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Ambulatory monitoring uncorrected for placebo overestimates long-term antihypertensive action. Systolic Hypertension in Europe (SYST-EUR) Trial Investigators

This study compares blood pressure (BP) changes during active antihypertensive treatment and placebo as assessed by conventional and ambulatory BP measurement. Older patients (> or = 60 years, n=337) with isolated systolic hypertension by conventional sphygmomanometry at the clinic were randomized t... Full description

Journal Title: Hypertension (Dallas Tex. 1979), 1996-03, Vol.27 (3 Pt 1), p.414-420
Main Author: Staessen, J A
Other Authors: Thijs, L , Bieniaszewski, L , O'Brien, E T , Palatini, P , Davidson, C , Dobovisek, J , Jääskivi, M , Laks, T , Lehtonen, A , Vanhanen, H , Webster, J , Fagard, R
Format: Electronic Article Electronic Article
Language: English
Subjects:
Aged
Antihypertensive Agents - therapeutic use
Blood Pressure
Double-Blind Method
Enalapril - therapeutic use
Female
Humans
Hydrochlorothiazide - therapeutic use
Hypertension - diagnosis
Hypertension - drug therapy
Male
Middle Aged
Monitoring, Ambulatory
Nitrendipine - therapeutic use
Placebos
Publisher: United States
ID: ISSN: 0194-911X
Link: https://www.ncbi.nlm.nih.gov/pubmed/8698447
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recordid: cdi_proquest_miscellaneous_77999402
title: Ambulatory monitoring uncorrected for placebo overestimates long-term antihypertensive action. Systolic Hypertension in Europe (SYST-EUR) Trial Investigators
format: Article
creator:
  • Staessen, J A
  • Thijs, L
  • Bieniaszewski, L
  • O'Brien, E T
  • Palatini, P
  • Davidson, C
  • Dobovisek, J
  • Jääskivi, M
  • Laks, T
  • Lehtonen, A
  • Vanhanen, H
  • Webster, J
  • Fagard, R
subjects:
  • Aged
  • Antihypertensive Agents - therapeutic use
  • Blood Pressure
  • Double-Blind Method
  • Enalapril - therapeutic use
  • Female
  • Humans
  • Hydrochlorothiazide - therapeutic use
  • Hypertension - diagnosis
  • Hypertension - drug therapy
  • Male
  • Middle Aged
  • Monitoring, Ambulatory
  • Nitrendipine - therapeutic use
  • Placebos
ispartof: Hypertension (Dallas, Tex. 1979), 1996-03, Vol.27 (3 Pt 1), p.414-420
description: This study compares blood pressure (BP) changes during active antihypertensive treatment and placebo as assessed by conventional and ambulatory BP measurement. Older patients (> or = 60 years, n=337) with isolated systolic hypertension by conventional sphygmomanometry at the clinic were randomized to placebo or active treatment consisting of nitrendipine (10 to 40 mg/d), with the possible addition of enalapril (5 to 20 mg/d) and/or hydrochlorothiazide (12.5 to 25 mg/d). At baseline, clinic systolic/diastolic BP averaged 175/86 mm Hg and 24-hour and daytime ambulatory BPs averaged 148/80 and 154/85 mm Hg, respectively. After 13 months (median) of active treatment, clinic BP had dropped by 22.7/7.0 mm Hg and 24-hour and daytime BPs by 10.5/4.5 and 9.7/4.3 mm Hg, respectively (P
language: eng
source:
identifier: ISSN: 0194-911X
fulltext: no_fulltext
issn:
  • 0194-911X
  • 1524-4563
url: Link


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titleAmbulatory monitoring uncorrected for placebo overestimates long-term antihypertensive action. Systolic Hypertension in Europe (SYST-EUR) Trial Investigators
creatorStaessen, J A ; Thijs, L ; Bieniaszewski, L ; O'Brien, E T ; Palatini, P ; Davidson, C ; Dobovisek, J ; Jääskivi, M ; Laks, T ; Lehtonen, A ; Vanhanen, H ; Webster, J ; Fagard, R
creatorcontribStaessen, J A ; Thijs, L ; Bieniaszewski, L ; O'Brien, E T ; Palatini, P ; Davidson, C ; Dobovisek, J ; Jääskivi, M ; Laks, T ; Lehtonen, A ; Vanhanen, H ; Webster, J ; Fagard, R
