Two-hundred and eighteen individuals with rheumatoid arthritis were randomly assigned to six months treatment with ibuprofen (900-1800 mg/day) or indomethacin (75-150 mg/day). The drugs were equally effective in the treatment of rheumatoid arthritis while the incidence of indomethacin side-effects was 1.5 times greater than the incidence of ibuprofen side-effects.
In a double-blind multiclinic trial, a new nonsteroidal anti-inflammatory agent (ibuprofen) was compared with an established therapeutic agent (phenylbutazone-alka) for the treatment of osteoarthritis. Of the 159 patients from the 17 contributing clinics, 144 completed the four weeks of therapy. More than 60 per cent of them reported improvement in exercise-related pain by week 4, and there was no significant difference between treatment groups. The patients' and the physicians' evaluations of the total state of disease, as well as range-of-motion and functional tests, demonstrated similar degrees of improvement in both treatment groups. The incidence of side effects was within acceptable limits, and the frequency distribution was similar in both groups. Of the 70 reported side effects, 29 were considered by the investigator (blind trial) to be drug-related-11 in association with ibuprofen and 18 with phenylbutazone-alka. Hematologic and blood chemical studies, as well as urine and stool examinations, yielded normal results with the exception of a reduced mean value for serum uric acid and a slightly elevated mean value for SGPT in the phenylbutazone-alka group.
The therapeutic effects of a number of antineoplastic agents administered subcutaneously to L1210 leukemic mice in silicone polymer (Silastic®, Dow Corning Medical Grade) implants is reported. 1-β-d-arabinofuranosylcytosine (ara-C, cytarabine), two 5′-acylates of ara-C (the 1-adamantanecarboxylate [AdO-ara-C] and acetate [AcO-ara-C]) and two nitrosoureas [l-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea {CCNU} and 1-(2-chloroethyl)-3-trans-4-methylcyclohexyl)-1-nitrosourea {MeCCNU}], when administered in this manner, significantly increased survival time and, in the case of ara-C, CCNU, and MeCCNU, resulted in a considerable number of cures. Silastic cylinders containing ara-C (625 mg ara-C/kg) implanted up to 3 days prior to tumor inoculation yielded significant therapeutic effects, suggesting that ara-C was being released at a slow rate such that cytotoxic levels of ara-C persisted in the mice for several days. This ‘depot’ effect was confirmed by studies of ara-C plasma levels and excretion after administration of 14C-ara-C in this manner. Silastic cylinders containing CCNU (25 mg CCNU/kg), when implanted 4 h prior to tumor inoculation showed activity, but no therapeutic effect was observed when administration was 24 h prior to inoculation. Studies in which drug implants were removed at various times after implantation indicated that the necessary exposure time (for optimum therapeutic effect) is considerably longer for an S-phase (DNA synthetic) specific agent such as ara-C than for nonphase-specific agents such as CCNU.
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