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Biomedical subjects

G Bruni

Publications and source records attributed to G Bruni.

At least 73 records · Page 4Linked to original sources

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↗

Indoprofen versus indomethacin in acute painful shoulder and other soft-tissue rheumatic complaints.

In a double-blind, parallel-group study indoprofen 800 mg daily was compared with indomethacin 100 mg daily in forty patients suffering from acute painful shoulder and other soft-tissue rheumatic complaints. Both drugs were administered orally for 14 days. Clinical assessments, carried out at baseline and on days 4, 8 and 15, included pain (at rest, upon pressure, on motion under load), quality of sleep, range of active motion and patient's opinion. A significant improvement in all variables was found for both indoprofen and indomethacin at each time of observation, almost reaching its maximum within the first week. Excellent or good results, as judged by the patients, were obtained in 90% of case in both treatment groups. No significant differences were observed between the two drugs. One patient taking indomethacin developed headache and dizziness, requiring discontinuation of treatment; three patients on indoprofen complained of mild or moderate gastric pain.

Adult↗

Effects of intravenous indoprofen on bleeding time and other haemostatic parameters.

The influence of i.v. administration of indoprofen on template bleeding time and other haemostatic parameters was investigated in ten elderly subjects with osteoarthritis. The drug was given first as a single dose (400 mg bolus) and then, after an appropriate interval, as a short-term treatment (200 mg bolus t.i.d. for 7 days). Platelet count, prothrombin time and partial thromboplastin time were never affected, whereas a significant, though moderate, lengthening of bleeding time and a parallel reduction of platelet aggregation were observed in both trials. In the acute one these changes were seen at the first hour following administration and waned in all patients within 96 hours. In the subacute test the bleeding time was steadily prolonged throughout the week of treatment, being slightly still above the baseline value 7 days later, at which time no residual effects were noticeable in platelet aggregation.

Aged↗

Adverse reactions to indoprofen: a survey based on a total of 6764 patients.

Safety data on indoprofen are presented, deriving from three sources: the first was a phase 4 multicentre clinical study based on 4042 patients suffering from osteoarthritis and treated with 400-800 mg daily by mouth for about 4 weeks; the second was a survey based on a heterogeneous series of 2722 subjects belonging to phase 1, 2 and 3 investigations, and treated with 200 to 1200 mg daily by the oral and/or parenteral route for from 1 to more than 180 days; the third was a safety laboratory study conducted in 472 patients, most of whom had participated in the first study, while the remainder were included in the second. Adverse events of any type occurred in 22% of patients in the first study and in 13% in the second, but treatment had to be withdrawn for drug-related reasons in less than 5% in both. Potentially life-threatening events were rare, overall including 16 instances of clinically overt gastro-intestinal bleeding and 2 anaphylactic reactions. Unfavourable laboratory changes, i.e. shifting from normal to abnormal values, were recorded in about 10% of the series studied. The adverse reaction profile of indoprofen was similar to that of most NSAIDs, with gastro-intestinal troubles prevailing over the other events, a distribution which, however, was clear-cut only with oral indoprofen. Tolerability problems appeared to be dose-related up to some point between 400 and 600 mg daily plateauing thereafter, and were less frequent following parenteral than following oral administration.

Adult↗

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↗

Intravenous indoprofen for prompt relief of acute gout: a regimen-finding study.

The results of an open exploratory trial with different regimens of indoprofen in patients with acute gouty arthritis are described. Two main daily regimens were assessed: (a) indoprofen 200 mg as an intravenous bolus, followed by slow infusion of 100 mg/hour for about 4 hours (24 attacks treated in twenty-three patients); and (b) indoprofen 400 mg as an intravenous bolus (13 attacks treated in twelve patients). In both regimens intravenous indoprofen was supplemented with 400-600 mg daily of indoprofen by mouth. The patient's response, as judged by pain, tenderness, local heat, redness, range of motion and joint circumference, was dramatic in both series, with no significant difference between them at any time of observation. Substantial improvement was apparent for subjective variables already within 2 hours after the beginning of treatment, and a complete resolution was obtained in 35 of 37 attacks within 48 hours. A mild adverse reaction was recorded in one patient for each group (dizziness and gastric pain, respectively). Intravenous indoprofen appears to afford an extremely rapid relief of acute gout; of the two regimens assessed, the second should be preferred in that it seems to be at least equally effective but less troublesome for the patients.

Acute Disease↗

A double-blind, crossover comparison between indoprofen and aspirin in rheumatoid arthritis.

