title: Thromboprophylaxis with dabigatran after total hip arthroplasty in Indian patients: A subanalysis of a double-blind, double-dummy, randomized RE-NOVATE II study.
abstract: OBJECTIVE
  In the Re-NOVATE II study, oral dabigatran provided thromboprophylaxis after total hip arthroplasty and improved compliance postdischarge in a global population. This article aims to identify trends (if any) in the Indian population.
  
  
  METHODS
  In this prospective, double-blind, double-dummy study, patients scheduled for primary, unilateral, elective total hip arthroplasty were randomized to 220 mg oral dabigatran once daily, starting with a 110 mg half-dose, 1-4 hours after surgery, or subcutaneous enoxaparin 40 mg once daily, starting the evening before surgery. Each group received a placebo of the other study drug. The primary efficacy outcome was the composite of total venous thromboembolism (VTE) and all-cause mortality. Secondary outcome measures were composite of major VTE and VTE-related mortality during the treatment period. The major safety outcome was incidence of bleeding events.
  
  
  RESULTS
  Of the 179 Indian patients randomized, 91 received oral dabigatran and 88 received subcutaneous enoxaparin for 28-35 days. Total VTE and all-cause mortality occurred in 18.7% of patients in the dabigatran group and 13.7% in the enoxaparin group [odds ratio = 1.4 (95% confidence interval 0.6, 3.5)]. Major VTE and VTE-related mortality was numerically lower in the dabigatran group (7.9%) compared with the enoxaparin group (9.9%). Safety outcomes were comparable between both groups.
  
  
  CONCLUSIONS
  Dabigatran is an effective oral alternative to enoxaparin for thromboprophylaxis as demonstrated by the RE-NOVATE II study global results. Data analyzed in Indian patients indicate comparable effects of dabigatran etexilate for major efficacy and safety outcomes.
authors.affiliation: All India Institute of Medical Sciences, New Delhi, India. Electronic address: rmalhotra62@hotmail.com.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Malhotra
authors.affiliation: Sushrut Hospital, Nagpur, Maharashtra, India.
authors.forename: Sushrut
authors.initials: S
authors.lastname: Babhulkar
authors.affiliation: Yashoda Hospital, Secunderabad, Telangana, India.
authors.forename: Kumar Behera
authors.initials: KB
authors.lastname: Sanjib
authors.affiliation: Boehringer Ingelheim, Mumbai, India.
authors.forename: Andreas
authors.initials: A
authors.lastname: Clemens
authors.affiliation: Yashoda Hospital, Secunderabad, Telangana, India.
authors.forename: Akhil
authors.initials: A
authors.lastname: Dadi
authors.affiliation: St. John's Medical College & Hospital, Bangalore, Karnataka, India.
authors.forename: Rajagopalan
authors.initials: R
authors.lastname: Iyer
authors.affiliation: Kasturba Medical College, Mangalore, India.
authors.forename: Surendra
authors.initials: S
authors.lastname: Kamath
authors.affiliation: Center for Knee Surgery, Baroda, India.
authors.forename: Bharat
authors.initials: B
authors.lastname: Mody
authors.affiliation: Siddhi Nursing Home, Mumbai, Maharashtra, India.
authors.forename: Satish
authors.initials: S
authors.lastname: Mutha
authors.affiliation: Krishna Institute of Medical Sciences, Hyderabad, India.
authors.forename: Gurava
authors.initials: G
authors.lastname: Reddy
authors.affiliation: Shalby Hospitals Pvt. Ltd., Ahmedabad, India.
authors.forename: Vikram
authors.initials: V
authors.lastname: Shah
authors.affiliation: Vadodara Institute for Reconstructive Orthopedic Care, Vadodara, India.
authors.forename: Vrajesh
authors.initials: V
authors.lastname: Shah
authors.affiliation: M.S. Ramaiah Memorial Hospital, Bangalore, Karnataka, India.
authors.forename: Naresh
authors.initials: N
authors.lastname: Shetty
authors.affiliation: Jehangir Hospital, Pune, Maharashtra, India.
authors.forename: Sachin
authors.initials: S
authors.lastname: Tapasvi
authors.affiliation: Fortis Hospital, Mohali, India.
authors.forename: Manuj
authors.initials: M
authors.lastname: Wadhwa
mesh_terms: D000284:Administration, Oral; D000368:Aged; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects* / Q000379:methods*; D016001:Confidence Intervals; D000069604:Dabigatran / Q000008:administration & dosage*; D004311:Double-Blind Method; D017984:Enoxaparin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007194:India; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011183:Postoperative Complications / Q000503:physiopathology / Q000517:prevention & control; D011322:Primary Prevention / Q000379:methods; D011446:Prospective Studies; D018570:Risk Assessment; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D017984:Enoxaparin; D000069604:Dabigatran
keywords: dabigatran etexilate; enoxaparin; total hip arthroplasty; venous thromboembolism