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PubMed1981

Preclinical studies on indoprofen, a new non-steroidal analgesic-antiinflammatory agent.

Indoprofen is an isoindoline derivative of phenylpropionic acid. At doses of 1-3 mg/kg it inhibited acute and subchronic experimental inflammation. Its strong analgesic activity lacks any specific CNS effect. The drug's pharmacological activity is directly related to inhibition of prostaglandin biosynthesis at the cyclo-oxygenase step. In carrageenin-induced oedema indoprofen and prednisolone had a synergistic anti-inflammatory effect, and indoprofen and acetylsalicylic acid showed an additive effect. Acute and chronic toxicity of indoprofen was determined in the mouse, rat, dog and monkey. Target organ for indoprofen toxicity is the gastrointestinal tract (ulcerogenic effect). In vitro and in vivo studies of mutagenicity did not show any mutagenic activity. No embryotoxic or teratogenic effect was noted in reproduction toxicity studies in rats, rabbits and monkeys.

Animals↗
PubMed1981

A study of the possible interaction of indoprofen with hypoglycemic sulfonylureas in diabetic patients.

Phenylbutazone was shown to impair tolbutamide metabolism with resulting potentiation of its hypoglycemic effect and increased danger of hypoglycemia. As indoprofen is widely used for treating rheumatic conditions, and in particular osteoarthritis, the possibility that it may increase the effect of sulfonylureas on blood glucose levels has been investigated. Clinical studies have been carried out in 24 patients with osteoarthritis. All of them had maturity-onset diabetes mellitus and were on sulfonylurea drugs (tolbutamide or glipizide). The trials were double-blind and were carried out according to two different experimental designs. Twelve patients were treated with 600 mg/daily of indoprofen for five days and placebo for an equivalent period of time according to a cross-over scheme. Another group of patients was treated with indoprofen for eight days preceded and followed by a four-day placebo treatment. In both studies concomitant treatment with the hypoglycemic drug was maintained with a fixed dosage. No important differences were found between blood glucose levels when the periods of treatment with indoprofen and placebo were compared. Consequently, it is unlikely that indoprofen treatment at the doses employed may interfere at the clinical level with the effect of tolbutamide or glipizide on glucose metabolism.

Aged↗
PubMed1981

A double-blind evaluation of oral indoprofen versus ASA in osteoarthritic patients: influence on haemostatic parameters and clinical effects.

Indoprofen, a non-steroidal anti-inflammatory agent, was investigated in a double-blind, randomized study in 44 osteoarthritic patients for its influence on haemostatic parameters and therapeutic effects. Twenty-two patients received indoprofen orally, 600 mg daily, and a similar group took acetylsalicylic acid 3 g daily for 21 days. Platelet count, partial thromboplastin time and prothrombin time showed no variations. Bleeding time wa prolonged and platelet aggregation reduced by both drugs. The effects of ASA, however, were significantly greater. Indoprofen, unlike ASA, showed almost no residual effect seven days after stopping medication. The therapeutic responses to indoprofen and ASA were comparable. However, adverse reactions (pyrosis and gastric pain) were much more frequent in the ASA group (15 patients) than in the indoprofen group (2 patients).

Adult↗
PubMed1981

Human pharmacokinetics of indoprofen.

The pharmacokinetics of indoprofen were investigated in several studies in healthy volunteers and in rheumatoid arthritis patients. In healthy subjects the drug is rapidly eliminated with a biological half-life of 2.3 h. The drug and its metabolites are almost completely excreted in urine within 24 h from administration. The absorption of indoprofen administered orally to fasting subjects as 100 mg capsules and 200 mg tablets is rapid and complete. The bioavailability of indoprofen tablets is not adversely affected by the presence of food in the gastrointestinal tract. Following administration of 600 mg of indoprofen per day for 7 days, no changes are observed in the drug plasma level profile. There are no substantial differences between healthy subjects and rheumatoid arthritis patients as regards the pharmacokinetics properties of oral indoprofen.

Administration, Oral↗
PubMedDate not supplied

An analgesic comparison study of indoprofen versus aspirin and placebo in surgical pain.

Single oral doses of 100 and 200 mg indoprofen were compared with 600 mg aspirin and placebo in a double-blind, completely randomized study of hospitalized patients with postoperative, post-fracture, or musculoskeletal pain. The patients evaluated their pain for 5 hours after administration of the study drug. Each of the three active treatments performed significantly better than placebo. The 200-mg dose level of indoprofen demonstrated the greatest analgesic activity based on pain intensity and pain relief scores and on the patients' global evaluations. The analgesic activity of 100 mg indoprofen fell between that of 200 mg indoprofen and 600 mg aspirin and was not significantly different from either.

