Protocol for the Study of Heart and Renal Protection-Extended Review

Additional 5-Year Follow-up of the Australian, New Zealand, and Malaysian SHARP Cohort

Louisa Sukkar, Ben Talbot, Min Jun, Erika Dempsey, Robert Walker, Lai Hooi, Alan Cass, Meg Jardine, Martin Gallagher

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    Abstract

    Background: There are limited studies on the effects of statins on outcomes in the moderate chronic kidney disease (CKD) population and their trajectory to end-stage kidney disease.

    Objective: To examine the long-term effects of lipid-lowering therapy on all-cause mortality, cardiovascular morbidity, CKD progression, and socioeconomic well-being in Australian, New Zealand, and Malaysian SHARP (Study of Heart and Renal Protection) trial participants—a randomized controlled trial of a combination of simvastatin and ezetimibe, compared with placebo, for the reduction of cardiovascular events in moderate to severe CKD.

    Design: Protocol for an extended prospective observational follow-up.

    Setting: Australian, New Zealand, and Malaysian participating centers in patients with advanced CKD.

    Patients: All SHARP trial participants alive at the final study visit.

    Measurements: Primary outcomes were measured by participant self-report and verified by hospital administrative data. In addition, secondary outcomes were measured using a validated study questionnaire of health-related quality of life, a 56-item economic survey.

    Methods: Participants were followed up with alternating face-to-face visits and telephone calls on a 6-monthly basis until 5 years following their final SHARP Study visit. In addition, there were 6-monthly follow-up telephone calls in between these visits. Data linkage to health registries in Australia, New Zealand, and Malaysia was also performed.

    Results: The SHARP-Extended Review (SHARP-ER) cohort comprised 1136 SHARP participants with a median of 4.6 years of follow-up. Compared with all SHARP participants who originally participated in the Australian, New Zealand, and Malaysian regions, the SHARP-ER participants were younger (57.2 [48.3-66.4] vs 60.5 [50.3-70.7] years) with a lower proportion of men (61.5% vs 62.8%). There were a lower proportion of participants with hypertension (83.7% vs 85.0%) and diabetes (20.0% vs 23.5%). Limitations: As a long-term follow-up study, the surviving cohort of SHARP-ER is a selected group of the original study participants, which may limit the generalizability of the findings.

    Conclusion: The SHARP-ER study will contribute important evidence on the long-term outcomes of cholesterol-lowering therapy in patients with advanced CKD with a total of 10 years of follow-up. Novel analyses of the socioeconomic impact of CKD over time will guide resource allocation.

    Trial Registration: The SHARP trial was registered at ClinicalTrials.gov NCT00125593 and ISRCTN 54137607.

    Original languageEnglish
    Pages (from-to)1-11
    Number of pages11
    JournalCanadian Journal of Kidney Health and Disease
    Volume6
    Issue numberJanuary-December
    Early online date14 Oct 2019
    DOIs
    Publication statusPublished - Oct 2019

    Fingerprint

    New Zealand
    Kidney
    Chronic Renal Insufficiency
    Telephone
    Hydroxymethylglutaryl-CoA Reductase Inhibitors
    Resource Allocation
    Information Storage and Retrieval
    Malaysia
    Self Report
    Chronic Kidney Failure
    Registries
    Disease Progression
    Cohort Studies
    Randomized Controlled Trials
    Cholesterol
    Placebos
    Economics
    Quality of Life
    Hypertension
    Morbidity