descriptionThis study compares blood pressure (BP) changes during active antihypertensive treatment and placebo as assessed by conventional and ambulatory BP measurement. Older patients (> or = 60 years, n=337) with isolated systolic hypertension by conventional sphygmomanometry at the clinic were randomized to placebo or active treatment consisting of nitrendipine (10 to 40 mg/d), with the possible addition of enalapril (5 to 20 mg/d) and/or hydrochlorothiazide (12.5 to 25 mg/d). At baseline, clinic systolic/diastolic BP averaged 175/86 mm Hg and 24-hour and daytime ambulatory BPs averaged 148/80 and 154/85 mm Hg, respectively. After 13 months (median) of active treatment, clinic BP had dropped by 22.7/7.0 mm Hg and 24-hour and daytime BPs by 10.5/4.5 and 9.7/4.3 mm Hg, respectively (P<.001 for all). However, clinic (9.8/1.6 mm Hg), 24-hour (2.1/1.1 mm Hg), and daytime (2.9/1.0 mm Hg) BPs decreased also during placebo (P<.05, except for daytime diastolic BP); these decreases represented 43%/23%, 20%/24%, and 30%/23% of the corresponding BP fall during active treatment. After subtraction of placebo effects, the net BP reductions during active treatment averaged only 12.9/5.4, 8.3/3.4, and 6.8/3.2 mm Hg for clinic, 24-hour, and daytime BPs, respectively. The effect of active treatment was also subject to diurnal variation (P<.05). Changes during placebo in hourly systolic and diastolic BP means amounted to (median) 21% (range, -1% to 42%) and 25% (-3% to 72%), respectively, of the corresponding changes during active treatment. In conclusion, expressed in millimeters of mercury, the effect of antihypertensive treatment on BP is larger with conventional than with ambulatory measurement. Regardless of whether BP is measured by conventional sphygmomanometry or ambulatory monitoring, a substantial proportion of the long-term BP changes observed during active treatment may be attributed to placebo effects. Thus, ambulatory monitoring uncorrected for placebo or control observations, like conventional sphygmomanometry, overestimates BP responses in clinical trials of long duration.
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subjectAged ; Antihypertensive Agents - therapeutic use ; Blood Pressure ; Double-Blind Method ; Enalapril - therapeutic use ; Female ; Humans ; Hydrochlorothiazide - therapeutic use ; Hypertension - diagnosis ; Hypertension - drug therapy ; Male ; Middle Aged ; Monitoring, Ambulatory ; Nitrendipine - therapeutic use ; Placebos
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6Dobovisek, J
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8Laks, T
9Lehtonen, A
10Vanhanen, H
11Webster, J
12Fagard, R
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0Ambulatory monitoring uncorrected for placebo overestimates long-term antihypertensive action. Systolic Hypertension in Europe (SYST-EUR) Trial Investigators
1Hypertension (Dallas, Tex. 1979)
addtitleHypertension
descriptionThis study compares blood pressure (BP) changes during active antihypertensive treatment and placebo as assessed by conventional and ambulatory BP measurement. Older patients (> or = 60 years, n=337) with isolated systolic hypertension by conventional sphygmomanometry at the clinic were randomized to placebo or active treatment consisting of nitrendipine (10 to 40 mg/d), with the possible addition of enalapril (5 to 20 mg/d) and/or hydrochlorothiazide (12.5 to 25 mg/d). At baseline, clinic systolic/diastolic BP averaged 175/86 mm Hg and 24-hour and daytime ambulatory BPs averaged 148/80 and 154/85 mm Hg, respectively. After 13 months (median) of active treatment, clinic BP had dropped by 22.7/7.0 mm Hg and 24-hour and daytime BPs by 10.5/4.5 and 9.7/4.3 mm Hg, respectively (P<.001 for all). However, clinic (9.8/1.6 mm Hg), 24-hour (2.1/1.1 mm Hg), and daytime (2.9/1.0 mm Hg) BPs decreased also during placebo (P<.05, except for daytime diastolic BP); these decreases represented 43%/23%, 20%/24%, and 30%/23% of the corresponding BP fall during active treatment. After subtraction of placebo effects, the net BP reductions during active treatment averaged only 12.9/5.4, 8.3/3.4, and 6.8/3.2 mm Hg for clinic, 24-hour, and daytime BPs, respectively. The effect of active treatment was also subject to diurnal variation (P<.05). Changes during placebo in hourly systolic and diastolic BP means amounted to (median) 21% (range, -1% to 42%) and 25% (-3% to 72%), respectively, of the corresponding changes during active treatment. In conclusion, expressed in millimeters of mercury, the effect of antihypertensive treatment on BP is larger with conventional than with ambulatory measurement. Regardless of whether BP is measured by conventional sphygmomanometry or ambulatory monitoring, a substantial proportion of the long-term BP changes observed during active treatment may be attributed to placebo effects. Thus, ambulatory monitoring uncorrected for placebo or control observations, like conventional sphygmomanometry, overestimates BP responses in clinical trials of long duration.
