24873
document
Cross-over trial of intensive monotherapy with atorvastatin and combined therapy with atorvastatin and colestimide for Japanese familial hypercholesterolemia . BACKGROUND In familial hypercholesterolemia ( FH ) , low-density lipoprotein-cholesterol ( LDL-C ) -lowering therapy is important to avoid predisposition to coronary artery disease . This study investigated the advantages of combined therapy with atorvastatin and colestimide vs intensive monotherapy with atorvastatin . METHODS AND RESULTS The trial used a randomized cross-over design consisting of 2 16-week periods of open-label drug therapy . Among the 24 initial patients , 17 heterozygous FH patients ( age : 54.1 years ; 5 males ) were enrolled after 20 mg/day atorvastatin failed to achieve their target level . The patients received 20 mg/day atorvastatin and 3 g/day colestimide or 40 mg/day atorvastatin . Fifteen patients completed the trial and their LDL-C reduced from 5.07 +/- 1.10 mmol/L to 3.76 +/- 0.90 mmol/L with the combined therapy and to 3.81 +/- 0.50 mmol/L with the intensive monotherapy . Although the 2 therapies showed comparable mean effects for decreasing LDL-C , similar adverse reaction and cost , each therapy was predominantly more effective in some patients than in others . The triglyceride and high-density lipoprotein cholesterol levels were similar in both therapies . CONCLUSIONS To achieve the therapeutic target of LDL-C level for refractory FH , the LDL-C-lowering therapy selected can be either intensive monotherapy or combined therapy as the next to standard statin therapy .
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Intervention_Pharmacological
atorvastatin
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Intervention_Pharmacological
atorvastatin
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Intervention_Pharmacological
colestimide
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Intervention_Pharmacological
atorvastatin
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Intervention_Physical
20 mg/day
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Intervention_Pharmacological
atorvastatin
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Intervention_Pharmacological
atorvastatin
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Intervention_Pharmacological
colestimide
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Intervention_Pharmacological
atorvastatin
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Outcome_Physical
low-density lipoprotein-cholesterol ( LDL-C ) -lowering
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Outcome_Physical
LDL-C
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Outcome_Physical
LDL-C
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Outcome_Physical
triglyceride
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Outcome_Mental
and
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Outcome_Physical
high-density lipoprotein cholesterol levels
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Outcome_Physical
LDL-C
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Participant_Condition
familial hypercholesterolemia
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Participant_Condition
familial hypercholesterolemia ( FH )
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Participant_Sample-size
24
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Participant_Sample-size
17
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Participant_Condition
heterozygous FH
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Participant_Age
54.1
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Participant_Sample-size
5
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Participant_Sex
males
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Participant_Sample-size
Fifteen