Adult↗
PubMedDate not supplied

A comparative oral analgesic study of indoprofen, aspirin, and placebo in postpartum pain.

The purpose of this study was to evaluate the analgesic efficacy and adverse effect liability of single oral doses of indoprofen, 50 mg, 100 mg, and 200 mg, compared with aspirin, 300 mg and 600 mg, and placebo in the relief of moderate to severe postpartum pain. Two hundred-ten patients entered a randomized, double-blind, parallel group study and were evaluated over a six-hour period by a single nurse-observer. There was a significant imbalance in the distribution of pain types across treatments that compromises the interpretation of the results. In addition to analyzing the data from all patients, the subsets with episiotomy/cesarean section pain and uterine cramp pain were examined separately. The latter group had too few patients to permit distinction between drugs. The 100 mg and 200 mg doses of indoprofen were significantly (P less than or equal to .05) more effective than placebo for many variables including the following summary values: sum of pain intensity difference (SPID), sum of hourly relief values (TOTPAR), and % SPID for all patients as well as in the subset of patients with episiotomy/cesarean section pain. Aspirin, 600 mg, was also significantly more effective than placebo for many of the same measures of analgesia in the episiotomy/cesarean section subset. Pairwise differences were also seen between placebo and aspirin, 300 mg, but on fewer variables. Indoprofen, 100 mg, was significantly more effective than aspirin, 600 mg, at hour 6 for pain intensity difference (PID) in the episiotomy/cesarean section subset. The effect of indoprofen appeared to plateau above 100 mg.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗
PubMed1986

Compared effects of the two antiinflammatory drugs indoprofen and lonazolac on thromboxane generation and on platelet aggregation, related to plasma concentrations after single oral doses.

Single doses of indoprofen 100 mg and lonazolac-Ca 200 mg were given orally to eight healthy volunteers. Blood samples were taken prior to and at various times until 24 hours after the dose. Drug concentrations in plasma were analyzed by HPLC and thromboxane B2 (TXB2) in serum by radioimmunoassay. Platelet aggregation in plasma was induced by various concentrations of arachidonic acid and evaluated with respect to different phases in the aggregatory response. The drugs were rapidly absorbed and for both compounds the decline in plasma concentrations described two phases. Although concentrations of indoprofen were up to ten times higher than those of lonazolac, the two drugs were almost equally potent inhibitors of generation of TXB2, with IC50 for indoprofen of 1.4-1.5 X 10(-7) M and for lonazolac 2.1-3.0 X 10(-7) M. Their effects on the lag phase in platelet aggregation paralleled the inhibition of TXB2 formation. However, the rate and extent of aggregation were more inhibited by indoprofen than by lonazolac, and the discrepancy was greater than would be expected from concomitant values for TXB2 suppression. The rate of aggregation appeared to be the most sensitive variable, since the extent of aggregation followed an all-or-none pattern. The present results show that the concentrations reached after clinically used doses of antiinflammatory drugs may vary widely in relation to the concentrations needed for maximum inhibition of platelet cyclooxygenase. The results from aggregation tests may support the idea that non-steroid antiinflammatory drugs can differ in their mechanisms of action.

Adult↗
PubMed1983

Indoprofen and pentazocine in post-traumatic pain. A double-blind, parallel-group comparative trial.

In a double-blind, randomized, parallel-group study involving sixty patients with severe pain due to fractures, the analgesic activity of indoprofen and pentazocine was evaluated. Each patient received one of the following treatments in random order: indoprofen 400 mg i.v., pentazocine 30 mg i.v., placebo. The analgesic effect was measured by rating the intensity of pain before treatment and after 1/2, 1, 2, 4 and 6 hours. Patients' final opinions on efficacy were assessed on the basis of categoric and visual analogue scales. Highly significant differences were found between the active drugs and placebo for all variables analyzed. Indoprofen was significantly superior to pentazocine when assessed through variables measuring total analgesic effects. Since both drugs were well tolerated, i.v. indoprofen appears to offer an effective and safe alternative to narcotic analgesics in acute pain due to fractures.

Adolescent↗
PubMed1989

[Indoprofen in chronic intermittent peritoneal dialysis: effects in the clearance of small molecules and protein loss].

