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J-CHF: Small doses of carvedilol per day as effective as higher recommended doses

However, discussant warns the data are not strong enough to change clinical practice.

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American Heart Association Scientific Sessions 2009

Results of the Japanese-Chronic Heart Failure study show that patients benefited from lower doses of the beta-blocker carvedilol and suggest that tailoring the dose of the drug to the individual patient’s response is better than a “one-size-fits-all” approach.

The J-CHF researchers enrolled 364 patients with NYHA II or III heart failure and assigned them to one of three dosages of carvedilol: 2.5 mg (n=116), 5 mg (n=121) and 20 mg (n=120). There were no real differences in baseline characteristics in patients. Patients aged 20 to 80 years old were included if they had NYHA Class II or III heart failure and ejection fraction ≤40%.

During three years of follow-up, 20% of patients reached the primary endpoint of all-cause death or hospitalization for CVD including heart failure. The researchers reported no statistically significant difference between the three groups. However, 23% of patients assigned to 20 mg per day had to discontinue or change their dose due to adverse effects compared with only 2% in the 2.5 mg group and 4.2% in the 5 mg group.

In the 20 mg group, patients experienced more hypotension bradycardia (11.2%) than in the 2.5 mg group (3.4%) or 5 mg group (6%). Cardevilol use was discontinued in 3.4% of the 20 mg group, 2.6% of the 5 mg group and 1.7% of the 2.5 mg group.

In most Western countries, 50 mg to 100 mg per day is recommended, Masatsugu Hori, MD, from Osaka Medical Center for Cancer and CVD in Japan, said. But based on the MUCHA trial conducted in Japan, a small dose of 5 mg to 20 mg of carvedilol is recommended as the maintenance dose.

“J-CHF suggests initiating carvedilol at the lowest dose and increasing the dose incrementally until the desired reductions in heart rate and/or plasma brain natriuretic peptide are achieved,” according to Hori’s slide presentation during the late-breaking clinical trial session this morning. – by Judith Rusk

For more information:

• Hori M. #152. Presented at: American Heart Association Scientific Sessions 2009; Nov. 14-18, 2009; Orlando, Fla.

To date, all outcomes studies are being conducted with drug up-titration to target maximal does. J-CHF is the first study to assess propsectively the different doses of a beta-blocker on a clinical outcome as a primary endpoint. Results must be considered only as hypothesis generating and must not change current clinical practice.

– Marco Metra, MD

Brescia, Italy

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