Pain and other non-neurological adverse events in children with sickle cell anemia and previous stroke who received hydroxyurea and phlebotomy or chronic transfusions and chelation: Results from the SWiTCH clinical trial

Ofelia A Alvarez, Nancy A. Yovetich, J. Paul Scott, William Owen, Scott T. Miller, William Schultz, Alexandre Lockhart, Banu Aygun, Jonathan Flanagan, Melanie Bonner, Brigitta U. Mueller, Russell E. Ware

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

To compare the non-neurological events in children with sickle cell anemia (SCA) and previous stroke enrolled in SWiTCH. The NHLBI-sponsored Phase III multicenter randomized clinical trial stroke with transfusions changing to hydroxyurea (SWiTCH) (ClinicalTrials.gov NCT00122980) compared continuation of chronic blood transfusion/iron chelation to switching to hydroxyurea/phlebotomy for secondary stroke prevention and management of iron overload. All randomized children were included in the analysis (intention to treat). The Fisher's Exact test was used to compare the frequency of subjects who experienced at least one SCA-related adverse event (AE) or serious adverse event (SAE) in each arm and to compare event rates. One hundred and thirty three subjects, mean age 13 ± 3.9 years (range 5.2-19.0 years) and mean time of 7 years on chronic transfusion at study entry, were randomized and treated. Numbers of subjects experiencing non-neurological AEs were similar in the two treatment arms, including SCA-related events, SCA pain events, and low rates of acute chest syndrome and infection. However, fewer children continuing transfusion/chelation experienced SAEs (P = 0.012), SCA-related SAEs (P = 0.003), and SCA pain SAEs (P = 0.016) as compared to children on the hydroxyurea/phlebotomy arm. The timing of phlebotomy did not influence SAEs. Older age at baseline predicted having at least 1 SCA pain event. Patients with recurrent neurological events during SWiTCH were not more likely to experience pain. In children with SCA and prior stroke, monthly transfusions and daily iron chelation provided superior protection against acute vaso-occlusive pain SAEs when compared to hydroxyurea and monthly phlebotomy. Am. J. Heamtol. 88:932-938, 2013.

Original languageEnglish
Pages (from-to)932-938
Number of pages7
JournalAmerican Journal of Hematology
Volume88
Issue number11
DOIs
StatePublished - Nov 1 2013

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Phlebotomy
Hydroxyurea
Sickle Cell Anemia
Stroke
Clinical Trials
Pain
Iron
Acute Chest Syndrome
National Heart, Lung, and Blood Institute (U.S.)
Intention to Treat Analysis
Iron Overload
Secondary Prevention
Blood Transfusion
Randomized Controlled Trials
Infection

ASJC Scopus subject areas

  • Hematology

Cite this

Pain and other non-neurological adverse events in children with sickle cell anemia and previous stroke who received hydroxyurea and phlebotomy or chronic transfusions and chelation : Results from the SWiTCH clinical trial. / Alvarez, Ofelia A; Yovetich, Nancy A.; Scott, J. Paul; Owen, William; Miller, Scott T.; Schultz, William; Lockhart, Alexandre; Aygun, Banu; Flanagan, Jonathan; Bonner, Melanie; Mueller, Brigitta U.; Ware, Russell E.

In: American Journal of Hematology, Vol. 88, No. 11, 01.11.2013, p. 932-938.

Research output: Contribution to journalArticle

Alvarez, Ofelia A ; Yovetich, Nancy A. ; Scott, J. Paul ; Owen, William ; Miller, Scott T. ; Schultz, William ; Lockhart, Alexandre ; Aygun, Banu ; Flanagan, Jonathan ; Bonner, Melanie ; Mueller, Brigitta U. ; Ware, Russell E. / Pain and other non-neurological adverse events in children with sickle cell anemia and previous stroke who received hydroxyurea and phlebotomy or chronic transfusions and chelation : Results from the SWiTCH clinical trial. In: American Journal of Hematology. 2013 ; Vol. 88, No. 11. pp. 932-938.
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