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document
Effect of gemfibrozil on change in renal function in men with moderate chronic renal insufficiency and coronary disease . BACKGROUND Limited data suggest that low levels of serum high-density lipoprotein cholesterol ( HDL-C ) and high levels of triglyceride-rich lipoproteins may be associated with more rapid rates of kidney function loss in individuals with chronic renal insufficiency ( CRI ) . Although fibric acid derivatives increase serum HDL-C levels and decrease triglyceride levels , their effects on renal function are largely unknown . We conducted this study to determine whether gemfibrozil reduced rates of renal function loss in people with moderate CRI . METHODS This was a post hoc subgroup analysis in the Veterans Affairs High-Density Lipoprotein Intervention Trial , a randomized double-blind trial of gemfibrozil versus placebo in 2,531 men with coronary disease , HDL-C levels of 40 mg/dL or less ( < or =1.0 mmol/L ) , low-density lipoprotein cholesterol levels of 140 mg/dL or less ( < or =3.6 mmol/L ) , and a range of triglyceride values . Moderate CRI is defined as estimated glomerular filtration rate ( GFR ) of 30 to 59.9 mL/min/1.73 m2 at baseline . Multivariate regression was used to calculate rates of decline in estimated GFR for individuals administered gemfibrozil or placebo , controlling for prospectively determined potential confounders . RESULTS Change in renal function could be calculated in 1,981 individuals , of whom 399 individuals ( 20.2 % ) were eligible for inclusion . Among 399 study subjects , the rate of change in renal function in the gemfibrozil group during a median of 61 months was not significantly different from that in the placebo group ( 0.49 mL/min/1.73 m2/y faster ; 95 % confidence interval , 0.09 slower to 1.09 faster ; P = 0.10 ) . No clinically relevant effect of gemfibrozil on renal function was observed in groups defined by baseline lipid levels , kidney function , diabetic status , or other components of the metabolic syndrome . The incidence of transient ( 10 % versus 4 % ; P = 0.01 ) , but not sustained ( 9 % versus 4 % ; P = 0.07 ) , increases in serum creatinine levels of 0.5 mg/dL or greater ( > or =44 micromol/L ) was significantly greater in the gemfibrozil group . However , in 5 subjects with acute increases in serum creatinine levels , serum creatine kinase levels were significantly elevated as well , suggesting that myocyte toxicity may have been responsible . Even when these individuals were excluded , no clinically significant effect of gemfibrozil on kidney function was observed . CONCLUSION Gemfibrozil does not appear to exert a clinically relevant effect on rates of kidney function loss in individuals with moderate CRI , low HDL-C levels , and concomitant coronary disease .
19303
Intervention_Pharmacological
gemfibrozil
19304
Intervention_Pharmacological
gemfibrozil
19305
Intervention_Pharmacological
gemfibrozil
19306
Intervention_Control
placebo
19307
Intervention_Pharmacological
gemfibrozil
19308
Intervention_Control
placebo
19309
Intervention_Pharmacological
gemfibrozil
19310
Intervention_Control
placebo
19311
Intervention_Pharmacological
gemfibrozil
19312
Intervention_Pharmacological
gemfibrozil
19313
Intervention_Pharmacological
gemfibrozil
19314
Intervention_Pharmacological
Gemfibrozil
19315
Outcome_Physical
renal function
19316
Outcome_Physical
rate of change in renal function
19317
Outcome_Physical
renal function
19318
Outcome_Physical
baseline lipid levels
19319
Outcome_Physical
kidney function
19320
Outcome_Physical
diabetic status
19321
Outcome_Physical
components of the metabolic syndrome
19322
Outcome_Physical
serum creatinine levels
19323
Outcome_Physical
serum creatinine
19324
Outcome_Physical
serum creatine kinase levels
19325
Outcome_Physical
kidney function
19326
Outcome_Physical
kidney function
19327
Participant_Sex
men
19328
Participant_Condition
moderate chronic renal insufficiency
19329
Participant_Condition
coronary disease
19330
Participant_Condition
chronic renal insufficiency ( CRI )
19331
Participant_Condition
moderate CRI
19332
Participant_Sample-size
2,531
19333
Participant_Sex
men
19334
Participant_Condition
coronary disease
19335
Participant_Condition
low-density lipoprotein cholesterol
19336
Participant_Sample-size
1,981
19337
Participant_Sample-size
399
19338
Participant_Sample-size
399
19339
Participant_Condition
moderate CRI
19340
Participant_Condition
low HDL-C levels
19341
Participant_Condition
coronary disease