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