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Titolo:
Microemulsion formulation of cyclosporin (Sandimmun Neoral (R)) vs Sandimmun (R): Comparative safety, tolerability and efficacy in severe active rheumatoid arthritis
Autore:
Yocum, DE; Allard, S; Cohen, SB; Emery, P; Flipo, RM; Goobar, J; Jayawardena, S; Job-Deslandre, C; Jubb, RW; Kruger, K; Vaz, AL; Manger, B; Mur, E; Nygaard, H; Weiner, SM; Rainer, F; Sack, MR; Schiff, MH; Schnitzer, TJ; Trigg, LB; Whatmough, I; Schmidt, AG;
Indirizzi:
Univ Arizona, Hlth Sci Ctr, Arthrit Ctr, Tucson, AZ 85724 USA Univ Arizona Tucson AZ USA 85724 i Ctr, Arthrit Ctr, Tucson, AZ 85724 USA W Middlesex Univ Hosp, Dept Rheumatol, Isleworth, Middx, England W Middlesex Univ Hosp Isleworth Middx England Isleworth, Middx, England Metroplex Clin Res Ctr, Dallas, TX USA Metroplex Clin Res Ctr Dallas TX USA roplex Clin Res Ctr, Dallas, TX USA Univ Leeds, Sch Med, Rheumatol & Rehabil Res Unit, Leeds LS2 9JT, W Yorkshire, England Univ Leeds Leeds W Yorkshire England LS2 9JT S2 9JT, W Yorkshire, England Hop Roger Salengro, Lille, France Hop Roger Salengro Lille FranceHop Roger Salengro, Lille, France Hosp Rheumat Dis, Ostersund, Sweden Hosp Rheumat Dis Ostersund SwedenHosp Rheumat Dis, Ostersund, Sweden Bollnas Iasarett Med Klinikum, Bollnas, Sweden Bollnas Iasarett Med Klinikum Bollnas Sweden Klinikum, Bollnas, Sweden Grp Hosp Cochin, Paris, France Grp Hosp Cochin Paris FranceGrp Hosp Cochin, Paris, France Selly Oak Hosp, Dept Rheumatol, Birmingham B29 6JD, W Midlands, England Selly Oak Hosp Birmingham W Midlands England B29 6JD W Midlands, England Univ Munich, Med Poliklin, Klinikum Links Isar, D-8000 Munich, Germany Univ Munich Munich Germany D-8000 kum Links Isar, D-8000 Munich, Germany Hosp S Joao, Unidade Reumatol, Porto, Portugal Hosp S Joao Porto Portugal sp S Joao, Unidade Reumatol, Porto, Portugal Univ Erlangen Nurnberg, Med Klin 3, Erlangen, Germany Univ Erlangen Nurnberg Erlangen Germany , Med Klin 3, Erlangen, Germany Univ Klin Innsbruck, Innsbruck, Austria Univ Klin Innsbruck Innsbruck Austria lin Innsbruck, Innsbruck, Austria Rheumatism Hosp, Lillehammer, Norway Rheumatism Hosp Lillehammer NorwayRheumatism Hosp, Lillehammer, Norway Univ Hosp, Dept Med, Div Rheumatol & Clin Immunol, Freiburg, Germany Univ Hosp Freiburg Germany Rheumatol & Clin Immunol, Freiburg, Germany Graz Univ, Med Klin, A-8036 Graz, Austria Graz Univ Graz Austria A-8036Graz Univ, Med Klin, A-8036 Graz, Austria Austin Diagnost Clin, Clin Res Ctr, Austin, TX USA Austin Diagnost Clin Austin TX USA st Clin, Clin Res Ctr, Austin, TX USA Denver Arthrit Clin, Denver, CO USA Denver Arthrit Clin Denver CO USADenver Arthrit Clin, Denver, CO USA Northwestern Univ, Off Clin Res & Training, Chicago, IL 60611 USA Northwestern Univ Chicago IL USA 60611 & Training, Chicago, IL 60611 USA Ctr Diagnost, Little Rock, AR USA Ctr Diagnost Little Rock AR USACtr Diagnost, Little Rock, AR USA Novartis Pharma AG, Basel, Switzerland Novartis Pharma AG Basel Switzerland rtis Pharma AG, Basel, Switzerland
Titolo Testata:
RHEUMATOLOGY
fascicolo: 2, volume: 39, anno: 2000,
pagine: 156 - 164
SICI:
1462-0324(200002)39:2<156:MFOC(N>2.0.ZU;2-4
Fonte:
ISI
Lingua:
ENG
Soggetto:
LOW-DOSE CYCLOSPORINE; DOUBLE-BLIND; T-CELL; MULTICENTER; PLACEBO; PHARMACOKINETICS; VARIABILITY; CONCLUSIONS; LYMPHOCYTES; MECHANISM;
Keywords:
rheumatoid arthritis; cyclosporin; microemulsion formulation;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
33
Recensione:
Indirizzi per estratti:
Indirizzo: Yocum, DE Univ Arizona, Hlth Sci Ctr, Arthrit Ctr, Room 6409,1501 N Campbell Ave, Tucson, AZ 85724 USA Univ Arizona Room 6409,1501 N Campbell Ave Tucson AZ USA 85724 A
Citazione:
D.E. Yocum et al., "Microemulsion formulation of cyclosporin (Sandimmun Neoral (R)) vs Sandimmun (R): Comparative safety, tolerability and efficacy in severe active rheumatoid arthritis", RHEUMATOLOG, 39(2), 2000, pp. 156-164

Abstract

Objective. To compare the safety, tolerability and efficacy of the new oral microemulsion formulation of cyclosporin A (CyA, Sandimmun Neoral(R)) andthe original CyA formulation (Sandimmun(R)), in patients with severe active rheumatoid arthritis (RA), over a 12-month period. Methods. In this double-blind. multicentre study. patients were randomizedto treatment with Neoral or Sandimmun. starting with 2.5 mg/kg/day, with dose adjustments after 4 weeks. Primary efficacy criteria included patients'assessment of disease activity. Pharmacokinetic and safety assessments were performed at regular intervals. Results. Compared with Sandimmun, Neoral showed a consistent trend towardsgreater clinical efficacy from week 12 onwards, including a significant difference in patients' assessment of disease activity at the study end-points. A significantly lower increase in dose from baseline was observed with Neoral at week 24. Pharmacokinetic assessments at week 24 showed increased absorption and decreased variability with Neoral. No differences in safety were found between treatment groups. Conclusion. These observations indicate that Neoral is as safe and at least as effective as Sandimmun and have important implications for patient management given the increasing role for CyA in the treatment of severe, active RA.

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Documento generato il 07/08/20 alle ore 07:12:16