Progression of kidney disease in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin versus usual care: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Am J Kidney Dis. 2008 Sep;52(3):412-24. doi: 10.1053/j.ajkd.2008.05.027. Epub 2008 Aug 3.

Abstract

Background: Dyslipidemia is common in patients with chronic kidney disease. The role of statin therapy in the progression of kidney disease is unclear.

Study design: Prospective randomized clinical trial, post hoc analyses.

Setting & participants: 10,060 participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (lipid-lowering component) stratified by baseline estimated glomerular filtration rate (eGFR): less than 60, 60 to 89, and 90 or greater mL/min/1.73 m(2). Mean follow-up was 4.8 years.

Intervention: Randomized; pravastatin, 40 mg/d, or usual care.

Outcomes & measurements: Total, high-density lipoprotein, and low-density lipoprotein cholesterol; end-stage renal disease (ESRD), eGFR.

Results: Through year 6, total cholesterol levels decreased in the pravastatin (-20.7%) and usual-care groups (-11.2%). No significant differences were seen between groups for rates of ESRD (1.36 v 1.45/100 patient-years; P = 0.9), composite end points of ESRD and 50% or 25% decrease in eGFR, or rate of change in eGFR. Findings were consistent across eGFR strata. In patients with eGFR of 90 mL/min/1.73 m(2) or greater, the pravastatin arm tended to have a higher eGFR.

Limitations: Proteinuria data unavailable, post hoc analyses, unconfirmed validity of the Modification of Diet in Renal Disease Study equation in normal eGFR range, statin drop-in rate in usual-care group with small cholesterol differential between groups.

Conclusions: In hypertensive patients with moderate dyslipidemia and decreased eGFR, pravastatin was not superior to usual care in preventing clinical renal outcomes. This was consistent across the strata of baseline eGFR. However, benefit from statin therapy may depend on the degree of the cholesterol level decrease achieved.

Trial registration: ClinicalTrials.gov NCT00000542.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anticholesteremic Agents / therapeutic use*
  • Cholesterol / blood
  • Disease Progression
  • Female
  • Glomerular Filtration Rate
  • Humans
  • Hypercholesterolemia / blood
  • Hypercholesterolemia / complications*
  • Hypercholesterolemia / drug therapy*
  • Hypertension / complications*
  • Incidence
  • Kidney Diseases / etiology*
  • Kidney Diseases / physiopathology
  • Kidney Failure, Chronic / epidemiology
  • Kidney Failure, Chronic / etiology
  • Male
  • Middle Aged
  • Pravastatin / therapeutic use*
  • Treatment Outcome

Substances

  • Anticholesteremic Agents
  • Cholesterol
  • Pravastatin

Associated data

  • ClinicalTrials.gov/NCT00000542