ABSTRACT
BACKGROUND: Monoclonal antibodies targeting calcitonin gene-related peptide (anti-CGRP mAbs) have shown clinical effectiveness and safety in randomized clinical studies. However, long-term studies in clinical practice remain limited. AIM: To assess the long-term effectiveness, clinical predictors and safety of three anti-CGRP mAbs (erenumab, galcanezumab, fremanezumab) in resistant migraine patients. METHOD: A single-center retrospective study was conducted from December 2019 to June 2023 involving 120 resistant migraine patients who received at least a month of anti-CGRP mAbs treatment. Patients completed a headache diary that included monthly acute medication intake (MAM), monthly migraine days (MMD), adverse events as well as completed Patient-Reported Outcome questionnaires (MIDAS [Migraine Disability Assessment] and Headache Impact Test 6 [HIT-6]). The number of patients achieving a ≥ 50% reduction in monthly migraine days was determined and classified as ≥ 50% responders, and baseline parameters and logistic regression between responders and non-responders were analyzed to identify potential predictors of response. Adverse events were registered in every follow-up. RESULTS: Treatment with anti-CGRP mAbs led to reductions in MIDAS, HIT-6, MMD and MAM from baseline to 6-24 months. At 6-12 months, responders (61% and 57%, respectively) exhibited lower baseline MMD and MAM. Medication overuse was associated with non-responders from 6 to 24 months and it was identified as a negative predictor of treatment effectiveness (OR 0.23, 95% CI 0.07-0.74; p = 0.014). CONCLUSION: Anti-CGRP mAbs prove effectiveness and safety over a 24-month period in a RM population. Patients with no medication overuse and lower basal MMDs and MAM may respond better to anti-CGRP mAbs.
ABSTRACT
OBJECTIVE: To report the case of a patient who developed a life-threatening agranulocytosis and acute tubular necrosis after the administration of allopurinol and rofecoxib. CASE REPORT: After minor surgery, a 70-year-old male underwent a routine blood test which encountered: anemia, leucopenia, neutropenia, thrombopenia, and altered creatinine levels. Both marrow and renal biopsies were performed, yielding the following results: acute tubular necrosis and agranulocytosis in the recovery stage. One month and a half before the aforementioned surgery a routine blood test had been performed, which showed normal values. The patient had then received allopurinol 100 mg/day for around 2 months, and rofecoxib 2.5 mg/day for 14 days. DISCUSSION: After ruling out other possible causes, a diagnosis of iatrogenically induced agranulocytosis and acute tubular necrosis was reached. We used a (modified) Karch-Lasagna algorithm with both drugs, and found the following imputability values: possible for rofecoxib and probable for allopurinol. In view of the widespread use of rofecoxib and COX-2 inhibitors, despite their recent availability, and of their potential role in the severe adverse effects discussed, healthcare professionals must be on the alert for the development of symptoms suggesting said or other adverse effects.
Subject(s)
Agranulocytosis/chemically induced , Allopurinol/adverse effects , Cyclooxygenase Inhibitors/adverse effects , Enzyme Inhibitors/adverse effects , Kidney Tubular Necrosis, Acute/chemically induced , Lactones/adverse effects , Aged , Humans , Male , SulfonesABSTRACT
Objetivo: Describir el caso de un paciente que desarrolló una agranulocitosis y una necrosis tubular aguda que comprometió su vida tras la administración de alopurinol y rofecoxib. Descripción del caso: Varón de 70 años, al que se le realizó una analítica de control tras una intervención menor, observándose anemia, leucopenia, neutropenia, trombopenia y alteración de los niveles de creatinina. Se efectuó biopsia renal y medular con el resultado de necrosis tubular aguda y médula compatible con agranulocitosis en fase de recuperación. Mes y medio antes de la intervención indicada se le había realizado una analítica de control encontrando valores dentro de la normalidad. Anteriormente el paciente había iniciado tratamiento con alopurinol 100 mg al día durante aproximadamente 2 meses, y rofecoxib 2,5 mg al día durante 14 días. Comentario: Tras descartar otras posibles causas, se llegó al diagnóstico de agranulocitosis y necrosis tubular aguda de origen iatrogénico. Aplicamos el algoritmo de Karsch-Lasagna (modificado) para ambos fármacos, encontrando los siguientes valores de imputabilidad: posible para el rofecoxib y probable para el alopurinol. Debido al amplio uso de rofecoxib y los inhibidores de la COX-2, a pesar de su reciente comercialización, y su posible implicación en los graves efectos adversos descritos, los profesionales sanitarios deben estar alertados ante la aparición de síntomas que puedan hacer sospechar la aparición de éstos u otros efectos adversos (AU)
