Original investigationsPathogenesis and treatment of kidney disease and hypertensionFirst United Kingdom Heart and Renal Protection (UK-HARP-I) study: Biochemical efficacy and safety of simvastatin and safety of low-dose aspirin in chronic kidney disease
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Eligibility
Men or women 18 years or older were eligible if: (1) they were a predialysis patient with the most recent serum or plasma creatinine level of 1.7 mg/dL or greater (≥150 μmol/L), a hemodialysis or peritoneal dialysis patient, or had a functioning renal transplant (with any creatinine level); and (2) their own nephrologist and primary care physician did not consider there was a definite indication for (or contraindication to) cholesterol-lowering therapy or aspirin. There was no upper limit to
Study population
The original target sample size was 600 patients, but recruitment was discontinued after an interim analysis of 448 patients showed that the annual rate of major bleeding events was less than anticipated (2.5%), suggesting that continuation would be unlikely to provide much additional information on aspirin-associated bleeding risks. Of 571 patients who attended a screening appointment, 448 patients (78%) were eventually randomized between October 1999 and March 2001. Of randomized patients,
Discussion
In this feasibility study, allocation to treatment with 20 mg of simvastatin daily in patients with CKD reduced LDL cholesterol levels by approximately one quarter, similar to the proportional reduction observed with such regimens in other types of patients irrespective of presenting cholesterol levels.20 This proportional reduction was not significantly different among predialysis, dialysis, and transplant patients, although because the number of dialysis patients was limited, effects of
Acknowledgment
The authors acknowledge the patients who took part in the study and the doctors, nurses, and administrative staff who assisted with its conduct. This report is dedicated to our colleague Dr David Newman (1959 to 2003), whose advice and support was integral to the success of this study and our planning for subsequent studies.
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Effects of aspirin on cardiovascular outcomes in patients with chronic kidney disease
2023, Kidney InternationalSpecial Populations: Chronic Kidney Disease
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2021, Biomedicine and PharmacotherapyPRavastatin Versus FlUVastatin After Statin Intolerance: The PRUV-Intolerance Study With Propensity Score Matching
2019, American Journal of Medicine
The HARP pilot studies and the Study of Heart and Renal Protection (SHARP) were funded by unrestricted grants from Merck & Co. C.B., M.L., J.A., and R.C. each received reimbursement from Merck for travel expenses in connection with various speaking engagements, but as members of the Clinical Trial Service Unit, comply with the Unit’s policy of not accepting honoraria. See Appendix for UK-HARP Pilot Study Investigators.
Originally published online as doi:10.1053/j.ajkd.2004.11.015 on January 25, 2005.