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Oral contraceptives combined with interferon ß in multiple sclerosis.
Pozzilli, Carlo; De Giglio, Laura; Barletta, Valeria T; Marinelli, Fabiana; Angelis, Floriana De; Gallo, Valentina; Pagano, Veronica A; Marini, Stefano; Piattella, Maria C; Tomassini, Valentina; Pantano, Patrizia.
Afiliação
  • Pozzilli C; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
  • De Giglio L; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
  • Barletta VT; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
  • Marinelli F; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
  • Angelis FD; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
  • Gallo V; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
  • Pagano VA; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
  • Marini S; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
  • Piattella MC; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
  • Tomassini V; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
  • Pantano P; Department of Neurology and Psychiatry (C.P., L.D.G., F.D.A., M.C.P., V.T., P.P.), Sapienza University of Rome, Italy; MS Center (C.P., L.D.G., V.T.B., F.M.), S. Andrea Hospital, Sapienza University of Rome, Italy; Centre for Primary Care and Public Health (V.G.), Queen Mary University of London, UK
Neurol Neuroimmunol Neuroinflamm ; 2(4): e120, 2015 Aug.
Article em En | MEDLINE | ID: mdl-26140279
OBJECTIVE: To test the effect of oral contraceptives (OCs) in combination with interferon ß (IFN-ß) on disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: One hundred fifty women with RRMS were randomized in a 1:1:1 ratio to receive IFN-ß-1a subcutaneously (SC) only (group 1), IFN-ß-1a SC plus ethinylstradiol 20 µg and desogestrel 150 µg (group 2), or IFN-ß-1a SC plus ethinylestradiol 40 µg and desogestrel 125 µg (group 3). The primary endpoint was the cumulative number of combined unique active (CUA) lesions on brain MRI at week 96. Secondary endpoints included MRI and clinical and safety measures. RESULTS: The estimated number of cumulative CUA lesions at week 96 was 0.98 (95% confidence interval [CI] 0.81-1.14) in group 1, 0.84 (95% CI 0.66-1.02) in group 2, and 0.72 (95% CI 0.53-0.91) in group 3, with a decrease of 14.1% (p = 0.24) and 26.5% (p = 0.04) when comparing group 1 with groups 2 and 3, respectively. The number of patients with no gadolinium-enhancing lesions was greater in group 3 than in group 1 (p = 0.03). No significant differences were detected in other secondary endpoints. IFN-ß or OC discontinuations were equally distributed across groups. CONCLUSIONS: Our results translate the observations derived from experimental models to patients, supporting the anti-inflammatory effects of OCs with high-dose estrogens, and suggest possible directions for future research. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in women with RRMS, IFN-ß plus ethinylstradiol and desogestrel decreases the cumulative number of active brain MRI lesions compared with IFN-ß alone.

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Neurol Neuroimmunol Neuroinflamm Ano de publicação: 2015 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Neurol Neuroimmunol Neuroinflamm Ano de publicação: 2015 Tipo de documento: Article