The
analgesic efficacy and safety of
dexketoprofen trometamol (the active enantiomer of the racemic compound
ketoprofen) (25mg q.i.d.) vs.
ketorolac (10mg q.i.d.) was assessed in 115 patients with
bone cancer pain included in a multicenter, randomized, double-blind, parallel group study. A level of >/=40 mm on the 100 mm visual analog scale (VAS) and >/=10 in the
pain rating index were required for inclusion. At the end of treatment on day 7 (+1 day), mean values of VAS were 32+/-24 mm for
dexketoprofen and 40+/-30 mm for
ketorolac (P=0.12) but the
pain rating index was significantly lower in patients given
dexketoprofen (8.5+/-2.3 vs. 9.7+/-2.9, P=0.04). Moreover, most of the patients reached a
pain intensity difference from baseline >/=20 mm (75% of patients for
dexketoprofen and 65% of patients for
ketorolac). Around half of patients in both treatments had a
pain intensity <30 mm on VAS at the end of treatment (55% for
dexketoprofen and 47% for
ketorolac). In the overall assessment of efficacy, a higher percentage of both patients and physicians rated
dexketoprofen as 'quite effective' or 'very effective' compared to
ketorolac. The percentage of patients withdrawn from the study for any reason as well as for insufficient
therapeutic effect or due to adverse events was lower in the
dexketoprofen group than in the
ketorolac group. Treatment-related adverse events occurred in 16% of patients given
dexketoprofen and in 24% given
ketorolac. Serious adverse events occurred in 3.5% of patients from both groups but only one case of
gastrointestinal hemorrhage was considered related to
ketorolac. We conclude that
dexketoprofen trometamol 25 mg q.i.d. oral route is a good
analgesic therapy in the treatment of
bone cancer pain, comparable to
ketorolac 10 mg q.i.d., with a good tolerability profile.