PMID- 22304793
OWN - NLM
STAT- MEDLINE
DCOM- 20120726
LR  - 20151119
IS  - 1879-1484 (Electronic)
IS  - 0021-9150 (Linking)
VI  - 221
IP  - 2
DP  - 2012 Apr
TI  - Renal safety of intensive cholesterol-lowering treatment with rosuvastatin: a 
      retrospective analysis of renal adverse events among 40,600 participants in the 
      rosuvastatin clinical development program.
PG  - 471-7
LID - 10.1016/j.atherosclerosis.2011.12.011 [doi]
AB  - OBJECTIVE: Intensive lowering of low-density lipoprotein cholesterol (LDL-C) with 
      statins reduces cardiovascular risk but can cause liver-, muscle-, and possibly 
      renal-related adverse events (AEs). We assessed the effects of rosuvastatin on 
      the risk of developing renal impairment or renal failure among participants in 
      the rosuvastatin clinical development program. METHODS: The analysis was based on 
      AE data reported by investigators from 36 studies that included 40,600 
      participants who did not have advanced, pre-existing renal disease. Rates of 
      renal AEs were determined based on time to first occurrence of renal impairment 
      or renal failure. RESULTS: Renal impairment or renal failure was reported in 536 
      study participants during 72,488 patient-years of follow-up. Renal event rates 
      were higher in patients with history of heart failure (n = 5011), hypertension (n 
      = 21,864), diabetes (n = 5165), or estimated glomerular filtration rate (eGFR) 
      <60 ml/min/1.73 m(2) (n = 9507) at baseline but did not differ with rosuvastatin 
      compared with placebo or with rosuvastatin 40 mg compared with rosuvastatin 10mg. 
      Relative risk (RR) estimates obtained from pooled analysis of placebo-controlled 
      trials were RR: 1.03 (95% CI: 0.86-1.23, p = 0.777) for any reported renal 
      impairment or renal failure event, RR: 1.02 (95% CI: 0.76-1.37, p = 0.894) for 
      serious renal AEs, and RR: 0.70 (95% CI: 0.36-1.35, p = 0.282) for renal AEs 
      leading to death. CONCLUSION: These findings suggest that intensive 
      LDL-C-lowering treatment with rosuvastatin does not affect the risk of developing 
      renal insufficiency or renal failure in patients who do not have advanced, 
      pre-existing renal disease.
CI  - Copyright (c) 2012. Published by Elsevier Ireland Ltd.
FAU - Stein, Evan A
AU  - Stein EA
AD  - Medpace Reference Laboratories, Inc, 4620 Wesley Avenue, Cincinnati, OH 45212, 
      USA. ESteinMRL@aol.com
FAU - Vidt, Donald G
AU  - Vidt DG
FAU - Shepherd, James
AU  - Shepherd J
FAU - Cain, Valerie A
AU  - Cain VA
FAU - Anzalone, Deborah
AU  - Anzalone D
FAU - Cressman, Michael D
AU  - Cressman MD
LA  - eng
SI  - ClinicalTrials.gov/NCT00206310
SI  - ClinicalTrials.gov/NCT00225589
SI  - ClinicalTrials.gov/NCT00239681
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20120103
PL  - Ireland
TA  - Atherosclerosis
JT  - Atherosclerosis
JID - 0242543
RN  - 0 (Biomarkers)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Fluorobenzenes)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Biomarkers/blood
MH  - Cholesterol, LDL/blood
MH  - Clinical Trials as Topic
MH  - Evidence-Based Medicine
MH  - Female
MH  - Fluorobenzenes/*adverse effects
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*adverse effects
MH  - Hypercholesterolemia/blood/*drug therapy
MH  - Kidney/*drug effects/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Proportional Hazards Models
MH  - Pyrimidines/*adverse effects
MH  - Renal Insufficiency/*chemically induced/physiopathology
MH  - Retrospective Studies
MH  - Risk Assessment
MH  - Risk Factors
MH  - Rosuvastatin Calcium
MH  - Sulfonamides/*adverse effects
MH  - Time Factors
EDAT- 2012/02/07 06:00
MHDA- 2012/07/27 06:00
CRDT- 2012/02/07 06:00
PHST- 2011/06/30 00:00 [received]
PHST- 2011/12/05 00:00 [revised]
PHST- 2011/12/06 00:00 [accepted]
PHST- 2012/02/07 06:00 [entrez]
PHST- 2012/02/07 06:00 [pubmed]
PHST- 2012/07/27 06:00 [medline]
AID - S0021-9150(11)01158-0 [pii]
AID - 10.1016/j.atherosclerosis.2011.12.011 [doi]
PST - ppublish
SO  - Atherosclerosis. 2012 Apr;221(2):471-7. doi: 
      10.1016/j.atherosclerosis.2011.12.011. Epub 2012 Jan 3.