Login
Subscribe
Azilsartan (EDARBI), eighth in the family of blood pressure-lowering drugs known as angiotensin receptor blockers (ARBs), was approved by the Food and Drug Administration (FDA) in February 2011. Public Citizen is recommending that consumers refrain from using azilsartan to lower blood pressure because there is no substantive evidence of a cardiovascular health benefit with this drug. Other ARBs that have not been shown to have any clinical benefit are eprosartan (TEVETEN), irbesartan...
Azilsartan (EDARBI), eighth in the family of blood pressure-lowering drugs known as angiotensin receptor blockers (ARBs), was approved by the Food and Drug Administration (FDA) in February 2011. Public Citizen is recommending that consumers refrain from using azilsartan to lower blood pressure because there is no substantive evidence of a cardiovascular health benefit with this drug. Other ARBs that have not been shown to have any clinical benefit are eprosartan (TEVETEN), irbesartan (AVAPRO) and olmesartan (BENICAR).
Lowering blood pressure can reduce the risk of fatal and nonfatal cardiovascular events — mainly strokes and heart attacks. Although no gold-standard trials have been conducted to demonstrate such risk reduction specifically with azilsartan, three other ARBs — candesartan (ATACAND), losartan (COZAAR) and telmisartan (MICARDIS) — have been shown to lower these risks. (See Table 1 for a list of ARBs available in the U.S.)
Such risk reduction also has been observed in controlled trials of blood pressure-lowering drugs from a wide variety of other drug families.
| Generic Name | Brand Name |
Approved to Reduce Fatal and/or Nonfatal Cardiovascular Events?*** |
|---|---|---|
| azilsartan* | EDARBI | No |
| candesartan** | ATACAND | Yes |
| candesartan and hydrochlorothiazide** | ATACAND HCT | No |
| eprosartan** | TEVETEN | No |
| irbesartan** | AVAPRO | No |
| irbesartan and hydrochlorothiazide** | AVALIDE | No |
| losartan** | COZAAR | Yes |
| losartan and hydrochlorothiazide** | HYZAAR | Yes† |
| olmesartan** | BENICAR | No |
| olmesartan and hydrochlorothiazide** | BENICAR HCT | No |
| telmisartan** | MICARDIS | Yes |
| telmisartan and hydrochlorothiazide** | MICARDIS HCT | No |
| valsartan** | DIOVAN | Yes |
| valsartan and hydrochlorothiazide** | DIOVAN HCT | No |
*Do Not Use
** Limited Use (offers limited benefit or benefits certain people or conditions)
*** Based on the most recent labels posted on the FDA’s website through June 1, 2012.
† Although HYZAAR is approved to reduce the risk of stroke in hypertensive patients with heart failure, the single clinical trial supporting this indication did not directly test the HYZAAR combination but rather only one component, losartan, against another anti-hypertensive, atenolol (TENORMIN).
ARBs with proven health benefits
ARBs work by affecting the renin-angiotensin-aldosterone system, a hormone system that regulates blood pressure and water balance. Unlike azilsartan, eprosartan, irbesartan and olmesartan, several approved ARBs (see Table 1 above) have been shown, in specific groups of patients, to reduce the risk of serious cardiovascular outcomes that can result from high blood pressure.
Candesartan is approved to reduce cardiovascular death and to reduce heart failure hospitalizations in patients with a malfunctioning left ventricle (the large chamber of the heart).
Losartan is FDA-approved to reduce the risk of stroke in patients with high blood pressure and an enlargement of one of the large chambers of the heart (left ventricular hypertrophy). Evidence exists that this benefit does not apply to African-American patients.
Telmisartan is approved to reduce the risk of heart attack, stroke or death from cardiovascular causes in patients 55 years or older at high risk of developing major cardiovascular events and unable to take angiotensin-converting enzyme (ACE) inhibitors, an older family of blood pressure-lowering drugs. (ACE inhibitors can cause an intolerable, persistent cough. ARBs can also cause cough but do so much less frequently.)