Twenty in-patients with rheumatoid arthritis took part in a double-blind, crossover clinical trial to compare the effectiveness and tolerance of 400 mg indoprofen with 1000 mg aspirin each given 3-times a day for 1 week, with an interval of 2 days during which patients received an indistinguishable placebo. At the start and at the end of each treatment period several subjective and objective indices were measured. Both indoprofen and aspirin to remable improvement in patient conditions, with no significant differences between drugs in overall pain, number of swollen joints, grip strength and functional index. Indoprofen, however, was significantly superior to aspirin with regard to the number of painful joints (p < 0.01), duration of morning stiffness (p < 0.05) and articular index (p < 0.05). Moreover, both patients' and investigators' opinion of overall response favoured indoprofen. Small but significant decreases were recorded in ertythrocyte sedimentation rate and seromucoid levels in both treatment periods. Adverse reactions, mainly as gastric pyrosis and/or gastralgia, occurred in 6 patients while on aspirin, in 2 while on indoprofen, and in a further 2 while on both drugs. No statistically significant changes were observed in safety laboratory tests.

Adult↗

Reaction time to acoustic or visual stimuli after administration of camazepam and diazepam in man.

3-N,N-Dimethylcarbamoyloxy-7-chloro-5-phenyl-1-methyl-1,3-dihydro-2H-1,4-ben zodiazepin-2-one (Camazepam), a new anxiolytic benzodiazepine with weak muscle relaxant and hypnotic effect, was tested versus diazepam and placebo on reaction time to visual and acustic stimuli with a double-blind cross-over design carried out on 11 healthy volunteer human subjects. The response to acoustic stimuli was more rapid than that to visual stimuli with all the three treatments. The pattern of reaction times after camazepam was similar to that after placebo; diazepam retarded reaction times, with the maximum effect 1 h after the administration. A single dose of camazepam and diazepam considered active on anxiety showed a different effect on reaction times, in that they were not altered by camazepam and were lengthened by diazepam, in comparison with placebo. Data show that 10 mg of camazepam giving an anxiolytic effect do not alter the physical performance.

Acoustic Stimulation↗

Indoprofen versus ibuprofen in osteoarthrosis: a short-term, double-blind, crossover trial.

A double-blind, crossover, short-term clinical trial was carried out in osteoarthrosis to compare the activity of two non-steroidal anti-inflammatory drugs. Twenty-four patients were given orally, in sequence, 600 mg indoprofen daily and 1200 mg ibuprofen daily, or vice-versa, for 1 week with no interval between treatment periods. Pain, quality of sleep, and overall effectiveness were recorded at the end of each week by inviting patients to express a score on a simple rating scale. Finally, patients were asked to express a preference for one treatment or the other. Significant improvement was observed in all parameters following treatment with both drugs. The distribution of score differences between indoprofen and ibuprofen was in favour of the former in all measurements; statistical analysis, however, demonstrated a significant superiority of indoprofen only for pain elicited by passive motion. The patients' preferences were also in favour of indoprofen, though not attaining statistical significance. Indoprofen was well tolerated, and no side-effects were observed. While on treatment with ibuprofen, 1 patient had to be withdrawn from the study because of gastric intolerance and 2 further patients had transient skin rashes.

Adult↗

Effect of quinestrol on plasma and urinary gonadotropins of postmenopausal women.

Ten postmenopausal women were given a 4-mg load of quinestrol by mouth and plasma FSH and LH were serially determined at monthly intervals. By bioassay, total urinary gonadotropins were also measured at the same times. Plasma FSH and apparent total gonadotropin levels in the urine were depressed to very low levels up to 3 months, while plasma LH was slightly affected. Tentative explanations of this discrepancy are presented.

Administration, Oral↗

Further evaluation of quinestrol in the inhibition of lactation: a double-blind comparison of two dose levels against placebo.

One hundred and ninetysix post-partum women, in whom lactation was to be prevented, were given under double-blind conditions either placebo or quinestrol 2 mg or 4 mg as a single oral dose within twentyfour hours of delivery. Early assessment of the results gave a failure rate of 58 per cent, 15 per cent and 5 per cent respectively, with statistically significant differences among the three groups of patients. At the follow-up evaluation, which could be made in only about one third of the women, breast troubles were recorded in 20 to 30 per cent, without significant differences among the groups. Post-partum amenorrhea showed a progressive prolongation from an average of 47.9 days in the controls to 64.6 and 72.6 days respectively in the 2 and 4 mg quinestrol groups. Adverse reactions, represented by delayed uterine involution during hospital stay and abnormal uterine bleeding in the late puerperium, were somewhat more frequent in the higher dose group than in the lower dose and control groups. On the basis of the prsent findings and of similar, though rare, experiences reported in the relevant literature, the question is therefore raised whether the 2 mg quinestrol dose would not be preferable to the 4 mg one for routine use in post-partum nonusing women.

Clinical Trials as Topic↗