title: [Efficacy and safety of anagrelide in treatment of essential thrombocythemia: multicenter, randomized controlled clinical trial].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of anagrelide in essential thrombocythemia (ET).
  
  
  METHODS
  Patients who diagnosed as ET according to the World Health Organization classification were enrolled. Each patient was assigned to take anagrelide hydrochloride capsule or hydroxyurea tablet by random 1∶1 ratio. Dose of anagrelide started at 2 mg/d, then increased gradually and the maximum dose was 10 mg/d until the platelet counts dropped to (100-400) × 10⁹/L, one month later gradually reduced to maintain dose. The dose of hydroxyurea was 1000 mg/d at beginning, then increased gradually, when platelet counts dropped to (100-400)×10⁹/L and kept for one month, reduced to maintain dose as 10 mg·kg⁻¹·d⁻¹. The observation period was 12 weeks.
  
  
  RESULTS
  A total of 222 patients were enrolled in seventeen centers (including 113 patients treated with anagrelide and 109 with hydroxyurea). Therapy efficacy can be evaluated in 198 patients (including 97 patients administered with anagrelide and 101 with hydroxyurea). At 12th weeks of therapy, the hematologic remission rate was 87.63% (85/97) in anagrelide group and 88.12% (89/107) in hydroxyurea group, the differences between the two groups were not significant (P=0.173). Treatment with anagrelide lowered the platelet counts by a median of 393 (362-1 339) × 10⁹/L from a median of 827 (562-1657) × 109/L at the beginning of the observation to 400(127-1130)×10⁹/L after 12 weeks (P<0.001), which were similar to the treatment result of hydroxyurea by a median drop of 398 (597-1846)× 10⁹/L (P=0.982). The median time to achieving response of anagrelide group was 7 (3-14) days, superior to that of hydroxyurea for 21 (14-28) significantly (P=0.003). Frequency of anagrelide related adverse events was 65.49 % (74/113), including cardiopalmus (36.28% ), headache (21.24% ), fatigue (14.16% ) and dizzy (11.50% ).
  
  
  CONCLUSIONS
  Anagrelide was effective in patients with ET which had similar hematologic remission rate to hydroxyurea and could take effect more quickly than hydroxyurea. Incidence of adverse events was undifferentiated between anagrelide and hydroxyurea, but anagrelide treatment had tolerable adverse effects and no hematologic toxicity.
authors: Department of Hematology, the Second Hospital of Shanxi Medical University, Taiyuan 030001, China.
authors: Xiaoyan
authors: X
authors: Ge
authors: Department of Hematology, the Second Hospital of Shanxi Medical University, Taiyuan 030001, China.
authors: Linhua
authors: L
authors: Yang
authors: Jie
authors: J
authors: Jin
authors: Wenbin
authors: W
authors: Qian
authors: Jianyong
authors: J
authors: Li
authors: Renchi
authors: R
authors: Yang
authors: Xiangshan
authors: X
authors: Cao
authors: Bin
authors: B
authors: Jiang
authors: Zhao
authors: Z
authors: Wang
authors: Ming
authors: M
authors: Hou
authors: Weihua
authors: W
authors: Zhang
authors: Zhongping
authors: Z
authors: Xiao
authors: Yongqiang
authors: Y
authors: Zhao
authors: Da
authors: D
authors: Gao
authors: Xiaohong
authors: X
authors: Zhang
authors: Shuye
authors: S
authors: Wang
authors: Aining
authors: A
authors: Sun
authors: Jinxiang
authors: J
authors: Fu
authors: Li
authors: L
authors: Su
authors: Kang
authors: K
authors: Li
mesh_terms: D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage / Q000627:therapeutic use; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D010976:Platelet Count; D011799:Quinazolines / Q000008:administration & dosage / Q000627:therapeutic use*; D013920:Thrombocythemia, Essential / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D011799:Quinazolines; C021139:anagrelide; D006918:Hydroxyurea