ABSTRACT
BACKGROUND: Eltrombopag is effective and safe in chronic immune thrombocytopenia (ITP). However, clinical trials may not accurately reflect what happens in clinical practice. We evaluated the efficacy and safety of eltrombopag in primary chronic ITP in a real-world setting. METHODS: A total of 164 primary patients with chronic ITP from 40 Spanish centers, who had been treated with eltrombopag, were retrospectively evaluated. RESULTS: The median age of our cohort (72% women) was 63 yr (interquartile range, IQR, 45-75 yr). The median time with ITP diagnosis was 81 months (IQR, 30-192 months). The median number of therapies prior to eltrombopag was 3 (IQR, 2-4). At the time of eltrombopag start, 45 patients (30%) were receiving concomitant treatment for ITP. Forty-six patients (30%) had bleeding signs/symptoms the month before the treatment started. The median platelet count at eltrombopag initiation was 22 × 10(9) /L (IQR, 8-39 × 10(9) /L). A total of 135 patients (88.8%) achieved a platelet response. The median time to platelet response was 12 d (95% CI, 9-13 d). Maintained platelet response rate during the 15-month period under examination was 75.2%. Twenty-eight patients (18.4%) experienced adverse events, mainly grades 1-2. CONCLUSION: Eltrombopag is highly effective and well tolerated in unselected patients with primary chronic ITP.
Subject(s)
Benzoates/therapeutic use , Hydrazines/therapeutic use , Purpura, Thrombocytopenic, Idiopathic/drug therapy , Pyrazoles/therapeutic use , Aged , Benzoates/administration & dosage , Benzoates/adverse effects , Chronic Disease , Female , Humans , Hydrazines/administration & dosage , Hydrazines/adverse effects , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/therapeutic use , Male , Middle Aged , Purpura, Thrombocytopenic, Idiopathic/diagnosis , Purpura, Thrombocytopenic, Idiopathic/immunology , Pyrazoles/administration & dosage , Pyrazoles/adverse effects , Retreatment , Retrospective Studies , Spain , Treatment OutcomeABSTRACT
Eltrombopag is effective and safe in immune thrombocytopenia (ITP). Some patients may sustain their platelet response when treatment is withdrawn but the frequency of this phenomenon is unknown. We retrospectively evaluated 260 adult primary ITP patients (165 women and 95 men; median age, 62 years) treated with eltrombopag after a median time from diagnosis of 24 months. Among the 201 patients who achieved a complete remission (platelet count >100 × 10(9) /l), eltrombopag was discontinued in 80 patients. Reasons for eltrombopag discontinuation were: persistent response despite a reduction in dose over time (n = 33), platelet count >400 × 10(9) /l (n = 29), patient's request (n = 5), elevated aspartate aminotransferase (n = 3), diarrhea (n = 3), thrombosis (n = 3), and other reasons (n = 4). Of the 49 evaluable patients, 26 patients showed sustained response after discontinuing eltrombopag without additional ITP therapy, with a median follow-up of 9 (range, 6-25) months. These patients were characterized by a median time since ITP diagnosis of 46.5 months, with 4/26 having ITP < 1 year. Eleven patients were male and their median age was 59 years. They received a median of 4 previous treatment lines and 42% were splenectomized. No predictive factors of sustained response after eltrombopag withdrawal were identified. Platelet response following eltrombopag cessation may be sustained in an important percentage of adult primary ITP patients who achieved CR with eltrombopag. However, reliable markers for predicting which patients will have this response are needed.
Subject(s)
Benzoates/administration & dosage , Erythropoiesis/drug effects , Hematinics/administration & dosage , Hydrazines/administration & dosage , Purpura, Thrombocytopenic, Idiopathic/drug therapy , Pyrazoles/administration & dosage , Adult , Aged , Blood Platelets/drug effects , Blood Platelets/pathology , Chronic Disease , Drug Administration Schedule , Drug Monitoring , Female , Follow-Up Studies , Humans , Male , Middle Aged , Platelet Count , Purpura, Thrombocytopenic, Idiopathic/pathology , Purpura, Thrombocytopenic, Idiopathic/surgery , Receptors, Thrombopoietin/agonists , Receptors, Thrombopoietin/genetics , Receptors, Thrombopoietin/metabolism , Recurrence , Remission Induction , Retrospective Studies , Splenectomy , Treatment OutcomeABSTRACT
Introducción. En España se estima que 400.000 personas reciben tratamiento con anticoagulantes orales (TAO). Se pretende evaluar sus hábitos de higiene oral y la información que reciben sobre las complicaciones derivadas del tratamiento odontológico. Pacientes y método. Seleccionamos 173 pacientes, 87 TAO y 86 portadores de prótesis valvulares cardiacas (PPV-TAO), que respondieron a un cuestionario sobre higiene oral y prevención de complicaciones hemorrágicas y de endocarditis bacteriana. Resultados. El 17,5 por ciento de los TAO y el 26,5 por ciento de los PPV-TAO admitieron no cepillarse los dientes nunca. El 68,1 por ciento de los TAO y el 73,9 por ciento de los PPV-TAO habían sido informados sobre el riesgo de sangrado y de endocarditis bacteriana respectivamente. Conclusión. La mayoría de los pacientes TAO y PPV-TAO reciben información específica previa al tratamiento odontológico sobre potenciales complicaciones y su prevención. Sin embargo, sus hábitos de higiene oral son deficientes, presumiblemente porque existen importantes carencias en educación odontológica (AU)
