Safety of lornoxicam in the treatment of postoperative pain: a post-marketing study of analgesic regimens containing lornoxicam compared with standard analgesic treatment in 3752 day-case surgery patients.

摘要

BACKGROUND: Post-marketing surveillance studies can provide supplemental data on the safety of medications in the general population. OBJECTIVE: This study aimed to evaluate the safety of analgesic regimens including the NSAID lornoxicam in the short-term treatment of postoperative pain in a clinically relevant population. STUDY DESIGN: Randomized, open-label, multicentre, multinational, observational cohort study of 4 days' duration. SETTING: In-hospital postoperative setting, with discharge to home treatment within 24 hours of surgery. PARTICIPANTS: Adults aged > or =18 years expected to be in need of analgesic treatment after day-case surgery. INTERVENTION: Analgesic regimens containing lornoxicam were compared with a standard analgesic treatment, which was defined as the treatment that the patient would normally receive at the centre. MAIN OUTCOME MEASURES: Following day-case surgery, patients were provided with appropriate analgesic medication, and adverse events (AEs; defined as all recorded events with symptoms) were recorded by the investigator during the in-hospital stay and by the patient for the next 3 days using entries recorded morning and evening in a patient diary. Statistical analyses tested for between-treatment differences in AEs, adverse drug reactions (ADRs; defined as events probably, possibly or unlikely to be related to treatment) and gastrointestinal AEs (GI-AEs). RESULTS: A total of 4152 patients were randomized to treatment. Since 400 patients did not take any analgesic, the safety population consisted of 1838 patients for lornoxicam and 1914 patients for standard analgesic treatment. Demographic and disease characteristics were similar between the two treatment groups, as were the type of surgery and the anaesthesia used in surgery. In the safety population, 16.9% of patients received no analgesic in hospital, and when analgesics were provided they were often administered in combination. Similarly, approximately 17% of patients did not take any analgesics at home. AEs were reported in 27.1% and 29.4% of patients in the lornoxicam and standard analgesic treatment groups, respectively, and ADRs constituted the majority of these events. No significant differences were demonstrated with regard to the incidence of AEs between the two groups. Most events were of mild or moderate intensity. Consistent with what may be expected for an NSAID, most AEs with lornoxicam were related to the GI system. GI-AEs were reported in 19.5% and 21.3% of patients in the lornoxicam and standard analgesic treatment groups, respectively, and most of these were considered ADRs. Most patients were satisfied with their pain treatment both in hospital and at home. CONCLUSION: Lornoxicam-containing regimens are as well tolerated as other analgesic regimens over 4 days in the treatment of postoperative pain.