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• W2125352042 abstract "RationaleTo evaluate the tolerability of BUD/FM pMDI in a large population of asthma patients aged ≥6 years.MethodsAE data from 12 active- and placebo-controlled studies (12-52 weeks) were pooled. Treatments with short- and long-term exposure included BUD/FM pMDI ([80/4.5μg ×2 inhalations (160/9μg) qd to 160/4.5μg ×4 inhalations (640/18μg) bid]; n = 4049) and BUD pMDI or DPI ([80μg ×2 inhalations (160μg) qd to 160μg ×4 inhalations (640μg) bid]; n = 1468).ResultsMean duration of treatment exposure was 166.3 days for BUD/FM and 102.7 days for BUD. Similar percentages of BUD/FM and BUD patients experienced ≥1 asthma AE (2.9%, 3.1%) or ≥1 potentially asthma-related AE (eg, breathlessness, chest tightness, cough, phlegm, wheezing; both 4.6%). The incidence of AEs potentially associated with β2-agonists was higher with BUD/FM (13.0%) versus BUD (9.5%); the most common were headache (9.0% vs 8.2%) and tremor (1.3% vs 0.3%). Cardiac events were low overall and slightly higher with BUD/FM (2.7%) versus BUD (1.3%); most were nonserious and did not result in discontinuation. The incidence of local corticosteroid effects was slightly higher with BUD/FM (4.5%) versus BUD (2.0%); the most common were oral candidiasis (2.8% vs 1.5%) and voice effects (1.8% vs 0.7%).ConclusionsBUD/FM and BUD were well tolerated in studies up to 52 weeks, with a similar incidence of asthma and asthma-related AEs. Overall AEs potentially associated with β2-agonists or local corticosteroid effects were slightly higher for BUD/FM versus BUD, which may be related to the longer duration of exposure to BUD/FM, with generally small differences for individual terms. RationaleTo evaluate the tolerability of BUD/FM pMDI in a large population of asthma patients aged ≥6 years. To evaluate the tolerability of BUD/FM pMDI in a large population of asthma patients aged ≥6 years. MethodsAE data from 12 active- and placebo-controlled studies (12-52 weeks) were pooled. Treatments with short- and long-term exposure included BUD/FM pMDI ([80/4.5μg ×2 inhalations (160/9μg) qd to 160/4.5μg ×4 inhalations (640/18μg) bid]; n = 4049) and BUD pMDI or DPI ([80μg ×2 inhalations (160μg) qd to 160μg ×4 inhalations (640μg) bid]; n = 1468). AE data from 12 active- and placebo-controlled studies (12-52 weeks) were pooled. Treatments with short- and long-term exposure included BUD/FM pMDI ([80/4.5μg ×2 inhalations (160/9μg) qd to 160/4.5μg ×4 inhalations (640/18μg) bid]; n = 4049) and BUD pMDI or DPI ([80μg ×2 inhalations (160μg) qd to 160μg ×4 inhalations (640μg) bid]; n = 1468). ResultsMean duration of treatment exposure was 166.3 days for BUD/FM and 102.7 days for BUD. Similar percentages of BUD/FM and BUD patients experienced ≥1 asthma AE (2.9%, 3.1%) or ≥1 potentially asthma-related AE (eg, breathlessness, chest tightness, cough, phlegm, wheezing; both 4.6%). The incidence of AEs potentially associated with β2-agonists was higher with BUD/FM (13.0%) versus BUD (9.5%); the most common were headache (9.0% vs 8.2%) and tremor (1.3% vs 0.3%). Cardiac events were low overall and slightly higher with BUD/FM (2.7%) versus BUD (1.3%); most were nonserious and did not result in discontinuation. The incidence of local corticosteroid effects was slightly higher with BUD/FM (4.5%) versus BUD (2.0%); the most common were oral candidiasis (2.8% vs 1.5%) and voice effects (1.8% vs 0.7%). Mean duration of treatment exposure was 166.3 days for BUD/FM and 102.7 days for BUD. Similar percentages of BUD/FM and BUD patients experienced ≥1 asthma AE (2.9%, 3.1%) or ≥1 potentially asthma-related AE (eg, breathlessness, chest tightness, cough, phlegm, wheezing; both 4.6%). The incidence of AEs potentially associated with β2-agonists was higher with BUD/FM (13.0%) versus BUD (9.5%); the most common were headache (9.0% vs 8.2%) and tremor (1.3% vs 0.3%). Cardiac events were low overall and slightly higher with BUD/FM (2.7%) versus BUD (1.3%); most were nonserious and did not result in discontinuation. The incidence of local corticosteroid effects was slightly higher with BUD/FM (4.5%) versus BUD (2.0%); the most common were oral candidiasis (2.8% vs 1.5%) and voice effects (1.8% vs 0.7%). ConclusionsBUD/FM and BUD were well tolerated in studies up to 52 weeks, with a similar incidence of asthma and asthma-related AEs. Overall AEs potentially associated with β2-agonists or local corticosteroid effects were slightly higher for BUD/FM versus BUD, which may be related to the longer duration of exposure to BUD/FM, with generally small differences for individual terms. BUD/FM and BUD were well tolerated in studies up to 52 weeks, with a similar incidence of asthma and asthma-related AEs. Overall AEs potentially associated with β2-agonists or local corticosteroid effects were slightly higher for BUD/FM versus BUD, which may be related to the longer duration of exposure to BUD/FM, with generally small differences for individual terms." @default.
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• W2125352042 title "Tolerability of Budesonide (BUD)/Formoterol (FM) Pressurized Metered-Dose Inhaler (pMDI): Pooled Adverse Event (AE) Data From Clinical Studies of Children, Adolescents, and Adults With Asthma" @default.
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