title: How safe is Celecoxib for Asian-Indian patients with rheumatic diseases?
abstract: BACKGROUND
  Cyclo-oxygenase (COX)-2 inhibitors have been the target of severe criticism, more so following the withdrawal of Rofecoxib. Post-marketing surveillance of Celecoxib in Asian Indians, who are predisposed to premature athero-thrombotic events, has not been studied.
  
  
  OBJECTIVE
  To study the adverse effects of Celecoxib and compare them with those of other non-steroidal anti-inflammatory drugs (NSAIDs) in an Asian Indian cohort.
  
  
  METHODS
  This is a retrospective chart review with convenience sampling of patients on NSAIDs (at least five tablets a week, for at least 3 months prior to the study), attending the Rheumatology clinic of a tertiary care institution in south India between June 2004 and November 2004. Those with pre-existing heart disease, hypertension, thrombo-embolic disease, peptic ulcer and patients on corticosteroids were excluded. All the recorded adverse events were noted and compared between the Celecoxib and non-selective NSAID users. Univariate analysis using Chi-square test was performed.
  
  
  RESULTS
  Of the 1387 patients included, 915 were on Celecoxib. In the NSAID group, 204 had used multiple NSAIDs in sequence. Of the Celecoxib users, 164 had switched over to an NSAID during the study period. New onset of hypertension was significantly higher in the Celecoxib users as compared to non-selective NSAID users (3.06% vs. 1.27%, P = 0.04). However, those who had switched over to NSAIDs did not show this trend. NSAID users, on the other hand, had significant gastrointestinal (GI) toxicity (2.54% vs. 0.327%, P = 0.001). A significant number of Celecoxib users who switched over to NSAIDs also developed GI toxicity (6.1% vs. 1.21%, P = 0.018) over a shorter time span, as compared to the continuous NSAID users. Multiple NSAID users had higher adverse events (6.37% vs. 2.23%, P = 0.023) as compared to single NSAID users.
  
  
  CONCLUSIONS
  Celecoxib significantly increased the incidence of new onset hypertension in this cohort of Indian patients with rheumatic diseases. No thromboembolic events were documented.
authors: Department of Clinical Immunology, Christian Medical College, Vellore, Tamil Nadu, India. debashish.danda@cmcvellore.ac.in
authors: Debashish
authors: D
authors: Danda
authors: Mohamed M
authors: MM
authors: Iliyas
authors: Sujith J
authors: SJ
authors: Chandy
authors: Cheemalapati
authors: C
authors: Chandra
authors: Ashish J
authors: AJ
authors: Mathew
mesh_terms: D000328:Adult; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects*; D004008:Diclofenac / Q000009:adverse effects; D057915:Drug Substitution; D005260:Female; D006801:Humans; D006973:Hypertension / Q000208:ethnology / Q000209:etiology; D007194:India / Q000208:ethnology; D007213:Indomethacin / Q000009:adverse effects; D008297:Male; D009288:Naproxen / Q000009:adverse effects; D011720:Pyrazoles / Q000009:adverse effects*; D012189:Retrospective Studies; D012216:Rheumatic Diseases / Q000188:drug therapy* / Q000208:ethnology; D013449:Sulfonamides / Q000009:adverse effects*; D062606:Tertiary Care Centers
chemical_list: D016861:Cyclooxygenase Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D004008:Diclofenac; D009288:Naproxen; D000068579:Celecoxib; D007213:Indomethacin