title: [Selective cyclooxygenase-2 inhibitors. A population-based analysis of use in France over a three-year period and comparison with randomised clinical trials].
abstract: OBJECTIVE
  The use of selective cyclooxygenase-2 (COX-2) inhibitors is highly controversial today, mainly because of doubts about cardiovascular tolerance. Few studies have assessed the use of these drugs in daily clinical practice. This study aims to assess the changes in their use in daily practice in France and to compare it with their use in randomized clinical trials.
  
  
  METHODS
  The French National Health Insurance Fund AMPI database of self-employed workers in non-agricultural occupations was used to obtain the following information: patients requesting reimbursement for celecoxib and rofecoxib between November 2000 and October 2003, morbidity assessed by enrollment on the lists of chronic diseases for which care is fully (100%) reimbursed, pregnancy (assessed by the payment of physicians' or hospital fees for delivery or by maternity benefits), and concomitant drugs (by claims for reimbursement). We compared these patients with those in randomized clinical trials (RCT) of celecoxib or rofecoxib published in either English or French before November 2003; we focused on their demographic characteristics, morbidity, pregnancy and concomitant drug use.
  
  
  RESULTS
  Use of COX-2 inhibitors in France did not vary over the study period, except for patients' mean age (range: 64.2-62.9 years), proportion of women (56.7%-54.7%) and use of gastroprotective drugs (18.2%-28.4%). The mean age of patients in our study was 10 years older than that of RCT patients, and the proportion of women in our study was 15% lower. The percentage of women who took these drugs while pregnant was 0.02% in our study and 0.09% in the RCT. The percentage of patients with long-term chronic disorders overall was higher in our study than in the RCT, and the percentage for all specific long-term diseases except rheumatoid arthritis was also higher (for example, more patients had cardiovascular diseases or diabetes in our study [15%] than in the RCT [6%]). Patients in our study also used concomitant drugs from 9 of the 14 principal Anatomical Therapeutic Chemical classification groups more frequently than RCT patients: for cardiovascular drugs, for example, the figures were 55% and 5%, respectively.
  
  
  CONCLUSIONS
  The demographic characteristics, prevalence of chronic morbidity and use of concomitant drugs among COX-2 inhibitor users in France varied little over the three years after marketing approval. Compared with RCT patients, these users were less often female, were older and more often had cardiovascular diseases. Cardiovascular events occurring among COX-2 inhibitor users in France should be evaluated.
authors: Caisse nationale d'assurance maladie, service medical national, régime AMPI, Centre Paris-Pleyel, Saint-Denis (93). guy-robert.auleley@canam.fr
authors: Guy-Robert
authors: GR
authors: Auleley
authors: Jean
authors: J
authors: Deligne
authors: Catherine
authors: C
authors: Hantson
authors: Claudine
authors: C
authors: Blum-Boisgard
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D001168:Arthritis / Q000188:drug therapy; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D019992:Databases as Topic; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D005602:France; D005765:Gastrointestinal Agents / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011247:Pregnancy; D016032:Randomized Controlled Trials as Topic; D017678:Sex Distribution
chemical_list: D016861:Cyclooxygenase Inhibitors; D005765:Gastrointestinal Agents