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Biomedical subjects

I Caruso

Publications and source records attributed to I Caruso.

At least 73 records · Page 4Linked to original sources
PubMed1977

Pharmacokinetic studies of indoprofen in healthy volunteers and in patients.

The pharmacokinetics of indoprofen in healthy subjects after single oral and i.v. administrations is reviewed. During repeated administration of indoprofen to 6 normal subjects (200-mg tablet every 8 hours for 6 days) no variations in the disposition of the drug were found in comparison with single dose administration. In 6 inpatients, with rheumatoid arthritis, the pharmacokinetics of indoprofen was studied after single oral (tablet) and i.m. administration. As for oral doses, no difference in main kinetic parameters was detected between the patients and normal subjects except for a higher volume of distribution in the former population. The bioavailability of the drug given by i.m. injection was not significantly different from that observed after oral administration.

Administration, Oral↗
PubMedDate not supplied

Double-blind study of dothiepin versus placebo in the treatment of primary fibromyalgia syndrome.

A double-blind study comparing the efficacy and tolerability of dothiepin with that of placebo in the treatment of primary fibromyalgia syndrome was carried out. Dothiepin was shown to improve significantly the condition of patients with primary fibromyalgia syndrome and there was a significant difference between dothiepin and placebo in all the clinical variables measured. Only mild and transient side-effects were reported. Further controlled studies are required to define the effects of dothiepin on fibromyalgia.

Adult↗
PubMedDate not supplied

A comparison of dothiepin versus placebo in the treatment of pain in rheumatoid arthritis and the association of pain with depression.

The effectiveness of dothiepin (a tricyclic anti-depressant) at a dose of 75 mg given orally at night was compared with placebo for 4 weeks in alleviating pain in 60 patients with classical or definite active rheumatoid arthritis. Patients were classified as either 'depressed' or 'not depressed'. The week before, during and 2 weeks after the study, 600 mg ibuprofen was given orally three times daily to all patients. Compared with placebo, dothiepin produced a significant reduction in daytime pain by the end of the treatment period. The Hamilton rating scale in 'depressed' patients was significantly improved in patients given dothiepin. The Cassano-Castrogiovanni self-evaluation rating scale in both 'depressed' and 'not depressed' patients showed a tendency (not significant) to be improved following dothiepin treatment compared with placebo. These results suggest that patients with rheumatoid arthritis may experience an increase in pain symptoms due to an alteration of mood. Therapy with tricyclic anti-depressants, such as dothiepin, therefore, may determine an improvement of pain indexes besides having an anti-depressant effect.

Arthritis, Rheumatoid↗
PubMedDate not supplied

Salsalate in the treatment of rheumatoid arthritis: a double-blind clinical and gastroscopic trial versus piroxicam. I. Clinical trial.

A double-blind, double-dummy controlled study to compare the clinical efficacy and gastric tolerability of salsalate and piroxicam in the treatment of rheumatoid arthritis was performed. Twenty-three patients were treated with 1.5 g salsalate twice daily and 20 with 20 mg piroxicam (taken after the evening meal) for a period of 4 weeks. Patients were submitted to gastroscopy at the start and end of treatment; only patients who presented a normal baseline gastroscopy were admitted to the trial. At the end of the planned treatment period, a statistically significant improvement of all clinical variables was observed in both treatment groups, the difference between the two drugs not being statistically significant. Seven (37%) patients treated with salsalate complained of tinnitus. The results show that salsalate and piroxicam have equal efficacy in relieving the symptoms of arthritis.

Arthritis, Rheumatoid↗
PubMedDate not supplied

Double-blind study of 5-hydroxytryptophan versus placebo in the treatment of primary fibromyalgia syndrome.

A double-blind, placebo-controlled study of the efficacy and tolerability of 5-hydroxytryptophan (5-HTP) was conducted in 50 patients with primary fibromyalgia syndrome. All the clinical parameters studied were significantly improved by treatment with 5-HTP and only mild and transient side-effects were reported. Further controlled studies are required to define properly the value of 5-HTP in patients with primary fibromyalgia syndrome.

5-Hydroxytryptophan↗
PubMedDate not supplied

A double-blind crossover study of two cyclobenzaprine regimens in primary fibromyalgia syndrome.

