Hypertension Drug Letairis Gets New Boxed Warning: No Monthly Liver Enyme Test Required

Monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), according to the U.S. Food and Drug Administration (FDA). The drug is used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

Citing data from clinical trials and post-market reports, the FDA said that the drug poses only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug’s boxed warning. [Read more…]

New Drug, Edarbi, Approved to Treat High Blood Pressure (Hypertension)

The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.

Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan). [Read more…]

High Blood Pressure and Cholesterol Not Being Treated Effectively in More than 50% of U.S. Adults, Says Report

Two out of three U.S. adults with high cholesterol and half of U.S. adults with high blood pressure are not being treated effectively, according to a recent report from the Centers for Disease Control (CDC).

The findings were reported in the CDC’s Vital Signs, a report that appears on the first Tuesday of the month as part of the CDC journal Morbidity and Mortality Weekly Report (MMWR). Vital Signs is designed to provide the latest data and information on key health indicators – cancer prevention, obesity, tobacco use, alcohol use, access to health care, HIV/AIDS, motor vehicle passenger safety, health care-associated infections, cardiovascular health, teen pregnancy, infant mortality, asthma and food safety. [Read more…]

Generic Versions of Cozaar and Hyzaar Tablets Approved for Hypertension Treatment

The U.S. Food and Drug Administration approved today the first generic versions of two drugs used for the treatment of hypertension. Losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets (a combination drug) are the generic equivalents of Cozaar and Hyzaar tablets, respectively.

Cozaar and Hyzaar tablets are widely-used antihypertensive drugs. Both generic losartan products will carry the same safety warnings as their brand counterparts. These warnings include a boxed warning against the use of these products during the second and third trimesters of pregnancy.

Losartan potassium tablets are approved in 25 milligram, 50 mg, and 100 mg strengths, and Losartan potassium and hydrochlorothiazide tablets are approved in 50 mg/12.5 mg, 100mg/12.5 mg, and 100 mg/25 mg strengths. Both products are manufactured by TEVA Pharmaceuticals USA in North Wales, Pa.

In related actions, the FDA also approved applications from several other companies for losartan potassium and hydrochlorothiazide tablets for the 100 mg/12.5 mg strength only. These companies include Mylan Pharmaceuticals Inc., Roxane Laboratories Inc., and Torrent Pharmaceuticals Ltd.

Source: FDA, April 7, 2010

Calcium-Channel Blockers No Better Than Diuretics for Treating Hypertension

Diuretics are just as effective as calcium-channel blockers, alpha-blockers or angiotensin-converting enzymes (ACE) inhibitors when treating hypertension among patients with metabolic syndrome, according to a report in the Archives of Internal Medicine.

Metabolic syndrome is defined as hypertension with at least two of the following factors: high glyceride levels, diabetes, a body mass index (BMI) of at least 30, and low levels of "good cholesterol." Patients with metabolic syndrome are at high risk for complications of cardiovascular disease.

While some alpha-blockers, ACE inhibitors and calcium channel blockers have more favorable short-term effects on blood glucose or blood cholesterol levels, they have been promoted over beta-blockers and diuretics to treat patients with metabolic syndrome.

Researchers at Case Western Reserve University, Cleveland, analyzed data from the Antihypertensive and Lipid- Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). 42,418 hypertension patients with at least one other risk factor for heart disease were randomly picked to take either a diuretic (chlorthalidone -15,255 patients), a calcium channel blocker (doxazosin mesylate – 9,061 patients), or an ACE inhibitor (lisinopril – 9,054 patients).

Other drugs could be added if necessary to control blood pressure, and patients were checked for an average of 4.9 years for all drugs administered except the alpha-blocker. Followup of this drug was discontinued after 3.2 years, because increased rates of cardiovascular disease were noted, including nearly twice the rate of heart failure, compared with the group taking diuretics. A total of 23,077 ALLHAT participants (54.4%) met criteria for metabolic syndrome.

"No differences were noted among the four treatment groups, regardless of race or metabolic syndrome status for the primary end point (non-fatal myocardial infarction [heart attack] and fatal coronary heart disease)," the authors write.

Among patients with the metabolic syndrome (7,327 black and 15,750 white patients), the calcium channel blocker, ACE inhibitor and alpha-blocker had higher rates of heart failure compared with the diuretic; the ACE inhibitor and the alpha-blocker also had an increased risk of combined cardiovascular disease.

"The lack of benefit of the agents with the most favorable metabolic profile (i.e., ACE inhibitors and alpha-blockers) was especially marked in the black participants with metabolic syndrome," the authors write. "The magnitude of the excess risk of end-stage renal disease (70 percent), heart failure (49 percent) and stroke (37 percent) and the increased risk of combined cardiovascular disease and combined coronary heart disease strongly argue against the preference of ACE inhibitors over diuretics as the initial therapy in black patients with metabolic syndrome. Similar higher risk was noted for those randomized to the alpha-blocker vs. the diuretic."

