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A placebo-controlled trial examining atorvastatin in dyslipidemic patients undergoing CAPD
Kevin P G Harris1, David C Wheeler, Camilla C Chong
1Department of Nephrology, Leicester General Hospital, Leicester, England, United Kingdom. kevin.harris@uhl-tr.nhs.uk
Insights
Atorvastatin effectively lowers LDL-cholesterol in patients on continuous ambulatory peritoneal dialysis (CAPD). This study shows atorvastatin is well-tolerated and achieves lipid goals in dyslipidemic CAPD patients.
Area of Science:
- Nephrology
- Cardiology
- Pharmacology
Background:
- Chronic kidney disease (CKD) patients face high cardiovascular risks.
- Dyslipidemia management is crucial for CKD patients.
- Continuous ambulatory peritoneal dialysis (CAPD) patients with dyslipidemia require effective lipid-lowering strategies.
Purpose of the Study:
- To evaluate the efficacy and safety of atorvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor.
- To assess atorvastatin's effectiveness in achieving target lipid levels in dyslipidemic CAPD patients.
Main Methods:
- A 16-week, double-blind, randomized placebo-controlled study.
- Patients with LDL-cholesterol ≥3.5 mmol/L received atorvastatin (10 mg, titrated to 20 mg and 40 mg) or placebo.
- LDL-cholesterol levels were monitored throughout the study.
Main Results:
- A significantly higher proportion of atorvastatin recipients achieved the LDL-cholesterol goal (< or =3.5 mmol/L) compared to placebo (85.4% vs. 16.0% at 4 weeks, P < 0.001).
- Atorvastatin significantly reduced LDL-cholesterol, total cholesterol, and triglycerides, while increasing HDL-cholesterol at 16 weeks (P < 0.001).
- The adverse event profile of atorvastatin was comparable to placebo.
Conclusions:
- Atorvastatin is effective in achieving target LDL-cholesterol levels in dyslipidemic CAPD patients.
- The study demonstrates good tolerability of atorvastatin at effective doses in this patient population.
Background:
Individuals with chronic renal disease are at high risk of cardiovascular morbidity and mortality, and therefore the management of dyslipidemia is particularly important in this patient population. This double-blind randomized study investigated the efficacy and safety of the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, atorvastatin, in continuous ambulatory peritoneal dialysis (CAPD) patients with dyslipidemia.
Methods:
Following a two- to four-week baseline period, patients with low-density lipoprotein (LDL)-cholesterol > or =3.5 mmol/L (135 mg/dL) were randomized to receive either atorvastatin 10 mg (N = 82) or placebo (N = 95) for 16 weeks. If LDL-cholesterol remained > or =3.5 mmol/L, the dose of atorvastatin was titrated to 20 mg and 40 mg after four and eight weeks, respectively.
Results:
After four weeks a significantly greater proportion of patients receiving atorvastatin 10 mg had achieved the LDL-cholesterol goal < or =3.5 mmol/L compared with patients receiving placebo (85.4% vs. 16.0%; P < or = 0.001). The statistically significant difference between the two groups was maintained at week 8 and week 16 (P < or = 0.001 at both time points). At week 16, patients receiving atorvastatin had significantly greater reductions from baseline in LDL-cholesterol, total cholesterol, triglycerides and total cholesterol:HDL-cholesterol ratio (all P = 0.0001), and a significantly greater increase from baseline in HDL-cholesterol (P = 0.001) than patients receiving placebo. The overall adverse event profile for atorvastatin was similar to that observed with placebo.
Conclusions:
Atorvastatin was effective in achieving target LDL-cholesterol levels in a high proportion of the dyslipidemic CAPD patients studied at doses that are well tolerated.