Effects of Hydroxyurea Therapy

Date:

Institutional Affiliation

Conceptual Framework Design/
Method

Sample/ Setting
Major Variables Studied and
Their Definitions

Measurement of Major Variables
Data
Analysis

Study Findings
Strength of the Evidence (i.e., level of evidence + quality [study strengths and weaknesses])
Author, Year, Title

 

Platt, O. (2008). Hudroxyurea for the treatment of sickle cell anemia. The new England Journal of medicine, 1362-1369.
No

 

RCT N=299

Age=18 years and above

 

Delivery; doses of 15-20 mg/kg/day with the possibility of increasing it to 35 mg/kg/day

IG; administration of placebo and hydroxyurea to adults who had experienced three painful crises at least. Follow to a maximum of 9 years for qualified correspondents.

 

 

IV= Hydroxyurea treatment

 

DV= sickle cell disease, prescription of myelosuppressive drugs.

Observation of responses or side effects from the initial dose of Hu of 10-12 mg/kg/day.

Patients divided into two different groups based on the 10-15.9 mg/kg/day and 16 to 26 mg/kg/day doses of HU.

 

Chi-square test

Median

 

Incidence of painful crises reduced on average from 4.5 to 2.5 per annum.

Reduction in mortality for patients receiving hydroxyurea by 40%

Level of evidence: III

 

Limitation: the lack ofinformation on the effect of the drug on children is lacking

 

Strength: indicatesa dependable attempt to study the reduction of side effects of drug.

 

↑ Applicability: can be used to reduce splenic dysfunction, secondary stroke and even cerebral artery stroke

Author, Year, Title

 

Segal, J., Stouse, J., Beach, M., & Haywood, C. (2008). Hdroxyurea for the treatment of Sickle cell disease. AHRQ Publication.
No Observational study  IG: analysis of articles that are included and used by MEDLINE, EMBASE, TOXLine and Cinahl up until the 30thJune 2007.

 

 

IV: Hydroxyirea therapy

 

DV: Sickle cell disease

 

The research team was paired into reviews of two who compared every article’s abstract and title as the best means of establishing eligibility for the program. Information and datawas abstracted in a sequential format with each being independently graded based on the evidence. Grading scheme provided by the GRADE WORKING group

The WHO Collaborating Centre for Drug Monitoring

In a small randomised exercise, children who were hospitalised with HY was lower than placebo, at 1.1 and 2.8 respectively with p=0.02

A lager randomized exercise studying the efficacy of HU in adults posted an increase of HbF% in the first two years by 3.2%.

The median number of painful side effects was lowerthan that of successful treatments as they constituted 44% with p<0.001

Level of evidence: I

 

Strength: Positive outcome of results.

 

Limitation: information is sourced from other research exercises.

 

↓applicable to research programs on sickle cell disease.

 

 

Author, Year, Title

 

McIntyre, B. (2010). NTP research concept; Hydroxyurea. NTP toxology branch.
No Cross sectional study  

IG: exposing rodents to hydroxyurea and observing the neonatal and prenatal developmental periods for the adverse effects of the drug.

IV: Hydrocabamide therapy

 

 

DV: Malformation, Neural behaviouralobservations, immunity, carcinogenicity, exposure.

Provide dosages for pregnant rat during the last phase of gestation as earlier administration is seen to result in resorptions with direct dosages of subsequent offspring.

The execution of perinatal carcinogenesis study in the rat as well as a 2-year bioassay on the sampled animal.

t-tests The establishment of long term effects of exposure to postnatal and prenatal hydroxyurea as well as effects on post-natal development.

Effects of hydrourea on neurotoxicity, carinogenirs and reproductive function.

 

Level of evidence: I

 

Limitation: studies on the effects of hydroxyurea are arguably at the human testing phase.

Strength;

Provide insight to the long term effects of the drug as well as the consequences of its use on infants and pregnant mothers.

Applicability; to further research on the prevention of the spread of sickle cell disease from mother to child.

 

 

 

Author, Year, Title

 

EPR. (2014). Evidence based management of sickle cell disease. Washington: U.S department of health and Human Services.
No Observational study N=54

IG: analysis of human studies that were published from 2007 to May 2010 in English that addressed in PICOS Query.

IG(B); Analysis of Publications from The 2008 National Institutes’ OF Heath Consensus Conference on Hydroxyurea

 

IV: Hydroxyurea

DV: sickle cell disease

Systematicreview of effectiveness, harms,barriers and effaces of using hydroxyurea as SCD treatment.

Three different trials on case studies.

  t-tests

regression

median

Lower annual rates of pain crises with median at 2.5 per year as opposed to 4.5 of no pain full treatment)

Longer time to accomplishinitial study at 3 months.

Second crisis on study took even longer at a mean of 8.8 moths.

There was a reduction of need for blood transfusions at 48 patients to 73.

There was an increase in HbF from 5.0 to 8.6 %.

An increase in total haemoglobin at 0.6 g/Dl.

Level of the evidence: II

 

Limitation: there was a limited number of correspondents.

 

Strength: Information indicated a positive outcome in the studies.

 

Author, Year, Title

 

Wang WC, O. S. (2013). Hydroxyurea is associated with lower costs of care of young children with sickle cell anemia. Pediatrics.
No Cohort study AGE= 1-3 years

IG; The research team collect information from the BABY HUG study as well as insurance claims data and applied that information as a means of understanding the healthcare expenditure that is associated with HU treatment for infants with sickle cell anaemia.

IV: hydroxyurea.

DV: sickle cell disease, medical costs, insurance, infants

Analysis of information from seven states involved in the Registry and surveillance for Hemoglobionpathies project.

Execution of the Public HealthResearch Epidemiology and Surveillance for Hemoglobinopathiers project in Mississippi, Georgia and California.

SPSS software

Paired samples t-test

Independent sample t-test

Mean

Median

Infants receiging treatment have lesser hospital stays making a 305 of all patinets receiving care.

The average Medicaid riembursements for admissions based the total cost of hospital care with $1.8 million forthose receing treatment in two yers and $2.5 million for those on a diferent tretment. The annual hospital bill averaged $9,450 and $13,716 respectively. Pioutpatient costs were $1,622 and $246 respectively.

Children receign treament has a total reduction cost avaraging at 21%.

Level of evidence: III

 

Limitation: limited to cost of treatment information.

Strengths; promotes advocacy for the treatment as the best cost effective means of addressing the problem.

 

 

References

EPR. (2014). Evidence based management of sickle cell disease. Washington: U.S department of health and Human Services.

McIntyre, B. (2010). NTP research concept; Hydroxyurea. NTP toxology branch.

Platt, O. (2008). Hudroxyurea for the treatment of sickle cell anemia. The new England Journal of medicine, 1362-1369.

Segal, J., Stouse, J., Beach, M., & Haywood, C. (2008). Hdroxyurea for the treatment of Sickle cell disease. AHRQ Publication.

Wang WC, O. S. (2013). Hydroxyurea is associated with lower costs of care of young children with sickle cell anemia. Pediatrics.

 

 

 

 

 

 

 

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