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 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
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Vilazodone HCl - Viibryd by Trovis/Forest • Approved for the treatment of adults with major depressive disorder (MDD). • An SSRI and partial serotonin 5-HT1A receptor agonist. • It is not clear what role the partial agonist activity contributes to the clinical activity of vilazodone.(like adding buspirone to an SSRI?) • Metabolized by CYP 3A4 and has a T1/2 of about 25 hours • 10, 20 and 40 mg tablets Vilazodone HCl - Viibryd • A randomized, double-blind, placebo-controlled trial with an 8-week treatment duration enrolled 410 adults 18 to 65 years of age diagnosed with a single or recurrent episode of MDD lasting for periods between 4 weeks and 2 years with a score of at least 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17) and a score of at least 2 on the HAM-D-17 item 1 (depressed mood). (J Clin Psychiatry. 2009;70(3):326-333) – Patients were randomized (1:1) to receive placebo or vilazodone 10 mg/day in week 1. The dosage was increased to 20 mg/day in week 2, and then to 40 mg/day for the remainder of the 8-week study. Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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