"These findings fail to provide support for the selection of alpha-blockers, ACE inhibitors, or calcium channel blockers over thiazide-type diuretics to prevent cardiovascular or renal outcomes in patients with metabolic syndrome, despite their more favorable metabolic profiles," the authors conclude.

This study was supported by a contract from the National Heart, Lung, and Blood Institute and by Pfizer Inc. (ALLHAT).

Source: Arch Intern Med. 2008;168[2]:207-217.

Cardiologists Call for New Approach in Treating Chest Pain

In a joint statement by the American College of Cardiology (ACC) and the American Heart Association (AHA), physicians are calling for a more aggressive approach to evaluating patients presenting with chest pain (unstable angina)—and quickly determining whether the therapeutic approach should be medical, invasive or a combination of two.

Guidelines released today by the ACC encourage the early use of tests such as a stress test, an echocardiogram or a radionuclide angiogram (which visualizes the coronary arteries) in patients considered stable.

Cessation of smoking, lowering blood pressure, and lowering cholesterol are all part of the effort to lower the risk of heart attack.

The new guidelines call for an LDL cholesterol to be lower than 100 mg/dL, with a target number of 70 mg/dL. Blood pressure should be lower than 140/90.

A significant new recommendation is the guideline to cease prescribing hormone replacement therapy (HRT) for post-menopausal women.

Increased Waist Circumference Flags Health Problems

The consequences of growing a "spare tire" means more than having to wear an oversize Hawaiian shirt to the pool.

According to a recently published study by Dr. Steven Kaplan, professor of urology at Cornell University, increased waist circumference provides "powerful correlation" for predicting whether male patients have an increased incidence of erectile and ejaculatory problems, diabetes, hypertension increased blood pressure, a high lipid level and an enlarged prostate.

Health Campaign Calls for 50% Less Salt Consumption

Because of the modern American diet, most people get too much sodium, though some older adults don’t get enough. How much salt is too much?

More and more evidence points to a need for Americans to decrease their salt intake. To that end, the American Medical Association (AMA), the American Heart Association (AHA), the American Dietetic Association (ADA), and the National Institutes of Health have kicked off a campaign with a goal of reducing individuals’ salt intake to 50% of the current levels.

Amy Schnabel, a clinical nutrition manager at UCLA Medical Center predicts that 90% of Americans will develop high blood pressure if they don’t take positive steps to prevent it.

High salt intake can lead to hypertension and increased risk of stroke or heart attack.
The good news is that there are some simple things that can be done to vastly decrease cardiovascular disease risks.

A recent study in the British Medical Journal showed that reducing salt intake by about 30% can reduce the risk of cardiovascular disease by 25%.

According to experts, the key is improved awareness about what you eat—identifying which foods contain high amounts of sodium.

The FDA recommends no more than 2,400 mg per day, or about 1 teaspoon.

Sources:

  • British Medical Journal (April 19, 2007)
  • Newswise: Belvoir Media Group

Novartis Combination Hypertension Drug May Be Unsafe

According to a U.K. medical journal, Novartis AG’s two hypertension drugs made by combining Diovan and Tekturna although more effective in lowering blood pressure, may have some life-threatening side effects.

A recent study found that these drugs when taken in combination, at the maximum recommended doses, are more beneficial than when taken separately. However, the combination drug may cause a life-threatening side effect of high blood potassium.

Novartis has disputed these results by claiming that these drugs are no more likely to increase blood potassium levels than when either of the two drugs is taken alone.

A Soft-Drink a Day Increases Heart Disease Risk Factors

Adults who drink at least one soft drink per day are 30% more likely to develop new-onset diabetes or have low levels of good cholesterol.

A recent study in Circulation: Journal of the American Heart Association reports that drinking at least one soft drink a day of a diet or regular soft drink are at greater risk for heart disease than those who don’t. The study was conducted on 3,500 middle aged men and women. The study found that soft-drink consumers are more likely to develop matabolic syndrome, a combination of
a combination of factors like high blood pressure and elevated triglycerides — are more likely to suffer diabetes and heart disease.

Adults who consume at least one soft drink a day are more likely to develop risk factors for heart disease than those who don’t, even if the beverage is diet, according to a study published today in Circulation: Journal of the American Heart Association.

Researchers studying about 3,500 middle-aged men and women as part of a larger, long-term heart study found an association between daily soft drink consumption and an increased risk of developing metabolic syndrome.

The American Heart Association defines metabolic syndrome as:

  • Abdominal obesity (excessive fat tissue in and around the abdomen)
  • Atherogenic dyslipidemia (blood fat disorders — high triglycerides, low HDL cholesterol and high LDL cholesterol — that foster plaque buildups in artery walls)
  • Elevated blood pressure
  • Insulin resistance or glucose intolerance (the body can’t properly use insulin or blood sugar)
  • Prothrombotic state (e.g., high fibrinogen or plasminogen activator inhibitor–1 in the blood)
  • Proinflammatory state (e.g., elevated C-reactive protein in the blood)
  • Metabolic syndrome is a growing problem in America, where an estimated 50 million people exhibit symptoms and have greater risk of coronary heart disease and other diseases related to plaque buildups in artery walls.