The importance of adherence and persistence: The advantages of once-daily dosing

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1 The importance of adherence and persistence: The advantages of once-daily dosing Craig I. Coleman, PharmD Professor, University of Connecticut School of Pharmacy Storrs, CT, USA Conflicts of interest Dr Coleman has received research support from Janssen Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals and Pfizer He has received honoraria for speaking for Bayer Pharma and Janssen Pharmaceuticals 1

2 Inhibition of Factor Xa (%) Audience survey question 1 Inhibition of Factor Xa activity up to 24 hours after administration in healthy volunteers A single-dose study in healthy volunteers C max reached within 2 4 hours of oral administration 1,2 Half-life: 5 9 hours (20 45 years) 2 ; hours (60 76 years) 3 10 mg rivaroxaban (n=8) 20 mg rivaroxaban (n=7) Placebo Time (hours) 1. Kubitza et al, 2005a; 2. Kubitza et al, 2005b; 3. Kubitza et al,

3 Rivaroxaban AUC 0 24 (µg/h/l) od versus bid: 24-hour exposure to rivaroxaban (VTE prevention after orthopaedic surgery) AUC (i.e. total exposure to drug) 0 24 hours from tablet intake with once-daily and twice-daily regimens for rivaroxaban (total daily dose: 20 mg) AUC, area under plasma concentration time curve; bid, twice daily; od, once daily; VTE, venous thromboembolism Mueck et al, mg od 10 mg bid Rivaroxaban: dosing regimens for patients with VTE or non-valvular AF Treatment of DVT and PE* and prevention of recurrent DVT/PE in adults 15 mg bid for 21 days Transition to 20 mg od from day 22 onwards # Prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors for stroke 20 mg od # *Not recommended in patients with PE who are haemodynamically unstable or who may receive thrombolysis or pulmonary embolectomy; # dose adjustments apply for some patients with renal impairment. Refer to the SPC for full details AF, atrial fibrillation; bid, twice daily; DVT, deep vein thrombosis; od, once daily; PE, pulmonary embolism Xarelto SPC

4 ROCKET AF: rivaroxaban versus warfarin in patients with non-valvular AF Rivaroxaban Warfarin HR 95% CI HR (95% CI) n/n (%/ year) n/n (%/ year) Stroke or systemic embolism* 269/ / Major/non-major 1475/ clinically relevant 7111 bleeding # / Major bleeding 395/ / *Primary endpoint measured in the intention-to-treat population; # principal safety outcome measured in the safety population during treatment CI, confidence interval; HR, hazard ratio Patel et al, , Favours Favours rivaroxaban warfarin EINSTEIN DVT/PE pooled: rivaroxaban versus enoxaparin/vka in patients with VTE Rivaroxaban Enox/VKA HR 95% CI HR (95% CI) n/n (%) n/n (%) Symptomatic recurrent VTE* 86/ / Major/non-major 388/ clinically relevant 4130 bleeding # / Major bleeding 40/ / , Favours Favours rivaroxaban Enox/VKA *Primary end point measured in the intention-to-treat population; # principal safety outcome measured in the safety population during treatment Prins et al,

5 Audience survey question 2 A shared understanding of the different medication-taking behaviour terminology Adherence Extent to which a patient acts in accordance with the prescribed dosing regimen Percentage of doses taken as prescribed MPR: the sum of the medication days of supply divided by the exposure to therapy PDC: measured over fixed periods of exposure; for example, 3, 6, 12 or 18 months Start medication or observation % of doses taken as prescribed Days taking medication Stop medication or end observation Persistence Duration of time from initiation to discontinuation of therapy Days taking medication (without exceeding permissible gap) MPR, medication possession ratio; PDR, proportion of days covered Cramer et al,

