A Canadian study in a Quebec hospital followed patients given enoxaparin for a variety of indications (e.g., 33.5% of patients with atrial fibrillation, 22.7% with myocardialinfarction, 20.6% with unstable angina). There was no maximum dose (i.e., no dose cap) for enoxaparin. Anti-Xa levels after 2-3 days of enoxaparin therapy were available for 214 patients, 81 of whom were categorized as being obese (range 66-136 kg). Mean anti-Xa levels 4 h after dose administration for patients with healthy weight (18-30 kg/m2) and those who were obese (> 30 kg/m2) were virtually identical in both the once-daily and twice-daily administration groups. Although bleeding rates were tracked, there was no comment on bleeding rates in relation to body weight. Anti-Xa levels were similar for those who experienced bleeding and those who did not.
From these pharmacokinetic-pharmacodynamic studies, there does not appear to be any evidence supporting the use of a dose cap for LMW heparins used at treatment doses in obese patients (defined on the basis of either total body weight or BMI). There is a lack of evidence regarding nadroparin at treatment doses in obesity.
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Acute Coronary Syndromes
Two trials of LMW heparins in acute coronary syndromes included obese patients and published patients’ body weights (Table 3). Three studies of LMW heparins in acute coronary syndromes were excluded from this review, as they did not provide any subgroup analyses for bleeding rates, event rates, or anti-factor Xa levels according to patient weight. Two large trials of enoxaparin in acute coronary syndromes published more recently included insufficient details about patient weight to allow analysis for this review.
In 1996, the first large-scale trial of dalteparin in acute coronary syndromes was published. Subgroup analysis of the primary end point compared patients with BMI less than 26 kg/m2 with patients whose BMI was 26 kg/m2 or above. The risk ratio for death or myocardial infarction during the first 6 days of dalteparin therapy (relative to placebo) was statistically significant only for patients with BMI less than 26 kg/m2. The risk ratio for patients with BMI of 26 kg/m2 or above was not statistically significant, which the study authors attributed to the small sample size (n = 356 patients with BMI of 26 kg/m2 or above in the active treatment group). The potential affect of the dose maximum of 10 000 units was not examined for this higher BMI subgroup, even though patients with BMI up to 44 kg/m2 were included in the study. cialis 10 mg
The largest pool of patients with both obesity and acute coronary syndrome treated with LMW heparin (enoxaparin) comes from a review of the treatment effects on obese patients and those with renal dysfunction enrolled.
Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q- Wave Coronary Events (ESSENCE) and Thrombolysis in Myocardial Infarction (TIMI) 11B studies. In these 2 landmark trials of acute coronary syndrome, the primary composite end point of death, myocardial infarction, and urgent revascularization was lower with LMW heparins than with adjusted-dose IV unfractionated heparin. In both studies, there was no cap on the enoxaparin dose. The highest recorded weight in the trials was 144 kg. About 26% of the patients in the ESSENCE and TIMI 11B trials were obese. The difference between the study groups reached statistical significance for nonobese patients, but the trend appeared consistent for the obese patients (p = 0.05). The outcome of all bleeding occurred more frequently among enoxaparin-treated patients, in both the obese and the nonobese groups. The difference for major bleeding was not as consistent as it was for all bleeding. Although not statistically significant, there was a trend toward more major bleeding among obese patients receiving unfractionated heparin than among those receiving enoxaparin (1.2% versus 0.4%, p = 0.08). In nonobese patients, the opposite occurred, with a trend toward greater rates of major bleeding among the enoxaparin-treated patients (1.0 versus 1.6%, p = 0.08).
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In summary, of 5 trials of acute coronary syndromes that enrolled obese patients, only 2 analyzed the obese participants as a subgroup. Only the trials with enoxaparin provided substantial details on outcomes for this patient group. The dose of enoxaparin was not capped in either study, and there was no evidence of a greater risk of bleeding with the larger doses used for obese subjects.