We studied the effects of indoprofen on urea and creatinine clearance and on protein loss in 6 patients submitted to intermittent peritoneal dialysis. The patients had no evidence of peritonitis. Dialysis fluid contained indoprofen (50 mg/l) or no drug. Mean protein loss into dialysis solution was 51.2 g without and 44.7 g with indoprofen (NS). Urea clearance was 33.3 and 33.6 ml/min and creatinine clearance 24.7 and 36.0 ml/min, respectively (NS). Levels of PGF2 alpha in the dialysate, measured in 2 subjects, were not affected by indoprofen. These results suggest that prostaglandins are not the main factors involved in control of urea and creatinine clearance and protein loss during intermittent peritoneal dialysis.

Adult↗
PubMed1986

Clinically controlled comparative study of intravenous single doses of suprofen versus indoprofen.

The analgesic effects of single intravenous doses of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) 200 mg/ml and alpha-4-(2-isoindolinyl-2-one)-phenylpropionic acid (indoprofen) 200 mg were compared within the scope of a randomized single-blind study. The test population consisted of 87 patients for whom analgesic treatment was indicated as soon as severe to major pain set in following meniscectomy or disease of a ligament. The treatment groups were homogeneous with respect to demographic data and intensity of pain prior to treatment. In the pain models chosen both drugs resulted in rapid pain relief within 15 min following their application. As to decreased intensity of pain (SPID) and pain relief (TOTPAR), the results obtained 2 h after the test were with indoprofen statistically significantly superior to those obtained with suprofen. The investigator's global appreciation of effectiveness revealed no intergroup differences. Therapeutic results were seen in 95.5% of the subjects on suprofen and in 97.6% of those on indoprofen. The tolerability of suprofen was very good in 95.3% of the cases on suprofen and in 97.3% of those on indoprofen. Four patients in the suprofen group experienced adverse reactions that were, however, not drug related.

Adult↗
PubMed1983

Intravenous indoprofen in the management of renal colic.

Recent reports imply that the prostaglandin system is involved in the pathogenesis of pain due to renal colic, and prostaglandin-synthetase inhibitors have been proposed in the management of this condition. A dose-response study has therefore been performed in patients with renal colic, using two intravenous non-steroidal antiinflammatory drugs, indoprofen and lysine acetylsalicylate (ASA). Seventy-five inpatients (15 per group) were treated with three dose levels of indoprofen (100, 200 and 400 mg) or two dose levels of ASA (500 and 1500 mg) according to a double-blind, randomized, parallel-group design. The patients scored their pain at 15, 30, 60, 120 and 180 minutes after treatment; they also assessed the overall efficacy of treatment by means of a visual analogue scale. The results showed that, in terms of mean pain score, there was a prompt analgesic response in each treatment group, higher effects being obtained with increasing dose levels of both drugs. However, the statistical prerequisites for calculating a potency ratio between the drugs under study were satisfied only for a few variables, in which cases the relative potency of indoprofen to ASA varied between 7.1 and 8.8. The analysis of the frequencies of response, on the other hand, revealed for indoprofen a significant dose-effect regression, the higher dose of this drug giving a complete or nearly complete relief of pain in the majority of patients.

Adult↗
PubMed1981

Double-blind comparative trial of indoprofen and acetylsalicylic acid in osteoarthritis.

The effectiveness, safety and acceptability of indoprofen (IP) and acetylsalicylic acid (ASA) were assessed in patients with osteoarthritis, in a double-blind comparative trial. Each patient received IP 600 mg/day or ASA 2100 mg/day for a four-week period; after a one-week wash-out period, the same drug was given at a higher dosage (IP 800 or ASA 2800 mg/day) for another four weeks. Seventeen patients on indoprofen and 14 on SAS completed the trial. A significant improvement was obtained with indoprofen in the different parameters measuring pain, from the first treatment period; results were similar at the end of the second period. Results with ASA, at both dosages, appeared less impressive. Two patients on indoprofen and five on ASA complained of side effects.

Adult↗
PubMed1981

Double-blind multicentre, between patients comparison of indoprofen and indomethacin in rheumatoid arthritis patients under basic steroid treatment.

