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New Study Reports Treatment with Toprol-XL (Metoprolol Succinate) Extended-Release Tablets for Hypertensive Children

WILMINGTON, DE -- May 18, 2005 -- AstraZeneca announced new data for beta-blocker Toprol-XL® (metoprolol succinate) extended-release tablets in treating hypertension in pediatric patients. The data were presented May 16 in a press briefing at the 20th annual scientific meeting of the American Society of Hypertension (ASH) in San Francisco. This study adds to the established data on Toprol-XL in the treatment of hypertension in adults. Hypertension affects one in three adults and approximately one in 100 children in the United States.1,2

"Hypertension in children is becoming increasingly common, in part related to the rise in childhood obesity. There is limited data on the treatment of pediatric hypertension. This study helps fill an unmet need by exploring new treatment options for children with hypertension," said lead investigator Bonita Falkner, M.D., Department of Medicine and Pediatrics, Thomas Jefferson University in Philadelphia and Chair of the National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents.

The trial was a double-blind, placebo-controlled, randomized, parallel group study of 144 children, ages six to 16, with primary hypertension. Each patient was randomized to one of four treatment arms (placebo or Toprol-XL 0.2 mg/kg "low," 1.0 mg/kg "medium," or 2.0 mg/kg "high") for four weeks. Systolic blood pressure served as the primary measure.

The mean systolic blood pressure was reduced with Toprol-XL (low/medium/high doses pooled) by 6.2 mm Hg versus placebo 1.9 mm Hg (P = .03). None of the patients receiving Toprol-XL required discontinuation because of an adverse event. The most common adverse events for Toprol-XL versus placebo were headache (11.7% vs. 16.7%), upper respiratory tract infection (6.8% vs. 4.2%), dizziness (4.2% vs. 4.2%), and cough (2.5% vs. 8.3%).

Important Information About Toprol-XL
Toprol-XL is a beta1-selective (cardioselective) adrenoceptor-blocking agent, for oral administration, available as extended-release tablets. Toprol-XL has been formulated to provide a controlled and predictable release of metoprolol succinate for once-daily administration. Toprol-XL currently is available in 25-mg, 50-mg, 100-mg, and 200-mg tablets.

Indications for Toprol-XL include the treatment of hypertension, alone or in combination with other antihypertensives; the long-term treatment of angina pectoris; and the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis.

Toprol-XL is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, and sick sinus syndrome (unless a permanent pacemaker is in place).

Patients taking Toprol-XL should avoid abrupt cessation of therapy. Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. The dosage should be reduced gradually over a one-to-two week period and the patient should be carefully monitored. For full prescribing information for Toprol-XL including boxed WARNING regarding abrupt cessation of therapy, call 1-800-236-9933 or visit www.astrazeneca-us.com.

As with other beta-blockers, Toprol-XL should be used with caution in patients who have diabetes, bronchospastic disease, thyrotoxicosis, peripheral vascular disease, who are undergoing major surgery, or who take calcium channel blockers of the verapamil and diltiazem type.

In patients with hypertension or angina pectoris, the most common side effects with Toprol-XL are tiredness (10%), depression (5%), diarrhea (5%), itching or rash (5%), shortness of breath (3%), and bradycardia (3%).

About Hypertension in Children

Hypertension is estimated to affect more than 50 million adults. Although hypertension is more prevalent in adults, it is occurring with increasing frequency in children as well. The changing epidemiology of pediatric hypertension is attributed to a rise in childhood obesity, inactivity, and poor dietary habits. The typical pediatric patient with hypertension is most commonly an otherwise healthy child with obesity and associated cardiovascular risk factors. These observations suggest that the trend of decreasing cardiovascular disease in adults observed over the past 50 years may be reversed as the current population of hypertensive children and adolescents grow into adulthood. Hypertension in childhood is considered a chronic medical condition and may require long-term treatment. Thus, early recognition and intervention for hypertension is recommended to begin in childhood by the National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents.

Toprol-XL is a registered trademark of the AstraZeneca group of companies.


References:
1 American Heart Association. Heart Disease and Stroke Statistics-2005 Update. Dallas, Texas. American Heart Association; 2005.
2 Temple ME, Nahata MC. Treatment of pediatric hypertension. Pharmacother. 2000;20(2):140-150.



SOURCE: AstraZeneca LP

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