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Biomedical subjects

G Velo

Publications and source records attributed to G Velo.

17 recordsLinked to original sources
PubMed2002

Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery.

BACKGROUND: Ketorolac is approved for the relief of postoperative pain but concerns have been raised over a possible risk of serious adverse effects and death. Two regulatory reviews in Europe on the safety of ketorolac found the data were inconclusive and lacked comparison with other non-steroidal anti-inflammatory drugs. The aim of this study was to compare the risk of serious adverse effects with ketorolac vs diclofenac or ketoprofen in adult patients after elective major surgery. METHODS: This prospective, randomized multicentre trial evaluated the risks of death, increased surgical site bleeding, gastrointestinal bleeding, acute renal failure, and allergic reactions, with ketorolac vs diclofenac or ketoprofen administered according to their approved parenteral and oral dose and duration of treatment. Patients were followed for 30 days after surgery. RESULTS: A total of 11,245 patients completed the trial at 49 European hospitals. Of these, 5634 patients received ketorolac and 5611 patients received one of the comparators. 155 patients (1.38%) had a serious adverse outcome, with 19 deaths (0. 17%), 117 patients with surgical site bleeding (1.04%), 12 patients with allergic reactions (0.12%), 10 patients with acute renal failure (0.09%), and four patients with gastrointestinal bleeding (0.04%). There were no differences between ketorolac and ketoprofen or diclofenac. Postoperative anticoagulants increased the risk of surgical site bleeding equally with ketorolac (odds ratio=2.65, 95% CI=1.51-4.67) and the comparators (odds ratio=3.58, 95% CI=1.93-6.70). Other risk factors for serious adverse outcomes were age, ASA score, and some types of surgery (plastic/ear, nose and throat, gynaecology, and urology). CONCLUSION: We conclude that ketorolac is as safe as ketoprofen and diclofenac for the treatment of pain after major surgery.

Acute Kidney Injury↗
PubMed2001

Adverse drug reactions related to the use of NSAIDs with a focus on nimesulide: results of spontaneous reporting from a Northern Italian area.

OBJECTIVE: To analyse and compare the adverse drug reactions (ADRs) associated with the use of nimesulide with those associated with diclofenac, ketoprofen, and piroxicam, reported spontaneously in a northern Italian area (Veneto and Trentino). METHODS: Data were obtained from the spontaneous reporting system database of Veneto-Trentino, the principal contributor to the Italian spontaneous surveillance system. All case reports that occurred in association with all formulations of the nonsteroidal anti-inflammatory drugs (NSAIDs) under investigation during the period from January 1988 to December 2000, were analysed in detail. Sales data from June 1996 to May 1999 and prescription data, from 1997 to 2000 from the Veneto region were utilised to select the most widely used NSAIDs to be included in the study. The prescription data were also used to look at the drug use in relation to age. RESULTS: During the study period, 10 608 reports describing 16 571 adverse reactions were entered into the surveillance system. We found 207 case reports for nimesulide, 187 for diclofenac, 174 for ketoprofen, and 137 for piroxicam. Analysis of sales and prescription data revealed that in the Veneto region nimesulide was the most widely prescribed drug followed at a long distance by diclofenac, piroxicam and ketoprofen. No age-related difference in the use of the four drugs was found. Analysis of the case reports revealed significantly different toxicity profiles for the four drugs. In particular, nimesulide was associated with fewer and less severe gastrointestinal (GI) ADRs compared with the other NSAIDs. Nimesulide was associated with about half the number of GI reactions (10.4%) than the other three NSAIDs (21.2% for diclofenac, 21.7% for ketoprofen, 18.6% for piroxicam). Two previously unreported reactions were also found for piroxicam and ketoprofen. CONCLUSIONS: Nimesulide is the most frequently used NSAID in Italy. Spontaneous reporting data suggest that nimesulide has the most favourable GI tolerability profile of the NSAIDs investigated, with few reports of severe GI reactions. A few reports of hepatic and renal impairment associated with nimesulide suggest caution in patients at risk. Age-related reporting analysis suggests a higher toxicity for diclofenac and piroxicam in the elderly compared with nimesulide and ketoprofen. This analysis of the Veneto-Trentino database on spontaneous reporting confirms that NSAIDs differ in their tolerability profile, and this fact should be taken into account in the choice of drugs in relation to patient characteristics.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

Spontaneous reporting of drug-related hepatic reactions from two Italian regions (Lombardy and Veneto).

