Study population and treatment titration in the International Nifedipine GITS Study

Intervention as a Goal in Hypertension Treatment (INSIGHT)

M. J. Brown, A. Castaigne, P. W. De Leeuw, G. Mancia, T. Rosenthal, L. M. Ruilope

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

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 ≥ 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 ≤ 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.

Original languageEnglish
Pages (from-to)2113-2116
Number of pages4
JournalJournal of Hypertension
Volume16
Issue number12 SUPPL.
Publication statusPublished - 1998

Fingerprint

Nifedipine
Hypertension
Blood Pressure
Population
Therapeutics
Myocardial Infarction
Random Allocation
Stroke
Pharmaceutical Preparations
Thiazides
Enalapril
Hydrochlorothiazide
Atenolol
Peripheral Vascular Diseases
Amiloride
Calcium Channel Blockers
Left Ventricular Hypertrophy
Proteinuria
Diuretics
Antihypertensive Agents

Keywords

  • Ca blockade
  • Diuretic
  • Minimization
  • Nifedipine
  • Outcome trial
  • Randomized

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology

Cite this

Brown, M. J., Castaigne, A., De Leeuw, P. W., Mancia, G., Rosenthal, T., & Ruilope, L. M. (1998). Study population and treatment titration in the International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT). Journal of Hypertension, 16(12 SUPPL.), 2113-2116.

Study population and treatment titration in the International Nifedipine GITS Study : Intervention as a Goal in Hypertension Treatment (INSIGHT). / Brown, M. J.; Castaigne, A.; De Leeuw, P. W.; Mancia, G.; Rosenthal, T.; Ruilope, L. M.

In: Journal of Hypertension, Vol. 16, No. 12 SUPPL., 1998, p. 2113-2116.

Research output: Contribution to journalArticle

Brown, MJ, Castaigne, A, De Leeuw, PW, Mancia, G, Rosenthal, T & Ruilope, LM 1998, 'Study population and treatment titration in the International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT)', Journal of Hypertension, vol. 16, no. 12 SUPPL., pp. 2113-2116.
Brown, M. J. ; Castaigne, A. ; De Leeuw, P. W. ; Mancia, G. ; Rosenthal, T. ; Ruilope, L. M. / Study population and treatment titration in the International Nifedipine GITS Study : Intervention as a Goal in Hypertension Treatment (INSIGHT). In: Journal of Hypertension. 1998 ; Vol. 16, No. 12 SUPPL. pp. 2113-2116.
@article{65f1064dcd904873a38cbdaf77b6c111,
title = "Study population and treatment titration in the International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT)",
abstract = "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 ≥ 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 ≤ 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.",
keywords = "Ca blockade, Diuretic, Minimization, Nifedipine, Outcome trial, Randomized",
author = "Brown, {M. J.} and A. Castaigne and {De Leeuw}, {P. W.} and G. Mancia and T. Rosenthal and Ruilope, {L. M.}",
year = "1998",
language = "English",
volume = "16",
pages = "2113--2116",
journal = "Journal of Hypertension",
issn = "0263-6352",
publisher = "Lippincott Williams and Wilkins",
number = "12 SUPPL.",

}

TY - JOUR

T1 - Study population and treatment titration in the International Nifedipine GITS Study

T2 - Intervention as a Goal in Hypertension Treatment (INSIGHT)

AU - Brown, M. J.

AU - Castaigne, A.

AU - De Leeuw, P. W.

AU - Mancia, G.

AU - Rosenthal, T.

AU - Ruilope, L. M.

PY - 1998

Y1 - 1998

N2 - 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 ≥ 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 ≤ 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.

AB - 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 ≥ 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 ≤ 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.

KW - Ca blockade

KW - Diuretic

KW - Minimization

KW - Nifedipine

KW - Outcome trial

KW - Randomized

UR - http://www.scopus.com/inward/record.url?scp=0032422343&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0032422343&partnerID=8YFLogxK

M3 - Article

VL - 16

SP - 2113

EP - 2116

JO - Journal of Hypertension

JF - Journal of Hypertension

SN - 0263-6352

IS - 12 SUPPL.

ER -