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Benicar Head-to-Head Trials

benicar head-to-head trials

Superior BP reductions for BENICAR vs Cozaar® based on 2 clinical trials1-3

In 2 head-to-head trials, patients taking BENICAR (olmesartan medoxomil) 40 mg monotherapy achieved significantly greater mean reductions in diastolic (DBP) and systolic blood pressure (SBP) than those taking Cozaar® (losartan) 100 mg monotherapy once daily at Week 8.1-3

Baseline values in a placebo-controlled head-to-head trial1,2

Baseline values in a placebo-controlled head-to-head trial
Baseline values in a placebo-controlled head-to-head trial
Baseline values in a placebo-controlled head-to-head trial

BENICAR 40 mg resulted in greater BP reductions vs Cozaar© 100 mg QD

After 8 weeks of treatment, there was a mean SBP difference of 4.3 mm Hg and a mean DBP difference of 3.5 mm Hg between the BENICAR and Cozaar® groups (P<0.001, both comparisons).1

Benicar Cozaar mean change from baseline in BP at Week 8
Benicar Cozaar mean change from baseline in BP at Week 8
Benicar Cozaar mean change from baseline in BP at Week 8
  • Mean BP difference between BENICAR and Cozaar® groups was 4.3/3.5 mm Hg; P<0.0011

The mean cuff baseline was 155/104 mm Hg for BENICAR, 155/104 mm Hg for Cozaar®, and 154/103 mm Hg for placebo.1

There was no significant difference in BP reductions between BENICAR 40 mg QD and Cozaar® 50 mg BID at Week 12.1

BENICAR 40 mg QD and Cozaar® 50 mg BID have not been studied in 2 head-to-head clinical trials.

BP reductions with BENICAR 40 mg were not significantly different from Diovan® 160 mg at Week 8 or Diovan® 320 mg at Week 12.1

A 12-week, randomized, placebo-controlled, forced-titration study (N=723). Following a 4-week placebo run-in, patients were randomized to treatment with once-daily doses of BENICAR 20 mg, Cozaar® 50 mg, Diovan® 80 mg, or placebo. After 4 weeks, patients were titrated to once-daily doses of BENICAR 40 mg, Cozaar® 100 mg, Diovan® 160 mg, or placebo for 4 additional weeks. At Week 8, patients on BENICAR 40 mg QD remained at this dose for another 4 weeks. Patients on Cozaar® or Diovan® were titrated to 50 mg BID or 320 mg QD, respectively. Week 12 data were analyzed to determine whether these doses of the 3 ARBs demonstrated equivalence. Entry requirements included a SeDBP ≥100 and ≤115 mm Hg and SeSBP ≤180 mm Hg. Primary endpoint: change from baseline in mean SeDBP at Week 8.1

A significantly greater goal rate was achieved: Twice as many patients reached their BP goal with BENICAR 40 mg vs Cozaar® 100 mg QD in this trial

Benicar Cozaar reaching cuff BP <140/90 mm Hg at Week 8
Benicar Cozaar reaching cuff BP <140/90 mm Hg at Week 8
Benicar Cozaar reaching cuff BP <140/90 mm Hg at Week 8

There was no significant difference in the secondary endpoint of cuff SBP goal attainment <140 mm Hg at Week 8 between BENICAR 40 mg and Cozaar® 100 mg QD.2

There was no significant difference in the percentage of patients achieving cuff BP goal <140/90 mm Hg between BENICAR 40 mg QD and Cozaar® 50 mg BID at Week 12.1

BENICAR 40 mg QD and Cozaar® 50 mg BID have not been studied in 2 head-to-head clinical trials.

In a separate, 12-week, randomized, double-blind, non-forced titration study (ie, titrate-to-goal) designed to show noninferiority and conducted in elderly/very elderly patients with hypertension (mean age 71.9 years), noninferiority, but not superiority, of BENICAR (20 mg and 40 mg QD) to Cozaar® (50 mg and 100 mg QD) was demonstrated based on the primary endpoint of mean DBP reductions from baseline at Week 12. The majority of patients were on low-dose ARB at time of primary endpoint assessment.2

 

Selected Safety Information: CONTRAINDICATIONS

Do not co-administer aliskiren with BENICAR, BENICAR HCT, AZOR, or TRIBENZOR in patients with diabetes.

