Sitemap | Contact Us

Daiichi-Sankyo

Home > About Benicar > Benicar Efficacy

Benicar Efficacy

Benicar Efficacy

Benicar goes the distance with the power to help patients reach their BP goals:

  • Benicar monotherapy provides significant mean blood pressure (BP) reductions vs. baseline at the starting dose of 20 mg once-daily.
  • Benicar 40 mg once-daily provides additional mean BP reductions versus baseline.

On this page:

Helping patients reach JNC 7 goal or lower
Benicar in patients with mild-to-moderate hypertension
Benicar in more challenging patients
Continuous 24-hour coverage
References

Helping patients reach JNC 7 goal or lower
Nearly 40% of patients with mild-to-moderate hypertension taking Benicar 40 mg reached their goal of BP <140/90 mm Hg at Week 8 (goal attainment: 39.7%; placebo: 12.4%).*1 Additionally, over 27% of patients with mild-to-moderate hypertension taking Benicar 20 mg reached their goal of BP <140/90 mm Hg at Week 4 (goal attainment: 27.4%; placebo: 10.3% ).*1

14.7% of patients on Benicar 40 mg monotherapy reached the more aggressive goal of BP <130/85 mm Hg at Week 8 (placebo: 1.1%).*1

*Week 4 and Week 8 cuff BP control results (secondary analysis, n=643, patients with available observation at visit) of the Benicar arm of a 12-week, randomized, double-blind, multicenter, forced-titration study (n=696, intent-to-treat population) investigating the efficacy and safety of Benicar in patients with Stage 2 hypertension. The primary endpoint was mean cuff DBP reductions at Week 8. In this study, 22% of placebo patients were African American.1

Back to top

Benicar in patients with mild-to-moderate hypertension
Benicar monotherapy provides significant BP reductions — beginning at the starting dose of 20 mg once-daily:1, 2

  • Studies show that Benicar 20 mg — the usual recommended starting dose — resulted in significant mean reductions vs. baseline at trough in systolic and diastolic blood pressure of up to 15/12 mm Hg (mean placebo reductions of 6/6 mm Hg).2
  • Benicar 40 mg resulted in significant mean reductions vs. baseline at trough in systolic and diastolic blood pressure of up to 18/13 mm Hg (mean placebo reductions of 6/6 mm Hg).2
  • Doses above 40 mg do not appear to have greater effect.1

For a detailed study description, see the Monotherapy Clinical Trials section.

Back to top

Benicar in more challenging patients
Benicar provides proven BP reductions in patients with higher baseline SBP — beginning at the starting dose.3 Benicar 20 mg/day reduced mean SBP by 16.9 mm Hg (P<.001 vs. baseline), and there were further dose-dependent decreases in mean SBP to a maximum of 35 mm Hg with Benicar HCT 40/25 mg/day.

For a detailed study description, see the BENISYS Clinical Trial section.

Back to top

Continuous 24-hour coverage
Benicar provides BP reductions maintained over 24 hours at the 20 mg starting dose.1

†ABPM Study: Results from 20 mg once-daily 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 of patients with hypertension.

Back to top

Excellent Coverage

A helpful handout is
available to provide
details to you and
your patients.

Get PDF

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.

DCSIMG