    Cite this

    Sukkar, Louisa ; Talbot, Ben ; Jun, Min ; Dempsey, Erika ; Walker, Robert ; Hooi, Lai ; Cass, Alan ; Jardine, Meg ; Gallagher, Martin. / Protocol for the Study of Heart and Renal Protection-Extended Review : Additional 5-Year Follow-up of the Australian, New Zealand, and Malaysian SHARP Cohort. In: Canadian Journal of Kidney Health and Disease. 2019 ; Vol. 6, No. January-December. pp. 1-11.
    @article{bbd1696b5191417098f271d4cbca2830,
    title = "Protocol for the Study of Heart and Renal Protection-Extended Review: Additional 5-Year Follow-up of the Australian, New Zealand, and Malaysian SHARP Cohort",
    abstract = "Background: There are limited studies on the effects of statins on outcomes in the moderate chronic kidney disease (CKD) population and their trajectory to end-stage kidney disease. Objective: To examine the long-term effects of lipid-lowering therapy on all-cause mortality, cardiovascular morbidity, CKD progression, and socioeconomic well-being in Australian, New Zealand, and Malaysian SHARP (Study of Heart and Renal Protection) trial participants—a randomized controlled trial of a combination of simvastatin and ezetimibe, compared with placebo, for the reduction of cardiovascular events in moderate to severe CKD. Design: Protocol for an extended prospective observational follow-up. Setting: Australian, New Zealand, and Malaysian participating centers in patients with advanced CKD. Patients: All SHARP trial participants alive at the final study visit. Measurements: Primary outcomes were measured by participant self-report and verified by hospital administrative data. In addition, secondary outcomes were measured using a validated study questionnaire of health-related quality of life, a 56-item economic survey. Methods: Participants were followed up with alternating face-to-face visits and telephone calls on a 6-monthly basis until 5 years following their final SHARP Study visit. In addition, there were 6-monthly follow-up telephone calls in between these visits. Data linkage to health registries in Australia, New Zealand, and Malaysia was also performed. Results: The SHARP-Extended Review (SHARP-ER) cohort comprised 1136 SHARP participants with a median of 4.6 years of follow-up. Compared with all SHARP participants who originally participated in the Australian, New Zealand, and Malaysian regions, the SHARP-ER participants were younger (57.2 [48.3-66.4] vs 60.5 [50.3-70.7] years) with a lower proportion of men (61.5{\%} vs 62.8{\%}). There were a lower proportion of participants with hypertension (83.7{\%} vs 85.0{\%}) and diabetes (20.0{\%} vs 23.5{\%}). Limitations: As a long-term follow-up study, the surviving cohort of SHARP-ER is a selected group of the original study participants, which may limit the generalizability of the findings. Conclusion: The SHARP-ER study will contribute important evidence on the long-term outcomes of cholesterol-lowering therapy in patients with advanced CKD with a total of 10 years of follow-up. Novel analyses of the socioeconomic impact of CKD over time will guide resource allocation. Trial Registration: The SHARP trial was registered at ClinicalTrials.gov NCT00125593 and ISRCTN 54137607.",
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    author = "Louisa Sukkar and Ben Talbot and Min Jun and Erika Dempsey and Robert Walker and Lai Hooi and Alan Cass and Meg Jardine and Martin Gallagher",
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    Protocol for the Study of Heart and Renal Protection-Extended Review : Additional 5-Year Follow-up of the Australian, New Zealand, and Malaysian SHARP Cohort. / Sukkar, Louisa; Talbot, Ben; Jun, Min; Dempsey, Erika; Walker, Robert; Hooi, Lai; Cass, Alan; Jardine, Meg; Gallagher, Martin.

    In: Canadian Journal of Kidney Health and Disease, Vol. 6, No. January-December, 10.2019, p. 1-11.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Protocol for the Study of Heart and Renal Protection-Extended Review

    T2 - Additional 5-Year Follow-up of the Australian, New Zealand, and Malaysian SHARP Cohort

