ANTIPYRETIC ACTIVITY AND SAFETY OF IBUPROFEN TABLETS IN THE TREATMENTOF FEVER IN ADULTS - MULTICENTER STUDY AMONG GENERAL-PRACTITIONERS

Ibuprofen is a non steroidal anti-inflammatory drug belonging to the c lass of propionic acid derivatives: it has analgesic and antipyretic p roperties when used at doses of less than 1200 mg/d in adults. The ana lgesic efficacy of ibuprofen, has been demonstrated in numerous clinic al trials. The antipyretic efficacy of ibuprofen has primarily been st udied in paediatric patients, mainly versus paracetamol or aspirin, bu t in adults only on a small number of patients. However, a broad study among a large number of adult outpatients in general practice, with r epeated temperature measurements, was necessary to confirm the antipyr etic activity and satisfactory safety of ibuprofen (Nureflex(R)). The open multicentre study with direct individual benefit was conducted am ong 2626 outpatients, aged between 18 and 60 years, and presenting fev er higher than or equal to 38 degrees C but less than 40 degrees C, re lated to an acute infection for less than 24 hours. The maximum dosage was 1200 mg/day, the inital dose at DO being 2 tablets tie 400 mg); t his could be repeated as required once every 6 hours. If the fever per sisted, treatment could be continued for 2 to 5 days. Evaluation crite ria: 1- Antipyretic activity (primary criterion: change in temperature over the 6-hour interval; secondary criteria: maximum drop in tempera ture, mean time-to a temperature of less than or equal to 37.5 degrees C, onset and duration of action assessed by both patient and physicia n). 2- Safety evaluated by the:patient in a diary card and by the phys ician at the final visit (global evaluation on a 4-point scale), numbe r of patients withdrawn because of adverse events, number of patients who experienced side effects. An intention-to-treat analysis was carri ed out on all patients included in the trial. A significant reduction in temperature relative to the initial pretreatment temperature was no ted starting from 30 minutes post-dose and up until 6 hours post-dose at all timepoints (p < 10(-5)). The mean maximum drop in temperature d uring the first eight hours was 1.2 degrees C, with a mean time to thi s reduction of appromately 2 hours and 30 minutes. The physicians rega rded ibuprofen's antipyretic activity as effective or very effective i n 96 % of the patients, its onset of action as rapid or very rapid in 90.3 % of patients, and its therapeutic benefit as moderate or major i n 98.7 % of patients. The patients themselves considered the treatment 's effect on the fever as effective or very effective in 94.1 % of cas es, and its action as rapid tin less than one hour in 90.9 % of patien ts, under 30 minutes in 49 % of patients), and prolonged (the effect p ersisted for mow than 4 hours following a single dose) in 80.9 % of ca ses. On the whole, 93.6 % of patients regarded the treatment as effect ive or very effective. 97.6 % of physicians assessed ibuprofen's safet y as good or excellent, and only 2.3 % of patients experienced adverse events.