BENICAR HCT and TRIBENZOR are contraindicated in patients with anuria. BENICAR HCT is contraindicated in patients with hypersensitivity to any component of BENICAR HCT. TRIBENZOR is contraindicated in patients with hypersensitivity to other sulfonamide-derived drugs.

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue BENICAR, BENICAR HCT, AZOR, or TRIBENZOR as soon as possible
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS AND PRECAUTIONS: Fetal Toxicity

Please see Important Safety Information on this page for BENICAR, BENICAR HCT, AZOR, and TRIBENZOR.

Please see Full Prescribing Information for BENICAR and BENICAR HCT, including Boxed WARNINGS regarding Fetal Toxicity.

 

In BeniVICTOR, the second head-to-head trial

Greater BP reductions for BENICAR 40 mg vs Cozaar® 100 mg QD2,3

After 8 weeks of treatment, there was a mean SBP difference of 3.9 mm Hg and a mean DBP difference of 2.6 mm Hg between the BENICAR and Cozaar® groups (SBP, P=0.0001; DBP, P<0.0001).2,3

Baseline values2,3

Benicar Cozaar cuff baseline 158/101 mm Hg

Benicar Cozaar change from baseline in BP at Week 8

Benicar Cozaar cuff baseline 158/101 mm Hg Benicar Cozaar change from baseline in BP at Week 8
Benicar Cozaar cuff baseline 158/101 mm Hg Benicar Cozaar change from baseline in BP at Week 8
  • Mean BP difference between BENICAR and Cozaar® groups: 3.9/2.6 mm Hg; P≤0.00012,3

 

Mean cuff baseline was 158/101 mm Hg for BENICAR and 158/101 mm Hg for Cozaar®.3

An 8-week, prospective, randomized, double-blind, active-comparator, forced-titration study (N=941). Following a 3–4-week placebo run-in, patients were randomized to treatment with BENICAR 20 mg, Cozaar® 50 mg, or placebo once daily. At Week 2, placebo-treated patients were rolled into the BENICAR 20 mg arm for the next 2 weeks. At Week 4, patients were titrated to BENICAR 40 mg or Cozaar® 100 mg once daily for 4 additional weeks. Entry requirements included a SeDBP ≥95 and ≤115 mm Hg and SeSBP ≤180 mm Hg. Primary endpoint: mean change from baseline in trough cuff SeDBP at Week 8.3

Significantly greater goal rate achievement with BENICAR 40 mg vs Cozaar® 100 mg QD3

Benicar Cozaar patients reaching cuff BP <140/90 mm Hg at Week 8
Benicar Cozaar patients reaching cuff BP <140/90 mm Hg at Week 8
Benicar Cozaar patients reaching cuff BP <140/90 mm Hg at Week 8

Percent of patients achieving cuff BP goal rate <140/90 mm Hg was a tertiary endpoint.3

In a subset of patients that underwent ABPM (n=216), there was a significant difference in mean 24-hour SBP and DBP ABPM reductions between BENICAR 40 mg and Cozaar® 100 mg QD at Week 8; however, there was no significant difference in the percent of patients achieving 24- hour ABPM target <130/80 mm Hg.3

BENICAR 40 mg QD and Cozaar® 50 mg BID have not been studied in 2 head-to-head clinical trials.

In a separate, 12-week, randomized, double-blind, non-forced titration study (ie, titrate-to-goal) designed to show noninferiority and conducted in elderly/very elderly patients with hypertension (mean age 71.9 years), noninferiority, but not superiority, of BENICAR (20 mg and 40 mg QD) to Cozaar® (50 mg and 100 mg QD) was demonstrated based on the primary endpoint of mean DBP reductions from baseline at Week 12. The majority of patients were on low-dose ARB at time of primary endpoint assessment.2

Selected Safety Information: FETAL TOXICITY

BENICAR, BENICAR HCT, AZOR, and TRIBENZOR are Pregnancy Category D.

