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Abstract: Poster Presentations |

EFFECT OF FLUTICASONE PROPIONATE/SALMETEROL COMBINATION ON CHANGE IN BONE MINERAL DENSITY IN SUBJECTS WITH COPD FREE TO VIEW

Richard ZuWallack, MD; Charles Fogarty, MD; Glenn Giessel, MD; Michael McClung; Nicholas Locantore, PhD; Ibrahim Raphiou, PhD; Stephanie Harris, BS; Glenn D. Crater, MD*
Author and Funding Information

GlaxoSmithKline, Research Triangle Park, NC


Chest


Chest. 2008;134(4_MeetingAbstracts):p104002. doi:10.1378/chest.134.4_MeetingAbstracts.p104002
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Abstract

PURPOSE:To evaluate the effects of the fluticasone propionate component of the fluticasone propionate/salmeterol DISKUS combination product (FSC 250/50mcg BID) on bone mineral density (BMD) by comparison to the effects of the salmeterol DISKUS product (SAL 50mcg BID) alone.

METHODS:Subjects with a smoking history of ≥10 pack-years, an established clinical history of COPD (Baseline pre-bronchodilator FEV1 <70% of predicted normal, FEV1/FVC ≤;70%) and an evaluable native hip participated in a 14–21 day single-blind run-in period and randomized to receive either SAL 50mcg BID or FSC 250/50mcg BID via the DISKUS inhaler. BMD was measured at the lumbar spine (L1-L4) (primary endpoint) and total hip (secondary endpoint), using dual energy X-ray absorptiometry (DXA) every six months. The total duration of subject participation was approximately three years.

RESULTS:Enrollment included 186 subjects (61% male; 96% White) with mean age of 65.6 (±8.94) years and mean BMI of 27.7 (±5.62) kg/m2. At screening, mean FEV1 values were 1.35 L and 1.26 L, and mean FEV1/FVC ratio 0.53 and 0.52, respectively for SAL 50 and FSC 250/50. Incidence of fractures was low with no increase noted with the steroid component of FSC 250/50.

CONCLUSION:Measurement of BMD at the lumbar spine and total hip did not show consistent differences between FSC 250/50 and SAL 50. These data support the long-term use of FSC 250/50 in this patient population. (SCO40041).

CLINICAL IMPLICATIONS:Detrimental effects of ICS on BMD were not seen in this 3yr study of subjects with COPD.

DISCLOSURE:Glenn Crater, Employee Employee of GlaxoSmithKline; No Product/Research Disclosure Information

Wednesday, October 29, 2008

1:00 PM - 2:15 PM


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