In a double-blind crossover study, the efficacy and tolerability of oral cyclobenzaprine administered in two different regimens were compared in 40 patients affected by primary fibromyalgia syndrome. The patients were randomly divided into two groups. Each group of 20 patients was treated for 15 days with either a single dose of 10 mg/day cyclobenzaprine at bedtime or 30 mg/day cyclobenzaprine in three equal doses daily. Following treatment there was a 15-day washout period before the groups were crossed over to the other treatment. Both regimens resulted in a significant decline in the number of tender points; significant improvements were also reported in the quality of sleep, anxiety, fatigue, irritable bowel syndrome and stiffness. There was no significant difference in efficacy between the two therapeutic regimens at any stage during the trial. The frequency of reported side-effects was significantly greater (P < 0.001) when patients received 30 mg/day cyclobenzaprine (26 patients, 84%) than when they received 10 mg/day (10 patients, 27%). A dose of 10 mg cyclobenzaprine at bedtime significantly improved the symptomatology of patients affected by primary fibromyalgia syndrome. The higher dose did not further reduce these symptoms but did result in a higher incidence of side-effects.

Adult↗
PubMedDate not supplied

Rifamycin SV administered by intra-articular infiltrations shows disease modifying activity in patients with pauci- or polyarticular juvenile rheumatoid arthritis.

The therapeutic activity of rifamycin SV administered by the intra-articular route was evaluated in 52 children with juvenile rheumatoid arthritis (oligopolyarthritis). Each active joint was injected once a week for 10 weeks; thereafter patients were followed for 3-48 months. The number of active joints and joints with limitation of motion, the erythrocyte sedimentation rate (ESR) and C-reactive protein improved significantly at the end of the treatment cycle, with progressive improvement during the subsequent period of observation. At 48-month of follow-up, 78% of joints did not present signs of inflammation; and 66% of joints showed no functional limitations. Joints without radiological lesions at baseline and large joints responded best to the rifamycin treatment. Persistent knee effusions were reabsorbed completely in most cases during the treatment and within the first 6 months of follow-up. Recurrences of synovitis were observed in 7% of joints. De novo radiological lesions in initially undamaged joints occurred during the second year of follow-up in only 10% of patients. At 24 months, 62% of patients with oligoarthritis and 24% with polyarthritis showed complete remission in all affected joints and recovered movement in all those joints which had shown limitations at baseline. There was also a normalization of inflammatory indexes (ESR, C-reactive protein) and regression of general features of disease. Further long term studies are now required to confirm these promising preliminary results.

Adolescent↗
PubMedDate not supplied

Twenty years of experience with intra-articular rifamycin for chronic arthritides.

Rheumatoid arthritis is a chronic progressive disease causing substantial morbidity and mortality for which current treatments are largely unsatisfactory. Over the past 20 years we have developed a novel therapeutic approach based on the intra-articular administration of rifamycin. The published studies on rifamycin therapy of rheumatoid arthritis and other chronic arthritic disorders, mainly from our group, are reviewed. Our results indicate that intra-articular rifamycin is effective against active synovitis and can profitably be combined with any basic therapy with slow-acting antirheumatic drugs. There is good evidence that the development of new erosions can be prevented or delayed by this treatment and that the balance between side-effects (mainly local pain) and antiarthritic activity is very favourable in the long term. Our observations have led us to hypothesize a possible systemic effect of rifamycin injected multilocally in peripheral joints; we believe that the available data deserve further investigation by independent researchers.

Arthritis, Rheumatoid↗
PubMedDate not supplied

Amtolmetin guacyl versus piroxicam in patients with osteoarthritis.

