Ten Years Longitudinal Follow-up Study of Sickle Cell Disease Patients Treated with Hydroxyurea in Four English Centres 20 20 th th September 2007 September 2007 Annette Gilmore RN BSc MSc Jo Howard MD, Mark Layton MD, Gavin Cho MD, Inderjeet Dokal MD, George Hughes MD, Nicola Philpott MD, Sally C Davies MD, London, England 1
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Ten Years Longitudinal Follow-up Study of Sickle Cell Disease Patients Treated with Hydroxyurea in Four English Centres 20 th September 2007 Annette Gilmore.
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Ten Years Longitudinal Follow-up Study of Sickle Cell Disease Patients
Treated with Hydroxyureain Four English Centres
2020thth September 2007 September 2007
Annette Gilmore RN BSc MScJo Howard MD, Mark Layton MD, Gavin Cho MD,
Inderjeet Dokal MD, George Hughes MD,Nicola Philpott MD, Sally C Davies MD, London, England
1
Introduction• The Registry was initiated in 1998, as a collaborative effort between
10 European countries, with the aim of addressing the effectiveness and toxicity of Hydroxyurea (HU) therapy in Sickle Cell Disease (SCD).
• Later developed into the North West London Sector Registry – Clinical Patient Database for all SCD patients attending local hospitals in North West London.
• UK Data Protection Act Registration[Registration No. Z5730583]
• REC [Approval - MREC/99/2/4]
• Patient Informed Consent for research
2
Aim
To evaluate the long-term effectiveness and toxicity of hydroxyurea treatment for sickle cell disease patients managed in routine clinical care settings
Methods
• Compare the change in various clinical and laboratory variables over time
• Analysis examined changes from baseline to each of the years 1,2,5,7 and 9
• Baseline = data collected for 12 months pre HU• Clinical outcomes – annual no. IP days, no. Pain Crisis, ACS
and Tx events• Incidence of serious adverse events and toxicities• Appropriate tests for paired data used (Paired t-tests, Wilcoxen
matched pairs test and paired exact test)
HU Follow-up Proforma
5
Sample Patient Graph
6
1 1 2Toxic Episodes
3
11 3 1 4 2 IP Days
0
5
10
15
20
25
30
35
0
20
40
60
80
100
120
140
HU
Do
se (m
g/k
g/d
ay)
MC
V (f
l) an
d H
b F
(%
)
MCV and Hb F & HU Dose - (13/05/1994 - 25/07/2007)
Calculated dose (mg/kg/day) MCV (fl) Hb F (%) HU Toxic Episodes IP Days
Patient Cohort
7
TotalPatients Started HU, No. 80Patients Excluded:
< 1 Year of Data 14SC and SβThal+ 4
Total, No. 62Person-years 263Follow-up, median (IQR) 3 (1-6)