El celecoxib frente al indomethacin en la prevención de osificación heterotópica

El celecoxib muestra mejor tolerancia y eficacia similar al indomethacin en la prevención de la osificación heterotópica posterior a una artroplastia toal de cadera.

Celecoxib prevents heterotopic ossification after total hip arthroplasty as effectively as does indomethacin, but with fewer side effects requiring discontinuation, according to a prospective, single-centre Italian study.

Heterotopic ossification occurs after total hip arthroplasty in about 14% to 63% of patients, and can be painful and reduces range of motion in 2% to 13%.

Nonsteroidal anti-inflammatory drugs, such as indomethacin, that inhibit both the cyclooxygenase (COX)-1 and COX-2 enzymes have been used to prevent the occurrence of ectopic ossification. However, it remains unknown whether selective COX-2 inhibitors can also effectively prevent ectopic ossification. The use of these selective drugs may reduce the occurrence of side effects typically seen with non-selective COX inhibitors.

Carlo L. Romano, MD, and colleagues at the Istituto Orthopedico Gaetano Pini, Milano, Italy, compared the efficacy and safety of the selective COX-2 inhibitor, celecoxib, with the non-selective COX inhibitor, indomethacin, in the prevention of heterotopic ossification after total hip arthroplasty.

The study included 400 patients, predominantly women, with coxarthrosis who underwent the same type of cementless total hip arthroplasty procedure. After surgery, 250 patients were given indomethacin (50 mg twice daily) and 150 were given celecoxib (200 mg twice daily) for 20 days. Radiographic review was performed 12 months after surgery.

Overall, similar incidences of heterotopic ossification were found in both treatment groups. Grade I and grade II ossification were found in 12.2% and 5.2% of patients given indomethacin and in 10.2% and 4.1% of those given celecoxib.

Notably, there was no evidence of grade III or IV ossification or of early aseptic loosening 1 year after surgery.

Importantly, celecoxib was better tolerated than indomethacin in this cohort. About 8% of patients taking indomethacin discontinued treatment due to adverse events compared to only 2% of those taking celecoxib.

Discontinuation in the indomethacin group occurred on average 9.5 days into treatment. Reasons for discontinuation included gastrointestinal side effects in 6.4% of all indomethacin-treated patients, excessive bleeding in 1.6%, and mental confusion in 0.4%.

Withdrawal in the celecoxib treatment group was due to nausea or gastrointestinal pyrosis that required discontinuation after an average of 14 days of treatment.

The authors conclude that «celecoxib, a highly selective COX-2 inhibitor, showed the same efficacy as indomethacin for preventing heterotopic ossification after total hip arthroplasty with significantly fewer side effects and a lower rate of discontinuation.»

«The risk of [developing ectopic ossification], even in the general population, remains so high that mandatory prophylactic treatment seems important in all patients undergoing total hip arthroplasty and, more generally, in hip surgery or trauma,» they add.

J Arthroplasty 2004 Jan;19:1:14-8.

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