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1Antihypertensive Agents - therapeutic use
2Blood Pressure
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4Enalapril - therapeutic use
5Female
6Humans
7Hydrochlorothiazide - therapeutic use
8Hypertension - diagnosis
9Hypertension - drug therapy
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14Placebos
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titleAmbulatory monitoring uncorrected for placebo overestimates long-term antihypertensive action. Systolic Hypertension in Europe (SYST-EUR) Trial Investigators
authorStaessen, J A ; Thijs, L ; Bieniaszewski, L ; O'Brien, E T ; Palatini, P ; Davidson, C ; Dobovisek, J ; Jääskivi, M ; Laks, T ; Lehtonen, A ; Vanhanen, H ; Webster, J ; Fagard, R
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1Antihypertensive Agents - therapeutic use
2Blood Pressure
3Double-Blind Method
4Enalapril - therapeutic use
5Female
6Humans
7Hydrochlorothiazide - therapeutic use
8Hypertension - diagnosis
9Hypertension - drug therapy
10Male
11Middle Aged
12Monitoring, Ambulatory
13Nitrendipine - therapeutic use
14Placebos
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7Jääskivi, M
8Laks, T
9Lehtonen, A
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7Jääskivi, M
8Laks, T
9Lehtonen, A
10Vanhanen, H
11Webster, J
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atitleAmbulatory monitoring uncorrected for placebo overestimates long-term antihypertensive action. Systolic Hypertension in Europe (SYST-EUR) Trial Investigators
jtitleHypertension (Dallas, Tex. 1979)
addtitleHypertension
date1996-03
risdate1996
volume27
issue3 Pt 1
spage414
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pages414-420
issn0194-911X
eissn1524-4563
abstractThis study compares blood pressure (BP) changes during active antihypertensive treatment and placebo as assessed by conventional and ambulatory BP measurement. Older patients (> or = 60 years, n=337) with isolated systolic hypertension by conventional sphygmomanometry at the clinic were randomized to placebo or active treatment consisting of nitrendipine (10 to 40 mg/d), with the possible addition of enalapril (5 to 20 mg/d) and/or hydrochlorothiazide (12.5 to 25 mg/d). At baseline, clinic systolic/diastolic BP averaged 175/86 mm Hg and 24-hour and daytime ambulatory BPs averaged 148/80 and 154/85 mm Hg, respectively. After 13 months (median) of active treatment, clinic BP had dropped by 22.7/7.0 mm Hg and 24-hour and daytime BPs by 10.5/4.5 and 9.7/4.3 mm Hg, respectively (P<.001 for all). However, clinic (9.8/1.6 mm Hg), 24-hour (2.1/1.1 mm Hg), and daytime (2.9/1.0 mm Hg) BPs decreased also during placebo (P<.05, except for daytime diastolic BP); these decreases represented 43%/23%, 20%/24%, and 30%/23% of the corresponding BP fall during active treatment. After subtraction of placebo effects, the net BP reductions during active treatment averaged only 12.9/5.4, 8.3/3.4, and 6.8/3.2 mm Hg for clinic, 24-hour, and daytime BPs, respectively. The effect of active treatment was also subject to diurnal variation (P<.05). Changes during placebo in hourly systolic and diastolic BP means amounted to (median) 21% (range, -1% to 42%) and 25% (-3% to 72%), respectively, of the corresponding changes during active treatment. In conclusion, expressed in millimeters of mercury, the effect of antihypertensive treatment on BP is larger with conventional than with ambulatory measurement. Regardless of whether BP is measured by conventional sphygmomanometry or ambulatory monitoring, a substantial proportion of the long-term BP changes observed during active treatment may be attributed to placebo effects. Thus, ambulatory monitoring uncorrected for placebo or control observations, like conventional sphygmomanometry, overestimates BP responses in clinical trials of long duration.
copUnited States
pmid8698447