BACKGROUNDPeanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions.
METHODS
Randomization and BlindingEligible participants were randomly assigned, in a 3:1 ratio, to receive either AR101, a peanut-derived pharmaceutical product that was manufactured
A previous New Zealand case-control study of asthma deaths in the 5-45 year age group during 1981-3 found that prescription of fenoterol (by metered dose inhaler) was associated with an increased risk of death in patients with severe asthma. One major criticism of this study was that drug data for the cases and controls came from different sources. A new case-control design has been used to evaluate the same hypothesis, with a different set of asthma deaths, the same source for drug information being used for both cases and controls. This depended on identifying deaths from asthma during 1977-81 from national mortality records, and ascertaining which patients from those who died had been admitted to a major hospital for asthma during the 12 months before death. The study was confined to this subgroup, which accounted for about 20% of all asthma deaths in the areas served by a major hospital. For each of the eligible patients who died four age matched controls were selected from patients admitted to hospital for asthma during the year that the death occurred who had also had an admission for asthma in the previous 12 months. For the 58 cases and 227 control subjects information on prescribed drugs was collected from the hospital records relating to the previous admission. The odds ratio of asthma death in patients prescribed inhaled fenoterol was 1-99 (95% confidence interval 112-3-55, p = 0 02). As in the previous study, subgroups defined by markers of chronic asthma severity were also considered. The inhaled fenoterol odds ratio was 2-98 (95% CI 1-15-7 70, p = 0 02) in patients prescribed three or more categories of asthma drugs, 3-91 (95% CI 179-8 54, p < 0-01) in patients with a previous admission for asthma in the past 12 months, and 5 83 (95% CI 1-62-21-0, p = 0-01) in patients prescribed oral corticosteroids at the time of admission. In patients with the most severe asthma (defined by a previous admission for asthma during the past 12 months and prescribed oral corticosteroids at time of admission) the inhaled fenoterol odds ratio was 9-82 (95% CI 2-23-43 4, p < 0 01). These findings add further support to the hypothesis that inhaled fenoterol increases the risk of death in patients with severe asthma.
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