Cardiac Safety Signals: Case Examples
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1 Cardiac Safety Signals: Case Examples
2 Testosterone Peripherally-acting mu-receptor antagonist PAMORAs Dabigatran (Pradaxa) 2
3 Testosterone Testosterone replacement therapy is approved for men with low levels of testosterone related to certain conditions Demonstrated effect: Normalization of testosterone levels Safety/efficacy not established in age-related hypogonadism CV Safety Signal 2 Observational studies showed increased risk of death, MI, stroke MOA?: adverse effect on BP; lipids; inflammatory marketers 3
4 Testosterone: CV Safety Signal Study Database Endpoint Risk (TRT vs. control) Xu, et al (MA #1; 2013) 27 RCT CV related events OR: 1.5 (1.1, 2.1) Corona, et al (MA #2; 2014) *Vigen, et al (Obs #1; 2013) *Finkle, et al (Obs #2; 2014) Shores, et al (Obs #3; 2012) Muraleedharan (Obs #4; 2013) Baillargeon (Obs #5; 2014) 26 RCT CV death; non-fatal MI; stroke; ACS; HF VA system (angiog plus low t) Commercial claims (pre vs. post rx) OR: 1.01 (0.57, 1.77) Death, MI, stroke HR 1.29 (1.04, 1.58) RD: 5.8% (-1.4, 13.1) Non-fatal MI RR: 1.36 (1.03, 1.81) Age effects RD: 1.27/1000 pt-yrs VA system Mortality HR: 0.61 (0.42, 0.88) RD: -2.3/100 pt-yrs Hypogonadism study Mortality HR 0.43 RD: 10.8% Medicare sample MI HR: 0.84 (0.69, 1.02) posted 3/3/
5 Investigating the CV signal Advisory Committee held in 2014 Safety signal is weak Use in age related hypogonadism inappropriate Only a prospective, well-controlled clinical trial could determine whether testosterone causes cardiovascular harm. Differing views on studied population FDA required RCT to investigate signal isorycommittee/ucm htm 5
6 PAMORAs Peripherally acting mu-opioid receptor antagonists Opioid induced constipation; post-operative ileus Entereg (alvimopan); Relistor (methylnaltrexone); Movantik (naloxegol) Abuse deterrent opioids Targiniq (naloxone+oxycodone) 6
7 PAMORAs: CV Safety Signal Signal originated from alvimopan Imbalance in MIs in 12 month controlled trial for opioid induced constipation MOA?: opioid withdrawal, vasoconstriction, class effect? No CV signal for Movantik in development program 2 12-week placebo controlled studies (n=1300) 1 52-week controlled safety study (n=800) Lack of signal for Relistor (4 weeks); Targiniq ittee/ucm htm 7
8 Investigating the signal Advisory committee on PAMORAs (2014) No dedicated controlled, pre-approval CVOT needed because signal weak 12 month controlled, modestly sized, pre-approval trial Reassuring to collect post-marketing data on cardiac safety via observational studies FDA required postmarket observational studies for Movantiq, Relistor, and Targiniq 8
9 FDA required study 9
10 Dabigatran Direct thrombin inhibitor approved (2010) for prevention of stroke in patients with NVAF First anticoagulant approved since warfarin (1954) Postmarketing reports of bleeding signaled concerns FAERS reports numerous (10,000 in first year) Literature reports Regulatory Authority alerts 10
11 FDA actions Modular programs run in Mini-Sentinel October 2011 (too little exposure) October 2012 (basis for drug safety communication and NEJM article) large numbers of reported cases of bleeding with dabigatran is an example of stimulated reporting. The Mini-Sentinel assessment suggests that bleeding rates with dabigatran are not higher than those with warfarin, a finding that is consistent with the results of RE-LY -April
12 Observational Study in Medicare Graham DJ et al, Circulation
13 FDA actions CMS Observational Study (basis for drug safety communication) In this study Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. -May
14 Other CV signals investigated NSAIDS Weight loss drugs Chantix (Varenicline) PAMORAs Zelnorm (Tegaserod) Benicar (Olmesartan) Diabetes drugs Stalevo (entacapone) Azithromycin Loperamide 14
15 Summary Inconsistent results limit confidence in observational studies Risk vs. No Risk vs. Protective Effect Implausible subgroup findings Results differ based on methodology used When Observational study consistent with RCT Use methodology/database to investigate similar signals? Need for/approach to safety study affected by Baseline risk of the treated population Benefit demonstrated Strength of signal Feasibility Risk aversion attitudes Policy Parameters stipulated in required studies are broad 15
16
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