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue BENICAR, BENICAR HCT, AZOR, or TRIBENZOR as soon as possible
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS AND PRECAUTIONS: Fetal Toxicity

Please see Important Safety Information on this page for BENICAR, BENICAR HCT, AZOR, and TRIBENZOR.

Please see Full Prescribing Information for BENICAR and BENICAR HCT, including Boxed WARNINGS regarding Fetal Toxicity.


Effiacy - benicar monotherapy

benicar monotherapy

Powerful BP reductions at both the 20 mg and 40 mg doses4

In 12-week, placebo-controlled studies of patients with mild-to-moderate hypertension, BENICAR monotherapy provided significant BP reductions—beginning at the starting dose of 20 mg once daily4:

  • Studies show that BENICAR 20 mg (the usual recommended starting dose) resulted in significant mean reductions in trough BP of 15/12 mm Hg (mean placebo reductions of 6/6 mm Hg, mean baseline 159–162/104 mm Hg)4
  • BENICAR 40 mg resulted in significant mean reductions in trough BP of 18/13 mm Hg (mean placebo reductions of 6/6 mm Hg, mean baseline 159–162/104 mm Hg)4
Benicar Placebo BP reductions
Benicar Placebo BP reductions
Benicar Placebo BP reductions

BENICAR placebo-controlled studies: Mean baseline BP for all treatment groups was 159–162/104 mm Hg.4

Continuous SBP power for the entire 24-hour dosing period: BENICAR 20 mg starting dose

Benicar 24-hour mean SBP Reductions
Benicar 24-hour mean SBP Reductions
Benicar 24-hour mean SBP Reductions

24-hour ambulatory blood pressure monitoring (ABPM) baseline for BENICAR 20 mg (n=39) was 149/95 mm Hg; 24-hour ABPM baseline for placebo (n=41) was 149/94 mm Hg.2

Selected Safety Information: SPRUE‐LIKE ENTEROPATHY

Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of BENICAR, BENICAR HCT, AZOR, or TRIBENZOR in cases where no other etiology is identified.

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue BENICAR, BENICAR HCT, AZOR, or TRIBENZOR as soon as possible
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS AND PRECAUTIONS: Fetal Toxicity

Please see Important Safety Information on this page for BENICAR, BENICAR HCT, AZOR, and TRIBENZOR.

Please see Full Prescribing Information for BENICAR and BENICAR HCT, including Boxed WARNINGS regarding Fetal Toxicity.


Efficay - BENICAR HCT MATRIX Trial

BENICAR HCT MATRIX Trial

Moderate patients taking BENICAR HCT experienced powerful BP drops.5

In the pivotal MATRIX trial, which studied patients with moderate hypertension, a mean systolic blood pressure (SBP) reduction of 27 mm Hg was seen in the BENICAR HCT (olmesartan medoxomil-hydrochlorothiazide) 40/25 mg treatment arm at Week 8.5

Baseline BP values and demographic characteristics2,5

Benicar Placebo mean baseline 154/103 mm Hg SBP drops in Pivotal Matrix

Benicar Placebo mean baseline 154/103 mm Hg SBP drops in Pivotal Matrix
Benicar Placebo mean baseline 154/103 mm Hg SBP drops in Pivotal Matrix

In the pivotal US MATRIX trial, there were too few subjects (14% ≥65 years) to identify response differences based on age greater than or less than 65 years.

A total of 502 patients were included in the pivotal US MATRIX trial across 12 different treatment arms evaluating monotherapy with placebo, BENICAR, HCTZ, or BENICAR HCT. Duration=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. The primary endpoint was the change in mean trough diastolic blood pressure (DBP) from baseline at Week 8.5

Nearly 80% of patients reached goal (<140/90 mm Hg) with BENICAR HCT 40/25 mg (BENICAR HCT: 79.5%; placebo: 19.0%; mean seated baseline for placebo was 152/103 mm Hg)6

Benicar Monotherapy 8 out of 10 patients reach goal at week 8
Benicar Monotherapy 8 out of 10 patients reach goal at week 8
Benicar Monotherapy 8 out of 10 patients reach goal at week 8

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.