BACKGROUND AND AIMS: Many currently used drugs are implicated in liver disorders ranging from asymptomatic abnormal liver function tests to fatal liver failure, and drug-induced hepatic reactions are the most frequent cause of the withdrawal of drugs from the market in the United States, United Kingdom and Spain. The aim of this study was to review the drug-induced hepatic reactions notified to the spontaneous surveillance system of two Italian regions (Lombardy and the Veneto) up to 31 December 1998. PATIENTS AND METHODS: The reports of hepatic adverse drug reactions were extracted from an inter-regional database of spontaneous adverse drug reaction reports and analysed by reporter category, patient age and sex, the underlying disease, the adverse reaction and drug exposure. In the case of drugs involved in more than four reports, a search was made of the Medline, Hepatox, Micromedex and WHO databases. RESULTS: Between 1988 and 1998, there were 310 reports of hepatic lesions associated with single drugs or fixed combinations, the most frequently involved patient categories being females and the elderly. Sixty percent of the reactions were classified as serious, with three fatal cases. Thirteen drugs were associated with more than four reports and accounted for 35% of all of the hepatic reactions. Six drugs not known as hepatotoxic agents were associated with hepatic reactions. CONCLUSIONS: In this study, spontaneous reports have suggested previously unknown hepatotoxicty of six drugs, and have improved drug safety profiles as shown in an Italian inter-regional health service.

Adverse Drug Reaction Reporting Systems↗
PubMed1999

Cutaneous reactions to drugs. An analysis of spontaneous reports in four Italian regions.

AIMS: Cutaneous manifestations are frequently reported in association with drug use. The aim of this study was to analyse the skin reactions reported to the spontaneous surveillance systems of four Italian regions (Friuli Venezia Giulia, Lombardy, Sicily and the Veneto), and correlate the reports with estimated drug consumption during the same period, paying particular attention to the reactions to antimicrobial agents and nonsteroidal anti-inflammatory drugs (NSAIDs). METHODS: All of the adverse drug reactions (ADRs) reported spontaneously between January 1996 and December 1997 to the surveillance systems of four Italian regions (a total population of about 20 million people) were analysed by a panel of experts including dermatologists. On the basis of the Critical Term List of the World Health Organization (WHO), the reactions were classified as either serious or nonserious events. Drug consumption was expressed as a daily defined dose (DDD)/1000 inhabitants/day. RESULTS: A total of 2224 adverse skin reaction reports (44.7% of all of the reported ADRs) were identified, making a reporting rate of about 5.5 per 100 000 inhabitants/year. The female/male ratio was 1.58, and the reporting rate progressively increased with age. The drug categories with the highest number of cutaneous reactions were antimicrobials, followed by NSAIDs, analgesics and radiology contrast media. There was a total of 372 (16.9%) serious reaction reports, the most frequent being angioedema (171 cases), erythema multiforme (68 cases) and photosensitivity (37 cases). Co-trimoxazole, followed by the cephalosporins and fluoroquinolones, were associated with the highest consumption-related reporting rate among the antimicrobials, and aspirin and dipyrone among the NSAIDs and analgesics. CONCLUSIONS: Spontaneous reports from four Italian regions revealed that the skin was the organ most frequently affected by ADRs. The paper shows the validity of a regional decentralized system in Italy.

