Update on Dronedarone and Cardiovascular Outcomes

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1 Update on and Cardiovascular Outcomes Dr. Stuart Connolly MD McMaster University Hamilton Ontario Disclosure: Research grants, speaker fees and consulting honoraria from sanofi aventis

2 has key structural differences to amiodarone O (CH 2 ) 3 CH 3 CH 3 SO 2 H N O(CH 2 ) 3 N (CH 2 ) 3 CH 3 O (CH 2 ) 3 CH 3 O (CH 2 ) 3 CH 3 I O(CH 2 ) 2 N CH 2 CH 3 Amiodarone O I CH 2 CH 3 Kathofer, et al. Cardiovasc Drug Rev. 25;23(3):217-3.

3 Cardiac ionic currents inhibited by dronedarone: Comparison with amiodarone IC5 (µm) Channel Amiodarone K Ach.1 1 I to I Kur (atrial) K r (h).6.7 Ca L.2 1 Na (h) ~.3 ~3 I Na I Ca I Kr I Ks K ur (h) K s 1 3 K 1 >3 ~3 I Ach (atrial) I K1 to NC 5* (h) = human; NC = not calculable; * Guo et al JMCC 1997

4 Cumulative Incidence Cumulative Incidence EURIDIS and ADONIS Primary Endpoint: Patients with First Recurrence of AF/Aflutter A Significant and Consistent Reduction in First Recurrence of Atrial Fibrillation/Atrial Flutter.8 EURIDIS.8 ADONIS Time (days) Log-rank test results: p= Time (days) Log-rank test results: p= HR=.8 p=.16 Placebo 95%CI = [.59; 1.9] SINGH, 27 4 mg bid

5 Heart rate (bpm) Change from baseline (bpm) ERATO: Primary Study Endpoint 1 Decreases Ventricular Rate by 12 bpm (Mean ± SEM) Placebo 4 mg BID B D14 D14-B DAVY, 28 *Treatment effect estimate by ANCOVA P<

6 ATHENA trial design ATHENA Prospective double-blind trial to assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in AF and AFL patients with additional risk factors* AF and AFL patients with additional risk factors* R 4 mg b.i.d. (n = 2,31) Double-blind Placebo (n = 2,327) 12 3 months All patients treated with standard of care treatment. * Age 75 years or 75 years with hypertension, diabetes, prior stroke/tia, LAD > 5 mm, or LVEF.4 AFL = atrial flutter; TIA = transient ischaemic attack. Hohnloser S, et al. N Engl J Med. 29;36:

7 Cumulative incidence (%) Primary Outcome: Unplanned cardiovascular hospitalization or death 5 Placebo on top of standard therapy 4 mg b.i.d. on top of standard therapy 4 3 Hazard ratio =.76 p <.1 2 Mean follow-up 21 ± 5 months 1 NNT =13 Patients at risk Follow-up time, months Placebo 2,327 1,858 1,625 1, mg b.i.d. 2,31 1,963 1,776 1, Hohnloser S, et al. N Engl J Med. 29;36:

8 Cumulative incidence (%) Secondary Outcome: Cardiovascular Death ATHENA 7.5 Placebo on top of standard therapy 4 mg b.i.d. on top of standard therapy 5. Hazard ratio =.71 p = Mean follow-up 21 ± 5 months Patients at risk Follow-up time, months Placebo 2,327 2,29 2,25 1, mg b.i.d. 2,31 2,274 2,24 1, Hohnloser S, et al. N Engl J Med. 29;36:

9 ATHENA Adjudicated Cause of Death in ATHENA Outcome Placebo n = 2,327 n = 2,31 Hazard ratio (95% CI) p value All deaths Non-cardiovascular death Cardiovascular death Cardiac non-arrhythmic death Cardiac arrhythmic death Vascular non-cardiac death Hohnloser S, et al. N Engl J Med. 29;36:

10 Cumulative incidence (%) Connolly SJ, et al. Circulation. 29;12: ATHENA Post-hoc Analysis: Stroke Placebo on top of standard therapy 4 mg b.i.d. on top of standard therapy Hazard ratio =.66 p = Mean follow-up 21 ± 5 months Patients at risk Placebo mg b.i.d Follow-up time, months

