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Titolo:
A multicenter, randomized, controlled trial to evaluate the safety profile, tolerability, and efficacy of rofecoxib in advanced elderly patients withosteoarthritis
Autore:
Truitt, KE; Sperling, RS; Ettinger, WH; Greenwald, M; DeTora, L; Zeng, Q; Bolognese, J; Ehrich, E;
Indirizzi:
Merck Res Labs, Rahway, NJ 07065 USA Merck Res Labs Rahway NJ USA 07065Merck Res Labs, Rahway, NJ 07065 USA
Titolo Testata:
AGING-CLINICAL AND EXPERIMENTAL RESEARCH
fascicolo: 2, volume: 13, anno: 2001,
pagine: 112 - 121
SICI:
0394-9532(200104)13:2<112:AMRCTT>2.0.ZU;2-2
Fonte:
ISI
Lingua:
ENG
Soggetto:
NONSTEROIDAL ANTIINFLAMMATORY DRUGS; GASTROINTESTINAL TOXICITY; HEALTHY-SUBJECTS; DOUBLE-BLIND; IBUPROFEN; CYCLOOXYGENASE-2; INHIBITOR; ARTHRITIS; PLACEBO; NABUMETONE;
Keywords:
advanced elderly; COX-2 inhibitors; safety; osteoarthritis;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
30
Recensione:
Indirizzi per estratti:
Indirizzo: Sperling, RS Merck Res Labs, 126 E Lincoln Ave RY 32-305, Rahway, NJ 07065USA Merck Res Labs 126 E Lincoln Ave RY 32-305 Rahway NJ USA 07065
Citazione:
K.E. Truitt et al., "A multicenter, randomized, controlled trial to evaluate the safety profile, tolerability, and efficacy of rofecoxib in advanced elderly patients withosteoarthritis", AGING-CLIN, 13(2), 2001, pp. 112-121

Abstract

This 6-week study was conducted to test the efficacy, safety, and tolerability of rofecoxib (a selective COX-2 inhibitor) compared to nabume-tone (a non-selective NSAID) and placebo in osteoarthritis (OA) patients aged 80 and older. Three hundred forty-one patients, mean age 83 years, were randomized. Allocations were made in an approximately 1:2:1:2 ratio (placebo: 12.5 mg rofecoxib: 25 mg rofecoxib: 1500 mg nabumetone). Least square mean changes from baseline in the primary efficacy endpoint, Patient Global Assessment of Disease Status, were as follows (with negative numbers indicating improvement): -14.85 mm for placebo; -25.34 mm for 12.5 mg rofecoxib; -25.40 mmfor 25 mg of rofecoxib; and -25.95 mm for nabumetone (p <0.001 for all active treatments vs placebo. ) Results from secondary end points, including the 3 WOMAC sub-scales (pain, stiffness, and disability) and the InvestigatorGlobal Assessment of Disease Status, were consistent with those for the primary endpoint. No significant between-group differences were observed in the proportions of patients who discontinued treatment due to either clinical or laboratory adverse experiences. Renal safety (edema and hypertension adverse experiences) was similar for rofecoxib and nabumetone. No gastroduodenal ulcers occurred; however, the demonstration of gastrointestinal risk with rofecoxib or nabumetone was beyond the scope of this trial. We concludethat in patients 80 years and older, rofecoxib, 12.5 mg and 25 mg once daily, demonstrated clinical efficacy for the treatment for OA as did 1500 mg of nabumetone. Rofecoxib and nabumetone were generally well tolerated in this elderly population. (C) 2001, Editrice Kurtis.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 20/01/20 alle ore 10:21:55