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Anagrelide Treatment and Cardiovascular Evaluation in 130 Patients with Essential Thrombocythemia (ET): Preliminary Report of the Registro Italiano Trombocitemia (RIT).
Luigi Gugliotta, Alessia Tieghi, Simona Bulgarelli, Giovanni Tortorella, Rosanna Ciancia, Potito Rosario Scalzulli, E Cacciola, Rossella Rosaria Cacciola, Davide Rossi, Emilio Usala, Monica Crugnola, Anna Candoni, Marcello Giordano, A Andriani, Carlos Malabet Santoro, Renato Vimercati, Marina A. Liberati, A. Sciorio, Giorgina Specchia, V. Martinelli, Gianluca Gaïdano, Maria G. Mazzucconi
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Abstract
Abstract Anagrelide treatment is considered potentially responsible of cardiovascular toxicity and side effects. For this reason, we have retrospectively evaluated 130 patients (pts) with Essential Thrombocythemia (ET) treated with Anagrelide in 10 Italian Hematological Centres belonging to the GIMEMA Group. The pts, 55 males and 75 females, had at diagnosis a mean age of 43 years (range 13–82) and a mean platelet (PLT) count of 1086x10(e)9/L. The Anagrelide treatment was started after a mean of 47 months from diagnosis(range 0–196). A previous treatment with cytoreductive drugs (mainly HU and IFN) and antiplatelet agents (mainly ASA), was performed in 65% and 98% of cases, respectively. The mean Anagrelide dose was 1 mg/day at start and 1.7 mg/day in the maintenance phase (mean PLT count below 500x10(e)9/L). Twenty-five patients (19%) discontinued the treatment after a mean of 27 months (range 1–85) for the following reasons: compliance loss (n8), no satisfactory response (n7), palpitations and tachycardia (n6), other side effects (n4), anemia (n1), renal toxicity (n1), thromboembolism (n1). During the follow-up (median 28 months) 4 thrombotic complications (1.15/100 pt-yrs) and 2 minor hemorrhages (0.57/100 pt-yrs) were registered. Moreover, 15 pts showed non lethal cardiovascular events: angina (n6), cardiomiopathy (n4), arrhythmia (n3), AMI (n2). An instrumental cardiovascular evaluation with Echocardiography (ECHO) and ECG was performed at Anagrelide start in 58 pts: the Ejection Fraction (EF) was abnormal in only one pt (EF 47%). The instrumental monitoring was done in 28 pts every 6–12 months. Four out of these 28 pts showed a decrease of the EF below the level of 50% (43%,45%,47%, and 49%), and only 1 pt discontinued Anagrelide for this reason (see table). The clinical and instrumental cardiovascular evaluation in ET patients receiving Anagrelide is becaming of routinary application and an observational prospective study of the Registro Italiano Trombocitemia (RIT) is now in progress. ECHO EF<50% IN 4 OUT OF THE 28 ET PATIENTS MONITORED DURING ANAGRELIDE TREATMENT CASES AGE EF % BASELINE EF % 1ST YEAR EF% 2ND YEAR *Anagrelide discontinuation because tachycardia and EF<50% 1 44 60 45 61 2 50 50 43 50 3 51 51 49* / 4 47 47 47 /