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Getting High Blood Pressure Under Control

Posted 10/15/2010

Getting High Blood Pressure Under Control

(NAPSI) - High blood pressure is one of the most common medical conditions in the U.S., affecting about one in three American adults.1 The condition has no specific symptoms, and can remain undetected for many years, increasing the risk of heart, brain and kidney related diseases such as stroke, heart attack, heart and kidney failure.2 In fact, it is estimated that more than 22 percent of people with high blood pressure in the U.S. are not aware they have the condition.1

Detection Is Key

The impact of high blood pressure is influenced by both gender and age. Up until age 45, more men than women have it, but the pendulum then swings back to the center from ages 45 to 54, where the percentages of men and women afflicted with high blood pressure are similar. After age 54, a much higher percentage of women have high blood pressure than men.3

The cause of 90 to 95 percent of the cases of high blood pressure isn't known. However, once it is detected, it is usually controllable.1 If you have been diagnosed with high blood pressure, it is important for you and your doctor to work together to bring it under control.

Steps You Can Take

The good news is that there are a number of things you can do about it, including the following4:

• ‑Eat a healthy diet and limit salt intake

• ‑Participate in regular physical activity

• Maintain a healthy weight

• Reduce stress

• Avoid smoking

• Limit alcohol consumption

• ‑Discuss appropriate prescription treatment options with your doctor

• ‑Know your blood pressure and work to keep it at appropriate levels.

Medication Can Help

Because high blood pressure is a "silent" condition, proper management is critical, however, it is often challenging to keep it at the recommended blood pressure goal of 140/90 mm Hg or 130/80 mm Hg for those with certain chronic health conditions, such as diabetes or kidney disease.2,5 Sometimes diet and exercise alone are not enough, and medical intervention is needed.

More than half of people taking current blood pressure−lowering therapies do not reach recommended blood pressure goals.5 According to experts, most patients with high blood pressure will need to take two or more antihypertensive medications to achieve their blood pressure goal.5 Fixed-dose combination therapies have become increasingly popular as effective treatment options to lower blood pressure within the medical community.5,6

In fact, a new combination product, TRIBENZOR™ (olmesartan medoxomil, amlodipine, hydrochlorothiazide), was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. It is not indicated for initial therapy. It combines three widely prescribed antihypertensive medications, each working in a different way, to lower blood pressure to help patients reach their goal7: olmesartan medoxomil (the active ingredient in Benicar, which blocks angiotensin II receptors), amlodipine (which blocks the entrance of calcium into the blood vessel walls), and hydrochlorothiazide (a diuretic which reduces water volume in the blood).7 Together these three medications allow blood vessels to relax so that blood can flow more easily. 7

The convenience of three effective medications in one product may help provide people with a simple and convenient treatment option. But as always, it's important for people with hypertension to speak with their doctor about establishing an appropriate treatment regimen that includes diet, exercise and, if necessary, the proper medication.

The most common adverse reactions (incidence ≥2 percent) seen in clinical trials for TRIBENZOR were dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling.

For more information about TRIBENZOR, including full prescribing information, please visit www.tribenzor.com.

1 American Heart Association. High Blood Pressure Statistics. Available at http://www.americanheart.org/presenter.jhtml?identifier=4621 Accessed on June 29, 2010.

2 American Heart Association. Discover Why High Blood Pressure Matters. Available at http://www.americanheart.org/presenter.jhtml?identifier=2129 Accessed on June 29, 2010.

3 American Heart Association. Heart Disease and Stroke Statistics: 2007 Update At-A-Glance, p. 20. Available at: http://www.americanheart.org/downloadable/heart/1166712318459HS_StatsInsideText.pdf. Accessed June 22, 2010.

4 American Heart Association. Prevent and Treat High Blood Pressure. Available at: http://www.americanheart.org/presenter.jhtml?identifier=2133. Accessed on June 29, 2010.

5 U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. NIH Publication No. 04-5230. August 2004.

6 Gupta AK, et al. Compliance, Safety, and Effectiveness of Fixed-Dose Combinations of Antihypertensive Agents: A Meta-Analysis. Hypertension. 2010;55;399-407.

7 Daiichi Sankyo, Inc.. TRIBENZOR Prescribing Information.

Note to Editor: IMPORTANT SAFETY INFORMATION ABOUT TRIBENZOR.

WARNING: AVOID USE IN PREGNANCY

When pregnancy is detected, discontinue TRIBENZOR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. See WARNINGS AND PRECAUTIONS. Fetal/Neonatal Morbidity and Mortality.

Contraindications

TRIBENZOR is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Hypotension in Volume- or Salt-Depleted Patients

In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients, symptomatic hypotension due particularly to the olmesar-

tan component may occur after initiation of treatment with TRIBENZOR. Treatment should start under close medical supervision.

Increased Angina and Myocardial Infarction

Patients, 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 dosage increase.

Impaired Renal Function

Avoid use in patients with severely impaired renal function (creatinine clearance ≤30 mL/min). If progressive renal impairment becomes evident, consider with

holding or discontinuing TRIBENZOR.

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 effects would be

expected with TRIBENZOR because of the olmesartan medoxomil component.

Thiazides may precipitate azotemia in patients with renal disease. Cumulative effects of the drug may develop in patients with impaired renal function.

Hepatic Impairment

Avoid use in patients with severely impaired hepatic function.

Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with severely impaired hepatic function.

Minor alterations of fluid and electrolyte balance due to hydrochlorothiazide may precipitate hepatic coma.

Electrolyte and Metabolic Imbalances

Due to the hydrochlorothiazide component, observe patients for clinical signs of fluid or electrolyte imbalance.

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 history.

Systemic Lupus Erythematosus

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Vasodilation

Although vasodilation attributable to amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration. Patients with severe

aortic stenosis may be at particular risk.

Lithium Interaction

Lithium generally should not be given with thiazides.

Adverse Reactions

The most frequently reported adverse reaction was dizziness (5.8 to 8.9%). The other most frequent adverse reactions occurring in greater than or equal to 2% of

patients treated with TRIBENZOR are 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%)

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