New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Denosumab - Prolia • FREEDOM Trial – 7868 women between the ages of 60 and 90 years who had a bone mineral density T score of less than 2.5 but not less than 4.0 at the lumbar spine or total hip. – Subjects were randomly assigned to receive either 60 mg of denosumab or placebo subcutaneously every 6 months for 36 months – The primary end point was new vertebral fracture. Secondary end points included nonvertebral and hip fractures Denosumab - Prolia • FREEDOM Trial results at 3 years Fracture Type Placebo Denosumab RRR ARR NNT Vertebral 7.2% 2.3% 68% 4.9% 21 Non-vertebral 8.0% 6.5% 20% 1.5% 67 Hip 1.2% 0.7% 40% 0.5% 200 Eczema and increased rates of hospitalization for cellulitis were the only two statistically significant adverse effects reported in this trial along with an increase in flatulence. N Engl J Med 2009;361:756-65 Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 FREEDOM Trial 5 Year Data • May 2, 2011 (San Diego, California) — Results from the first 2 years of the international multicenter (FREEDOM) trial 10 year extension, in 4550 postmenopausal women with osteoporosis, showed that the drug maintains its efficacy in improving bone mineral density (BMD) and reducing the incidence of fractures over 5 years without any increase in adverse events, according to researchers here at the American Association of Clinical Endocrinologists 20th Annual Meeting and Clinical Congress. – In the fourth and fifth year of denosumab treatment, those in the original intervention group (2342 women) experienced further benefits in BMD of the lumbar spine and hip. In the fourth year, BMD of the lumbar spine increased by 1.9% in the long-term treatment group and BMD of the hip increased by 0.7%. In the fifth year of treatment, BMD of the lumbar spine increased by 1.7% in the long-term treatment group and BMD of the total hip increased by 0.6%. – The de novo group (2207 women) in the extension trial experienced improvements in BMD similar to those seen in the intervention group in the first 2 years of the original FREEDOM trial. In the first 2 years of their treatment, the crossover group experienced a 7.9% increase in lumbar spine BMD and a 4.1% increase in total hip BMD (P < .0001, compared with baseline). FREEDOM Trial 5 Year Data • The yearly incidence of new vertebral fractures was 1.4% in the long-term denosumab group and 0.9% in the crossover group. Rates of new nonvertebral fractures were also low, with a yearly incidence of 1.4% in the fourth year and 1.1% in the fifth year for the long-term treatment group. In contrast, the yearly incidence rate of new nonvertebral fractures in the crossover group was 2.4% in the first year of treatment and 1.7% in the second year of treatment • The incidence of serious adverse events were low, with just 2 cases of osteonecrosis of the jaw and 1 case of cellulitis in the crossover group of the extension trial. Three subjects in the long-term treatment group experienced cellulitis. Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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