Successful treatment of biliary colic with intravenous ketoprofen or lysine acetylsalicylate.

In a double-blind trial, 60 patients with biliary colic were allocated at random to receive 200 mg ketoprofen, 1.8 g lysine acetylsalicylate or placebo by intravenous bolus. The patients were asked to rate their pain at intervals within 3 hours of injection and to indicate their overall pain experience on a visual analogue scale. Both ketoprofen and lysine acetylsalicylate proved significantly more effective than placebo in relieving pain, with no significant difference between them. A good analgesic response, reflected by complete or almost complete relief of pain within 30 minutes of injection, was recorded in 4, 17, and 16 patients, respectively, in the placebo, ketoprofen, and lysine acetylsalicylate treatment groups. All drugs were well tolerated. It is concluded that the results provide further evidence for a useful therapeutic role of prostaglandin inhibitors in the treatment of biliary colic.

Intravenous ketoprofen in renal colic: a placebo-controlled pilot study.

In a double-blind trial 30 patients with renal colic were allocated at random to receive 200 mg of ketoprofen, 1 gm of lysine acetylsalicylate, or placebo by intravenous bolus injection. The patients were asked to rate their pain at intervals within three hours of injection and to indicate on a visual analogue scale the overall pain relief obtained. Both ketoprofen and lysine acetylsalicylate proved significantly more effective than placebo, with no apparent difference between them. Complete relief of pain was obtained in seven of ten patients in each of the active treatment groups compared with only one of ten patients given placebo. No untoward events were observed in any patient.

Effects of intravenous high doses of ketoprofen on blood clotting, bleeding time and platelet aggregation in man.

The effect of ketoprofen (Orudis, Farmitalia) on ADP, epinephrine (EPI) and collagen (COLL) induced platelet aggregation (PlA), simplate bleeding time (SBT), partial thromboplastin time (PTT) and per cent prothrombin activity (PrA) was studied in eleven patients, four males and seven females (median age 59 years) with rheumatoid arthritis (six cases), cancer (four cases) and osteoarthrosis (one case). Tests were performed before and 1, 8 and 24 hours after a single intravenous dose (600 mg) of ketoprofen and on Days 4 and 8 during a 7-day treatment (200 mg i.v. every 8 hours) and 1 day after withdrawal of the drug. PTT and PrA were not affected by the drug. Bleeding time was not significantly modified by the acute treatment, but was prolonged during the subacute course, though it was not different from baseline values at the end of the trial. Significant reduction of platelet aggregation was seen in both acute and subacute conditions with complete or almost complete recovery 36 hours after the last dose. It is concluded that ketoprofen affects platelets with readily reversible inhibition of in vitro aggregation and a slight increase of bleeding time.

Bioavailability study on a new slow-release formulation of ketoprofen.

Four healthy subjects volunteered for a crossover bioavailability study to compare the rate and extent of absorption of plain capsules and new slow-release capsules of ketoprofen. The formulations were administered in two consecutive 4-day periods at the following dose schedules: 2 x 50 mg plain capsules t.i.d. and 150 mg slow-release capsules b.i.d. The plasma levels profile of unchanged ketoprofen was assessed by GLC during the 4th day of treatment with each formulation. The absorption from slow-release capsules was slower and more sustained than from plain capsules but almost complete. The bioavailability properties of new slow-release capsules of ketoprofen appear suitable for clinical use with reduced frequency of daily dosing.

A double-blind cross-over evaluation of ketoprofen (Orudis) and ibuprofen in the management of rheumatoid arthritis.

In a multi-centre double-blind cross-over trial using the double-placebo technique, 55 patients with rheumatoid arthritis were treated for 10 days for each trial drug with ketoprofen (200 mg/day) and ibuprofen (1200 mg/day). Both drugs induced a clinically and statistically significant improvement of all the symptoms studied, except for pain at night during ibuprofen administration. Ketoprofen displayed a therapeutic efficacy significantly superior to ibuprofen in five of the eight symptoms studied. Side-effects were recorded in 10 patients receiving ketoprofen (one patient withdrew because of heartburn) and in nine patients receiving ibuprofen.

Parenteral administration of ketoprofen in osteoarthritis: a double-blind trial versus the N-methyl-d-glucamine salt of indomethacin.

In a double-blind trial 40 patients with ostheoarthritis were treated for relief of pain with ketoprofen or with the N-methyl-d-glucamine salt of indomethacin, both drugs being administered i.m. at the dosage of 100 mg/day for 12 days. Ketroprofen and the indomethacin salt significantly improved pain, functional capacity and walking distance, while only the former reduced the knee size in the patients with gonarthritis. The two drugs showed roughly the same latency period and the same duration of activity. Ketoprofen was perfectly tolerated: on the contrary, in one patient treated with the indomethacin salt, the treatment was stopped because of vascular hypotension and cutaneous rash. A significant increase of blood urea nitrogen was observed only in the group of patients treated with the indomethacin salt.

Single nightly administration of ketoprofen (Orudis) and indomethacin suppositories in the management of osteoarthritis: a double-blind trial.

In a double-blind trial carried out on 60 patients with osteoarthritis at various localizations, ketoprofen (Orudis), administered as a single nightly 100 mg suppository for ten days, was significantly more active and better tolerated than indomethacin, administered in the same way. Patient's and doctor's assessment was also in favour of Orudis. Laboratory examinations were not affected by either drug.