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Titolo:
The incidence of adverse events and risk factors for upper gastrointestinal disorders associated with meloxicam use amongst 19087 patients in generalpractice in England: cohort study
Autore:
Martin, RM; Biswas, P; Mann, RD;
Indirizzi:
Univ Southampton, Fac Med Hlth & Biol Sci, Sch Med, Southampton, Hants, England Univ Southampton Southampton Hants England , Southampton, Hants, England Drug Safety Res Unit, Southampton SO31 1AA, Hants, England Drug Safety ResUnit Southampton Hants England SO31 1AA A, Hants, England
Titolo Testata:
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
fascicolo: 1, volume: 50, anno: 2000,
pagine: 35 - 42
SICI:
0306-5251(200007)50:1<35:TIOAEA>2.0.ZU;2-4
Fonte:
ISI
Lingua:
ENG
Soggetto:
NONSTEROIDAL ANTIINFLAMMATORY DRUGS; CYCLOOXYGENASE-2; INHIBITION; MARKET;
Keywords:
adverse drug reaction; cardiotoxicity; drug monitoring; gastrointestinal toxicity; liver toxicity; meloxicam; nephrotoxicity; nonsteroidal anti-inflammatory agent; pharmacoepidemiology; prescription-event monitoring;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
29
Recensione:
Indirizzi per estratti:
Indirizzo: Martin, RM Univ Bristol, Dept Social Med, Canynge Hall,Whiteladies Rd, Bristol BS8 2PR, Avon, England Univ Bristol Canynge Hall,Whiteladies Rd Bristol Avon England BS8 2PR
Citazione:
R.M. Martin et al., "The incidence of adverse events and risk factors for upper gastrointestinal disorders associated with meloxicam use amongst 19087 patients in generalpractice in England: cohort study", BR J CL PH, 50(1), 2000, pp. 35-42

Abstract

Aims Meloxicam is a novel nonsteroidal anti-inflammatory drug (NSAID) which may be associated with fewer adverse upper gastrointestinal events than other NSAIDs because it preferentially inhibits the inducible enzyme cyclo-oxygenase-2 relative to the constitutive isoform, cyclo-oxygenase-1. The aims of the study were to: determine the rate of adverse events associated with meloxicam in general practice, stratify these rates by selected risk factors, and to identify signals of previously unsuspected adverse events associated with meloxicam. Methods As part of the national prescription-event monitoring pharmacovigilance system for newly launched drugs in general practice, all patients prescribed meloxicam in England between December 1996 and March 1997 were identified by the central Prescription Pricing Authority. We sent short questionnaires to all prescribers asking about adverse events experienced within 6months of the first prescription. Results There were 19 087 patients in the study. The rate of dyspepsia during the first month of exposure was 28.3 per 1000 patient-months. There were 33 reports of upper gastrointestinal haemorrhage during treatment (rate: 0.4 per 1000 months). A history of gastrointestinal disorder in the previous year was associated with an increased rate of dyspepsia (rate ratio: 3.0;95% confidence interval: 2.6, 3.4), abdominal pain (2.1; 1.6, 2.6), and peptic ulcer (4.0; 1.4, 13.2). Prior NSAID use was associated with a 20-30% decrease in the rate of dyspepsia and abdominal pain in patients starting meloxicam, while patients prescribed concomitant gastroprotective agents had a two to three-fold increased rate of dyspepsia, abdominal pain and peptic ulceration. Other rare events were thrombocytopenia (n = 2); interstitial nephritis (n = 1) and idiosyncratic liver abnormalities (n = 1). Conclusions In the absence of gastro-intestinal risk factors the incidenceof gastro-intestinal disturbance was low. Such risk factors should be carefully reviewed prior to prescribing meloxicam.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 20/01/20 alle ore 07:32:38