Janssen Pharmaceuticals, Inc.Janssen Pharmaceuticals, Inc.

Study Designs* Claxton et al: This study reviewed 76 studies of patient medication compliance

using electronic monitoring devices in published literature from 1986 through 2000. Dosing behavior in patients with a variety of medical disorders (eg, hypertension, asthma, infectious diseases, etc) was described. Mean compliance rates from each study were extracted and averaged; dose-taking and dose-timing compliance rates were compared using analysis of variance. The Bonferroni adjustment was used as a conservative approach to determine significance.2

† Coleman et al: This study was a meta-analysis that included 29 studies (published

between 1987 and 2011); 41 study arms evaluated once-daily dosing, 29 arms

evaluated twice-daily dosing, and 27 arms evaluated thrice-daily dosing. Only

studies that included electronic monitoring (which is considered to be the most

accurate method to evaluate adherence) were included in the analysis. Chronic

CVD states evaluated in the studies were hypertension (48%), hyperlipidemia

(10%), heart failure (10%), stable angina (10%), anticoagulation (10%), coronary

artery disease (7%), and a mixed cohort of CVD conditions (4%).8

‡ Laliberté et al: This study analyzed health insurance claims from the PharMetrics

database between January 2004 and December 2009. Patients with VTE who

were initiating a once-daily (n=4867) or twice-daily (n=1069) oral regimen

of antidiabetic or antihypertensive medications were identified. The patient

observation period was from the index date through the earliest date between

a switch to an agent in another drug class, change in health plan enrollment, or

end of data availability. Adherence to the dosing regimen was estimated using the

medication possession ratio and the proportion of days covered.9

Adherence Rates Consistently Higher for Once-Daily Versus Twice-Daily Dosing

© Janssen Pharmaceuticals, Inc. 2014 July 2014 016604-140609

References1. Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation. 2009;119(23):3028-3035. 2. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23(8):1296-1310. 3. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006;166(5):565-571. 4. Ho PM, Magid DJ, Shetterly SM, et al. Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease. Am Heart J. 2008;155(4):772-779. 5. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353(5):487-497. 6. Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011;86(4):304-314. 7. Kimmel SE, Chen Z, Price M, et al. The influence of patient adherence on anticoagulation control with warfarin—results from the International Normalized Ratio Adherence and Genetics (IN-RANGE) study. Arch Intern Med. 2007; 167(3):229-235. 8. Coleman CI, Roberts MS, Sobieraj DM, Lee S, Alam T, Kaur R. Effect of dosing frequency on chronic cardiovascular disease medication adherence. Curr Med Res Opin. 2012;28(5):669-680. 9. Laliberté F, Bookhart BK, Nelson WW, et al. Impact of once-daily versus twice-daily dosing frequency on adherence to chronic medications among patients with venous thromboembolism. Patient. 2013;6(3):213-224.

HIGHER

ONCE DAILY

62%

4X DOSING MISTAKES

TWICE DAILYHIGHER

BID79% 51%

1X 2X 3X 4X

14%

DOSES PER DAY

QD

DOSING MISTAKESADHERENCE IN CVD ADHERENCE IN VTE

Medication adherence

was inversely related to the

number of prescribed doses

per day.2 In addition to better

adherence rates, once-daily

dosing was also associated with

fewer dosing mistakes.†8

ONCE-DAILY DOSING REGIMENS RESULTED IN FEWER DOSING MISTAKES AND FEWER DAYS WITHOUT MEDICATION [The number of dosing mistakes

was 4 times greater with twice-daily dosing]†8

The first meta-analysis to evaluate dosing frequency and CVD medication adherence showed that once-daily dosing significantly improved adherence to medications for chronic CVD conditions.†8 Similarly, another study found that venous thromboembolism (VTE) patients were 62% more likely to adhere to once-daily dosing compared with twice-daily (BID) dosing schedules for antihypertensive and antidiabetic medications.‡9

When Making Treatment Selections, Dosing Frequency Matters For many patients, dosing complexity can affect medication

adherence.1 In a review of multiple adherence studies using

electronic monitoring devices, once-daily (QD) dosing

regimens had the highest rates of patient adherence.*2

When choosing treatment options, factors that impact

medication adherence, like dosing frequency, should

be considered. Due to the risk of poor outcomes,

medication nonadherence is a particular concern for

patients who require anticoagulation. A patient who is

nonadherent to their medication regimen may be at an

increased risk of an event, which could potentially result in

hospital readmission and other adverse outcomes.3,4

Areas of focus to improve medication adherence include

providing patient education, improved dosing frequency,

increased access to care, and better communications

between healthcare providers (HCPs) and patients.5

Medication adherence is a concern for all therapies, but particularly important for medications prescribed for chronic conditions,6 including thrombotic disorders. One study demonstrated that poor adherence is potentially a major source of poor anticoagulation control in patients, even those being treated at anticoagulation clinics.7 A study in patients with a history of cardiovascular disease (CVD) found that poor adherence was associated with worse health outcomes.4

ONCE-DAILY DOSING REGIMENS HAD THE HIGHESTADHERENCE RATES in a review of

multiple adherence studies in various different medical conditions using electronic monitoring devices*2

Medication Adherence

Impact on Patients Who Require Anticoagulation

VTE PATIENTS TREATED WITH ONCE- DAILY THERAPY WERE MORE ADHERENT THAN PATIENTS ON TWICE-DAILY DOSING SCHEDULES for antihypertensive

and antidiabetic medications‡9

ONCE-DAILY DOSING SHOWED A 14% HIGHER REGIMEN ADHERENCE RATE COMPARED WITH TWICE-DAILY DOSING FOR MEDICATIONS FOR CVD CONDITIONS†8