Anti-Bacterial Agents↗
PubMed1998

Neutrophil behavior following exposure to in vivo or in vitro zinc in normal and acutely-inflamed rats: studies on lysozyme secretion, superoxide anion release and platelet adhesion.

The mechanism was studied of the anti-inflammatory effect of oral zinc (114 mg/kg/day of elemental metal, given for 14 days) on the development of the carrageenan-induced paw oedema of the rat, and the impact of in vivo treatment on the activity of neutrophils isolated from the blood of inflamed and non-inflamed animals. The effects of the in vitro incubation with the metal on either non-inflamed or inflamed neutrophils coming from zinc-untreated rats were also examined. It was found that the administration of oral zinc inhibited markedly the process of ex vivo adhesion of the cells obtained from the inflamed rats (an observation confirmed by the in vitro experiments). In vitro release of lysozyme and superoxide anion productions were measured: in the absence of zinc, the 30' of pre-incubation carried out before stimulating with PMA did not influence the cell's reactivity of the non-inflamed neutrophils. It was, on the contrary, capable of significantly reducing that of the inflamed ones. As a consequence, it is quite difficult to properly interpret the data obtained studying the activity of the cells exposed to the metal in vitro.

Animals↗
PubMed1993

Copper and zinc body levels in inflammation: an overview of the data obtained from animal and human studies.

The development of acute and chronic inflammatory processes induces, in the laboratory animal, a net accumulation of both copper and zinc in many body compartments, the inflamed area included. In rheumatoid arthritis, as well as in animal models, only plasma zinc concentration seems to be significantly correlated with disease severity, while the increase in total plasma copper could be described as an "all or nothing" phenomenon. Moreover, in rheumatoid arthritis, it appears that the disease develops and progresses without being linked to either copper or zinc deficiency conditions. Thus, it seems reasonable to suggest that a rationale for the use of copper and/or zinc in the treatment of inflammatory disorders can only be drawn from the intrinsic pharmacological properties of such trace elements, rather than from the need for their repletion.

Animals↗
PubMed1993

Antibiotic prescribing patterns in Italian hospital inpatients with pneumonia, chronic obstructive pulmonary disease, and urinary tract infections.

OBJECTIVE: The primary objective of this study was to describe the antibiotic prescribing patterns in hospital inpatients with pneumonia (PN), exacerbations of chronic obstructive pulmonary disease (COPD), and urinary tract infections (UTIs). A second objective was to verify if some selected variables (i.e., risk factors, patient age, size of hospitals) were affecting the therapeutic choice. DESIGN: Survey was performed on 1609 patients. The data were collected by physicians using a special form, covering a six-month period. SETTING: Twenty-six medical wards and 8 geriatric wards in 24 acute-care hospitals in the Veneto Region in Northern Italy. PATIENTS: A consecutive sample of PN, COPD, and UTI patients treated with antibiotics. MAIN OUTCOME MEASURES: The following information was collected: patient and hospital demographics, risk factors, diagnoses, and antibiotic regimens. RESULTS: Sixty-three antimicrobial agents used, with 2115 administrations, 1227 of which were single-drug therapy. The most frequently used drugs were third-generation cephalosporins (24.6 percent), fluoroquinolones (15.4 percent), aminopenicillins (15.0 percent), and ureidopenicillins (9.7 percent). There is great variability of therapeutic regimens in the various hospitals for the same disease. However, this variability is not explained by the different types of hospitals or by the patients' characteristics (e.g., age, risk factors). CONCLUSIONS: Our results show that the use of broad-spectrum antibiotics probably is excessive. Moreover, the treatment seems to be based more on the opinion of the treating physician and the local habits rather than objective criteria. These factors may have negative repercussions not only in economic terms, but also in terms of alteration of the bacterial ecology.

Adolescent↗
PubMed1990

Theophylline inhibition of BCG-induced pulmonary inflammatory responses.

