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Benicar/Benicar HCT

Benicar/Benicar HCT: Help patients reach JNC 7 goal or lower1-3

Help patients on the road to normotension with the power of Benicar/Benicar HCT. In clinical trials, Benicar monotherapy and in combination with HCT is shown to help a broad range of patients across all stages of hypertension reach JNC 7goal or lower.1-3

Help reach JNC 7 goal or lower in patients with mild hypertension

Nearly 45% of patients with stage 1 hypertension reached normotension (<120/80 mm Hg) on a Benicar/Benicar HCT treatment regimen in a double-blind, placebo-controlled study (cumulative goal attainment: 44.8%; placebo: 1%).1

A total of 276 patients were included in the 15-16-week, double-blind, placebo-controlled BeniFORCE trial with 130 of the patients having Stage 1 hypertension. Following a 3-4-week placebo run-in period, patients were randomized to placebo (12 weeks) or Benicar 20 mg (3 weeks). If SBP remained >120 mm Hg or DBP remained >80 mm Hg, patients were titrated at 3-week intervals until BP was normalized as follows: Benicar 40 mg, Benicar HCT 40 mg/12.5 mg, and Benicar HCT 40 mg/25 mg. Patients with BP <120/80 mm Hg at any visit continued with their currently assigned therapy.1
See study description

Help reach JNC 7 goal or lower in patients with mild-to-moderate hypertension
Nearly 80% of patients reached goal (<140/90 mm Hg) with Benicar HCT 40 mg/25 mg in a pivotal study (goal attainment: 79.5%; placebo: 19%).1

A total of 502 patients were included in the pivotal U.S. MATRIX trial across 12 different treatment arms evaluating monotherapy with placebo, Benicar, or HCTZ, and different combinations of Benicar and HCTZ. Duration equalled 8 weeks following a 4-week placebo run-in period. When 8-week data were unavailable, the last observation after day 1 for that patient was carried forward.
See study description

Help reach JNC 7 goal or lower in more challenging patients
Over 70% of patients reached a cumulative goal (<140/90 mm Hg) with a Benicar/Benicar HCT treatment regimen in an open-label study (cumulative goal attainment: 70.4%).1

Entry requirements included a mean 8-hour daytime ambulatory SBP >140 mm Hg and ≤180 mm Hg and a mean ambulatory DBP <110 mm Hg.

In total, 26 patients (15.4%) achieved BP normalization of <120/80 mm Hg and exited the study and last observation was carried forward; these patients are included in the 119 patients (70.4%) who reached BP goal (<140/90 mm Hg) and the 59 patients (34.9%) who reached the lower goal of BP <130/85 mm Hg.1,3

The results of this open-label trial differ from those obtained in the pivotal, placebo-controlled U.S. MATRIX Study.
See study description

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References

1 Data on file. Daiichi Sankyo, Inc. Parsippany, NJ.

2 The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda, Md: National Institutes of Health, National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program; May 2003. NIH publication 03-5233.

3 Izzo JL, Jr., Neutel JM, Silfani T, Dubiel R, Walker F. Efficacy and safety of treating stage 2 systolic hypertension with olmesartan and olmesartan/HCTZ: results of an open-label titration study. J Clin Hypertens (Greenwich). 2007;9:36-44.

Indication

BENICAR and BENICAR HCT are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. BENICAR HCT is not indicated for initial therapy.

Important Safety Information

USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, BENICAR or BENICAR HCT should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality in the prescribing information.

Hypotension in Volume- or Salt-Depleted Patients
In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (eg, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with BENICAR. Treatment should start under close medical supervision. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Impaired Renal Function
In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.

The prescribing information for BENICAR HCT also includes the following warnings regarding its hydrochlorothiazide component:

  • BENICAR HCT is not recommended in patients with severe renal impairment, and is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs

Fetal/Neonatal Morbidity and Mortality
Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Hepatic Impairment
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hypersensitivity Reaction
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.

Systemic Lupus Erythematosus
Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Lithium Interaction
Lithium generally should not be given with thiazides.

Adverse Events

  • The withdrawal rates due to adverse events (AEs) were similar with BENICAR and BENICAR HCT to placebo: BENICAR (2.4% vs. 2.7%); BENICAR HCT (2.0% vs. 2.0%)
  • The incidence of AEs with BENICAR and BENICAR HCT was similar to placebo
    • The only AE that occurred in >1% of patients treated with BENICAR and more frequently than placebo was dizziness (3% vs. 1%)
    • AEs reported in >2% of patients taking BENICAR HCT and more frequently than placebo included nausea (3% vs. 0%), hyperuricemia (4% vs. 2%), dizziness (9% vs. 2%), and upper respiratory tract infection (7% vs. 0%)

Dosing and Administration

  • No initial dosage adjustments are recommended with BENICAR in elderly or in moderate to marked renal impairment*/hepatic dysfunction
    • In patients with possible depletion of intravascular volume (eg, patients on diuretics, particularly with impaired renal function), BENICAR should be initiated under close medical supervision and consideration given to use of a lower starting dose
  • For BENICAR HCT, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range

*Creatinine clearance <40 mL/min

Please see full prescribing information for BENICAR and BENICAR HCT.

The information on this page is intended to be used by U.S. healthcare professionals only. Patients and consumers are directed to BENICAR and BENICAR HCT Product Information.

The photos depict models, not actual patients or healthcare professionals.

Benicar and Benicar HCT are promoted by Daiichi Sankyo, Inc.
© 2008 Daiichi Sankyo, Inc.

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