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Home > Prescribing Benicar/Benicar HCT > Patients: Stages of Hypertension > Patients With Mild-to-Moderate Hypertension

Patients With Mild-to-Moderate Hypertension

In Patients With Mild-to-Moderate Hypertension:
Help them reach JNC 7 goal or lower

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 For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.

Benicar HCT is shown to provide BP reductions in patients with mild-to-moderate hypertension to help them reach JNC 7 goal or lower.3

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Benicar monotherapy
Benicar HCT
References

Benicar monotherapy

For patients with possible depletion of intravascular volume (eg, patients treated with diuretics, particularly those with impaired renal function), Benicar should be initiated under close medical supervision, and consideration should be given to use of a lower starting dose.

Benicar may be administered with or without food. If blood pressure is not controlled by Benicar alone, a diuretic may be added. Benicar may be administered with other antihypertensive agents

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Benicar HCT

Benicar HCT: Distribution of SBP reductions within the 27 mm Hg mean reduction, as measured from baseline at trough(1,3)

With Benicar HCT 40 mg/25 mg, nearly 80% of patients with mild-to-moderate hypertension (mean baseline 154/103 mm Hg) reached their goal of BP <140/90 mm Hg in a pivotal study (79.5%; placebo: 19%).1 Additionally, approximately 51% of patients achieved the more aggressive goal of BP <130/85 mm Hg (51.3%; placebo: 4.8%), and nearly 18% achieved normotension, which is defined by JNC 7 as BP <120/80 mm Hg (Benicar HCT: 17.9%; [n=7] / placebo: 2.4%; [n=1]; mean baseline: 144/103 mm Hg).1

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In general, dose selection of BENICAR HCT for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant diseases or other drug therapy.

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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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