The present study was performed to evaluate the effect(s) of theophylline on BCG-induced pulmonary inflammatory responses in an experimental rat model system. Five groups of six animals each received the following: group 1: theophylline-treated, BCG-challenged, and sacrificed three days later; group 2: saline-treated, BCG-challenged, and sacrificed three days later; group 3: theophylline-treated, BCG-challenged, and sacrificed five days later; group 4: saline-treated, BCG-challenged, and sacrificed five days later; and group 5: no treatment and no BCG-challenge ("absolute controls"). Quantitative recovery of bronchoalveolar lavage (BAL) cells was performed and compared with histopathologic changes in lung specimens from each animal in all five groups. No significant differences in quantitative BAL cellular recovery were observed in theophylline-treated animals from saline-treated controls. There was a significant reduction in BAL cell number in saline-treated animals sacrificed five days after BCG-challenge (group 4) from that seen in saline-treated animals sacrificed three days after BCG-challenge (group 2). The most striking finding, however, was a marked diminution in granuloma formation induced by theophylline five days after BCG challenge (group 3). These findings suggest an antiinflammatory effect of theophylline.

Animals↗
PubMed1989

[Zinc sulfate in the treatment of psoriatic arthritis].

We evaluated oral zinc sulphate as a disease-modifying antirheumatic drug (DMARD) in psoriatic arthritis in a preliminary open uncontrolled trial. Twenty patients with psoriatic arthritis were given oral zinc sulphate three times a day at total dose of 600 mg/die, i.e. 120 mg/die of elemental zinc, for 6 months. The 18 patients who completed the trial showed a significant decrease in the number of swollen (p less than 0.01) and tender (p less than 0.05) joints, Ritchie articular index (p less than 0.01), need for nosteroidal anti-inflammatory drugs (p less than 0.001), erythrocyte sedimentation rate (p less than 0.01), and plasma copper level (p less than 0.001). We suggest that zinc sulphate may be an effective and well-tolerated DMARD in psoriatic arthritis. To more strictly verify these preliminary data, a double-blind placebo controlled study is in progress.

Adult↗
PubMed1987

Imipenem kinetics in serum, lung tissue and pericardial fluid in patients undergoing thoracotomy.

Imipenem serum pharmacokinetics, lung tissue and pericardial fluid concentrations were measured in 10 patients undergoing thoracotomy, following a 1 g intravenous infusion of imipenem-cilastatin. The serum concentrations of imipenem 0.5 h and 4 h after the end of the 40 min infusion were 53.3 (+/- 16.7) and 2.0 (+/- 0.3) mg/l, respectively. The concentration of imipenem in lung tissue at 1 h was lower than in pericardial fluid and at 2.25 h the mean concentration of imipenem in pericardial fluid was 10.5 mg/l, vs. 0.28 mg/kg of lung tissue. Imipenem concentrations in pericardial fluid remained above 5 mg/l, well above the MIC for most pathogens, for 1 h whereas in pericardial fluid the concentration was 10.5 mg/l at 2.25 h.

Body Fluids↗
PubMed1985

Copper and inflammation--a possible rationale for the pharmacological manipulation of inflammatory disorders.

Acute and chronic inflammations are characterized, among other features, by changes in the metabolism of copper and by a widespread responsiveness to the therapy with copper-containing molecules. The exact map of inflammation-induced copper movements as well as the role played by the metal in the pathogenesis of inflammatory disorders are, however, far from being clear, and this is especially true in the case of chronic processes. Nevertheless the present knowledge suggests that the "copper approach' may provide a new way for coping with the problem of anti-inflammatory/anti-arthritic therapies. The administration of exogenous copper, and the in vivo manipulation of the endogenous metal levels are proposed as two possible therapeutic strategies, not necessarily mutually exclusive. For a better understanding of the value of such an approach, further research work is needed, especially to attain a more detailed know-how on the involved chemical forms, distribution and functions of copper in both normal as well as inflamed organisms.

Acute Disease↗