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Clinical Studies

Clinical Studies

The efficacy and safety of Benicar/Benicar HCT have been established in several clinical studies. Summaries of the objectives, study designs, and key results are provided in this section for your reference, along with the full citations of the published articles.

On this page:

Benicar Placebo-Controlled Studies
BeniFORCE Trial
Pivotal U.S. MATRIX Study
BENISYS systolic hypertension trial
24 Hour Coverage ABPM Study

Benicar Placebo-Controlled Studies

Placebo and Benicar sitting data. Derived from 7 dose-ranging studies. Duration=6 to 12 weeks. Patients taking Benicar 2.5 mg to 80 mg, n=2,145. Patients taking placebo, n=548.1

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BeniFORCE Trial

A 15-16 week, double-blind, randomized, placebo-controledd, titration trial conducted in 276 patients with Stage 1 or Stage 2 hypertension. 130 patients had Stage 1 hypertension (active=58, placebo=72) and had a mean baseline of 151/90 mm Hg (active=151/90 mm Hg, placebo=150/91 mm Hg). Following a 3-4 week placebo run-in, 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 during active treatment continued their currently assigned therapy. The primary endpoint was change from baseline in mean SBP at study end. The secondary endpoints included change form baseline in mean DBP, and the percent of patients achieving BP goals of <140/90, <130/80, and <120/80 mm Hg at each titration period and study end and a subgroup analysis by baseline stage of hypertension (Stage 1 and Stage 2). Overall mean baseline BP was 157/94 and 155/94 mm Hg for the active treatment and placebo group, respectively.2

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Pivotal U.S. MATRIX Study

A randomized, double-blind, factorial study (N=502) conducted at 48 investigational sites in the U.S. to evaluate the efficacy and safety of Benicar+HCTZ across a range of doses. After an initial single-blind, 4-week, placebo run-in period, eligible patients were randomized to one of 12 treatment groups for 8 weeks of double-blind treatment with placebo, Benicar monotherapy (all doses), HCTZ monotherapy (12.5 or 25 mg/day), or Benicar+HCTZ combination therapy (all possible combinations). Primary endpoint: change from baseline in mean trough DBP at Week 8, using the last observation carried forward (LOCF) for patients who did not complete the protocol. Combined goal rate calculations were a secondary analysis.3

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BENISYS systolic hypertension trial

A 12-week, prospective, open-label, multicenter, titration trial conducted in the U.S. (N=170). Following a 3- to 4-week placebo run-in, patients were started on Benicar 20 mg, and if they did not reach goal of <120/80 mm Hg, they were titrated at 3-week intervals to Benicar 40 mg, Benicar HCT 40 mg/12.5 mg, then 40 mg/25 mg. 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. If a patient exited the study due to reaching BP normalization, the patient's last BP measurement was carried forward. The primary endpoint was the change in mean trough SBP from baseline at Week 12. Cumulative goal attainment for BP <140/90 mm Hg, <130/85 mm Hg, and <120/80 mm Hg were secondary endpoints. In this trial, the mean BP baseline for all treatment groups was 171/95 mm Hg, the mean age was 60 years, 46% of patients were male, and 84% of patients were nonblack.4

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24 Hour Coverage ABPM Study

Results from 20 mg QD ABPM component, n=39. Part of an 8-week, randomized, double-blind, placebo-controlled, parallel-group study, N=289. Assessment of Benicar efficacy and safety in patients with hypertension.2

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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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