Interventions for chronic kidney disease in people with sickle cell disease

Noemi BA Roy; Patricia M Fortin; Katherine R Bull; Carolyn Doree; Marialena Trivella; Sally Hopewell; Lise J Estcourt

doi:10.1002/14651858.CD012380.pub2

Cochrane Database of Systematic Reviews

Intervenciones para la nefropatía crónica en pacientes con drepanocitosis

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DOI:

https://doi.org/10.1002/14651858.CD012380.pub2 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

03 julio 2017see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Fibrosis quística y enfermedades genéticas

Copyright:

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Noemi BA Roy

Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, UK
Patricia M Fortin

Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK
Katherine R Bull

Oxford Kidney Unit and Nuffield Department of Medicine, Oxford University Hospitals Trust and the University of Oxford, Oxford, UK
Carolyn Doree

Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK
Marialena Trivella

Centre for Statistics in Medicine, University of Oxford, Oxford, UK
Sally Hopewell

Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK
Lise J Estcourt

Correspondencia a: Haematology/Transfusion Medicine, NHS Blood and Transplant, Oxford, UK

[email protected]

[email protected]

Contributions of authors

Noemi Roy: searching; selection of trials; eligibility assessment; content expert, and review content development

Patricia Fortin: searching; selection of trials; eligibility assessment; and review content development

Katherine Bull: protocol development and content expert

Carolyn Doree: protocol development, search methods and strategies

Sally Hopewell: methodological expert and review development

Marialena Trivella: statistical and methodological expert and review development

Lise Estcourt: review conception, review development and content expert

Sources of support

Internal sources

NHS Blood and Transplant, Research and Developmen, UK.

To fund the work of the Systematic Review Initiative (SRI)

External sources

National Institute for Health Research (NIHR) Cochrane Programme Grant, UK.

To provide funding for systematic reviewers and methodological support from the Centre for Statistics in Medicine, Oxford

Declarations of interest

Noemi Roy: none known.

Patricia Fortin: funded by the NIHR Cochrane Programme Grant ‐ Safe and Appropriate Use of Blood Components.

Katherine Bull: none known.

Carolyn Doree: none known.

Sally Hopewell: partly funded by the NIHR Cochrane Programme Grant ‐ Safe and Appropriate Use of Blood Components.

Marialena Trivella: partly funded by the NIHR Cochrane Programme Grant ‐ Safe and Appropriate Use of Blood Components.

Lise Estcourt: partly funded by the NIHR Cochrane Programme Grant ‐ Safe and Appropriate Use of Blood Components.

Acknowledgements

We thank the editorial base of the Cochrane Cystic Fibrosis and Genetic Disorders Group for their help and support.

We thank the National Institute for Health Research (NIHR). This review is part of a series of reviews that have been partly funded by the NIHR Cochrane Programme Grant ‐ Safe and Appropriate Use of Blood Components. This research was also supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre Programme. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2023 Aug 04

Interventions for chronic kidney disease in people with sickle cell disease

Review

Noemi BA Roy, Abigail Carpenter, Isabella Dale-Harris, Carolyn Dorée, Lise J Estcourt

https://doi.org/10.1002/14651858.CD012380.pub3

2017 Jul 03

Interventions for chronic kidney disease in people with sickle cell disease

Review

Noemi BA Roy, Patricia M Fortin, Katherine R Bull, Carolyn Doree, Marialena Trivella, Sally Hopewell, Lise J Estcourt

https://doi.org/10.1002/14651858.CD012380.pub2

2016 Oct 05

Interventions for chronic kidney disease in people with sickle cell disease

Protocol

Noemi BA Roy, Patricia M Fortin, Katherine R Bull, Carolyn Doree, Marialena Trivella, Sally Hopewell, Lise J Estcourt

https://doi.org/10.1002/14651858.CD012380

Differences between protocol and review

We adjusted the following statement for reporting 99% confidence intervals for SAEs and other adverse events: "We reported secondary outcomes as groups of transfusion‐related and drug‐related adverse event. If this was not possible due to duplicate counting of the same participant who may have experienced more than one adverse event of the same category (e.g. more than one transfusion‐related adverse event). In this case, we reported subgroup categories of adverse events separately and reported the 99% CI of the pooled RR to allow for multiple statistical testing".