Valsartan (DIOVAN), another ARB, is indicated to reduce hospitalizations from heart failure and to reduce the likelihood of death from cardiovascular causes after a heart attack for patients who have experienced heart failure.
No blood pressure combination therapies that include an ARB (see Table 1) have been proven to reduce the risk of cardiovascular events in hypertensive patients. They have been proven only to reduce blood pressure. One combination therapy, losartan and hydrochlorothiazide (HYZAAR), is approved to reduce the risk of stroke in hypertensive patients with heart failure. However, the single clinical trial supporting this approval did not directly test the combination, but rather only one component, losartan, against another anti-hypertensive, atenolol (TENORMIN), with hydrochlorothiazide (ESIDRIX, HYDRODIURIL, MICROZIDE) given to patients in both groups.
Therefore, despite the FDA’s approval, there is no credible evidence to indicate whether the combination of losartan and hydrochlorothiazide is truly beneficial in reducing cardiovascular risk in patients with high blood pressure.
FDA black box warning
When taken during pregnancy, these drugs can cause serious problems in the fetus and infant, including low blood pressure, poor development of skull bones, kidney failure and death. Women who use azilsartan and become pregnant should notify their physicians as soon as possible. As is the case with all other ARBs, azilsartan carries this warning in its product label. (See Azilsartan's black box warning.)
|
Do not use ARBs, ACE inhibitors and aliskiren (TEKTURNA) together In the September 2011 Worst Pills, Best Pills News, Public Citizen reviewed a study published in the Canadian Medical Association Journal that found that people prescribed an angiotensin-converting enzyme (ACE) inhibitor in combination with an angiotensin receptor blocker (ARB) had greater risks of kidney toxicity and higher levels of potassium in the blood compared to people using a drug from either of the two families alone. In addition, in April 2012, the FDA released a safety alert warning patients not to take any ARB or ACE inhibitor with aliskiren, a relatively new blood pressure drug that also works by suppressing the renin-angiotensin-aldosterone system. Taking aliskiren in combination with ACE-inhibitor or ARB therapy resulted in higher rates of kidney toxicity and low blood pressure, and higher levels of potassium. These rates and levels were increased compared to those in people on either ACE-inhibitor or ARB therapy alone. |
| Generic Name | Brand Name |
|---|---|
| benazepril** | LOTENSIN |
| benazepril and amlodipine* | LOTREL |
| benazepril and hydrochlorothiazide** | LOTENSIN HCT |
| captopril** | CAPOTEN |
| captopril and hydrochlorothiazide** | CAPOZIDE |
| enalapril** | VASOTEC |
| enalapril and diltiazem* | TECZEM |
| enalapril and felodipine* | LEXXEL |
| enalapril and hydrochlorothiazide** | VASERETIC |
| fosinopril** | MONOPRIL |
| lisinopril** | PRINIVIL, ZESTRIL |
| lisinopril and hydrochlorothiazide** | PRINZIDE, ZESTORETIC |
| moexipril** | UNIVASC |
| perindopril** | ACEON |
| quinapril | ACCUPRIL |
| ramipril** | ALTACE |
| trandolapril** | MAVIK |
| trandolapril and verapamil* | TARKA |
* Do Not Use
** Limited Use (offers limited benefit or benefits certain people or conditions)
What You Can Do
You should not use azilsartan to treat high blood pressure.
If you are newly diagnosed with high blood pressure and have no other underlying medical conditions (such as diabetes or high cholesterol), you should try lifestyle modification first — reducing salt intake in your diet and exercising more. If these changes do not work and medical treatment is necessary, a low-dose water pill (thiazide diuretic) such as hydrochlorothiazide is recommended as the foundation for blood pressure-lowering treatment.
Control of high blood pressure should always be part of a comprehensive program that includes, as appropriate, cholesterol control, diabetes management, anti-blood-clotting treatment, smoking cessation, regular exercise and limited sodium intake.
If you must take an ARB to lower your blood pressure, you should use one with a documented cardiovascular health benefit specific to your condition.
