Australian public assessment for Ibuprofen - Therapeutic Goods ...

AusPAR Caldolor Ibuprofen Phebra Pty Ltd PM-2010-02393-3-1
Final 2 January 2013
Therapeutic Goods Administration
not have affected the efficacy assessment because of the statistical methods for handling
temperature measurements after the use of rescue medication.
Baseline data
The four treatment groups in the ITT population were similar in respect of their baseline
characteristics. Overall, about half of the patients (n=58) were Caucasian and one-third
(n=40) were Asian; 44% were critically ill and 56% were not. The mean age was 37.8
years (range 17-89). Mean baseline temperatures were 38.9°C, 39.1°C, 39.1°C and 39.2°C
and in the placebo, Caldolor 100 mg, 200 mg, and 400 mg groups, respectively.
Two notable features of the ITT population were the high proportion of patients with
malaria (31%) compared to the patient population that is likely to receive Caldolor if it is
registered in Australia and a high number of males compared to females (88 versus 32).
The patients with malaria all came from the Thai study centre. As previously noted,
malaria is one of the standard models for testing the efficacy of antipyretic treatments and
the inclusion of patients with malaria does not adversely affect the generalisability of the
efficacy results. The reason for the predominance of males in the study is not clear and
was not explored in the study report but the gender imbalance was consistent across the 4
treatment groups and should not invalidate the efficacy results.
Results for the primary efficacy outcome
At 4 hs, in the ITT population, 24 of 31 (77%) patients in the Caldolor 400 mg group,
compared to 9 of 28 (32%) in the Placebo group had a temperature