Phase IV evaluation of piroxicam in acute and chronic painful inflammatory disorders: an Indian study
Navani, S.R.; Raghu, C.N.; Jha, R.J.; Bowalekar, S.K.; Oke, V.G.
International Journal of Tissue Reactions 11(1): 47-51
1989
ISSN/ISBN: 0250-0868 PMID: 2681034 Document Number: 346166
We report the first phase-IV computerized study on Piroxicam in Indian patients. Comprehensive subject record sheets were distributed to 1,000 doctors. Piroxicam at 20 mg/day was given to patients categorized as suffering from rheumatoid arthritis (RA), osteoarthritis (OA), cervical spondylitis (CS), ankylosing spondylosis (AS), soft-tissue and other pains (ST) for up to 12 weeks. Assessments of pain, tenderness, swelling, range of movments, morning stiffness as well as the grip test and walking test, were made at 24 and 72 h, and 1, 4 and 8 weeks after therapy. All side-effects were noted. Data entry and statistical analysis (95% confidence interval) for proportions expressed as percentages were handled by computer. A total of 174 doctors (17.4%) co-operated by giving data for 844 patients, consisting of the followign cases: RA (306), OA (253), AS (52), CS (113) and ST (120). Piroxicam was found to be uniformly effective in the above disorders, a favourable response to the treatment being obtained in 82%-96% of the patients. The overall reponse rates (with 95% confidence interval in brackets) were 93% (91-95%) in pain, 93% (91-95%) in tenderness, 90% (80-93%) in swelling, 90% (87-92%) in range of movements and 86% (83-89%) in morning stiffness. The average duration of therapy ranged from 22 to 42 days. A total of 88 (10.4%) patients reported 224 incidences of side-effects, 91% of them being gastrointestinal, but no patient had ulcer or Gl bleeding. In 1.9% of the patients, therapy was stopped due to an adverse reaction. This first computerized phase-IV evaluation of Piroxicam indicates its efficacy and safety in Indian patients to be excellent and comparable to its international performance already reported.