The study was aimed at comparing effectiveness, safety and possible steroid sparing effects of indoprofen (800 mg/day) and indomethacin (100 mg/day), in patients with classical or definite rheumatoid arthritis, in active phase, receiving basic steroid treatment at a fixed, not reducible dosage. Treatments were given in double-blind condition, for 1,3 or 6 months, and 97 patients were evaluated. A significant improvement of baseline conditions was obtained with both drugs in all variables considered for evaluation of effectiveness. The initial steroid dosage could be reduced 72% in the indoprofen group and 53% in the indomethacin group; 50% of the patients receiving indoprofen and 22.4% of those receiving indomethacin stopped steroid intake during the trial. Adverse reactions, considered drug related, were observed in 6.7% of patients in the indoprofen group and 34.1% of those given indomethacin.

Adult↗
PubMed1981

Study of the possible interactions of indoprofen on the diuretic effect of furosemide.

Twelve elderly in-patients undergoing chronic furosemide treatment (25 mg/day), with stable diuresis, were admitted to a cross-over, double-blind study to investigate the possible interactions between indoprofen and the diuretic. Indoprofen (200 mg t.i.d.) and identical placebo tablets were administered in randomized sequences for 4 days each. The sequence were preceded by a 4-day run-in observation period and followed by a 4-day follow-up. 24-hour urinary volume and the excretion of Na, K and endogenous creatinine were monitored, with serum Na, K, creatinine and creatinine clearance. Blood pressure and heart rate were measured and routine clinical blood chemistry tests and urinalysis were made for safety. The findings of this pilot study suggest that indoprofen does not alter the natriuretic action of furosemide; a tendency was noted towards a reduction of glomerular filtrate and urine volume, but the values after indoprofen were not significantly different from those after placebo.

Aged↗
PubMed1981

Double-blind, cross-over, international multicentre investigation of two doses of indoprofen compared with ASA and placebo in rheumatoid arthritis.

Indoprofen 600 mg or 1000 mg/day, ASA 3600 mg/day and placebo were administered in randomized sequences according to a multiple 4 x 4 latin square design, balancing the treatments, periods and residual effects. Each treatment lasted 7 days. A total of 98 patients suffering from classical or definite rheumatoid arthritis completed the study. Analysis of the effectiveness indicates that both doses of indoprofen and ASA are significantly more active than placebo; indoprofen 1000 mg/day was the treatment preferred in most of the cases. Both doses of indoprofen were better tolerated than ASA.

Adult↗
PubMed1981

Results of a double-blind study with indomethacin and indoprofen, a new non-steroidal antirheumatic agent.

Indoprofen, a new non-steroidal antirheumatic agent, was tested in a controlled, double-blind, cross-over study versus indomethacin and placebo, in 30 patients with rheumatoid arthritis. The study consisted of three fourteen-day treatment periods. At the end of the trial 14 patients expressed a preference for the indoprofen therapy (200 mg q.i.d.), 10 patients for indomethacin (25 mg q.i.d.) and 5 patients decided in favour of the placebo. Judging from the patients' assessment of spontaneous pain, a complete analgesic effect was observed in 44% of the patients under indoprofen, in 26% under indomethacin and in 13% under placebo. Indoprofen showed good efficacy on all the other parameters measured (Ritchie's index, morning stiffness, number of painful and swollen joints, and grip strength) and good clinical and biological safety.

Adult↗
PubMed1981

Indoprofen compared with naproxen and placebo in rheumatoid arthritis.

Thirty-six patients suffering from rheumatoid arthritis took part in a double-blind controlled cross-over trial, in which they received either indoprofen 800 mg daily, naproxen 500 mg daily, or a matching placebo. Each treatment was administered for two weeks. Indoprofen was shown to be significantly superior as an analgesic and in improving grip strength, and was the drug the patients preferred. Adverse effects were comparable, although indigestion was seen slightly more often during indoprofen treatment. Indoprofen is therefore at least as effective as existing anti-inflammatory drugs in rheumatoid arthritis and should be used as an alternative.

Adult↗
PubMed1978

Determination of indoprofen in physiological fluids by reversed-phase liquid chromatography.

A rapid, sensitive, reversed-phase high-performance liquid chromatographic procedure was developed for the quantitative analysis of indoprofen in plasma and urine. Minimal sample preparation is required for the analysis of unconjugated urinary or plasma drug levels. The method provided quantitative results for indoprofen levels of 0.5-50 microgram/ml of plasma and 0.5-200 microgram/ml of urine and had a lower detection limit of 1 ng. Total urinary indoprofen levels required enzymatic hydrolysis of the conjugated drug prior to analysis. Results are presented for the plasma and urinary excretion levels of indoprofen for a patient receiving a single oral dose.

Analgesics↗