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Efficacy The effect of mexiletine and/or clopidogrel alone or in combination with other medications on the rate of coronary angiography was evaluated according to the following two-dimensional cut-off method: Patients randomized to mexiletine and clopidogrel 1.0 mg placebo plus an aspirin 400 mg tablet 4 times or patients randomized to mexiletine alone or placebo plus clopidogrel 1.0 mg aspirin 400 tablet 4 times were classified as having a significant decrease in the use of coronary angiography in the first 24 hours mexiletine/clopidogrel group; and patients randomized to mexiletine/clopidogrel 1.0 mg alone or placebo plus aspirin 400 mg tablets 4 times were classified as having a significant decrease in the use of coronary angiography in the first 24 hours mexiletine/clopidogrel group.
The percentage of patients in mexiletine/clopidogrel group for whom an angiogram was positive on angiography at the end of trial increased with the first dose, to a significantly greater extent with the first dose than second and third doses. Patients randomized to mexiletine/clopidogrel 1.0 mg alone had no statistically significant change in the percentage
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The percentage of patients in mexiletine/clopidogrel group who had coronary angiography in the first 24 hours mexiletine/clopidogrel group was significantly greater than that in the placebo group at all dosages. Clopidogrel alone (1.0 mg) and mexiletine (0.9 alone had no difference in the number of patients with coronary angiography in the first 24 hours mexiletine/clopidogrel group.
The results of efficacy trial are summarized in Table 8.
Table 8. Results of the efficacy trial
Mexiletine Group Placebo Angiography Positive Negative N (%) 1.0 mg, 49 (85) 47 (88) 0 (0) 43 (81) 2.0 mg 25 (42) 22 (50) 16 (33) 7 (28) 0.9 mg 18 (30) 0 (0)
The efficacy of mexiletine/clopidogrel in reduction adverse events hypertensive patients with acute coronary syndrome at the end of trial is similar to the results of an earlier study. In the study of Mente et al.,10 patients (5/group, 6-18 years) with moderate or severe symptoms during an exercise stress test after 3 days of mexiletine were randomly assigned either to mexiletine and clopidogrel (60 mg/day) or to a placebo/clopidogrel combination (20 mg/day) for up to 24 hours. No difference between mexiletine and clopidogrel (P=0.8, data not given); the difference between mexiletine and placebo is 0.1. The most frequent adverse reaction reported in the MEXITROL group with mexiletine and clopidogrel is pain (10 patients in the mexiletine group and 6 in the clopidogrel group [P=0.01]), followed by fatigue (10 patients in group 1: mexiletine and clopidogrel 2; 10 patients in group 3: mexiletine and clopidogrel 4 [P=0.03]).
The following two adverse effects occurred at similar frequencies in all 3 treatment groups: (1) headache in 3 patients (30%) the placebo/clopidogrel group and 5 patients (12%) in the mexiletine group (P=0.04); (2) nausea (1 patient in the placebo/clopidogrel group and 3 patients in the mexiletine group; P=0.03), and (3) upper respiratory tract infection in 1 patient (9%) the placebo/clopidogrel and 3 patients (18%) in the mexiletine group (P=0.9). Only one patient (9%) in the placebo group reported an increase in the incidence of upper respiratory tract infection.
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