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Titolo:
The effects on gastroduodenal mucosa of a new nonsteroidal anti-inflammatory drug, amtolmetin-guacyl, versus piroxicam in healthy volunteers: a short-term, double-blind, endoscopically controlled study
Autore:
Lazzaroni, M; Anderloni, A; Porro, GB;
Indirizzi:
L Sacco Univ Hosp, Chair Gastroenterol, I-20157 Milan, Italy L Sacco Univ Hosp Milan Italy I-20157 astroenterol, I-20157 Milan, Italy
Titolo Testata:
EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY
fascicolo: 7, volume: 13, anno: 2001,
pagine: 833 - 839
SICI:
0954-691X(200107)13:7<833:TEOGMO>2.0.ZU;2-W
Fonte:
ISI
Lingua:
ENG
Soggetto:
HELICOBACTER-PYLORI INFECTION; ANTIINFLAMMATORY DRUG; RHEUMATOID-ARTHRITIS; GASTROINTESTINAL TOXICITY; DISEASE; DAMAGE; ULCER; MISOPROSTOL; PREVENTION; NAPROXEN;
Keywords:
amtolmetin-guacyl; anti-inflammatory drugs; piroxicam;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
42
Recensione:
Indirizzi per estratti:
Indirizzo: Porro, GB L Sacco Univ Hosp, Chair Gastroenterol, Via GB Grassi 74, I-20157 Milan, Italy L Sacco Univ Hosp Via GB Grassi 74 Milan Italy I-20157 n, Italy
Citazione:
M. Lazzaroni et al., "The effects on gastroduodenal mucosa of a new nonsteroidal anti-inflammatory drug, amtolmetin-guacyl, versus piroxicam in healthy volunteers: a short-term, double-blind, endoscopically controlled study", EUR J GASTR, 13(7), 2001, pp. 833-839

Abstract

Aim Amtolmetin-guacyl (AMG) (2-[2[1-methyl-5-(4-methylbenzoyl)pyrrol-2-yl]acetamido] acetic acid 2-methoxyphenyl ester) is a recent drug that, in preliminary studies, has shown effective anti-inflammatory properties with improved gastrointestinal safety. Our study was designed to investigate the effects of AMG and piroxicam on gastroduodenal mucosa in healthy volunteers. Materials and methods Forty-two healthy volunteers aged 18-45 years were randomized in a double-blind manner to AMG 1200 mg for 2 days and 600 mg for12 days, or piroxicam 40 mg for 2 days and 20 mg for 12 days. Endoscopic evaluation and laboratory tests were performed at baseline and at the end ofthe treatment. The mucosa was evaluated by endoscopy using a predefined scale: the score could range from 0 to 4. Only volunteers with endoscopy grade 0-1 entered the trial. Results The median post-treatment endoscopy gastric injury scores were 1 (range 0-4) in the AMG-treated volunteers and 3 (range 0-4) in the piroxicam-treated volunteers (P = 0.04). There were two cases with an endoscopic gastric score of 4 in the AMG group. and seven in the piroxicam group (P = 0.1). The corresponding values in the duodenum were 1/21 volunteers in the AMGgroup and 1/21 in the piroxicam group, Eight out of 11 subjects with an endoscopic score of 4 were Helicobacter pylori negative, and 3/11 were infected by the micro-organism. Different adverse reactions were reported by 15/21 volunteers (71%) in the AMG group and by 12/21 (57%) in the piroxicam group. None of these events resulted in interruption of the study. Conclusions AMG is a new anti-inflammatory drug with limited gastric toxicity, If these findings are confirmed on a wider scale in long-term trials, then the drug might become a valid alternative to current treatments, especially for patients such as those with rheumatoid arthritis who need steroids and second-line drugs simultaneously. (C) 2001 Lippincott Williams & Wilkins.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 30/03/20 alle ore 20:08:57