The efficacy and tolerability of amtolmetin guacyl (AMG), a new non-steroidal anti-inflammatory drug, were compared with piroxicam, in patients with osteoarthritis. In a randomized double-blind study patients with arthritis (n = 99) received either 600 mg AMG on an empty stomach or 20 mg of piroxicam on a full stomach, once daily for 30 days. All clinical parameters improved significantly with both drugs; there were no significant differences between the two treatments. Tolerability, assessed by the patients, was significantly better in the AMG group. In the piroxicam group nine of 50 patients withdrew because of side-effects (gastrointestinal) compared with two of 49 (nausea and headache) in the AMG group. There were three cases of perforation, ulcer and bleeding in the piroxicam group but no serious side-effects with AMG. Total numbers of side-effects were similar in the two groups, but epigastric and abdominal pain were more frequent and more intense with piroxicam. AMG was as effective as piroxicam in controlling the symptoms of osteoarthritis, but showed better gastrointestinal tolerability.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMedDate not supplied

Clinical and gastroscopic evaluation of amtolmetin guacyl versus diclofenac in patients with rheumatoid arthritis.

AIM: Amtolmetin guacyl (2-[2[1-methyl-5-(4-methylbenzoyl) pyrrol-2-yl] acetamido] acetic acid 2-methoxyphenyl ester) is a recently developed drug which, in preliminary studies, has shown effective anti-inflammatory properties with improved gastrointestinal safety. Our study was designed to investigate the efficacy and tolerability of amtolmetin guacyl 600 mg bid when compared to diclofenac 50 mg tid for 4 weeks. PATIENTS AND METHODS: A total of 64 patients aged 18-80 years, suffering from rheumatoid arthritis for more than 6 months and American Rheumatism Association functional class I, II or III were randomized in a double blind manner to amtolmetin guacyl or diclofenac for 4 weeks. Clinical and endoscopic evaluation were performed at baseline and at the end of the treatment. The mucosa was graded by means of a rating system emphasizing mucosal erosions. Only patients with endoscopy grade 0-1 entered the trial. RESULTS: The median post-treatment endoscopy injury scores were 0 (range 0-4) in the amtolmetin guacyl-treated patients and 2 (range 0-4) in the diclofenac-treated patients (p = 0.005). There were nine gastric ulcers: 1/32 (3%) in the amtolmetin guacyl group and 8/32 (25%) in the diclofenac group (p < 0.05; 95% confidence interval, -30-5%). 16/32 (50%) patients in amtolmetin guacyl group and 8/32 (25%) in diclofenac group had normal gastroduodenal findings (score = 0) (p < 0.05; 95% confidence interval, 5-50%). In patients with a history of peptic ulcer, a recurrence of gastric damage (score 3-4) was observed in 18% in the amtolmetin guacyl and in 53% in the diclofenac group (p < 0.05). The incidence of gastrointestinal symptoms did not differ in the two groups. Amtolmetin guacyl significantly reduced the number of swollen and painful joints, and the functional disability index; diclofenac significantly reduced the number of painful joints and the functional disability index score (p = ns). CONCLUSIONS: Amtolmetin guacyl effectively controlled the symptoms of rheumatoid arthritis, with very limited gastric toxicity. If these findings are confirmed on a wider scale, the drug might become a valid alternative to current therapies, especially for patients at risk, such as those with rheumatoid arthritis simultaneously requiring steroids and second-line drugs, or those with a history of peptic ulcer.

Adolescent↗
PubMedDate not supplied

Oral type II collagen in the treatment of rheumatoid arthritis. A six-month double blind placebo-controlled study.

OBJECTIVE: To evaluate the efficacy of oral chicken type II collagen (CII) in the treatment of rheumatoid arthritis (RA). METHODS: Sixty patients with clinically active RA of long duration (mean 7.2 +/- 5.5 years) were treated for 6 months with oral chicken CII at 0.25 mg/day (n = 31) or with placebo (n = 29) in a double-blind randomized study. RESULTS: The response rate to treatment of the collagen-treated group, based on the ACR 20% criteria, was higher than that of the control group but this difference was not statistically significant at any time. Intention-to-treat (ITT) analysis did not show statistically significant improvement in any of the several secondary outcome measures over the 6 months of the study in the collagen-treated patients in comparison with the placebo-treated group. However, in 2 collagen-treated patients we observed a clinical remission according to the criteria of the American Rheumatism Association. CONCLUSION: Our study seems to show that the oral treatment of RA patients with chicken CII is ineffective and results in only small and inconsistent benefits. Furthermore, our results raise the possibility that in a sub-group of patients oral collagen administration, usually considered devoid of harmful effects, may actually induce disease flares.

Administration, Oral↗