Comparison of Generic (Rolexan) and Brand (Clexan) Forms of Enoxaparin in Critically Ill Patients: A Cross Over, Open Label, Randomized Prospective Clinical Trial

  • Shadi Ziaie
  • Hanieh Malekmohammadi
  • Mohammad Sistanizad 1- Associate Professor of Clinical Pharmacy, Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran 2- Associate Professor of Clinical Pharmacy, Department of Pharmaceutical Care Unit, Imam Hossein Medical and Educational Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Abstract

Backgrounds

Several generic forms of enoxaparin were introduced to the market after expiring the patent of Clexane. But the main problem with generic forms is its bio-equivalency with brand form as a little difference in active ingredients characteristics, could led to significant clinical differences. For evaluating the efficacy of enoxaparin, it is recommended to measure its activity against Anti Xa.

Objectives

The aim of this study was comparison of Anti Xa Activity of Enoxan® versus Clexane ® in critically ill patients with prophylactic doses.

Methods

This was a cross over, open label, randomized prospective study which was performed between September 2016 and December 2017 in intensive care unit of Labbafineghad hospital, Tehran, Iran. Thirty adult patients, who received enoxaparin for prophylaxis of thromboembolic events, recruited by written consent. Subjects were subsequently randomized to one of the treatment sequences (Generic–brand or brand–generic). The generic drug was enoxaparin sodium 40 mg (4,000 IU anti-FXa/0.4 mL), manufactured by Ronakpharm, Iran; the brand drug was enoxaparin sodium 40 mg (Clexane® 4,000 IU anti-FXa/0.4 mL), manufactured by Sanofi, France.

Results

Anti-Xa activity was assessed with Stago kit. The anti-Xa activity between 0.2 and 0.5 U/mL was defined as prophylaxis. The average Anti-Xa activities of Clexan and Rolexan were 0.3 ± 0.12 and 0.22 ± 0.10, respectively which reveals statistically no significant difference (p = 0.35). Also Anti-Xa activity in 6 and 11 patients in Clexan and Rolexan groups were under 0.2 p = 0.16.

Conclusion

In conclusion our study showed comparable efficacy of prophylactic doses between Clexan and Rolexan in critically ill patients. Further studies in different patient population are recommended.

Published
2020-03-24
How to Cite
1.
Ziaie S, Malekmohammadi H, Sistanizad M. Comparison of Generic (Rolexan) and Brand (Clexan) Forms of Enoxaparin in Critically Ill Patients: A Cross Over, Open Label, Randomized Prospective Clinical Trial. J Pharm Care. 8(1):23-25.
Section
Original Article(s)