Search

To evaluate the safety profile of eight oral nonsteroidal anti-inflammatory drugs (NSAIDs) available in France, using data reported through the French pharmacovigilance system. Data (from 2002 to 2006) were analysed for aceclofenac, diclofenac, ketoprofen, meloxicam, naproxen, nimesulide, piroxicam and tenoxicam, focusing on the reported rates of serious adverse drug reactions (ADRs) in the following system organ classes: gastrointestinal, hepatic, cutaneous, renal and cardiovascular. A total of 42 389 serious ADR reports were identified, and 38 506 were included in a case/noncase analysis. Ketoprofen was associated with the highest cumulative reported rate of serious ADRs (0.78 cases per million defined daily doses), followed by diclofenac (0.58), nimesulide (0.52), naproxen (0.50), piroxicam (0.47), tenoxicam (0.42), meloxicam (0.41) and aceclofenac (0.30). The most frequently reported serious ADRs were cutaneous, followed by gastrointestinal, hepatic, renal and rarely, cardiovascular events. In the case/noncase analysis, ketoprofen, piroxicam and naproxen were associated with the highest risk of serious gastrointestinal ADRs (odds ratios [ORs] of 6.87, 6.54 and 5.07, respectively). Nimesulide and aceclofenac were associated with the highest risk of liver ADRs (adjusted ORs of 4.53 and 3.67, respectively), as was meloxicam for cutaneous ADRs (adjusted OR of 3.15) and tenoxicam for renal ADRs (adjusted OR of 3.17). The most frequent serious ADRs reported with the selected oral NSAIDs are cutaneous, followed by gastrointestinal, hepatic and renal events. The highest risks for serious gastrointestinal, hepatic, cutaneous and renal adverse events were linked, respectively, with ketoprofen, nimesulide, meloxicam and tenoxicam compared with the other NSAIDs. [ABSTRACT FROM AUTHOR]

Generalized convulsive status epilepticus (GCSE) needs immediate management. Despite guidelines, adherence to management protocols is often poor, this contributing to poor outcome. We aimed to evaluate the usefulness of a management protocol in GCSE. This is a prospective population-based study of consecutive adults with GCSE in Haute-Garonne district, France. Demographics and treatment procedures were documented. Factors associated with seizure termination and refractoriness were analyzed using logistic regression. One hundred eighteen episodes in 111 adults (mean age 55 years) between October 2006 and February 2008 were included. SE was convulsive in 101 episodes. Incidence was 6.6 per 100,000 and case fatality was 9%. Adequate initial treatment according to protocol was observed in 38%; 64% were treated out-of-hospital, and SE was refractory in 27% [no response after two antiepileptic drugs (AED)]. Patients who received adequate first-line treatment were 6.8 times [95% confidence interval (CI) 2.8-16.9] more likely to have seizure termination, with 74% versus 29% efficacy rate (p < 0.0001). Inadequate initial management was 4.7 times (1.9-11.1) more likely to need several benzodiazepine doses (p = 0.0004) and 9.1 times (3.7-20) more likely to require a long-acting AED as next treatment (p < 0.0001). Seizure termination after initial treatment was associated with decreased intensive care unit stay [1 (1-2) versus 2 (1-5.5) days, p < 0.0001] and hospital stay [3 (2-11) versus 7 (3-18) days, p = 0.009]. GCSE termination and outcome seem clearly associated with adherence to treatment protocol. Results add to the debate on appropriate allocation of resources for out-of-hospital treatment, licensed drugs, and achievement of guideline implementation to improve SE outcome. [ABSTRACT FROM AUTHOR]