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Posible exantema pruriginoso secundario a lenalidomida Translated title: Suspected itchy rash secondary to lenalidomide

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Farmacia Hospitalaria

Grupo Aula Médica

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      Most cited references 13

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      A method for estimating the probability of adverse drug reactions

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        Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma.

        Lenalidomide is a structural analogue of thalidomide with similar but more potent biologic activity. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide plus dexamethasone in the treatment of relapsed or refractory multiple myeloma. Of 351 patients who had received at least one previous antimyeloma therapy, 176 were randomly assigned to receive 25 mg of oral lenalidomide and 175 to receive placebo on days 1 to 21 of a 28-day cycle. In addition, all patients received 40 mg of oral dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for the first four cycles and subsequently, after the fourth cycle, only on days 1 to 4. Patients continued in the study until the occurrence of disease progression or unacceptable toxic effects. The primary end point was time to progression. The time to progression was significantly longer in the patients who received lenalidomide plus dexamethasone (lenalidomide group) than in those who received placebo plus dexamethasone (placebo group) (median, 11.3 months vs. 4.7 months; P<0.001). A complete or partial response occurred in 106 patients in the lenalidomide group (60.2%) and in 42 patients in the placebo group (24.0%, P<0.001), with a complete response in 15.9% and 3.4% of patients, respectively (P<0.001). Overall survival was significantly improved in the lenalidomide group (hazard ratio for death, 0.66; P=0.03). Grade 3 or 4 adverse events that occurred in more than 10% of patients in the lenalidomide group were neutropenia (29.5%, vs. 2.3% in the placebo group), thrombocytopenia (11.4% vs. 5.7%), and venous thromboembolism (11.4% vs. 4.6%). Lenalidomide plus dexamethasone is more effective than high-dose dexamethasone alone in relapsed or refractory multiple myeloma. (ClinicalTrials.gov number, NCT00424047 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
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          The ten most common adverse drug reactions (ADRs) in oncology patients: do they matter to you?

          To assess incidence, predictability, preventability and severity of adverse drug reactions (ADRs) in hospitalised oncology patients. Patients hospitalised at Peter MacCallum Cancer Centre from 28 February to 2 June 2000 were selected for interviews about symptoms related to their drug therapy. Medical records were also reviewed. Causality, predictability, preventability and severity were assessed for each ADR. One hundred and sixty-seven patients associated with 171 admissions were interviewed. Four hundred and fifty-four ADRs were identified in 127 (74.3%) separate admissions (mean ADRs per admission 2.7; range 0-18). Eighty-eight percent of ADRs were predictable. Of these, 1.6% was classified as definitely preventable and 46.1% probably preventable. The ten most common ADRs were constipation, nausea +/- vomiting, fatigue, alopecia, drowsiness, myelosuppression, skin reactions, anorexia, mucositis and diarrhoea. These ADRs have high-documented incidence rates and were also the ten most predictable ADRs in this study. Common reasons for ADRs to be assessed as definitely or probably preventable were omission or inadequate/inappropriate use of preventative measures. The results also showed a discrepancy between clinical severity and patients' perception of the impact of ADRs on well being. ADRs are common in hospitalised oncology patients and are predictable and at least probably preventable in many instances. Improved use of preventative measures has the potential to contribute to reducing the incidence and severity of ADRs. Recognition and understanding of the discrepancy that exists between clinical severity and patient-perceived severity of ADRs will enable specific areas to be identified and targeted for vigourous intervention.
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            Author and article information

            Affiliations
            Madrid orgnameHospital General Universitario Gregorio Marañón orgdiv1Servicio de Hematología España
            orgnameHospital General Universitario Gregorio Marañón orgdiv1Servicio de Farmacia
            orgnameInstituto de Investigación Sanitaria Gregorio Marañón
            Contributors
            Role: ND
            Role: ND
            Role: ND
            Journal
            fh
            Farmacia Hospitalaria
            Farm Hosp.
            Grupo Aula Médica (Toledo, Toledo, Spain )
            1130-6343
            2171-8695
            December 2014
            : 38
            : 6
            : 495-496
            S1130-63432014000600012 10.7399/FH.2014.38.6.8176

            This work is licensed under a Creative Commons Attribution 4.0 International License.

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            Product Information: SciELO Spain

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