Desirudin clinical studies
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Clinical Studies
Iprivask was evaluated in two controlled, randomized, multicenter, clinical efficacy trials and a controlled, double-blind, dose-finding study. In the efficacy studies, Iprivask was compared to subcutaneously administered unfractionated heparin or enoxaparin sodium for the reduction of the risk of venous thromboembolic events (VTE) in patients undergoing total hip replacement surgery. In all studies Iprivask was initiated prior to surgery and continued for 8 to 12 days postoperatively (median duration 10 days). Patients who received Iprivask had a lower incidence of VTE. The efficacy studies are described below.
In the first study, Iprivask 15 mg subcutaneously administered every 12 hours was compared to unfractionated heparin 5000 IU subcutaneously administered every 8 hours. A total of 445 patients were randomized in the study, 436 patients were treated, and 85 of the treated patients were excluded from efficacy analysis, mainly because of no phlebography or inadequate reading of phlebography. Patients ranged in age from 34 to 89 years (mean age 68.4 years) with 41.8% men and 58.2% women. All enrolled patients were Caucasian. Iprivask significantly reduced the number of total VTE compared to unfractionated heparin: Evaluable population: Iprivask, 13/174 (7.5%) vs. heparin, 41/177 (23.2%); p value <0.001; Intent-to-Treat population: Iprivask 13/225 (5.8%) vs. heparin 42/220 (19.1%);p value <0.0001.]. Significantly fewer patients in the group treated with Iprivask experienced proximal DVT than those patients treated with heparin: Evaluable population: Iprivask 6/174 (3.4%) vs. heparin 29/177 (16.4%); p value <0.001: Intent-to-Treat population: Iprivask 6/225 (2.7%) vs. heparin 30/220 (13.6%); p value <0.0001.
In a second study, Iprivask 15 mg subcutaneously administered every 12 hours was compared to enoxaparin sodium 40 mg subcutaneously administered every 24 hours. A total of 2079 patients were randomized in the study, 2049 patients were treated, and 508 of the treated patients were excluded from efficacy analysis mainly because of no phlebography or inadequate reading of phlebography. Patients ranged in age from 18 to 90 years (mean age 68.5 years) with 41.7% men and 58.5% women. All enrolled patients were Caucasian. In both the evaluable patient population and the intent-to-treat population, patients who received Iprivask had a lower incidence of major VTE, total VTE, and proximal DVT than did patients who received enoxaparin (see table below).
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a Treatment was initiated no more than 30 minutes preoperatively, but after induction of regional block anesthesia, if used. b Major VTE included proximal DVT, PE, or death. c Total number of patients in this evaluation: Iprivask 802; Enoxaparin 785. d Odds ratio 0.61 with 95% Confidence Interval of: 0.40; 0.92 e Total VTE = Venous thromboembolic events which included DVT (including proximal events), PE, or death considered to be thromboembolic in origin. f Odds ratio 0.62 with 95% Confidence Interval of 0.41; 0.94
In a multicenter, double-blind, dose-finding study, Iprivask 10 mg, 15 mg, and 20 mg subcutaneously administered every 12 hours was compared to unfractionated heparin 5,000 IU administered every 8 hours SC in patients undergoing hip replacement surgery. A dose response was seen with regard to both effectiveness and bleeding complications. The 15-mg and 20-mg doses were superior to heparin and the 10-mg dose. In a smaller, open-labeled, dose-finding study of Iprivask 10 mg, 15 mg, 20 mg, and 40 mg subcutaneously administered every 12 hours in patients undergoing hip replacement surgery, the 40-mg dose was associated with unacceptable major bleeding. [1]
References
- ↑ "IPRIVASK (DESIRUDIN) KIT [MARATHON PHARMACEUTICALS, LLC]". Retrieved 3 February 2014.