The phosphodiesterase inhibitor cilostazol induces regression of carotid atherosclerosis in subjects with type 2 diabetes mellitus: principal results of the Diabetic Atherosclerosis Prevention by Cilostazol (DAPC) study: a randomized trial.
BACKGROUND
Antiplatelet drugs are effective in preventing recurrence of atherosclerosis in type 2 diabetic patients. However, the efficacy and usefulness of 2 different antiplatelet drugs, aspirin and cilostazol, in the progression of carotid intima-media thickening are unknown.


RESULTS
To compare prevention by cilostazol and aspirin of progression of atherosclerosis, we conducted a prospective, randomized, open, blinded end point study in 4 East Asian countries. A total of 329 type 2 diabetic patients suspected of peripheral artery disease were allocated to either an aspirin-treated (81 to 100 mg/d) group or a cilostazol-treated (100 to 200 mg/d) group. The changes in intima-media thickness of the common carotid artery during a 2-year observation period were examined as the primary end point. The regression in maximum left, maximum right, mean left, and mean right common carotid artery intima-media thickness was significantly greater with cilostazol compared with aspirin (-0.088 + or - 0.260 versus 0.059 + or - 0.275 mm, P<0.001; -0.042 + or - 0.274 versus 0.045 + or - 0.216 mm, P=0.003; -0.043 + or - 0.182 versus 0.028 + or - 0.202 mm, P=0.004; and -0.024 + or - 0.182 versus 0.048 + or - 0.169 mm, P<0.001). In a regression analysis adjusted for possible confounding factors such as lipid levels and hemoglobin A(1c), the improvements in common carotid artery intima-media thickness with cilostazol treatment over aspirin treatment remained significant.


CONCLUSIONS
Compared with aspirin, cilostazol potently inhibited progression of carotid intima-media thickness, an established surrogate marker of cardiovascular events, in patients with type 2 diabetes mellitus. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: C000000215.
Katakami
Naoto
N
Department of Internal Medicine and Therapeutics, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita City, Osaka 565-0871, Japan.
Kim
Young-Seol
YS
Kawamori
Ryuzo
R
Yamasaki
Yoshimitsu
Y
D000368:Aged; D050197:Atherosclerosis / Q000188:drug therapy / Q000201:enzymology / Q000209:etiology; D002340:Carotid Artery Diseases / Q000201:enzymology / Q000209:etiology / Q000517:prevention & control*; D000077407:Cilostazol; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000201:enzymology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D011446:Prospective Studies; D013777:Tetrazoles / Q000627:therapeutic use*
D010726:Phosphodiesterase Inhibitors; D013777:Tetrazoles; D000077407:Cilostazol