New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

2 nd Annual Essentials in Primary Care
Fall Conference
Friday, November 11, 2011
Risedronate - Atelvia
HIP Trial results: (NEJM 2001;344:333-340)
• Hip fractures
Group Placebo n % Fx Drug n % Fx RRR P Value ARR NNT
Overall 3134 3.9% 6197 2.8% 30% 0.02 1.1% 91
Age 70-79 1821 3.2% 3624 1.9% 40% 0.009 1.3% 77
+Hx Vert Fx 575 5.7% 1128 2.3% 60% 0.003 3.4% 30
-Hx Vert Fx 875 1.6% 1773 1.0% 40% 0.14 ns
Age 80+* 1313 5.1% 2573 4.2% 20% 0.35 ns
*Women 80 and older did not have to have documented osteoporosis on the
basis of low T-scores only one or more clinical risk factors, BMD is a better
predictor of fracture risk than clinical risk factors in the absence of a history of fracture.
Non-vertebral fractures (overall)
11.2% placebo vs. 9.4% risedronate RRR 20% (P=0.03);
ARR 2.8%; NNT 33
Risedronate - Atelvia
Table 4. Adverse Reactions Occurring in 3% of Patients With Delayed-Release
vs Immediate-Release Risedronate
Delayed-Release 35 mg Weekly
After Breakfast (n = 307)
Immediate-Release 5 mg Daily
Before Breakfast (n = 307)
Diarrhea 8.8% 4.9%
Influenza 7.2% 6.2%
Arthralgia 6.8% 7.8%
Back pain 6.8% 5.9%
Abdominal pain 5.2% 2.9%
Constipation 4.9% 2.9%
Vomiting 4.9% 1.6%
Bronchitis 3.9% 4.2%
Dyspepsia 3.9% 3.9%
Wayne Weart
New Drug Update Part I