Fernandez-Gallego, V. (V.)

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    Randomized crossover pharmacokinetic evaluation of subcutaneous versus intravenous granisetron in cancer patients treated with platinum-based chemotherapy
    (AlphaMed Press, 2007) Campanero, M.A. (Miguel Angel); Perez-Gracia, J.L. (Jose Luis); Martin-Algarra, S. (Salvador); Olier, C. (Clara); Blanco-Prieto, M.J. (María José); Fernandez-Gallego, V. (V.); Lopez-Picazo, J.M. (José M.); Gurpide, A. (Alfonso); Garcia-Foncillas, J. (Jesús); Gil-Aldea, I. (I.); Sadaba, B. (Belén); Cruz, S. (S.) de la; Ceballos-Viro, J. (Jaime); Cabello, J.P. (J.P.); Azanza, J.R. (José Ramón); Reyna, C. (Carmen)
    BACKGROUND: 5-HT3-receptor antagonists are one of the mainstays of antiemetic treatment, and they are administered either i.v. or orally. Nevertheless, sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective was to evaluate the bioavailability of s.c. granisetron. PATIENTS AND METHODS: Patients receiving platinum-based chemotherapy were randomized to receive 3 mg of granisetron either s.c. or i.v. in a crossover manner during two cycles. Blood and urine samples were collected after each cycle. Pharmacokinetic parameters observed with each administration route were compared by analysis of variance. RESULTS: From May to November 2005, 31 patients were included and 25 were evaluable. Subcutaneous granisetron resulted in a 27% higher area under the concentration-time curve for 0-12 hours (AUC(0-12h)) and higher levels at 12 hours, with similar values for AUC(0-24h). The maximum concentration was lower with the s.c. than with the i.v. route and was observed 30 minutes following s.c. administration. CONCLUSION: Granisetron administered s.c. achieves complete bioavailability. This is the first study that shows that s.c. granisetron might be a valid alternative to i.v. delivery. Further trials to confirm clinical equivalence are warranted. This new route of administration might be especially relevant for outpatient management of emesis in cancer patients.
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    Posibles indicaciones del tratamiento de las enfermedades autoinmunes con tacrolimus
    (Ediciones Universidad de Navarra, 2004) Fernandez-Gallego, V. (V.); Garcia-Quetglas, E. (Emilio); Sadaba, B. (Belén); Azanza, J.R. (José Ramón)
    Tacrolimus is an immunosuppressive drug used most successfully as a primary drug to suppress the rejection of transplants. Tacrolimus may also be useful as a novel therapy for autoimmune disease. There are various reports in the bibliography about the use of tacrolimus in the treatment of some autoimmune diseases: inflammatory bowel disease, autoimmune hepatitis, cutaneous, neurologic, renal, endocrine or eye disease. In this review of more than 130 papers, we discuss the rationale for the use of tacrolimus in autoimmune disease and report the clinical experience with the drug in the management of a variety of autoimmune diseases. But, although there are a lot questions that require future research (dose, duration of treatment, when to begin tacrolimus treatment, how to monitor it, etc.), there is also wide experience with tacrolimus in the treatment of this type of disease.