/publishe

Cardiorenal End Points in a Trial of Aliskiren for Type 2 Diabetes

BACKGROUND: This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 diabetes and chronic kidney disease, cardiovascular disease, or both. METHODS: In a double-blind fashion, we randomly assigned 8561 patients to aliskiren (300 mg daily) or placebo as an adjunct to an angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker. The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation; nonfatal myocardial infarction; nonfatal stroke; unplanned hospitalization for heart failure; end-stage renal disease, death attributable to kidney failure, or the need for renal-replacement therapy with no dialysis or transplantation available or initiated; or doubling of the baseline serum creatinine level. RESULTS: The trial was stopped prematurely after the second interim efficacy analysis. After a median follow-up of 32.9 months, the primary end point had occurred in 783 patients (18.3%) assigned to aliskiren as compared with 732 (17.1%) assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98 to 1.20; P=0.12). Effects on secondary renal end points were similar. Systolic and diastolic blood pressures were lower with aliskiren (between-group differences, 1.3 and 0.6 mm Hg, respectively) and the mean reduction in the urinary albumin-to-creatinine ratio was greater (between-group difference, 14 percentage points; 95% CI, 11 to 17). The proportion of patients with hyperkalemia (serum potassium level, ≥6 mmol per liter) was significantly higher in the aliskiren group than in the placebo group (11.2% vs. 7.2%), as was the proportion with reported hypotension (12.1% vs. 8.3%) (P<0.001 for both comparisons). CONCLUSIONS: The addition of aliskiren to standard therapy with renin-angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful. (Funded by Novartis; ALTITUDE ClinicalTrials.gov number, NCT00549757.)

Cardiorenal End Points in a Trial of Aliskiren for Type 2 Diabetes

BACKGROUND This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 diabetes and chronic kidney disease, cardiovascular disease, or both. METHODS In a double-blind fashion, we randomly assigned 8561 patients to aliskiren (300 mg daily) or placebo as an adjunct to an angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker. The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation; nonfatal myocardial infarction; nonfatal stroke; unplanned hospitalization for heart failure; end-stage renal disease, death attributable to kidney failure, or the need for renal-replacement therapy with no dialysis or transplantation available or initiated; or doubling of the baseline serum creatinine level. RESULTS The trial was stopped prematurely after the second interim efficacy analysis. After a median follow-up of 32.9 months, the primary end point had occurred in 783 patients (18.3%) assigned to aliskiren as compared with 732 (17.1%) assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98 to 1.20; P = 0.12). Effects on secondary renal end points were similar. Systolic and diastolic blood pressures were lower with aliskiren (between-group differences, 1.3 and 0.6 mm Hg, respectively) and the mean reduction in the urinary albumin-to-creatinine ratio was greater (between-group difference, 14 percentage points; 95% CI, 11 to 17). The proportion of patients with hyperkalemia (serum potassium level, = 6 mmol per liter) was significantly higher in the aliskiren group than in the placebo group (11.2% vs. 7.2%), as was the proportion with reported hypotension (12.1% vs. 8.3%) (P <0.001 for both comparisons). CONCLUSIONS The addition of aliskiren to standard therapy with renin-angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful. (Funded by Novartis; ALTITUDE ClinicalTrials.gov number, NCT00549757.