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adolescent; Adult; Child; Humans;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Sickle cell nephropathy pathophysiology in sickle cell disease: Adapted fromOkafor 2013andNath 2015

RBC: red blood cells; FSGS: focal segmental glomerulosclerosis; ESRD: end‐stage renal disease

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Figure 2

Structure of the kidney. From: Wikispaces. Human Physiology. 12. Urology.https://humanphysiology2011.wikispaces.com/12.+Urology

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Figure 3

Study flow diagram.

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Figure 4

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 5

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Hydroxyurea vs placebo, Outcome 1 Slower progression or improvement in GFR (mL per min per 1·73 m²).

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Analysis 1.2

Comparison 1 Hydroxyurea vs placebo, Outcome 2 Improvement in ability to concentrate urine (mOsm/kg).

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Analysis 1.3

Comparison 1 Hydroxyurea vs placebo, Outcome 3 SAEs assessed with acute chest syndrome.

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Analysis 1.4

Comparison 1 Hydroxyurea vs placebo, Outcome 4 SAEs assessed with painful crisis.

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Analysis 1.5

Comparison 1 Hydroxyurea vs placebo, Outcome 5 SAEs assessed with hospitalisations.

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Analysis 1.6

Comparison 1 Hydroxyurea vs placebo, Outcome 6 SAEs assessed with stroke.

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Analysis 1.7

Comparison 1 Hydroxyurea vs placebo, Outcome 7 AEs assessed with neutropenia.

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Analysis 1.8

Comparison 1 Hydroxyurea vs placebo, Outcome 8 AEs assessed with thrombocytopenia.

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Analysis 1.9

Comparison 1 Hydroxyurea vs placebo, Outcome 9 Number of participants transfused.

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Analysis 2.1

Comparison 2 ACEI (captopril) vs placebo, Outcome 1 Slower progression or reduction in proteinuria (mg/day).

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Analysis 2.2

Comparison 2 ACEI (captopril) vs placebo, Outcome 2 Other drug‐related adverse events (dry cough).

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Summary of findings for the main comparison. Hydroxyurea compared to placebo for preventing or reducing kidney complications in people with sickle cell disease

Hydroxyurea compared to placebo for preventing or reducing kidney complications in people with sickle cell disease
Patient or population: people with sickle cell disease Setting: multiple centres Intervention: hydroxyurea Comparison: placebo
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (99% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with hydroxyurea
Slower progression or improvement in GFR mL per min per 1.73 m² (measured at 18 to 24 months)	The mean slower progression or improvement in GFR mL per min per 1.73 m² (measured at 18 to 24 months) was 146.64 (43.7)	MD 0.58 higher (14.6 lower to 15.76 higher)	‐	142 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1, 2}
Improvement in ability to concentrate urine mOsm/kg (measured at 18 to 24 months)	The mean improvement in ability to concentrate urine mOsm/kg (measured at 18 to 24 months) was 494.57 (110.07)	MD 42.23 higher (12.14 higher to 72.32 higher)	‐	178 (1 RCT)	⊕⊕⊝⊝ LOW ^2,3
SAEs assessed with acute chest syndrome	Study population		RR 0.39 (0.13 to 1.16)	193 (1 RCT)	⊕⊕⊝⊝ LOW ^{2, 3}
	186 per 1000	72 per 1000 (24 to 215)
SAEs assessed with painful crisis	Study population		RR 0.68 (0.45 to 1.02)	193 (1 RCT)	⊕⊕⊝⊝ LOW ^{2, 3}
	567 per 1000	386 per 1000 (255 to 578)
SAEs assessed with hospitalisations	Study population		RR 0.83 (0.68 to 1.01)	193 (1 RCT)	⊕⊕⊝⊝ LOW ^{2, 3}
	866 per 1000	719 per 1000 (589 to 875)
Mortality due to any cause	No deaths reported in either group		not estimable	193 (1 RCT)	⊕⊕⊝⊝ LOW ^{2, 4}
Quality of life	Not reported	‐	‐	‐	‐
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; GFR: glomerular filtration rate; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio; SAEs: serious adverse events.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ We downgraded the quality of evidence by one due to unclear risk of attrition bias. ² We downgraded the quality of evidence by one due to indirectness as the results apply only to small children aged 8 to 19 months. ³ We downgraded the quality of evidence by one due to imprecision as confidence intervals are wide indicating clinically significant harm or benefit. ⁴ We downgraded the quality of evidence by one due to imprecision; rare event no deaths occurred.

