Comparison of original and generic clopidogrel 600 mg loading dose in the patients who planned undergoing coronary angiography.

OBJECTIVE: To compare the efficacy and safety of original (Plavix) and generic (Apolets) clopidogrel 600 mg loading in patients planning to undergo coronary angiography. MATERIAL AND METHOD: This is an experimental design, parallel, randomized-controlled study. Coronary artery disease patients planned for cardiac catheterization were recruited Patients were randomized to receive either original or generic clopidogrel 600 mg loading dose. Platelet aggregation induced by 5 micromol/L and 20 micromol/L adenosine diphosphate (ADP) was measured by light transmission aggregometry (LTA) at baseline and 6 hours after clopidogrel 600 mg administration. RESULTS: Forty-nine patients were enrolled, 24 patients received original clopidogrel, and 25 patients received generic clopidogrel. After six hours of loading, there was significantly reduction in platelet aggregation induced by adenosine 5 micromol/L from 41.08 +/- 3.04% to 19.50 +/- 1.68% (p < 0.001) in original group compared to 36.76 +/- 2.66% to 21.32 +/- 2.60% (p < 0.001) in generic group. When induced by 20 micromol/L, the platelet aggregation was reduced from 58.50 +/- 2.09% to 32.25 +/- 2.30% (p < 0.001) in original group and from 61.12 +/- 2.54% to 30.04 +/- 3.14% (p < 0.001) in generic group. There was no significant difference between original and generic clopidogrel in reducing platelet aggregation induced by both adenosine 5 and 20 micromol/L. Groin hematoma was found in one case (4.2%) in the original clopidogrel group. CONCLUSION: Generic clopidogrel (Apolets) 600 mg loading dose is as effective as original clopidogrel (Plavix) in term of platelet aggregation inhibition.

Comparison of efficacy and safety of intracoronary nicardipine and adenosine for fractional flow reserve assessment of coronary stenosis.

BACKGROUND: Administration of intracoronary (IC) adenosine allows an easily feasible, inexpensive, and more rapid alternative method for fractional flow reserve (FFR). It is common practice in many centers worldwide. Nicardipine is a strong coronary vasodilator but its efficacy and safety for assessing FFR is not established. The purpose of present study was to compare the efficacy and safety of IC nicardipine and adenosine for assessing FFR. METHODS: One hundred and fifty-nine patients with a total of 193 vessels undergoing clinically indicated FFR assessment of intermediate coronary stenoses were included. For the initial assessment of FFR, hyperemia was induced by an IC adenosine. After a washout period of 3 min, FFR was reassessed using 200 µg of IC nicardipine. RESULTS: Hyperemic efficacy among two different stimuli was compared. The mean FFR with IC adenosine was 0.83 ± 0.09 and that with an IC nicardipine was 0.84 ± 0.09. The median FFR with an IC adenosine was 0.83 (0.78-0.91) and that with an IC nicardipine was 0.85 (0.79-0.91) (p-value 0.246). Both FFR values showed an excellent correlation (R2 = 0.982, p < 0.001). Nicardipine produced fewer changes in heart rate, less chest pain and less flushing than adenosine. Transient atrioventricular block occurred in 29 patients with IC adenosine and none with IC nicardipine. CONCLUSIONS: IC bolus injection of nicardipine could be introduced as a safe and practical alternative method of inducing hyperemia during FFR measurements. Compared to IC adenosine, IC nicardipine has a similar hyperemic efficacy and excellent side-effect profile.