Double-blind evaluation of short-term analgesic efficacy of orally administered dexketoprofen trometamol and ketorolac in bone cancer pain

Abstract

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 The percentage of patients withdrawn from the study for any reason as well as for insufficient therapeutic effect or due to adverse events was lower in the dexketoprofen group than in the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.

Neutropenia, thrombocytopenia and hepatic injury associated with dexketoprofen trometamol therapy in a previously healthy 35-year-old woman

“…The time association between dexketoprofen‐withdrawal and haematological and liver function tests normalization strongly suggest a cause‐and‐effect relationship, although G‐CSF therapy could have accelerated the normalization of leucocyte count. Although safety data on dexketoprofen trometamol are mainly from short‐term trials (1–6), in patients with bone cancer or osteoarthritis of the knee treated for 1–2 weeks (2, 3), as was the case in this report, adverse events most frequently described are gastrointestinal complaints such as abdominal pain, dyspepsia, nausea, vomiting and flatulence. Only two out of 57 patients with bone cancer, treated with dexketoprofen trometamol, showed liver and biliary system‐related adverse events.…”

“…Dexketoprofen trometamol, the active enantiomer of rac‐ketoprofen, is a non‐steroidal antiinflamatory drug (NSAID) of the arylpropionate family, widely used for pain relief. Several clinical trials conducted with orally administered dexketoprofen trometamol in patients affected by acute and chronic pain have confirmed its high analgesic potency and good tolerability profile (1–4). The parenteral formulation has also shown a good safety profile in acute pain conditions (5, 6).…”

Analgesic Properties of Dexketoprofen Trometamol

“…Fewer adverse events were reported in the dexketoprofen group but the numbers were too small to reach statistical significance [35].…”

Dexketoprofen

“…Dexketoprofen trometamol 25 mg qds and ketorolac 10 mg qds have been compared in 115 patients with bone cancer pain in a multicenter, randomized, double-blind, parallel-group study [7]. Fewer patients withdrew for any reason, including insufficient therapeutic effect or adverse events, among those who were given dexketoprofen.…”