24-hour blood pressure control by once-daily administration of irbesartan assessed by ambulatory blood pressure monitoring. Irbesartan Multicenter Investigators' Group.
OBJECTIVE
To compare 24 h ambulatory blood pressure and trough office blood pressure lowerings after 8 weeks of therapy with 75 mg irbesartan once a day, 150 mg irbesartan once a day , and 75 mg irbesartan twice a day versus placebo; and to assess safety and tolerability of irbesartan therapy.


METHODS
Multicenter, double-blind, randomized, placebo-controlled trial.


METHODS
Sixteen centers in Italy.


METHODS
Caucasian patients (n = 215) aged > or = 18 years with seated diastolic blood pressure 95-110 mmHg and ambulatory diastolic blood pressure (ADBP) > or = 85 mmHg.


METHODS
Mean 24 h ADBP after 8 weeks of irbesartan therapy.


RESULTS
Mean changes (value before treatment minus value after treatment) in ADBP for placebo, 75 mg irbesartan once a day, 150 mg irbesartan once a day, and 75 mg irbesartan twice a day were -0.2, -5.4, -7.2, and -7.2 mmHg, respectively; respective changes in ambulatory systolic blood pressure were +1.6, -8.3, -10.5, and -9.7 mmHg. All irbesartan regimens reduced trough office seated diastolic blood pressure and seated systolic blood pressure after 2 and 8 weeks of treatment (all P < 0.01, versus placebo except for seated systolic blood pressure in patients in the 75 mg irbesartan once a day group). Trough: peak ratios were > or = 55% with 150 mg irbesartan once a day. Percentages of patients whose blood pressures were normalized with 150 mg irbesartan once a day (45%) and 75 mg irbesartan twice a day (47%) were greater than those with placebo (14%, P < 0.01) and with 75 mg irbesartan once a day (19%, NS, versus placebo). Adverse events with irbesartan were similar to those with placebo.


CONCLUSIONS
All irbesartan regimens significantly reduced mean 24 h ADBP and ambulatory systolic blood pressure, and were well tolerated. Administration of 150 mg irbesartan once a day provided significant reduction of blood pressure for 24 h, equivalent to that obtained with the same daily dose divided into two separate administrations.
Fogari
R
R
Department of Internal Medicine, University of Pavia, Italy.
Ambrosoli
S
S
Corradi
L
L
Degli Esposti
E
E
Mos
L
L
Nami
R
R
Nicrosini
F
F
Pessina
A C
AC
Salvetti
A
A
Vaccarella
A
A
Zanchetti
A
A
Martin
A
A
Reeves
R A
RA
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D001713:Biphenyl Compounds / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects*; D001795:Blood Pressure Determination / Q000379:methods*; D002940:Circadian Rhythm / Q000502:physiology*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077405:Irbesartan; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory; D013777:Tetrazoles / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D013777:Tetrazoles; D000077405:Irbesartan