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document
Dipyridamole in chronic stable angina pectoris ; a randomized , double blind , placebo-controlled , parallel group study . BACKGROUND Oral dipyridamole induces accumulation of endogenous adenosine , which in a hypoxic milieu exerts experimentally an angiogenic effect on coronary collateral circulation . A meta-analysis of 13 randomized placebo-controlled trials published between 1960 and 1992 showed evidence of benefit for dipyridamole in the treatment of angina pectoris , especially with longer duration of treatment . Aim To assess the efficacy and safety of dipyridamole in the treatment of patients with chronic stable angina in a large scale , international , randomized , placebo-controlled , parallel group study . METHODS Four hundred patients with chronic stable angina pectoris and a positive treadmill exercise test were randomized to receive either modified release dipyridamole ( 200 mg b.i.d . p.o. , n=198 ) or corresponding placebo ( n=202 ) , for 24 weeks as an add-on to conventional antianginal therapy and for 4 additional weeks as monotherapy -- the latter after withdrawal of standard treatment with calcium antagonists and/or beta-blockers and/or long-acting ( prophylactic ) nitrates . RESULTS Of the 198 patients randomized to dipyridamole , 134 completed the add-on and only 12 the monotherapy phase . Of the 202 patients randomized to placebo , 162 reached the add-on and only 12 the monotherapy phase . Serious adverse events occurred in 15 patients with dipyridamole and in 12 with placebo ( 7.6 % vs 6.0 , P=0.52 ) . Increase over the baseline treadmill exercise test was similar in the treatment groups at each stage of the trial for all the main efficacy parameters : total treadmill exercise test duration ; time to first anginal pain ( except for a -13 s difference in favour of placebo at week 24 ; P=0.040 ) ; time to ST segment depression > 0.1 mVolt ( except for a +21 s difference in favour of dipyridamole at week 8 ; P=0.024 ; this latter difference was totally attributable to patients with lower exercise tolerance -- Bruce stage II at study entry ) . CONCLUSION In patients with chronic stable angina treated with regular antianginal background medication , the use of oral dipyridamole is safe and well tolerated . Antianginal and antiischaemic efficacy , as assessed by exercise testing , is comparable to placebo , except for a beneficial effect on time to ischaemia after 2 months , totally attributable to patients with lower exercise tolerance at study entry .
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Intervention_Pharmacological
Dipyridamole
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Intervention_Pharmacological
dipyridamole
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Intervention_Pharmacological
dipyridamole
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Intervention_Pharmacological
modified release dipyridamole
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Intervention_Control
corresponding placebo
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Intervention_Pharmacological
conventional antianginal therapy
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Intervention_Pharmacological
withdrawal of standard treatment with calcium antagonists and/or beta-blockers and/or long-acting ( prophylactic ) nitrates
7078
Intervention_Pharmacological
dipyridamole
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Intervention_Control
placebo
7080
Outcome_Other
efficacy and safety
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Outcome_Adverse-effects
Serious adverse events
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Outcome_Other
Increase over the baseline treadmill exercise test
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Outcome_Other
total treadmill exercise test duration
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Outcome_Physical
time to first anginal pain
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Outcome_Physical
time to ST segment depression
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Outcome_Other
safe
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Outcome_Other
tolerated
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Participant_Condition
chronic stable angina pectoris
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Participant_Condition
patients with chronic stable angina in a large scale , international
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Participant_Sample-size
Four hundred
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Participant_Sample-size
198
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Participant_Condition
patients with chronic stable angina treated with regular antianginal background medication