 

Selected Safety 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, BENICAR HCT, AZOR, or TRIBENZOR.

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue BENICAR, BENICAR HCT, AZOR, or TRIBENZOR as soon as possible
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS AND PRECAUTIONS: Fetal Toxicity

Please see Important Safety Information on this page for BENICAR, BENICAR HCT, AZOR, and TRIBENZOR.

Please see Full Prescribing Information for BENICAR and BENICAR HCT, including Boxed WARNINGS regarding Fetal Toxicity.

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4 Prod - Important Safety Information

INDICATIONS:

BENICAR (olmesartan medoxomil), BENICAR HCT (olmesartan medoxomil-hydrochlorothiazide), AZOR (amlodipine and olmesartan medoxomil), and TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) are indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which these drugs principally belong. There are no controlled trials demonstrating risk reduction with BENICAR, BENICAR HCT, AZOR, or TRIBENZOR.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

BENICAR, BENICAR HCT, AZOR, and TRIBENZOR can be used alone or with other antihypertensive agents.

AZOR is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Initial therapy with AZOR is not recommended in patients ≥75 years of age or in hepatically impaired patients.

BENICAR HCT and TRIBENZOR are not indicated for the initial therapy of hypertension.

Important Safety Information for BENICAR®, BENICAR HCT®, AZOR®, and TRIBENZOR®

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue BENICAR, BENICAR HCT, AZOR, or TRIBENZOR as soon as possible
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS AND PRECAUTIONS: Fetal Toxicity

CONTRAINDICATIONS

Do not co-administer aliskiren with BENICAR, BENICAR HCT, AZOR, or TRIBENZOR in patients with diabetes.

BENICAR HCT and TRIBENZOR are contraindicated in patients with anuria. BENICAR HCT is contraindicated in patients with hypersensitivity to any component of BENICAR HCT. TRIBENZOR is contraindicated in patients with hypersensitivity to other sulfonamide-derived drugs.

WARNINGS AND PRECAUTIONS

Morbidity in Infants: Children <1 year of age must not receive BENICAR for hypertension. Safety and effectiveness of AZOR, BENICAR HCT or TRIBENZOR have not been established in pediatric patients.

Fetal Toxicity: BENICAR, BENICAR HCT, AZOR, and TRIBENZOR are Pregnancy Category D.

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, BENICAR HCT, AZOR, or TRIBENZOR.

Impaired Renal Function:

Patients whose renal function may depend in part upon the activity of the renin-angiotensin-aldosterone system (eg. patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion), may be at particular risk of developing acute renal failure on BENICAR, BENICAR HCT, AZOR and TRIBENZOR. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on BENICAR, BENICAR HCT, AZOR and TRIBENZOR.

Safety and effectiveness of BENICAR HCT in patients with severe renal impairment (CrCl ≤ 30 mL/min) have not been established. Avoid use of TRIBENZOR in patients with severely impaired renal function (creatinine clearance ≤30 mL/min). If progressive renal impairment becomes evident, consider withholding or discontinuing TRIBENZOR.

Sprue-like Enteropathy: Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of BENICAR, BENICAR HCT, AZOR, or TRIBENZOR in cases where no other etiology is identified.

Hepatic Impairment: Initial therapy with AZOR or TRIBENZOR is not recommended in hepatically impaired patients. In patients with severe hepatic impairment, exercise caution with AZOR and avoid use of TRIBENZOR. Thiazides (a component in BENICAR HCT and TRIBENZOR) may cause minor alterations of fluid and electrolyte balance that may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.

Electrolyte and Metabolic Imbalances: BENICAR HCT and TRIBENZOR contain hydrochlorothiazide which can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. BENICAR, BENICAR HCT, AZOR and TRIBENZOR also contain olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalemia. Monitor serum electrolytes periodically.

