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Data Presented at the European Working Group on Gaucher Disease Demonstrate Continuous Improvements in Bone Mineral Density for VPRIV(R) (Velaglucerase Alfa) Through 69 Months
Date:7/1/2010

through the 69 month period by analysis of lumber spine (LS) and femoral neck (FN) DXA Z-scores.  Four of the patients received bisphosphonates and VPRIV throughout the 69 month period, and 6 were treated with only VPRIV. The study found that BMD improved significantly for the ITT patient population (n=10), and for those who received VPRIV alone (n=6) by months 24 and 33 demonstrating a continuous improvement in BMD among patients for up to 69 months (5.75 years) following dose reductions.

"The data presented provide additional and compelling support that VPRIV is able to provide patients with continuous improvement of key therapeutic goals, including bone, in a clinically meaningful way," said Professor Ari Zimran from the Shaare Zedek Medical Center, Jerusalem, Israel.

TKT-025 EXT BMD Results Highlights Include:

  • Among those treated with VPRIV alone, 3 patients with osteopenia (2 LS and 1 FN) achieved normal BMD and 1 patient with osteoporosis (FN) became osteopenic by 69 months.
  • Among the ITT population, lumbar and femoral BMD improved significantly by months 24 and 33, respectively (LS: 0.39; 95%CI 0.06, 0.72 and FN: 0.39; 95%CI 0.16, 0.62)).
  • At baseline, Z-scores among ITT patients were significantly lower than those seen in age and gender matched controls and showed significant improvement over time during VPRIV treatment (LS and FN p< 0.001 for all measures).
  • Among VPRIV-only treated patients, significant improvement was seen over time [the Z-score LS y-intercept was -1.29 (P= 0.005), LS slope = +0.16/year (P=0.028), FN slope +0.10/year (P=0.006)].

Also presented at the EWGGD were data from a Phase III clinical trial (TKT-034) that demonstrated pati
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SOURCE Shire plc
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