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Benicar HCT Facts

Benicar HCT combines the angiotensin II receptor blocker (ARB) Benicar (olmesartan medoxomil) with the diuretic hydrochlorothiazide (HCTZ).

The U.S. Food and Drug Administration (FDA) granted marketing approval for Benicar HCT for the treatment of hypertension in June 2003.

Benicar/Benicar HCT was ranked #3 in the ARB class for total prescriptions (TRx).1,2

Benicar HCT is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Benicar HCT is not indicated for initial therapy.

Because of the HCTZ component, Benicar HCT is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Benicar HCT is not recommended in patients with severe renal impairment or in pregnant women.

Studies show that Benicar HCT — taken once a day — produces significant mean reductions vs. baseline at trough in systolic and diastolic blood pressure of up to 27/22 mm Hg with Benicar 40 mg and HCTZ 25 mg (mean placebo reductions of 3/8 mm Hg).

Three doses of Benicar HCT were launched in August 2003:

  • 20 mg olmesartan medoxomil and 12.5 mg HCTZ
  • 40 mg olmesartan medoxomil and 12.5 mg HCTZ
  • 40 mg olmesartan medoxomil and 25 mg HCTZ

Dosing should be individualized depending on blood pressure response.

Benicar HCT is a combination of Benicar and hydrochlorothiazide that works by blocking angiotensin II receptors in the blood vessels and increasing excretion of sodium and chloride in approximately equivalent amounts, resulting in lower systolic and diastolic blood pressure. Angiotensin II increases blood pressure by causing the constriction of blood vessels, while sodium and chloride cause the retention of water, increase in blood volume, and ultimately an increase in blood pressure. Therefore, Benicar HCT reduces blood pressure by two complementary methods of action.

The safety and efficacy of Benicar HCT was evaluated in clinical trials of more than 1,200 patients. Benicar HCT, given once a day in doses of 20 mg olmesartan medoxomil/12.5 mg HCTZ, 40 mg olmesartan medoxomil/12.5 mg HCTZ, or 40 mg olmesartan medoxomil/25 mg HCTZ, produced significant mean blood pressure reductions versus baseline at trough in systolic and diastolic blood pressure of up to 27/22 mm Hg (mean placebo reductions of 3/8 mm Hg). Onset of action occurred within one week of starting Benicar HCT.3

Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) has a side-effect profile similar to placebo. In a placebo-controlled clinical trial, the following adverse events reported with Benicar HCT occurred in more than 2% of patients, and more often on the Benicar HCT combination than on placebo, regardless of drug relationship: nausea (3% vs. 0%), hyperuricemia (4% vs. 2%), dizziness (9% vs. 2%), and upper respiratory infection (7% vs. 0%).

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References

1 Data representing May 2002-July 2008 from IMS Health. National Prescription Audit, July 2008.

2 Based on NRx volume for the first 75 months following the launch of the respective ARB from IMS Health. National Prescription Audit, July 2008.

3 American Heart Association. 2002 Heart and Stroke Statistical Update. Dallas, Tex: American Heart Association, 2002, Health United States 2001, CDC/NCHS.

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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