bivalirudin and Body-Weight

Reducing bleeding events is a priority in patients diagnosed with acute coronary syndromes (ACS). The effectiveness of optimization measures for reducing abciximab-related bleeding was evaluated through the implementation of a pilot program developed by the Pharmacy and the Cardiology Departments at a tertiary-care hospital.. Percentage of bleeding events.. Intervention was effective in reducing the incidence of the three factors associated with an increased risk of bleeding between the pre-intervention phase (n = 86) and the post-intervention phase (n = 73): unknown body weight (24.4 vs. 1.4 %, p = 0.0001), overdosing (31.4 vs. 0 %, p < 0.0001) and combination with bivalirudin (12.8 vs. 1.4 %, p = 0.016). Bleeding events associated with these factors were numerically reduced in all three cases but these differences were not statistically significant between both periods.. The implementation of a multidisciplinary prevention program can reduce situations associated with an increased risk of bleeding in patients treated with abciximab. Larger scale trials are needed to confirm whether such programs can also reduce the incidence of bleeding at a statistically significant level.

Topics: Abciximab; Acute Coronary Syndrome; Aged; Antibodies, Monoclonal; Antithrombins; Body Weight; Cohort Studies; Drug Dosage Calculations; Drug Therapy, Combination; Female; Hemorrhage; Hirudins; Humans; Immunoglobulin Fab Fragments; Incidence; Male; Middle Aged; Peptide Fragments; Pharmacy Service, Hospital; Pilot Projects; Platelet Aggregation Inhibitors; Recombinant Proteins; Retrospective Studies; Risk Factors; Spain; Tertiary Care Centers; Workforce

To compare dosing strategies using total body weight (actual measured body weight), adjusted body weight, and ideal body weight when starting bivalirudin for the treatment for heparin-induced thrombocytopenia (HIT) in obese patients, and to compare differences in dosing requirements and clinical outcomes between obese and nonobese patients.. Retrospective medical record review.. Academic tertiary care medical center.. One hundred thirty-five medical and surgical patients who were treated with bivalirudin for HIT between June 1, 2004, and October 1, 2009.. The 135 patients were separated into two groups based on body mass index (BMI): 46 patients had a BMI greater than 30 kg/m(2) and were classified in the obese group; the nonobese group consisted of 89 patients with a BMI less than 30 kg/m(2) . The mean BMI in the obese group was 37.7 kg/m(2) (range: 30.1-56.2 kg/m(2) ). Weight-standardized doses that achieved activated partial thromboplastin time (aPTT) goal were compared in the obese group. The mean ± SD doses that achieved aPTT goal with total (actual), adjusted, and ideal body weights in this group were 0.1 ± 0.07, 0.11 ± 0.08, and 0.14 ± 0.09 mg/kg/hour, respectively. Of the three weight-based dosing approaches, total body weight followed by adjusted body weight provided the closest correlation to rates observed at the target aPTT goal. The secondary analysis compared initial doses of bivalirudin, doses required to reach goal aPTT, time to achieve goal aPTT, and clinical outcomes (number of patients not achieving goal, new thrombosis, major bleeding, and 30-day all-cause mortality) between the obese and nonobese groups. A significant difference in initial dose was noted between groups; however, no significant differences in dose required to achieve goal aPTT, time to achieve goal aPTT, and clinical outcomes were noted between the obese and nonobese groups.. This study provides evidence that the dosing strategy for bivalirudin based on total body weight is the most accurate predictor of achieving aPTT goal in obese patients with HIT. The study also suggests that there are no clinical differences that warrant different dosing strategies between obese and nonobese patients. Further prospective studies are needed to confirm these findings.

Topics: Adult; Aged; Aged, 80 and over; Body Mass Index; Body Weight; Dose-Response Relationship, Drug; Female; Heparin; Hirudins; Humans; Ideal Body Weight; Male; Middle Aged; Obesity; Partial Thromboplastin Time; Peptide Fragments; Recombinant Proteins; Retrospective Studies; Thrombocytopenia; Young Adult