INSIGHT: international nifedipine GITS study intervention as a goal in hypertension treatment.
The objective of the study is to compare fatal and nonfatal cardiovascular endpoints in hypertensive patients randomised to the calcium-channel blocker, nifedipine GITS or a thiazide diuretic, co-amilozide. A total of 6592 patients from nine countries (UK, France, Israel, Spain, Italy, The Netherlands, Sweden, Denmark and Norway) will be recruited, aged 55-80 and with a blood pressure (BP) > or = 150/95 or > or = 160 mm Hg (systolic). All patients will have at least one other major cardiovascular risk factor. Patients will be minimised by country and risk factors and randomised to double-blind treatment with either nifedipine GITS or diuretic. After a single dose titration, additional treatment will be atenolol or enalapril (where beta-blockade is contra-indicated). After achieving a target BP of 140/90 mm Hg patients will be followed for a total of 3 years. Primary endpoints are myocardial infarction, stroke, subarachnoid haemorrhage, heart failure and sudden cardiac death. The study has a power of 80% at 5% significance to detect a difference between 8% event rate over 3 years in diuretic-treated patients and 6% in those receiving nifedipine.
Brown
M J
MJ
Department of Medicine, University of Cambridge, UK.
Castaigne
A
A
Ruilope
L M
LM
Mancia
G
G
Rosenthal
T
T
de Leeuw
P W
PW
Ebner
F
F
D000368:Aged; D000369:Aged, 80 and over; D000584:Amiloride / Q000627:therapeutic use; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004232:Diuretics; D004311:Double-Blind Method; D004338:Drug Combinations; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy*; D007391:International Cooperation; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage / Q000627:therapeutic use*; D012307:Risk Factors; D049993:Sodium Chloride Symporter Inhibitors / Q000627:therapeutic use
D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D004232:Diuretics; D004338:Drug Combinations; D049993:Sodium Chloride Symporter Inhibitors; D006852:Hydrochlorothiazide; C010247:amiloride, hydrochlorothiazide drug combination; D000584:Amiloride; D009543:Nifedipine