11 Cumulative Incidence (%) ATHENA: Stroke, ACS, or Cardiovascular death 15 Placebo Number of events HR=.75 (.62-.9) P<.1 5 Placebo on top of standard therapy DR 4mg bid on top of standard therapy Patients at risk: Months Placebo DR 4mg bid Data on file Connolly et al; Circulation. 29;12:

12 reduced downstream cardiovascular complications ATHENA Reason for first CV hospitalization Placebo n = 2,327 n = 2,31 HR 95% CI p value Any reason ;.82 <.1 AF ;.72 <.1 CHF ; ACS ;.97.3 Hohnloser SH, et al. N Engl J Med. 29;36:

13 Adverse events Outcome Placebo n = 2,313 n = 2,291 p value Patients with any TEAE 1,63 (69%) 1,649 (72%).48 Gastro-intestinal 58 (22%) 6 (26%) <.1 Respiratory 337 (15%) 332 (15%).97 Skin 176 (8%) 237 (1%).1 Creatinine increase 31 (1%) 18 (4.7%) <.1 Patients with any serious TEAE 489 (2%) 456 (2%).31 Gastro-intestinal 68 (3%) 81 (4%).28 Respiratory 45 (2%) 41 (2%).74 Skin 6 (.3%) 7 (.3%).79 Creatinine increase 1 (<.1%) 5 (.2%).12 TEAE = treatment-emergent adverse event. Hohnloser S, et al. N Engl J Med. 29;36:

14 Cumulative Incidence (%) ATHENA: Stroke, ACS, or Cardiovascular death 15 Placebo Number of events HR=.75 (.62-.9) P<.1 5 Placebo on top of standard therapy DR 4mg bid on top of standard therapy Patients at risk: Months Placebo DR 4mg bid Data on file Connolly et al; Circulation. 29;12:

15 Cumulative incidence (%) ATHENA Post-hoc Analysis reduces the risk of cardiovascular hospitalization or death in "permanent" AF patients 5 4 Placebo on top of standard therapy 4 mg b.i.d. on top of standard therapy Hazard ratio =.74 p =.96 Mean follow-up 21 ± 5 months 26% reduction in relative risk Patients at risk Follow-up time, months Placebo mg b.i.d Page R, et al. AHA Scientific Sessions 28; Page R, et al. Circulation. 28;118:S_827

16 in Patients with Heart Failure Andromeda and Athena Trial Results

17 Cumulative Incidence ANDROMEDA: Time from Randomization to Death from Any Cause Placebo 4 mg bid Analysis up to January 16 th 23 Placebo (n=317) 8 mg (n=31) Number of patients who died Relative risk (relative to placebo) % CI [1.71; 4.247] Log rank p value Time (days) No. at risk: Placebo mg bid

18 Primary Outcome: Consistency Across Important Clinical Subgroups Age (years) <75 75 Gender Male Female Presence of AF/AFL Yes No Structural Heart Disease Yes No Congestive Heart Failure Yes No LVEF (%) < ACE/ARB Yes No Beta Blocking Agents Yes No N HR [95% CI].76 [.67;.87].75 [.65;.87].74 [.64;.85].77 [.67;.89].74 [.61;.91].76 [.68;.85].76 [.67;.85].77 [.65;.92].75 [.64;.88].76 [.68;.86].68 [.44;1.3].66 [.47;.92].78 [.7;.86].74 [.66;.83].79 [.66;.95].78 [.69;.87].71 [.58;.86] P-value Placebo better better Hohnloser SH et al. ATHENA Investigators. N Engl J Med. 29 Feb 12;36(7):

19 Cummulative Incidence (%) Cummulative Incidence (%) Primary Endpoint and Death in Patients with NYHA Class III CHF at Baseline Primary Endpoint Death from Any Cause 1 75 HR=.56 p=.28 Placebo 3 2 HR=.66 p=.2472 Placebo Months Placebo Drinedarone Months Placebo Drinedarone Mean follow-up 21 ± 5 months (intent-to-treat) Hohnloser S. Oral presentation, Hotline HRS 29

