Antiplatelet agents have a beneficial effect in reducing all cause mortality and fatal cardiovascular events in patients with IC .
BACKGROUND Peripheral arterial disease ( PAD ) is common and is a marker of systemic atherosclerosis .
Patients with symptoms of intermittent claudication ( IC ) are at increased risk of cardiovascular events ( myocardial infa rct ion ( MI ) and stroke ) and of both cardiovascular and all cause mortality .
OBJECTIVES To determine the effectiveness of antiplatelet agents in reducing mortality ( all cause and cardiovascular ) and cardiovascular events in patients with intermittent claudication .
Sarpogrelate, a 5-HT2A receptor antagonist in intermittent claudication. A Phase II European study
This was a multinational , multicentre , double-blind Phase II study in Europe to evaluate the efficacy and safety of two dose regimens ( 200 mg bid and 200 mg tid ) of sarpogrelate ( MCI-9042 , 5-HT2A receptor antagonist ) compared to placebo in patients with stable , moderately severe intermittent claudication . Following a single-blind placebo run-in period of 6 weeks , 364 ( 309 male and 55 female ) patients ( 59.2 ± 8.4 years , mean SD ) were r and omized to receive sarpogrelate 200 mg bid , 200 mg tid or placebo for 24 weeks with a follow-up of 8 weeks . The primary objective was the increase of absolute claudication distance ( ACD ) at the end of treatment ( week 24 ) compared to placebo . Analysis of covariance ( ANCOVA ) was performed on the log-transformed percentage of baseline ACD : loge ( ACD/baseline ) . A responder analysis ( defined as a 50 % improvement in ACD ) was also performed . There was a marked training/placebo effect on the ACD which persisted up to 16 weeks . At 24 weeks the primary objective did not reach statistical significance ( 200 mg bid vs placebo , p = 0.225 ; 200 mg tid vs placebo , p = 0.580 ) . In the responder analysis , 200 mg bid showed a statistically significant difference vs placebo ( p = 0.035 ) . In the exploratory analysis with completers ( patients completing all treadmill tests ) , there was a statistical difference in ACD/baseline change for 200 mg bid ( p = 0.035 ) and in the responder analysis for 200 mg tid ( p = 0.044 ) at 24 weeks compared to placebo . Both treatments showed a carry-over effect for ACD during the 8-week follow-up ( weeks 28 - 32 ) . The treatment was well tolerated and no clinical ly significant safety concerns were reported . In conclusion , the study results confirm that sarpogrelate is well tolerated and although the primary endpoint failed to reach statistical significance , the responder analysis showed an increased absolute walking distance , which makes a further trial warranted , including a larger population , and possibly also a longer treatment period
Antiplatelet agents have a beneficial effect in reducing all cause mortality and fatal cardiovascular events in patients with IC .
BACKGROUND Peripheral arterial disease ( PAD ) is common and is a marker of systemic atherosclerosis .
Patients with symptoms of intermittent claudication ( IC ) are at increased risk of cardiovascular events ( myocardial infa rct ion ( MI ) and stroke ) and of both cardiovascular and all cause mortality .
OBJECTIVES To determine the effectiveness of antiplatelet agents in reducing mortality ( all cause and cardiovascular ) and cardiovascular events in patients with intermittent claudication .