New guidelines from the Kidney Disease: Improving Global Outcomes (KDIGO) workgroup recommend wider statin use among patients with chronic kidney disease (CKD). However, some experts are critical of the new recommendations.
A synopsis of 8 key recommendations regarding lipid management and monitoring in adults with CKD, including those receiving chronic dialysis or who have had kidney transplants, was published online December 9 in the Annals of Internal Medicine by Marcello Tonelli, MD, from the University of Alberta, Canada, and colleagues from the workgroup.
In 2013, KDIGO developed a clinical practice guideline of 13 recommendations on lipid management and treatment of all adults and children with CKD. The guidelines workgroup defined the scope of these recommendations and chose topics for systematic review. They also graded the quality of evidence collected and summarized by an evidence review team, based on searches of English-language publications through August 2011 and additional targeted searches through June 2013.
The KDIGO board of directors had input into final modification of the guidelines, which were also reviewed publicly by registered stakeholders.
Key Recommendation for Statin Treatment
A key recommendation was for treatment with statin or statin with ezetimibe of adults at least 50 years of age who have an estimated glomerular filtration rate (eGFR) less than 60 mL/minute per 1.73 m2 and who are not treated with chronic dialysis or kidney transplantation.
This was a 1A level recommendation, based on the Study of Heart and Renal Protection (SHARP; Lancet. 2011;377:2181-2192). In this study, simvastatin and ezetimibe combination therapy was associated with lower risk for major atherosclerotic events (coronary death, myocardial infarction, nonhemorrhagic stroke, or any revascularization) compared with placebo in persons with GFR categories G3a to G5.
"The SHARP study objective was changed when randomization was completed, near end of follow-up, [which is] not acceptable at all," Ali J. Olyaei, PharmD, a professor of medicine and pharmacotherapy and director of clinical research in nephrology and hypertension at Oregon State University/Oregon Health & Sciences University in Portland, told Medscape Medical News when asked for independent comment. "Why did they change it? Because no cardiovascular mortality benefit was observed."
Even using the modified outcome of major atherosclerotic events, Dr. Olyaei explained that absolute risk reduction was only 2.1 events over the course of 4.9 years, or 0.42 per year, or 4.2 of 1000 patients.
"The cost of combination therapy is $140 per month, or $8400 for 5 years, or more than $400,000 to prevent 4 [myocardial infarctions]," Dr. Olyaei said. "Where is the common sense here?"
A cost-effectiveness analysis of statins for primary cardiovascular prevention in CKD ( J Am Coll Cardiol. 2013;61(12):1250-1258) showed that statins reduced absolute cardiovascular disease risk in patients with CKD but that the increased risk for rhabdomyolysis, and competing risks associated with progressive CKD, partly offset these gains. For 65-year-old men with moderate hypertension and mild-to-moderate CKD, statins lowered the combined rate of MI and stroke but increased costs by $18,000 per quality-adjusted life-year gained. For patients with lower baseline cardiovascular risks, there were even smaller health and economic benefits.
Adults with dialysis-dependent CKD should not begin treatment with statins or statin/ezetimibe. (2A)
Patients already taking a statin at the time of dialysis should continue to do so. (2C)
Kidney transplant patients should receive statin treatment because their risk for coronary events is dramatically increased. (2B)
Adults aged 18 to 49 years who have an eGFR less than 60 mL/minute per 1.73 m2 but who are not treated with dialysis or kidney transplantation should be treated with statins if they are known to have coronary disease, diabetes, prior ischemic stroke, or an estimated 10-year incidence of coronary death or nonfatal myocardial infarction exceeding 10%. (2A)
Among persons with CKD, low-density lipoprotein cholesterol is an insufficient test for cardiovascular risk. Adults with newly diagnosed CKD should therefore undergo lipid profile testing. (1C)
However, follow-up measurement is not needed. (Not graded)
Adults aged 50 years or older who have CKD and an eGFR 60 mL/minute per 1.73 m2 or higher (GFR categories G1 - G2) should be treated with a statin. (1B)
"Most of their recommendations are wrong and inappropriate," Dr. Olyaei said. "Except for the single 1A recommendation, they are mostly graded 2B and 2C, based on opinion and no data. The guidelines authors need to present the number of patients to treat and number needed to harm."
"Previous studies convincingly demonstrated that the prevalence of statin use among persons with CKD who were at risk for cardiovascular events was lower than among otherwise similar persons with normal kidney function," conclude the authors. "We are optimistic that the current guideline will help to close this quality gap by emphasizing the high cardiovascular risk associated with CKD (regardless of [low-density lipoprotein] cholesterol levels) while also reducing complexity for practitioners and enhancing implementation."
The guidelines authors reported various financial disclosures involving Boehringer Ingelheim, Keryx, Reata, AMAG, Baxter, Mitsubishi, Genzyme, Abbott, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Fresenius Medical Care, Merck, Sharp & Dohme, Roche, Novartis, Opsona, Pfizer, Commission on Human Medicines (UK), European Medicines Agency, US Food and Drug Administration, Sanofi, Daiichi Sankyo, Dainippon Sumitomo, Mochida, Shionogi, Kowa, Kyowa Hakko, Kirin, and/or Shionogi. Dr. Olyaei has disclosed no relevant financial relationships.
Ann Intern Med. Published online December 9. 2013.
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Cite this: CKD: KDIGO Guidelines Recommend Wider Use of Statins - Medscape - Dec 09, 2013.