Comparison of Efficacy and Safety of Two Different Enoxaparin Products in Prevention of Venous Thromboembolism Following Major Obstetric-gynecological Surgeries: An Open-label Randomized Clinical Trial

Authors

  • Ashraf Aleyasin Department of Obstetrics and Gynecology, Dr. Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
  • Kheirollah Gholami Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. | Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
  • Manoochehr Abdolvand Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Mohammad Reza Javadi Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
  • Mohammad Solduzian Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Samira Chaibakhsh Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.
  • Seyed Hossein Hosseini Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Zohreh Ziaei Department of Obstetrics and Gynecology, Dr. Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Abstract:

Venous thromboembolism (VTE) occurs in about 5 percent of patients undergoing major abdominal surgeries. Prophylaxis of VTE is recommended using unfractionated heparin (UF) or low molecular weight heparin (LMWH) in high-risk patients. In spite of advantages and confirmed cost-effectiveness of LMWH, high costs of enoxaparin branded preparations limit its use. We aimed to compare the efficacy and safety of two enoxaparin preparations. In this open-label randomized clinical trial, 200 patients were recruited to recieve PDxane® or Clexane®, 40 mg subcutaneously daily, from the day of surgery for 10 days. The patients were evaluated for VTE occurrence and side effects considering clinical and laboratory examinations at the beginning and day 10. No cases of proximal or distal VTE or life threatening bleeding  were observed among 102 and 98 patients who received PDxane® and Clexane®, respectively. The adverse effects observed in PDxane® and Clexane® groups included injection site reactions (rash: P = 0.97; pain: P = 0.55 and erythema:P = 0.33), anemia (P = 0.32), hematuria (P = 0.16), confusion (P = 0.3), and increased liver transaminases (AST ≥ 3 × ULN: P = 0.16 and ALT ≥ 3 * ULN: P = 0.66). In according to the study results PDxane® was of similar efficacy and safety compared to Clexane® in preventing VTE following major obstetric-gynecological surgeries. Considering lower cost of PDxane®, it could be a safe and effective alternate for VTE prophylaxis in the patients undergoing such types of surgeries.

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Journal title

volume 18  issue 4

pages  2172- 2179

publication date 2019-12-01

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