Objectives: The aim of the study was to identify any unexpected clinical events associated with starting the new CFC-free formulation of Atrovent MDI in general practice in England.
Methods: An active surveillance cohort study was conducted with a focus on selected clinical events, including respiratory symptoms, in past users of Atrovent CFC MDI ('switchers') and Atrovent naïve users. Incidence density rate ratios (with 99% confidence intervals) for events occurring in the first 3 months of exposure (risk period-ID ) compared to 3 months prior to starting treatment (reference period-ID ) were calculated.
Results: The cohort consisted of 13 211 patients (median age 70 years, 50.1% female; 63.5% prior users of Atrovent CFC MDI ('switchers')). Common respiratory events occurred at higher rates after starting treatment than before for switchers, for example lower respiratory tract infection (LRTI) [ID /ID = 1.45 (99% CI: 1.17, 1.81)] and worsening asthma [ID /ID = 1.58 (99% CI: 1.00, 2.51)]. Of these events only LRTI was significant for Atrovent naïve patients [ID /ID = 1.42 (99% CI: 1.04, 1.95)].
Conclusions: The results of this study suggest effect modification of risk as a result of prior Atrovent CFC MDI use. Overall, Atrovent CFC-free MDI appeared to be reasonably well tolerated in the immediate postmarketing period and the safety profile appeared similar to that of the CFC formulation.
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