    AU - Sukkar, Louisa

    AU - Talbot, Ben

    AU - Jun, Min

    AU - Dempsey, Erika

    AU - Walker, Robert

    AU - Hooi, Lai

    AU - Cass, Alan

    AU - Jardine, Meg

    AU - Gallagher, Martin

    PY - 2019/10

    Y1 - 2019/10

    N2 - Background: There are limited studies on the effects of statins on outcomes in the moderate chronic kidney disease (CKD) population and their trajectory to end-stage kidney disease. Objective: To examine the long-term effects of lipid-lowering therapy on all-cause mortality, cardiovascular morbidity, CKD progression, and socioeconomic well-being in Australian, New Zealand, and Malaysian SHARP (Study of Heart and Renal Protection) trial participants—a randomized controlled trial of a combination of simvastatin and ezetimibe, compared with placebo, for the reduction of cardiovascular events in moderate to severe CKD. Design: Protocol for an extended prospective observational follow-up. Setting: Australian, New Zealand, and Malaysian participating centers in patients with advanced CKD. Patients: All SHARP trial participants alive at the final study visit. Measurements: Primary outcomes were measured by participant self-report and verified by hospital administrative data. In addition, secondary outcomes were measured using a validated study questionnaire of health-related quality of life, a 56-item economic survey. Methods: Participants were followed up with alternating face-to-face visits and telephone calls on a 6-monthly basis until 5 years following their final SHARP Study visit. In addition, there were 6-monthly follow-up telephone calls in between these visits. Data linkage to health registries in Australia, New Zealand, and Malaysia was also performed. Results: The SHARP-Extended Review (SHARP-ER) cohort comprised 1136 SHARP participants with a median of 4.6 years of follow-up. Compared with all SHARP participants who originally participated in the Australian, New Zealand, and Malaysian regions, the SHARP-ER participants were younger (57.2 [48.3-66.4] vs 60.5 [50.3-70.7] years) with a lower proportion of men (61.5% vs 62.8%). There were a lower proportion of participants with hypertension (83.7% vs 85.0%) and diabetes (20.0% vs 23.5%). Limitations: As a long-term follow-up study, the surviving cohort of SHARP-ER is a selected group of the original study participants, which may limit the generalizability of the findings. Conclusion: The SHARP-ER study will contribute important evidence on the long-term outcomes of cholesterol-lowering therapy in patients with advanced CKD with a total of 10 years of follow-up. Novel analyses of the socioeconomic impact of CKD over time will guide resource allocation. Trial Registration: The SHARP trial was registered at ClinicalTrials.gov NCT00125593 and ISRCTN 54137607.

    AB - Background: There are limited studies on the effects of statins on outcomes in the moderate chronic kidney disease (CKD) population and their trajectory to end-stage kidney disease. Objective: To examine the long-term effects of lipid-lowering therapy on all-cause mortality, cardiovascular morbidity, CKD progression, and socioeconomic well-being in Australian, New Zealand, and Malaysian SHARP (Study of Heart and Renal Protection) trial participants—a randomized controlled trial of a combination of simvastatin and ezetimibe, compared with placebo, for the reduction of cardiovascular events in moderate to severe CKD. Design: Protocol for an extended prospective observational follow-up. Setting: Australian, New Zealand, and Malaysian participating centers in patients with advanced CKD. Patients: All SHARP trial participants alive at the final study visit. Measurements: Primary outcomes were measured by participant self-report and verified by hospital administrative data. In addition, secondary outcomes were measured using a validated study questionnaire of health-related quality of life, a 56-item economic survey. Methods: Participants were followed up with alternating face-to-face visits and telephone calls on a 6-monthly basis until 5 years following their final SHARP Study visit. In addition, there were 6-monthly follow-up telephone calls in between these visits. Data linkage to health registries in Australia, New Zealand, and Malaysia was also performed. Results: The SHARP-Extended Review (SHARP-ER) cohort comprised 1136 SHARP participants with a median of 4.6 years of follow-up. Compared with all SHARP participants who originally participated in the Australian, New Zealand, and Malaysian regions, the SHARP-ER participants were younger (57.2 [48.3-66.4] vs 60.5 [50.3-70.7] years) with a lower proportion of men (61.5% vs 62.8%). There were a lower proportion of participants with hypertension (83.7% vs 85.0%) and diabetes (20.0% vs 23.5%). Limitations: As a long-term follow-up study, the surviving cohort of SHARP-ER is a selected group of the original study participants, which may limit the generalizability of the findings. Conclusion: The SHARP-ER study will contribute important evidence on the long-term outcomes of cholesterol-lowering therapy in patients with advanced CKD with a total of 10 years of follow-up. Novel analyses of the socioeconomic impact of CKD over time will guide resource allocation. Trial Registration: The SHARP trial was registered at ClinicalTrials.gov NCT00125593 and ISRCTN 54137607.

    KW - chronic renal insufficiency

    KW - disease progression

    KW - follow-up studies

    KW - income

    KW - myocardial infarction

    KW - poverty

    KW - statins

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    U2 - 10.1177/2054358119879896

    DO - 10.1177/2054358119879896

    M3 - Article

    VL - 6

    SP - 1

    EP - 11

    JO - Canadian Journal of Kidney Health and Disease

    JF - Canadian Journal of Kidney Health and Disease

    SN - 2054-3581

    IS - January-December

    ER -