Pivotal Data Showed SYMBICORT(R) Improved Lung Function in Adults... (red to placebo.(2) -- The incidence o...)

Pivotal Data Showed SYMBICORT(R) Improved Lung Function in Adults with COPD

Date:10/29/2008

red to placebo.(2)

-- The incidence of other potential lung infections (e.g., bronchitis) was generally higher for all active treatment groups, except SYMBICORT 80/4.5 mcg, compared to placebo.(2)

-- The most common drug-related adverse events were oral candidiasis, dysphonia, a voice disorder,(7) and headache.(2)

SUN Study Results (Abstracts 303 and 308)

The long-term efficacy and tolerability of SYMBICORT was assessed in a 12-month, randomized, double-blind, multicenter study evaluating 1,964 patients ages 40 years and older with moderate to very severe COPD.(3,4) After two weeks of treatment based on previous therapy (ICS and short-acting bronchodilators were allowed), patients were then randomized to receive twice-daily treatment with two inhalations of SYMBICORT pMDI 160/4.5 mcg, SYMBICORT pMDI 80/4.5 mcg, formoterol DPI 4.5 mcg or placebo.(3,4) Study results include:

-- SYMBICORT 160/4.5 mcg demonstrated significantly (P Less Than or Equal To .023) greater improvements from baseline in pre-dose FEV1 and one-hour post-dose FEV1 compared with formoterol.(3)

-- Improvements from baseline in morning and evening PEF were significantly (P Less Than or Equal To .017) greater for both SYMBICORT doses compared with formoterol and placebo.(3)

-- Exacerbation rates were significantly (P Less Than or Equal To .004) reduced by approximately 25-30 percent with both doses of SYMBICORT compared to formoterol and by approximately 40 percent compared to placebo.(3)

-- Both SYMBICORT doses demonstrated significantly (P<.038) greater improvements in BCSS (160/4.5 mcg only), sleep score, awakening-free nights (80/4.5 mcg only), and rescue medication use versus formoterol.(3)

-- Both doses of SYMBICORT were well-tolerated versus formoterol and placebo for up to 12 months.(4) The incidence of pneumonia-related adverse events were similar for all treatment arms compared to placebo.(4)

-- The incidence of other pote
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SOURCE AstraZeneca
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