HIGHER

ONCE DAILY

62%

4X DOSING MISTAKES

TWICE DAILYHIGHER

BID79% 51%

1X 2X 3X 4X

14%

DOSES PER DAY

QD

DOSING MISTAKESADHERENCE IN CVD ADHERENCE IN VTE

Medication adherence

was inversely related to the

number of prescribed doses

per day.2 In addition to better

adherence rates, once-daily

dosing was also associated with

fewer dosing mistakes.†8

ONCE-DAILY DOSING REGIMENS RESULTED IN FEWER DOSING MISTAKES AND FEWER DAYS WITHOUT MEDICATION [The number of dosing mistakes

was 4 times greater with twice-daily dosing]†8

The first meta-analysis to evaluate dosing frequency and CVD medication adherence showed that once-daily dosing significantly improved adherence to medications for chronic CVD conditions.†8 Similarly, another study found that venous thromboembolism (VTE) patients were 62% more likely to adhere to once-daily dosing compared with twice-daily (BID) dosing schedules for antihypertensive and antidiabetic medications.‡9

When Making Treatment Selections, Dosing Frequency Matters For many patients, dosing complexity can affect medication

adherence.1 In a review of multiple adherence studies using

electronic monitoring devices, once-daily (QD) dosing

regimens had the highest rates of patient adherence.*2

When choosing treatment options, factors that impact

medication adherence, like dosing frequency, should

be considered. Due to the risk of poor outcomes,

medication nonadherence is a particular concern for

patients who require anticoagulation. A patient who is

nonadherent to their medication regimen may be at an

increased risk of an event, which could potentially result in

hospital readmission and other adverse outcomes.3,4

Areas of focus to improve medication adherence include

providing patient education, improved dosing frequency,

increased access to care, and better communications

between healthcare providers (HCPs) and patients.5

Medication adherence is a concern for all therapies, but particularly important for medications prescribed for chronic conditions,6 including thrombotic disorders. One study demonstrated that poor adherence is potentially a major source of poor anticoagulation control in patients, even those being treated at anticoagulation clinics.7 A study in patients with a history of cardiovascular disease (CVD) found that poor adherence was associated with worse health outcomes.4

ONCE-DAILY DOSING REGIMENS HAD THE HIGHESTADHERENCE RATES in a review of

multiple adherence studies in various different medical conditions using electronic monitoring devices*2

Medication Adherence

Impact on Patients Who Require Anticoagulation

VTE PATIENTS TREATED WITH ONCE- DAILY THERAPY WERE MORE ADHERENT THAN PATIENTS ON TWICE-DAILY DOSING SCHEDULES for antihypertensive

and antidiabetic medications‡9

ONCE-DAILY DOSING SHOWED A 14% HIGHER REGIMEN ADHERENCE RATE COMPARED WITH TWICE-DAILY DOSING FOR MEDICATIONS FOR CVD CONDITIONS†8

Janssen Pharmaceuticals, Inc.Janssen Pharmaceuticals, Inc.

Study Designs* Claxton et al: This study reviewed 76 studies of patient medication compliance

using electronic monitoring devices in published literature from 1986 through 2000. Dosing behavior in patients with a variety of medical disorders (eg, hypertension, asthma, infectious diseases, etc) was described. Mean compliance rates from each study were extracted and averaged; dose-taking and dose-timing compliance rates were compared using analysis of variance. The Bonferroni adjustment was used as a conservative approach to determine significance.2

† Coleman et al: This study was a meta-analysis that included 29 studies (published

between 1987 and 2011); 41 study arms evaluated once-daily dosing, 29 arms

evaluated twice-daily dosing, and 27 arms evaluated thrice-daily dosing. Only

studies that included electronic monitoring (which is considered to be the most

accurate method to evaluate adherence) were included in the analysis. Chronic

CVD states evaluated in the studies were hypertension (48%), hyperlipidemia

(10%), heart failure (10%), stable angina (10%), anticoagulation (10%), coronary

artery disease (7%), and a mixed cohort of CVD conditions (4%).8

‡ Laliberté et al: This study analyzed health insurance claims from the PharMetrics

database between January 2004 and December 2009. Patients with VTE who

were initiating a once-daily (n=4867) or twice-daily (n=1069) oral regimen

of antidiabetic or antihypertensive medications were identified. The patient

observation period was from the index date through the earliest date between

a switch to an agent in another drug class, change in health plan enrollment, or

end of data availability. Adherence to the dosing regimen was estimated using the

medication possession ratio and the proportion of days covered.9

Adherence Rates Consistently Higher for Once-Daily Versus Twice-Daily Dosing

© Janssen Pharmaceuticals, Inc. 2014 July 2014 016604-140609

References1. Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation. 2009;119(23):3028-3035. 2. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23(8):1296-1310. 3. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006;166(5):565-571. 4. Ho PM, Magid DJ, Shetterly SM, et al. Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease. Am Heart J. 2008;155(4):772-779. 5. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353(5):487-497. 6. Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011;86(4):304-314. 7. Kimmel SE, Chen Z, Price M, et al. The influence of patient adherence on anticoagulation control with warfarin—results from the International Normalized Ratio Adherence and Genetics (IN-RANGE) study. Arch Intern Med. 2007; 167(3):229-235. 8. Coleman CI, Roberts MS, Sobieraj DM, Lee S, Alam T, Kaur R. Effect of dosing frequency on chronic cardiovascular disease medication adherence. Curr Med Res Opin. 2012;28(5):669-680. 9. Laliberté F, Bookhart BK, Nelson WW, et al. Impact of once-daily versus twice-daily dosing frequency on adherence to chronic medications among patients with venous thromboembolism. Patient. 2013;6(3):213-224.