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document
Are brand-name and generic warfarin interchangeable ? Multiple n-of-1 randomized , crossover trials . BACKGROUND Warfarin is a commonly used anticoagulant in North America . Several generic formulations have been approved , raising concern over the safety and efficacy of these products compared with brand-name Coumadin . OBJECTIVE To ensure that generic warfarin products can be safely interchanged with Coumadin . METHODS Multiple n-of-1 randomized , double-blind , crossover trials switched outpatients ( N = 7 ) between a generic warfarin formulation ( Apo-warfarin ) and Coumadin over 30 weeks . Study patients took each drug for five 3-week periods , with international normalized ratio ( INR ) measurements taken twice per period . Inter- and intrapatient differences between generic warfarin and Coumadin were compared , and overall study patient results were compared with those of a Coumadin control group . RESULTS There were no differences between warfarin products in terms of mean INR results or number of dosage adjustments required . There also was no difference in INR variation based on warfarin formulation ( p > 0.69 ) , nor was a patient and warfarin interaction found ( p > 0.81 ) . The INR results were not influenced by whether patients were maintained on Coumadin only ( control group ) or interchanged between Coumadin and generic warfarin ( p = 0.98 ) . CONCLUSIONS It appears that patients can safely and effectively switch between generic warfarin and Coumadin .
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Intervention_Pharmacological
generic warfarin
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Intervention_Pharmacological
Warfarin
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Intervention_Pharmacological
Coumadin
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Intervention_Pharmacological
generic warfarin formulation ( Apo-warfarin )
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Intervention_Pharmacological
Coumadin over 30 weeks
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Intervention_Pharmacological
warfarin
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Intervention_Pharmacological
Coumadin
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Intervention_Pharmacological
Coumadin
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Intervention_Pharmacological
generic warfarin
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Intervention_Pharmacological
warfarin
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Intervention_Pharmacological
Coumadin
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Outcome_Other
safety
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Outcome_Other
efficacy
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Outcome_Physical
international normalized ratio ( INR )
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Outcome_Other
INR results
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Outcome_Other
safely and effectively switch
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Participant_Sample-size
( N = 7 )
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Participant_Condition
Study patients took each drug for five 3-week periods
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Participant_Condition
with international normalized ratio ( INR ) measurements taken twice per period