A comparative evaluation of prasugrel and clopidogrel in patients with acute
coronary syndrome undergoing percutaneous coronary intervention.
Author(s): Dasbiswas A(1), Rao MS(2), Babu PR(3), Vijayvergiya R(4), Nayak R(5), Dani S(6),
Tyagi S(7), Hiremath S(8), Patel T(9), Alexander T(10), Prakash VS(11), Singh
DP(8), Yadav MK(4), Pathak K(12), Srivastava A(12).
Affiliation(s): Author information:
(1)Institute of Post Graduate Medical Education & Research, Cardiology Division,
244, A.J.C. Road, Kolkata - 700 020.
(2)Care Hospital, Nampally, Hyderabad-500 001.
(3)Dr. Ramesh Cardiac and Multispeciality Hospital Ltd., Ring Road, Near ITI
College, Vijayawada- 520 008.
(4)Department of Cardiology, Post Graduate Institute of Medical Education &
Research, Sector-12, Chandigarh-160 012.
(5)Wockhardt Heart Hospitals, 14, Cunningham Road, Bangalore-560 052.
(6)Vikram Hospital, 71/1, Millers Road, Bangalore 560052.
(7)Life Care Institute of Medical Sciences & Research, Stadium Road, Sardar Patel
Statue Corner, Naranpura, Ahmedabad- 380 014.
(8)G. B. Pant Hospital & Maulana Azad Medial College, Dept. of Cardiology, J. L.
Nehru Marg, New Delhi-110O 002.
(9)Grant Medical Foundation, Ruby Hall Clinic, 40 Sassoon Road, Pune- 411 001.
(10)SAL Hospital, Opp: Doordarshan Tower, Drive In Road, Ahmedabad-380054.
(11)Kovai Medical Centre & Hospital Limited, P.B. No.:3209, Avanashi Road,
Coimbatore-641 014.
(12)Department of Clinical Research, Torrent Research Center, Bhat, Gandhinagar,
Gujarat.
Publication date & source: 2013, J Assoc Physicians India. , 61(2):114-6, 126
OBJECTIVE: Primary objective of this study was to compare the efficacy of
Prasugrel vs. Clopidogrel in the patients with acute coronary syndromes (ACS)
undergoing percutaneous coronary intervention (PCI) by measuring inhibition of
platelet aggregation after loading and maintenance dose of both the drugs. The
patients were also assessed for safety of the drugs.
METHODS: This was a randomised, double-blind, double-dummy, comparative,
multicentric clinical trial in patients with acute coronary syndrome (unstable
angina, non-ST elevation MI and ST elevation MI) undergoing PCI. The patients
were randomly assigned to receive prasugrel (loading dose of 60 mg followed by
maintenance dose of 10-mg once daily) or clopidogrel (loading dose of 300 mg
followed by maintenance dose of 75 mg once daily) for a period of 12 weeks. All
the patients were co-prescribed aspirin 325 mg with both the drugs. The primary
efficacy end point in this study was percentage inhibition of ADP induced
platelet aggregation (IPA) at 4 +/- 1 hours after the loading dose and at 30 +/-
3 days during maintenance treatment. The platelet aggregation of both the drugs
was measured by whole blood aggregometer using 10 mmol of ADP as an aggregant.
Though this study was not powered to see the difference in clinical efficacy
parameters, the patients were observed for the incidence of nonfatal MI, nonfatal
stroke, re-hospitalization, death, or need for urgent revascularization due to a
cardiac ischemic event at days 30 and 90 during the study. The safety of study
drugs were evaluated by incidence of major bleeding, reported adverse drug
reaction and alterations of any laboratory parameters.
RESULT: A total of 220 patients were enrolled at 11 centres across India. Ten
patients were given the loading dose of prasugrel or clopidogrel but did not
underwent PCI due to change in investigator's decision to go for PCI. Out of 210
eligible patients, 21 patients were discontinued during the study. 157 patients
were evaluated for platelet inhibition after loading dose at 4 hours and 150
patients at day 30 during maintenance phase of antiplalelet therapy. The
investigators could not perform this test in remaining patients due to urgency
and criticality of the patients. 189 patients were observed for the incidence of
nonfatal MI, nonfatal stroke, rehospitalisation, urgent revascularisation or
death due to a cardiac ischemic event. All eligible patients who received at
least a loading dose were evalauted for safety. In prasugrel group, 85 and 77
patients were evaluated for IPA at 4 hours and day 30 respectively whereas in
clopdogrel group 72 and 73 patients were tested for IPA at 4 hours and at 30
days. Patients in prasugrel group have demonstrated significantly higher
inhibition of platelets as compared to clopidogrel group (82.5% vs 71.1%) at 4
hours and at 30 days (84.1% vs 67.4%). The difference in inhibition of platelets
between prasugrel and clopidogrel after loading dose and maintenenace dose was
statistically significant (p < or = 0.01). The patients were also evaluated for
drug hyporesponsiveness to antiplatelet therapy if IPA was < 20% at day 30 from
the baseline. More patients on prasugrel have shown response to antiplatlet
therapy than on clopidogrel (97.4% vs 87.6%). The difference between the two
groups was statistically significant (p < 0.05). There was no difference observed
during the study in the incidence of nonfatal MI, nonfatal stroke, death,
rehospitalisation or need for urgent revascularisation due to a cardiac event
between prasugrel and clopidogrel. Both the drugs were found to be to be well
tolerated and have comparable safety profile.
CONCLUSION: This study suggests that prasugrel is more effective than clopidogrel
as an anti platelet drug as evident by inhibition of platelet aggregation. More
patients on clopidogrel are likely to have poor response to therapy as compared
to prasugrel. Both the drugs were well tolerated and have comparable safety
profile.
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