New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences
New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Varenicline Safety Update Adjudicated Cardiovascular Events During the 52-Week Study Period (1% in any group) Rigotti et al Circulation 2011;121:221-229 Varenicline N=353* n (%) Placebo N=350 n (%) Nonfatal myocardial infarction 7 (2.0) 3 (0.9) Need for coronary revascularizaon† 8 (2.3) 3 (0.9) Hospitalization for angina pectoris 8 (2.3) 8 (2.3) New diagnosis of peripheral vascular disease (PVD) or admission for a procedure for the treatment of PVD 5 (1.4) 3 (0.9) The FDA recommends providers weigh the known benefits of Chantix against its potential risks when deciding to use the drug in smokers with cardiovascular disease. They also are working with the manufacturer to gain further data and plan on further updates. Varenicline Safety Update • A recent meta-analysis (early release CMAJ 7-4-2011) of 14 double blind randomized controlled trials involving 8216 participants. The trials ranged in duration from 7 to 52 weeks. Varenicline was associated with a significantly increased risk of serious adverse cardiovascular events compared with placebo (1.06% [52/4908] in varenicline group v. 0.82% [27/3308] in placebo group; Peto odds ratio [OR] 1.72, 95% confidence interval [CI] 1.09–2.71. RRI 72%; ARI 0.24%; NNH ~400 – 57.3% of the weight of this meta-analysis comes from the recent Circulation data by Rigotti Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Citalopram hydrobromide (Celexa) Safety Alert August 24, 2011 FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of citalopram. • Previously doses up to 60 mg per day were FDA approved but based upon new data and case reports of dose related QT interval prolongation, leading to an abnormal heart rhythm (including Torsade de Pointes), citalopram should no longer be used at doses greater than 40 mg per day. Citalopram hydrobromide (Celexa) Safety Alert • Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood. • Studies have not shown a benefit in the treatment of depression at doses higher than 40 mg per day. • Citalopram and sertraline are the recommended agents of choice for patients with depression and CVD according to the AHA/APA – Circulation 2008;118:1768-75 Wayne Weart New Drug Update Part I
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2 nd Annual Essentials in Primary Care<br />
Fall Conference<br />
Friday, November 11, <strong>2011</strong><br />
Varenicline Safety <strong>Update</strong><br />
Adjudicated Cardiovascular Events During the 52-Week<br />
Study Period (1% in any group) Rigotti et al Circulation<br />
<strong>2011</strong>;121:221-229<br />
Varenicline N=353* n (%) Placebo N=350 n (%)<br />
Nonfatal myocardial infarction 7 (2.0) 3 (0.9)<br />
Need for coronary<br />
revascularizaon†<br />
8 (2.3) 3 (0.9)<br />
Hospitalization for angina pectoris 8 (2.3) 8 (2.3)<br />
<strong>New</strong> diagnosis of peripheral<br />
vascular disease (PVD) or<br />
admission for a procedure for the<br />
treatment of PVD<br />
5 (1.4) 3 (0.9)<br />
The FDA recommends providers weigh the known benefits of Chantix against its<br />
potential risks when deciding to use the drug in smokers with cardiovascular disease.<br />
They also are working with the manufacturer to gain further data and plan on further updates.<br />
Varenicline Safety <strong>Update</strong><br />
• A recent meta-analysis (early release CMAJ 7-4-<strong>2011</strong>)<br />
of 14 double blind randomized controlled trials<br />
involving 8216 participants. The trials ranged in<br />
duration from 7 to 52 weeks. Varenicline was<br />
associated with a significantly increased risk of<br />
serious adverse cardiovascular events compared with<br />
placebo (1.06% [52/4908] in varenicline group v.<br />
0.82% [27/3308] in placebo group; Peto odds ratio<br />
[OR] 1.72, 95% confidence interval [CI] 1.09–2.71.<br />
RRI 72%; ARI 0.24%; NNH ~400<br />
– 57.3% of the weight of this meta-analysis comes from the<br />
recent Circulation data by Rigotti<br />
Wayne Weart<br />
<strong>New</strong> <strong>Drug</strong> <strong>Update</strong> Part I
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