A pharmaceutical company sponsors a randomized, double-blind study evaluating a new monoclonal antibody for severe uncontrolled asthma. The study enrolls 800 patients with a history of frequent exacerbations. Patients are randomized in a 1:1 ratio to receive either standard of care plus the new antibody or standard of care plus placebo. Over the 12-month follow-up period, 100 of the 400 patients in the placebo group experience a severe asthma exacerbation requiring hospitalization. In the treatment group, 60 of the 400 patients experience a similar exacerbation. Based on these study results, how many patients must be treated with the new monoclonal antibody for one year to prevent one additional severe asthma exacerbation?
- A3
- B4
- C7
- 10Cevap
- E40
Cevap
10
The number needed to treat (NNT) is the inverse of the absolute risk reduction (ARR). First, calculate the control event rate (CER), which is the incidence in the placebo group: . Next, calculate the experimental event rate (EER), which is the incidence in the treatment group: . The ARR is the difference between these two rates: . Finally, calculate the NNT by taking the inverse of the ARR: This means 10 patients need to be treated with the new drug for one year to prevent one severe asthma exacerbation.
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Anahtar Kavram
The number needed to treat (NNT) is calculated as the inverse of the absolute risk reduction (). It represents the number of patients who must receive the treatment to prevent one additional adverse event.