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document
Results of a phase III , 8-week , multicenter , prospective , randomized , double-blind , parallel-group clinical trial to assess the effects of amlodipine camsylate versus amlodipine besylate in Korean adults with mild to moderate hypertension . BACKGROUND Amlodipine besylate has been used in Korea for the treatment of hypertension for > 17 years , with well-established efficacy and tolerability . Amlodipine camsylate is a newer formulation developed for generic use . It has been assessed in terms of physical stability and pharmacokinetic and pharmacodynamic properties and been found to be effective in lowering blood pressure in preclinical and Phase I and II trials . However , to date , no studies have compared the clinical effectiveness of amlodipine camsylate and amlodipine besylate in treating hypertension . OBJECTIVE This study was designed to determine the effectiveness and tolerability of amlodipine camsylate compared with amlodipine besylate in Korean patients with mild to moderate hypertension . METHODS This Phase III , 8-week , prospective , randomized , double-blind , parallel-group study was conducted in 13 cardiology centers across the Republic of Korea . Male and female Korean patients aged 18 to 75 years having uncomplicated , mild to moderate , essential hypertension ( sitting diastolic blood pressure [ SiDBP ] 90- < 110 mm Hg ) and receiving no antihypertensives in the 2 weeks before randomization were eligible . Patients were randomly assigned to receive oral treatment with amlodipine camsylate or amlodipine besylate . For the first 4 weeks , patients received amlodipine 5 mg QD ( morning ) . After 4 weeks , if either blood pressure was > or =140/ > or =90 mm Hg or SiDBP had not decreased by > or =10 mm Hg from baseline , the dose of amlodipine was increased to 10 mg QD for 4 weeks . Trough blood pressure and heart rate were measured in duplicate with the patient in the sitting position at each clinic visit ( baseline [ week 0 ] and weeks 4 and 8 of treatment ) ; mean values were calculated and recorded . At weeks 4 and 8 , tolerability was assessed using history taking and laboratory analysis , and compliance was assessed using pill counts . The primary end point was change from baseline in SiDBP at week 8 . Secondary end points were change from baseline in sitting systolic blood pressure ( SiSBP ) at week 8 in the total population and in the subgroup of patients who had previously received antihypertensive treatment versus those who had not . RESULTS A total of 189 patients were enrolled ( mean age , 53 years ; 105 women , 84 men ; mean body weight , 65.8 kg ) . One patient in the amlodipine camsylate group dropped out of the study at week 0 of treatment ( this patient did not use any study medication ) and was excluded from the modified intent-to-treat ( ITT ) analysis . Thus , 188 patients were treated and included in the ITT analysis ( 94 patients per treatment group ; ITT analysis ) ; 161 patients were included in the perprotocol ( PP ) analysis ( n = 80 for amlodipine camsylate , n = 81 for amlodipine besylate ) ( 14 patients in the amlodipine camsylate group and 13 patients in the amlodipine besylate group were excluded from the PP analysis due to consistent withdrawal or protocol violation ) . Mean ( SD ) SiSBP and SiDBP were significantly decreased from baseline in both groups ( amlodipine camsylate , from 146.7 [ 12.3 ] /96.6 [ 5.4 ] to 127.9 [ 14.8 ] /83.4 [ 7.7 ] mm Hg [ both , P < 0.001 ] ; amlodipine besylate , from 146.8 [ 12.8 ] /96.7 [ 5.1 ] to 128.0 [ 10.1 ] /83.8 [ 7.5 ] mm Hg [ both , P < 0.001 ] ) . The differences in SiSBP/SiDBP between the 2 groups at week 8 were not significant . The SiDBP response rates in the subgroups that had and had not been previously treated with antihypertensives were statistically similar ( 56/69 [ 81.2 % ] and 83/92 [ 90.2 % ] , respectively ) . The prevalences of clinical adverse events ( AEs ) were not significantly different between the 2 treatment groups ( amlodipine camsylate , 27.3 % ; amlodipine besylate , 28.7 % ) . The most common AEs were dizziness and dyspnea ( both in 3/94 [ 3.2 % ] and 1/94 [ 1.1 % ] patients who received amlodipine camsylate and amlodipine besylate , respectively ) . CONCLUSION The effectiveness and tolerability of amlodipine camsylate were not significantly different from those of amlodipine besylate in these Korean adults with mild to moderate hypertension .
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Intervention_Pharmacological
amlodipine camsylate
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Intervention_Pharmacological
amlodipine besylate
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Intervention_Pharmacological
Amlodipine besylate
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Intervention_Pharmacological
Amlodipine camsylate
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Intervention_Pharmacological
amlodipine camsylate
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Intervention_Pharmacological
amlodipine besylate
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Intervention_Pharmacological
amlodipine camsylate
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Intervention_Pharmacological
amlodipine besylate
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Intervention_Pharmacological
amlodipine camsylate
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Intervention_Pharmacological
amlodipine besylate
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Intervention_Pharmacological
amlodipine 5 mg QD ( morning )
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Intervention_Physical
dose of amlodipine
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Intervention_Pharmacological
amlodipine camsylate
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Intervention_Pharmacological
amlodipine besylate )
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Intervention_Pharmacological
amlodipine camsylate
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Intervention_Pharmacological
amlodipine besylate
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Intervention_Pharmacological
amlodipine camsylate
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Intervention_Pharmacological
amlodipine besylate
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Outcome_Other
effectiveness and tolerability
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Outcome_Physical
blood pressure
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Outcome_Physical
Trough blood pressure and heart rate
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Outcome_Other
tolerability
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Outcome_Physical
SiDBP
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Outcome_Physical
sitting systolic blood pressure
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Outcome_Physical
Mean ( SD ) SiSBP
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Outcome_Physical
SiDBP
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Outcome_Physical
SiSBP/SiDBP
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Outcome_Physical
SiDBP response rates
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Outcome_Adverse-effects
clinical adverse events
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Outcome_Adverse-effects
dizziness and dyspnea
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Participant_Age
adults
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Participant_Condition
hypertension
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Participant_Condition
mild to moderate hypertension
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Participant_Sample-size
13
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Participant_Sex
Male
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Participant_Sex
female
33763
Participant_Age
aged 18 to 75
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Participant_Condition
hypertension
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Participant_Sample-size
189
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Participant_Age
mean age , 53 years
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Participant_Sample-size
105
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Participant_Sex
women
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Participant_Sample-size
84
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Participant_Sex
men
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Participant_Sample-size
188
33772
Participant_Age
adults
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Participant_Condition
mild to moderate hypertension