6 Adherence (%) Modifiers of medication-taking behaviour Major predictors of poor medication-taking behaviour include: Complexity of regimen (e.g. dosing frequency, total pill burden, drug monitoring) Patient perception of their medication or health (e.g., symptomatology, disease, satisfaction) Barriers to care or medication Poor patient provider relationship Side-effects and tolerability issues Psychological problems Cognitive impairment (including advanced age) Osterberg and Blaschke, 2005 od dosing is associated with higher adherence than bid dosing: adherence to chronic cardiovascular disease medication (95% CI 11.2 to 2.6) p< (95% CI 19.9 to 8.1) p< (95% CI 33.1 to 12.7) p< Dosing frequency 50.4 od bid Taking adherence Regimen adherence Timing adherence Less stringent Number of bottle cap openings divided by the prescribed number of doses Percentage of days with the appropriate number of doses taken Percentage of near optimal inter-administration intervals More stringent Coleman et al,

7 Patient preference for anticoagulant dosing regimen (%) Annual adherence rate (MPR) od dosing: better adherence across a number of different therapy areas versus bid dosing US study of >1 million cardiovascular patients in ,440,254 medication claims (od=1,384,226; bid=56,028) 0,8 0,7 0,6 +16%* (p<0.01) +3%* (p<0.01) +21%* (p<0.01) +42%* (p<0.01) Dosing frequency od bid 0,5 0,4 All agents Antidiabetic agents *od versus bid MPR: days for which medication was supplied/365 days Bae et al, 2012 Antihyperlipidaemic agents Antiplatelet agents Patients with AF prefer once-daily anticoagulation for stroke prevention European survey: 1507 patients with AF (February July 2011; mean age 70.1 years; mean 5.7 medications/patient) Overall, 81% preferred once-daily anticoagulation n = France 210 Zamorano et al, as presented at ESC Germany 231 Italy 222 Spain 245 UK 230 Total 1138 od bid Not sure/declined to answer 7

8 Recurrent events during follow-up (%) Hazard ratio/ 10% decrease in PDC Non-adherence is associated with worse outcomes during non-valvular AF treatment 1,15 HR= % CI HR= % CI ,10 1,05 HR= % CI Shore et al, ,00 0,95 Mortality/stroke Stroke Non-fatal bleeding event HR= % CI US veterans with non-valvular AF (71.3±9.7 years; 98.3% were men and mean CHADS 2 score was 2.4±1.2; mean PDC 84%±22%; 27.8% with a PDC <80%; median follow-up of 244 days) initiated on dabigatran from October 2010 to September 2012 AF, atrial fibrillation; MI, myocardial infarction; PDC, proportion of days covered MI Non-adherence is associated with increased VTE recurrences during treatment Adherent (PDC/MPR>0.80) Non-adherent (PDC/MPR 0.80) 3,5 3,0 2,5 2,0 HR= % CI ,5 HR= % CI ,9 2,9 1,5 1,0 0,9 0,5 0,0 PDC analysis (N=8040) MPR analysis (N=7612) Warfarin adherence was assessed over 1 year in 8040 patients with VTE identified as being at high risk of recurrence Chen et al,

9 Proportion of patients persistent with treatment (%) Probability of persistence (%) Higher persistence with rivaroxaban than warfarin Matched sample included 3654 rivaroxaban and 14,616 warfarin patients Two retrospective US database analyses 1,2 Rivaroxaban Warfarin rivaroxaban patients were matched 1:1 with warfarin patients HR=0.66 ( ); p< ahr=0.63 (95% CI ), p< Time to non-persistence (days) Patients were significantly more likely to persist with rivaroxaban treatment than with warfarin 1. Laliberté et al, 2014; 2. Nelson et al, Time to non-persistence (days) Summary Strict adherence and persistence to oral anticoagulant therapy is critical to avoid thrombosis in patients with AF or VTE Once-daily dosing has a number of advantages over multiple-daily-dose regimens, including better medication-taking behaviour There is clear evidence that patients prefer once-daily dosing 9

10 Thank you for your attention Drugs don t work in patients who don t take them. -C. Everett Koop, MD Former U.S. Surgeon General Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatment. -World Health Organization 10

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