Pharmacodynamics assessment of Bemiparin after multiple prophylactic and single therapeutic doses in adult and elderly healthy volunteers and in subjects with varying degrees of renal impairment

A systematic review on the accumulation of prophylactic dosages of low-molecular-weight heparins (LMWHs) in patients with renal insufficiency

“…Five studies examined dalteparin accumulation, and five articles examined enoxaparin [ 31 – 37 , 40 , 41 ]. For tinzaparin, bemiparin, and certoparin, there was one study for each LMWH [ 35 , 38 , 39 ].…”

“…Maximum value per patient was used in the analysis Sanderink 2002 c [ 37 ] Cohort Enoxaparin 4000 IU 48 (12/group) CrCl > 80 50 < CrCl ≤ 80 30 < CrCl ≤ 5 CrCl ≤ 30 18–75 years old. BMI 18–30 4 days C max , AUC, half-life, and CL/F Rico 2014 d [ 38 ] 2-period cohort Bemiparin 3500 IU 48 n = 25 CrCl > 80 n = 8 50 ≤ CrCl ≤ 80 n = 7 30 ≤ CrCl < 50 n = 8 CrCl < 30 Persons with normal renal function had no medical history 4 days C max , AUC, half-life, and CL/F Alban 2013 e [ 39 ] Cohort Certoparin 3000 IU 24 n = 12 normal renal function n = 12 CrCl < 30 5 days C max , AUC, half-life Polkinhorne 2002 e [ 40 ] Randomized Enoxaparin 4000 IU Dalteparin 2500 IU 21 HD Each drug n = 7 Thrice-weekly hemodialysis patients 4 weeks Anti-Xa activity 1, 2, 3, 4, 24, and 28 h postinjection Brown 2010 e [ 41 ] Cohort Enoxaparin 3000 IU 12 CVVH NA ICU patients receiving CVVH 30 ml/kg/h 9 days g Trough anti-Xa levels All studies administered a once daily dosage. Peak anti-Xa: activity 4 h postinjection in all studies CrCl was estimated using the a Cockroft Gault formula; b MDRD formula; c formula: (urine creatinine (mg/dl) × 24 h urine volume (ml)/1440 min)/(Ʃ[serum creatinine from days 1, 4, and 5 (mg/dl)]/3); d formula: urine creatinine concentration × 24 h collected urine volume/plasma creatinine concentration × 24 × 60. e CrCl formula is not mentioned.…”

“…For 3500 IU bemiparin, C max was higher and mean half-life was 2–4 h prolonged in patients with severe renal insufficiency after 4 days administration in 48 patients [ 38 ]. AUC significantly increased with the degree of renal insufficiency.…”

“…In conclusion, for several LMWHs the guidelines that recommend dose reduction for prophylactic use in patients with renal insufficiency are evidence based, except for dalteparin, tinzaparin, and nadroparin. We recommend a dose reduction for prophylactic use of enoxaparin, bemiparin, and certoparin in patients with CrCl below 30 ml/min [ 24 , 28 , 29 , 38 , 39 ]. Prophylactic dosages of tinzaparin and dalteparin are likely to be safe in patients with renal insufficiency and do not need dose reduction.…”

Modern low-molecular-weight heparins in the prevention and treatment of venous thromboembolic complications in oncourologic patients

“…Таким образом, у пациентов среднего и пожилого возраста анти-Ха-активность бемипарина и относящиеся к ней показатели значимо не различаются. В связи с этим пожилым пациентам с сохраненной выделительной функцией почек (при клиренсе креатинина более 30 мл/мин) коррекция профилактической (3500 МЕ / 24 ч) и разовой терапевтической (115 МЕ/кг) дозы не требуется [21]. В результате систематического обзора статей за 2015 г., опубликованных в международных базах цитирования, было обнаружено, что у пациентов с выраженными нарушениями выделительной функции почек, не находящихся на диализной терапии, наблюдается накопление эноксапарина, бемипарина и цертопарина, что требует уменьшения их профилактических доз [22].…”