20 Cummulative Incidence (%) Cummulative Incidence (%) Primary Endpoint and Death in Patients with LVEF <.35 at Baseline Primary Endpoint Death from Any Cause 1 75 HR=.68 p=.683 Placebo 3 2 HR=.55 p=.1311 Placebo Months Placebo Drinedarone Months Placebo Drinedarone Mean follow-up 21 ± 5 months (intent-to-treat) Hohnloser S. Oral presentation, Hotline HRS 29

21 Cumulative incidence (%) First Hospitalisation for CHF During Study Numbers at risk: HR=.855 Placebo p= Events 112 Events Months Placebo DR 4mg bid Hohnloser S. Oral presentation, Hotline HRS 29

22 and Potential Liver Injury Phase 3 Trials and Post marketing Surveillance

23 Cumulative Incidence AF/AFL Pool: 5 PCB-controlled trials Time to First Serious Hepatic Adverse Events*.1 Placebo Donedarone 4mg BID. 5 HR=.875 [ ] p= events Number at risk: 36 events Months Placebo mg BID *ALT 5ULN or hepatic adverse events from SOC Hepatobiliary disorders and the SMQ Liver related investigation signs and symptoms ; All randomized and treated patients in DRI355/DAFNE, EFC3153/EURIDIS, EFC4788/ADONIS, EFC458/ERATO, EFC5555/ATHENA 23 Data on file, sanofi-aventis

24 4 Phase-3 trials with liver monitoring (DAFNE, EURIDIS, ADONIS, ERATO) ALT / AST Elevations Period Parameter PCSA criteria Placebo (N=564) 4 mg BID (N=989) > 2 ULN 34/559 (6.1%) 57/979 (5.8%) ALT > 3 ULN 11/559 (2.%) 24/979 (2.5%) > 5 ULN 5/559 (.9%) 8/979 (.8%) On-treatment > 2 ULN 16/558 (2.9%) 24/979 (2.5%) AST > 3 ULN 6/558 (1.1%) 1/979 (1.%) > 5 ULN /558 (.%) 5/979 (.5%) * ULN: Upper Limit of Normal; Denominator refers to patients with post baseline value for the parameter 24 Data on file, sanofi-aventis

25 Post-marketing hepato-biliary reports of MULTAQ as of 21st Nov 21 ESTIMATED > 18, patients exposed 155 reported hepato-biliary AEs Expert Panel Review of 1 Most Serious cases Includes 2 cases with liver transplant 5 cases considered possible/probably due to dronedarone 5 unlikely due to dronedarone Increased liver monitoring during initiation (6 months) recommended

26 Cumulative Incidence (%) ATHENA: Stroke, ACS, or Cardiovascular death 15 HR=.75 (.62-.9) P< Placebo on top of standard therapy DR 4mg bid on top of standard therapy Patients at risk: Months Placebo DR 4mg bid Data on file Connolly et al; Circulation. 29;12:

27 Cumulative incidence (%) ATHENA Post-hoc Analysis reduces the risk of cardiovascular hospitalization or death in "permanent" AF patients 5 4 Placebo on top of standard therapy 4 mg b.i.d. on top of standard therapy Hazard ratio =.74 p =.96 Mean follow-up 21 ± 5 months 26% reduction in relative risk Patients at risk Follow-up time, months Placebo mg b.i.d Page R, et al. AHA Scientific Sessions 28; Page R, et al. Circulation. 28;118:S_827

28 PALLAS: 1,8 Patient Vascular Outcome Trial of in Permanent AF Permanent AF/FL + CV Risk Factor R 4 mg BID 54 patients On top of Standard of Care 54 patients Co-Primary Outcome: 1. Stroke, MI, SE, CV Death 2. CV hospitalization or Death Placebo BID Coordinated by Population Health Research Institute at McMaster University

29 Conclusions is the only antiarrhythmic agent shown to cardiovascular outcomes CV hospitalization, CV death It reduces Unplanned CV hospitalizations both due to AF and to other causes It is effective against AF recurrence and it slows ventricular rate during AF

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