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Blood, 29 October 2009, Vol. 114, No. 18, pp. 3742-3747.
Prepublished online as a Blood First Edition Paper on August 28, 2009; DOI 10.1182/blood-2009-06-227330.


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CLINICAL TRIALS AND OBSERVATIONS

A randomized, controlled clinical trial of ketoprofen for sickle-cell disease vaso-occlusive crises in adults

Pablo Bartolucci1, Tony El Murr1, Françoise Roudot-Thoraval2, Anoosha Habibi3, Aline Santin4, Bertrand Renaud4, Violaine Noël1, Marc Michel1, Dora Bachir3, Frédéric Galactéros3, and Bertrand Godeau1

1 Service de Médecine Interne, 2 Service d'Epidémiologie, 3 Service de Référence de la Drépanocytose, and 4 Service d'Accueil des Urgences, Hôpital Henri-Mondor, Assistance Publique–Hôpitaux de Paris, Université Paris 12, Créteil, France

Vaso-occlusive crisis (VOC) is the primary cause of hospitalization of patients with sickle-cell disease. Treatment mainly consists of intravenous morphine, which has many dose-related side effects. Nonsteroidal antiinflammatory drugs have been proposed to provide pain relief and decrease the need for opioids. Nevertheless, only a few underpowered trials of nonsteroidal antiinflammatory drugs for sickle-cell VOC have been conducted, and conflicting results were reported. We conducted a phase 3, double-blind, randomized, placebo-controlled trial with ketoprofen (300 mg/day for 5 days), a nonselective cyclooxygenase inhibitor, for severe VOC in adults. A total of 66 VOC episodes were included. The primary efficacy outcome was VOC duration. The secondary end points were morphine consumption, pain relief, and treatment failure. Seven VOC episodes in each group were excluded from the analysis because of treatment failures. No significant between-group differences were observed for the primary outcome or the secondary end points. Thus, although ketoprofen was well-tolerated, it had no significant efficacy as treatment of VOC requiring hospitalization. These findings argue against its systematic use in this setting.


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