Janelle D Vaughns1,2, Victoria C Ziesenitz3,4, Elaine F Williams5, Evan P Nadler6, Gerd Mikus7, Johannes van den Anker5,3. 1. Division of Anesthesiology, Pain and Perioperative Medicine, Children's National Health System/The George Washington University School of Medicine and Health Sciences, Washington, DC, USA. jvaughns@childrensnational.org. 2. Division of Pediatric Clinical Pharmacology, Children's National Health System/The George Washington University School of Medicine and Health Sciences, Washington, DC, USA. jvaughns@childrensnational.org. 3. Division of Pediatric Pharmacology & Pharmacometrics, University of Basel Children's Hospital, Basel, Switzerland. 4. Department of Pediatric and Congenital Cardiology, University Hospital Heidelberg, Heidelberg, Germany. 5. Division of Pediatric Clinical Pharmacology, Children's National Health System/The George Washington University School of Medicine and Health Sciences, Washington, DC, USA. 6. Division of Surgery, Children's National Health System/The George Washington University School of Medicine and Health Sciences, Washington DC, USA. 7. Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Heidelberg, Germany.
Abstract
INTRODUCTION: Severe obesity predisposes youth to a higher risk of venous thromboembolism (VTE). This study evaluates a BMI-stratified prophylactic dosing regimen of enoxaparin in adolescents with severe obesity undergoing surgery. METHODS: Adolescents aged 12-20 years received prophylactic enoxaparin at 40 mg SC (for a BMI < 50 kg/m2) and 60 mg SC (for a BMI ≥ 50 kg/m2) every 12 h until discharge. Blood samples were drawn at pre-dose, 1, 2, 4, 6, and 12 h. Plasma Anti-Factor Xa (Anti-FXa) activity was used as a surrogate marker for enoxaparin pharmacokinetics. RESULTS: Ten female and two male obese adolescents (age range 14-19 years) had a mean BMI of 49.9 kg/m2 (38.4-58 kg/m2). Four patients had a BMI of less than 50 kg/m2 and received 40 mg enoxaparin, resulting in a mean dosage of 0.352 ± 0.070 mg/kg body weight. Eight patients were dosed with 60 mg enoxaparin every 12 h, resulting in a mean dosage of 0.395 ± 0.028 mg/kg. Peak plasma anti-FXa activity (Cmax) ranged from 0.14 to 0.30 IU/mL, median Cmax was 0.205 IU/mL. Median Tmax was 5.67 h (range 3.78-7.52 h). Median AUCi was 1.00 h IU/mL (range 0.42-1.67 h IU/mL). Ten out of 12 patients (83%) reached the primary endpoint with anti-FXa activity in the range for VTE prevention (0.1-0.3 IU/mL). CONCLUSIONS: Our dosing scheme of 40 mg vs. 60 mg enoxaparin stratified according to BMI proved to be effective in reaching prophylactic anti-FXa activity in 83% of adolescent patients.
INTRODUCTION: Severe obesity predisposes youth to a higher risk of venous thromboembolism (VTE). This study evaluates a BMI-stratified prophylactic dosing regimen of enoxaparin in adolescents with severe obesity undergoing surgery. METHODS: Adolescents aged 12-20 years received prophylactic enoxaparin at 40 mg SC (for a BMI < 50 kg/m2) and 60 mg SC (for a BMI ≥ 50 kg/m2) every 12 h until discharge. Blood samples were drawn at pre-dose, 1, 2, 4, 6, and 12 h. Plasma Anti-Factor Xa (Anti-FXa) activity was used as a surrogate marker for enoxaparin pharmacokinetics. RESULTS: Ten female and two male obese adolescents (age range 14-19 years) had a mean BMI of 49.9 kg/m2 (38.4-58 kg/m2). Four patients had a BMI of less than 50 kg/m2 and received 40 mg enoxaparin, resulting in a mean dosage of 0.352 ± 0.070 mg/kg body weight. Eight patients were dosed with 60 mg enoxaparin every 12 h, resulting in a mean dosage of 0.395 ± 0.028 mg/kg. Peak plasma anti-FXa activity (Cmax) ranged from 0.14 to 0.30 IU/mL, median Cmax was 0.205 IU/mL. Median Tmax was 5.67 h (range 3.78-7.52 h). Median AUCi was 1.00 h IU/mL (range 0.42-1.67 h IU/mL). Ten out of 12 patients (83%) reached the primary endpoint with anti-FXa activity in the range for VTE prevention (0.1-0.3 IU/mL). CONCLUSIONS: Our dosing scheme of 40 mg vs. 60 mg enoxaparin stratified according to BMI proved to be effective in reaching prophylactic anti-FXa activity in 83% of adolescent patients.
Authors: Alvina Mushtaq; Janelle D Vaughns; Victoria C Ziesenitz; Evan P Nadler; John N van den Anker Journal: Obes Surg Date: 2015-10 Impact factor: 4.129
Authors: Jacqueline G Gerhart; Fernando O Carreño; Matthew Shane Loop; Craig R Lee; Andrea N Edginton; Jaydeep Sinha; Karan R Kumar; Carl M Kirkpatrick; Christoph P Hornik; Daniel Gonzalez Journal: Clin Pharmacol Ther Date: 2022-05-18 Impact factor: 6.903