Objectives To evaluate the efficacy and safety of the first COXIB, namely Rofecoxib in the Turkish osteoarthritis (OA) patients.

Methods The study included a total number of 138 patients with hip or knee osteoarthritis diagnosed according to the ACR functional class I, II or III. An open-label prospective trial of 138 adults patients (120 female and 18 male) with OA was conducted. Patients with OA in whom the knee or hip was the primary source of pain were included. Patients received either 12.5 mg or 25 mg rofecoxib once daily. Patients whom did not benefit from 12.5 mg were allowed to receive 25 mg. Clinical efficacy and safety were monitored during a 6 week of therapy. Clinical efficacy were evaluated by comparing pretreatment and treatment values of the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), investigator global assesment of disease status and Hip or Knee osteoarthritis and Lequesne-Algofunction Index. Pysical examination, vital signs, body weight, laboratory examinations and adverse event reporting were monitored for safety purposes.

Results The Lequesne-Algofunction Index and WOMAC demonstrated that patients with knee osteoarthritis were significantly better starting from the 3rd visit (p < 0.001). The number of patients with hip osteoarthritis (n = 9) were very low. Thus the evaluations of hip efficacy did not reach to statistical significance eventhough the indexes were showing a numerical improvements in hip osteoarthritis patients. The investigator global assessment of disease status were significantly better in 4th and 5th visits comparing to 3rd visit. The efficacy data shows that, rofecoxib 12.5 mg once daily or 25 mg once daily provides efficacy clinically comparable with the pretreatment period on all primary end points. Treatment with rofecoxib was generally well tolerated. There were no serious adverse event during the entire period.

Conclusion The Lequesne-Algofunction Index and WOMAC demonstrated that patients with knee osteoarthritis were significantly better starting from the 3rd visit (p < 0.001). The number of patients with hip osteoarthritis (n = 9) were very low. Thus the evaluations of hip efficacy did not reach to statistical significance even though the indexes were showing a numerical improvements in hip osteoarthritis patients. The investigator global assessment of disease status were significantly better in 4th and 5th visits comparing to 3rd visit. The efficacy data shows that, rofecoxib 12.5 mg once daily or 25 mg once daily provides efficacy clinically comparable with the pretreatment period on all primary end points. Treatment with rofecoxib was generally well tolerated. There were no serious adverse event during the entire period.

Co-authors are: Members of the Rofecoxib Osteoartrhitis Group* as follows: Afsar Levent MD, Akarirmak Ulku MD, Akinci Ayse MD, Akkoc Nurullah MD, Aktuglu Kemal MD, Akyuz Gulseren MD, Alper Serap MD, Altinmakas Mehmet MD, Arasil Tansu MD, Asik Mehmet MD, Atalay Fatma MD, Atik Sahap MD, Berk Haluk MD, Direskenli Haner MD, Erdogan Fahri MD, Ertenli Ihsan MD, Eskiyurt Nurten** MD, Gedikoglu Oner MD, Goncu Kamil MD, Guzel Rengin MD, Hepguler Simin MD, Kabasakal Yasemin MD, Kuru Omer MD, Kucukoglu Selcuk MD, Oncel Sema MD, Onen Fatos MD, Suleyman Ozbek MD, Ahmet Ozgul MD, Sepici Vesile MD, Sindel Dilsad MD, Togrul Emre MD, Yurtkuran Merih MD.

*In alphabetical order.

**Clinical study co-ordinator.