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

Hypersensitivity Reaction: Hypersensitivity reactions to HCTZ (a component in BENICAR HCT and TRIBENZOR) 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: Thiazides (a component in BENICAR HCT and TRIBENZOR) have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Acute Myopia and Secondary Angle-Closure Glaucoma: Thiazides can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Discontinue HCTZ (a component in BENICAR HCT and TRIBENZOR) as rapidly as possible in these patients.

Vasodilation: Although vasodilation attributable to amlodipine (a component in AZOR and TRIBENZOR) is gradual in onset, acute hypotension has rarely been reported after oral administration. Patients with severe aortic stenosis may be at particular risk.

Increased Angina and/or Myocardial Infarction: Patients taking AZOR or TRIBENZOR, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dose increase.

Laboratory Tests: There was a greater decrease in hemoglobin and hematocrit with AZOR compared to either component alone. Other lab abnormalities may include increased blood creatinine levels and hyperkalemia (olmesartan medoxomil), hepatic enzyme elevations (amlodipine), and increased cholesterol and triglyceride levels (HCTZ).

DRUG INTERACTIONS

Non-Steroidal Anti-Inflammatory Agents: Concurrent administration of non-steroidal anti-inflammatory drugs (NSAIDs) may lead to increased risk of renal impairment (including possible acute renal failure) and loss of antihypertensive effect of BENICAR, BENICAR HCT, AZOR, and TRIBENZOR.

Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on BENICAR, BENICAR HCT, AZOR, or TRIBENZOR and other agents that affect the RAS.

Do not co-administer aliskiren with BENICAR, BENICAR HCT, AZOR, or TRIBENZOR in patients with diabetes. Avoid use of aliskiren with BENICAR, BENICAR HCT, AZOR, or TRIBENZOR in patients with renal impairment (GFR <60 mL/min).

Concurrent Use with Colesevelam Hydrochloride: Concurrent administration of colesevelam hydrochloride with BENICAR, BENICAR HCT, AZOR, or TRIBENZOR reduces the systemic exposure and peak plasma concentration of olmesartan. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose.

Effect of Amlodipine on Simvastatin: Due to increased exposure to simvastatin, when co-administered with amlodipine (a component in AZOR and TRIBENZOR), do not exceed doses of greater than 20 mg daily of simvastatin.

Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of olmesartan or thiazide diuretics. Monitor lithium levels in patients receiving BENICAR, BENICAR HCT, AZOR, or TRIBENZOR and lithium.

Antidiabetic drugs: Dosage adjustment of the antidiabetic drug may be required due to hydrochlorothiazide (a component of BENICAR HCT and TRIBENZOR).

Cholestyramine and colestipol: Reduced absorption of thiazides. Consider administering BENICAR HCT 4 hours before or 4-6 hours after the administration of the resin.

Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia due to hydrochlorothiazide (a component of BENICAR HCT and TRIBENZOR).

ADVERSE REACTIONS

BENICAR: The only adverse reaction that occurred in >1% of patients treated with BENICAR and more frequently than placebo was dizziness (3% vs 1%).

BENICAR HCT: Adverse reactions 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%).

AZOR: The most common adverse reaction (incidence ≥3%) in patients treated with AZOR was edema.

TRIBENZOR: The most frequently reported adverse reaction was dizziness (5.8% to 8.9%). The other most frequent adverse reactions occurring in ≥2% of patients treated with TRIBENZOR were peripheral edema (7.7%), headache (6.4%), fatigue (4.2%), nasopharyngitis (3.5%), muscle spasms (3.1%), nausea (3.0%), upper respiratory tract infection (2.8%), diarrhea (2.6%), urinary tract infection (2.4%), and joint swelling (2.1%).

USE IN SPECIFIC PATIENT POPULATIONS

Nursing Mothers: Avoid use while nursing; discontinue either nursing or the drug.

Please see Full Prescribing Information for BENICARBENICAR HCTAZOR, and TRIBENZOR.

Efficacy - Footnote

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