Summary of findings for the main comparison. Hydroxyurea compared to placebo for preventing or reducing kidney complications in people with sickle cell disease

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Summary of findings 2. ACEI compared to placebo in preventing or reducing kidney complications in people with sickle cell disease

ACEI compared to placebo in preventing or reducing kidney complications in people with sickle cell disease
Patient or population: people with sickle cell disease Setting: hospital outpatient Intervention: ACEI Comparison: placebo
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with ACEI
Slower progression or reduction in proteinuria (mg/day 6 months follow‐up)	The mean slower progression or reduction in proteinuria (mg/day 6 months follow‐up) was 76 (45)	MD 49.00 lower (124.10 lower to 26.10 higher)	‐	22 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1, 2 ,3}
Improvement in ability to concentrate urine mOsm/kg	Not reported		‐	‐	‐
SAEs assessed with acute chest syndrome	Not reported		‐	‐	‐
SAEs assessed with painful crisis	Not reported		‐	‐	‐
SAEs assessed with hospitalisations	Not reported		‐	‐	‐
Mortality due to any cause	Not reported		‐	‐	‐
Quality of life	Not reported		‐	‐	‐
ACEI: angiotensin converting enzyme inhibitor; CI: confidence interval; MD: mean difference; SAEs: serious adverse events
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ We downgraded the quality of evidence by two due to unclear or high risk of bias in all domains. ² We downgraded the quality of evidence by one due to indirectness because a small sample population of adults with normal blood pressure and microalbuminuria. ³ We downgraded the quality of evidence by one due to imprecision as very wide CIs including clinically significant harm or benefit.

Summary of findings 2. ACEI compared to placebo in preventing or reducing kidney complications in people with sickle cell disease

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Table 1. Unadjusted HRs for SAEs and AEs reported in BABY HUG 2011

Unadjusted HRs reported in BABY HUG 2011
Outcome	HR	95% CI
Acute chest syndrome	0.36	0.15 to 0.87
Painful crisis	0.54	0.36 to 0.83
Hospitalisations	0.73	0.53 to 1.00
Neutropenia	3.0	1.7 to 5.1
Thrombocytopenia	1.6	0.6 to 4.1
Transfusions	0.55	0.32 to 0.96
CI: confidence interval HR: hazard ratio

Table 1. Unadjusted HRs for SAEs and AEs reported in BABY HUG 2011

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Comparison 1. Hydroxyurea vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Slower progression or improvement in GFR (mL per min per 1·73 m²) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

1.1 at 18 to 24 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2 Improvement in ability to concentrate urine (mOsm/kg) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

2.1 at 18 to 24 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
3 SAEs assessed with acute chest syndrome Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

4 SAEs assessed with painful crisis Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

5 SAEs assessed with hospitalisations Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

6 SAEs assessed with stroke Show forest plot	1		Peto Odds Ratio (Peto, Fixed, 99% CI)	Totals not selected

7 AEs assessed with neutropenia Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

8 AEs assessed with thrombocytopenia Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

9 Number of participants transfused Show forest plot	1		Risk Ratio (IV, Random, 95% CI)	Totals not selected

Comparison 1. Hydroxyurea vs placebo

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Comparison 2. ACEI (captopril) vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Slower progression or reduction in proteinuria (mg/day) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

1.1 at 6 months follow‐up	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2 Other drug‐related adverse events (dry cough) Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

Comparison 2. ACEI (captopril) vs placebo

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Intervenciones para la nefropatía crónica en pacientes con drepanocitosis

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