Edarbi (Page 4 of 5)

14 CLINICAL STUDIES

The antihypertensive effects of Edarbi have been demonstrated in a total of seven double-blind, randomized studies, which included five placebo-controlled and four active comparator-controlled studies (not mutually exclusive). The studies ranged from six weeks to six months in duration, at doses ranging from 20 mg to 80 mg once daily. A total of 5941 patients (3672 given Edarbi, 801 given placebo, and 1468 given active comparator) with mild, moderate or severe hypertension were studied. Overall, 51% of patients were male and 26% were 65 years or older; 67% were white and 19% were black.

Two 6-week, randomized, double-blind studies compared the effect on blood pressure of Edarbi at doses of 40 mg and 80 mg, with placebo and with active comparators. Blood pressure reductions compared to placebo based on clinic blood pressure measurements at trough and 24-hour mean blood pressure by ambulatory blood pressure monitoring (ABPM) are shown in Table 1 for both studies. Edarbi, 80 mg, was statistically superior to placebo and active comparators for both clinic and 24-hour mean blood pressure measurements.

Table 1. Placebo Corrected Mean Change from Baseline in Systolic/Diastolic Blood Pressure at 6 Weeks (mm Hg)
Study 1N=1285Study 2N=989
Clinic Blood Pressure(Mean Baseline 157.4/92.5)24 Hour Mean by ABPM(Mean Baseline 144.9/88.7)Clinic Blood Pressure(Mean Baseline 159.0/91.8)24 Hour Mean by ABPM(Mean Baseline 146.2/87.6)
Edarbi 40 mg -14.6/-6.2-13.2/-8.6-12.4/-7.1-12.1/-7.7
Edarbi 80 mg -14.9/-7.5-14.3/-9.4-15.5/-8.6-13.2/-7.9
Olmesartan 40 mg -11.4/-5.3-11.7/-7.7-12.8/-7.1-11.2/-7.0
Valsartan 320 mg -9.5/-4.4-10.0/-7.0

In a study comparing Edarbi to valsartan over 24 weeks, similar results were observed.

Most of the antihypertensive effect occurs within the first two weeks of dosing.

Figure 2 shows the 24-hour ambulatory systolic and diastolic blood pressure profiles at endpoint.

Figure 2. Mean Ambulatory Blood Pressure at 6 Weeks by Dose and Hour
Figure 2
(click image for full-size original)

Other studies showed similar 24-hour ambulatory blood pressure profiles.

Edarbi has a sustained and consistent antihypertensive effect during long-term treatment, as shown in a study that randomized patients to placebo or continued Edarbi after 26 weeks. No rebound effect was observed following the abrupt cessation of Edarbi therapy.

Edarbi was effective in reducing blood pressure regardless of the age, gender, or race of patients, but the effect, as monotherapy, was smaller, approximately half, in black patients, who tend to have low renin levels. This has been generally true for other angiotensin II antagonists and ACE inhibitors.

Edarbi has about its usual blood pressure lowering effect size when added to a calcium channel blocker (amlodipine) or a thiazide-type diuretic (chlorthalidone).

There are no trials of Edarbi demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits.

16 HOW SUPPLIED/STORAGE AND HANDLING

Edarbi tablets are unscored and white to nearly white, debossed with “ASL” on one side and “40″ or “80″ on the other.

Tablet NDC 60631-xxx-xx
Bottle/30
40 mg 040-30
80 mg 080-30

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture and light. Do not repackage; dispense and store in original container.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (17.2).

17.1 General Information

Pregnancy

Tell female patients of childbearing potential about the consequences of exposure to Edarbi during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible.

17.2 FDA-Approved Patient Labeling

Patient Information
Edarbi (eh-DAR-bee)
(azilsartan medoxomil)
Tablets

Read this Patient Information leaflet before you start taking Edarbi and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about Edarbi?

  • Edarbi can cause harm or death to your unborn baby.
  • Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
  • If you become pregnant while taking Edarbi, tell your doctor right away. Your doctor may switch you to a different medicine to treat your high blood pressure.

What is Edarbi?

Edarbi is a prescription medicine called an angiotensin II receptor blocker (ARB) used to treat high blood pressure (hypertension) in adults.

Your doctor may prescribe other medicines for you to take along with Edarbi to treat your high blood pressure.

It is not known if Edarbi is safe and effective in children under 18 years of age.

What should I tell my doctor before taking Edarbi?

Before you take Edarbi, tell your doctor if you:

  • have been told that you have abnormal body salt (electrolytes) levels in your blood
  • are pregnant or plan to become pregnant. See What is the most important information I should know about Edarbi?
  • are breastfeeding or plan to breastfeed. It is not known if Edarbi passes into your breast milk. You and your doctor should decide if you will take Edarbi or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Edarbi.

Tell your doctor about all the medicines you take , including prescription and nonprescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

  • other medicines used to treat your high blood pressure or heart problem
  • water pills (diuretic)

Ask your doctor if you are not sure if you are taking a medicine listed above.

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

How should I take Edarbi?

  • Your doctor will tell you how much Edarbi to take and when to take it. Follow his/her instructions.
  • Edarbi can be taken with or without food.
  • If you take too much Edarbi, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of Edarbi?

Edarbi may cause side effects, including:

  • Harm or death to your unborn fetus if taken in the second or third trimester. See What is the most important information I should know about Edarbi?
  • Low blood pressure (hypotension) and dizziness is most likely to happen if you also:
    • take water pills (diuretics)
    • are on a low-salt diet
    • take other medicines that affect your blood pressure
    • get sick with vomiting or diarrhea
    • do not drink enough fluids

If you feel faint or dizzy, lie down and call your doctor right away.

These are not all the possible side effects with Edarbi. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store Edarbi?

  • Store Edarbi at 59°F to 86°F (15°C to 30°C).
  • Store Edarbi in the original container that you received from your pharmacist or doctor. Do not put Edarbi into a different container.
  • Keep Edarbi in a tightly closed container, and keep Edarbi out of the light.

Keep Edarbi and all medicines out of the reach of children.

General information about Edarbi.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not give Edarbi to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Edarbi. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Edarbi that is written for health professionals.

For more information, go to www.edarbi.com or call 1-866-516-4950.

What is high blood pressure (hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too great.

High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. Edarbi tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure may lower your chance of having a stroke or heart attack.

What are the ingredients in Edarbi?

Active ingredient: azilsartan medoxomil

Inactive ingredients: mannitol, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.

Manufactured by:
Takeda
Osaka, Japan

Manufactured for:

arbor
PHARMACEUTICALS, LLC

Atlanta, GA 30328

Revised: May 2014

Edarbi is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Arbor Pharmaceuticals, LLC.

©2014 Arbor Pharmaceuticals, LLC

EB-PI-02

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