In this study, designed to show equivalent rate of change in bone mineral density (BMD) for Advair and salmeterol, results for bone mineral density in the lumbar spine did not meet clinical equivalence although the rate of change favored Advair.
Effects of treatment with Advair Diskus 250/50 or salmeterol 50mcg on BMD were evaluated in 186 patients (females and males 43 to 87 years of age) with chronic obstructive pulmonary disease (COPD) in a three-year double-blind study. BMD evaluations were conducted at baseline and at six-month intervals. The study was designed to show equivalence in the rate of change of BMD at the L1-L4 lumbar spine and total hip between Advair and salmeterol.
The difference in the rate of change of BMD for Advair versus salmeterol at the lumbar spine was +0.8% per year (95% CI: 0.06, 1.49). The study was powered for equivalence but instead showed a trend favoring Advair. The study showed equivalence between the two groups in the rate of change at the hip (-0.3% per year (95% CI: -0.78, 0.24)).
Richard ZuWallack, managing director of St Francis Hospital and Medical Center, Hartford, Connecticut, said: “These data are very encouraging for patients with COPD since most patients with this debilitating disease are at an age where they may also be at risk for bone loss. These data inform on the long-term impact of inhaled corticosteroids on bone mineral density.”