| Resumo: | Beclomethasone dipropionate (BDP) is an established inhaled therapy for the management of asthma. BDP is commonly delivered via a pressurized metered-dose inhaler (MDI) using a chlorofluorocarbon (CFC) propellant system. A new extrafine aerosol of BDP (QVAR, 3M Pharmaceuticals) has been developed which uses hydrofluoroalkane-134a (HFA) as its propellant. This study, conforming to the UK Safety Assessment of Marketed Medicines (SAMM) guidelines, evaluates the long-term tolerability of QVAR in a patient population treated in primary care. In an open-label, non-randomized study conducted in 124 UK general practices over a period of 12 weeks, 6161 patients were prescribed either QVAR or CFC-BDP. The primary outcome was the number of patients with at least one hospital admission due to the condition for which BDP was prescribed. Other outcome parameters included the number of unscheduled visits to Accident and Emergency (AandE) departments, and general practitioner (GP) home visits for the condition for which BDP was prescribed. This study reflected prescribing patterns in primary care. After analysis to adjust for demographic discrepancies in gender, age, baseline consultations and baseline BDP dose, there were no statistically significant differences between groups in terms of safety outcomes for any outcome. For the primary outcome variable the adjusted odds ratio was 0.67 (95% confidence interval = 0.36-1.32). In addition, it was shown that patients can be successfully switched to CFC-free MDIs.
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