| Literature DB >> 24532967 |
Jiyoon C Choi1, Marco D Dibonaventura2, Lewis Kopenhafer2, Winnie W Nelson3.
Abstract
BACKGROUND: Oral dabigatran was recently approved as an alternative to warfarin for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Unlike warfarin, dabigatran has a fixed dosage and few drug interactions, and does not require anticoagulation monitoring or dietary restrictions.Entities:
Keywords: atrial fibrillation; dabigatran; warfarin
Year: 2014 PMID: 24532967 PMCID: PMC3923612 DOI: 10.2147/PPA.S56187
Source DB: PubMed Journal: Patient Prefer Adherence ISSN: 1177-889X Impact factor: 2.711
Figure 1Dyspepsia questionnaire.
Patient demographics
| Warfarin users (n=204)
| Dabigatran users (n=160)
| ||||
|---|---|---|---|---|---|
| % | n | % | n | ||
| Sex | |||||
| Male | 73 | 149 | 63 | 101 | 0.043 |
| Health insurance | |||||
| Yes | 96 | 195 | 98 | 156 | 0.329 |
| Education | |||||
| High school graduate or equivalent (eg, GED) | 16 | 32 | 13 | 21 | 0.028 |
| College graduate (eg, BA, AB, BS) | 20 | 41 | 23 | 37 | |
| Completed graduate school (eg, MS, MD, PhD) | 16 | 33 | 23 | 37 | |
| Declined to answer | 0 | 0 | 0.6 | 1 | |
| Ethnicity | |||||
| African American | 3 | 7 | 4 | 6 | 0.167 |
| American Indian | 1 | 2 | 0 | 0 | |
| Asian | 3 | 5 | 0 | 0 | |
| Hispanic | 2 | 4 | 4 | 6 | |
| White | 91 | 186 | 91 | 146 | |
| Multiethnic | 0 | 0 | 0.6 | 1 | |
| Declined to answer | 0 | 0 | 0.6 | 1 | |
| Marital status | |||||
| Married | 66 | 135 | 68 | 108 | 0.481 |
| Single, never married | 5 | 11 | 8 | 12 | |
| Divorced | 12 | 25 | 11 | 17 | |
| Separated | 0.5 | 1 | 3 | 4 | |
| Widowed | 13 | 26 | 10 | 16 | |
| Living with partner | 3 | 6 | 2 | 3 | |
| BMI level | |||||
| Under 18.5 | <0.001 | ||||
| 18.5 to <25 | 13 | 27 | 16 | 26 | |
| 25 to <30 | 30 | 61 | 49 | 78 | |
| ≥30 | 53 | 109 | 32 | 51 | |
| Declined to answer | 3 | 6 | 3 | 5 | |
| CCI | |||||
| 0 | 37 | 76 | 48 | 77 | 0.037 |
| 1 or more | 63 | 128 | 52 | 83 | |
|
| |||||
| Age, years | 68 | 9.12 | 69 | 12 | <0.001 |
| Years diagnosed with AF | 8 | 8.79 | 6 | 7.58 | 0.008 |
| Number of pills taken daily | 7 | 3.39 | 5 | 3.59 | <0.001 |
| 1 | 5 | 2.59 | 3 | 2.50 | <0.001 |
| 2 | 2 | 1.70 | 2 | 1.70 | 0.355 |
| 3 | 0.21 | 0.66 | 0.19 | 0.74 | 0.743 |
| ≥4 | 0.17 | 1.00 | 0.06 | 0.32 | 0.120 |
| As needed | 0.22 | 0.64 | 0.19 | 0.58 | 0.670 |
Note:
Values are significantly different at P<0.05 in the two-sided test of equality for column proportions and equality of means.
Abbreviations: AF, atrial fibrillation; BMI, body mass index; CCI, Charlson Comorbidity Index; SD, standard deviation; GED, General Educational Development; BA, Bachelor of Arts; AB, Artium Baccalaureus; BS, Bachelor of Science; MS, Master of Science; MD, Doctor of Medicine; PhD, Doctor of Philosophy.
Figure 2Analysis group definitions.
Incidence and frequency of symptoms
| WUs (n=204)
| NAUs (n=160)
| ||||
|---|---|---|---|---|---|
| % | n | % | n | ||
| Experienced heart palpitations | |||||
| No | 57 | 117 | 31 | 50 | |
| Yes | 43 | 87 | 69 | 110 | |
| Experienced irregular heartbeat | |||||
| No | 41 | 84 | 30 | 48 | 0.028 |
| Yes | 59 | 120 | 70 | 112 | |
| Experienced lack of energy | |||||
| No | 27 | 54 | 21 | 33 | 0.194 |
| Yes | 74 | 150 | 79 | 127 | |
| Experienced dizziness | |||||
| No | 51 | 104 | 34 | 55 | 0.002 |
| Yes | 49 | 100 | 66 | 105 | |
| Experienced chest discomfort | |||||
| No | 72 | 147 | 52 | 83 | <0.0001 |
| Yes | 28 | 57 | 48 | 77 | |
| Experienced shortness of breath | |||||
| No | 41 | 83 | 36 | 57 | 0.325 |
| Yes | 59 | 121 | 64 | 103 | |
| Overall frequency of indigestion | |||||
| Not at all | 78 | 159 | 44 | 70 | <0.0001 |
| Less than once a month | 10 | 21 | 21 | 34 | |
| Between once a month and once a week | 7 | 15 | 18 | 28 | |
| Between once a week and once a day | 3 | 5 | 14 | 23 | |
| Once a day or more | 2 | 4 | 3 | 5 | |
| Overall frequency of heartburn | |||||
| Not at all | 74 | 151 | 45 | 72 | |
| Less than once a month | 14 | 29 | 16 | 26 | |
| Between once a month and once a week | 6 | 13 | 17 | 27 | |
| Between once a week and once a day | 4 | 9 | 13 | 20 | |
| Once a day or more | 1 | 2 | 9 | 15 | |
| Overall frequency of regurgitation | |||||
| Not at all | 76 | 155 | 56 | 89 | <0.0001 |
| Less than once a month | 18 | 36 | 21 | 33 | |
| Between once a month and once a week | 4 | 8 | 13 | 21 | |
| Between once a week and once a day | 2 | 3 | 8 | 13 | |
| Once a day or more | 1 | 2 | 3 | 4 | |
| Overall frequency of nausea | |||||
| Not at all | 86 | 176 | 54 | 87 | <0.0001 |
| Less than once a month | 7 | 15 | 19 | 30 | |
| Between once a month and once a week | 3 | 7 | 16 | 26 | |
| Between once a week and once a day | 2 | 3 | 9 | 14 | |
| Once a day or more | 2 | 3 | 2 | 3 | |
| Overall frequency of stomach pain | |||||
| Not at all | 79 | 162 | 49 | 78 | <0.0001 |
| Less than once a month | 12 | 24 | 22 | 35 | |
| Between once a month and once a week | 6 | 12 | 21 | 33 | |
| Between once a week and once a day | 0.5 | 1 | 6 | 10 | |
| Once a day or more | 3 | 5 | 3 | 4 | |
Note:
Values are significantly different at P<0.05 in the two-sided test of equality for column proportions and equality of means.
Abbreviations: WUs, warfarin users; NAUs, newer anticoagulant users.
Figure 3(A) Gastrointestinal bleeding in the 3 months before the survey, (B) severity of gastrointestinal bleeding, (C) frequency of gastrointestinal bleeding, (D) duration of gastrointestinal bleeding, and (E) use of treatments for stomach-related symptoms.
Abbreviations: WU, warfarin users; NAU, newer anticoagulant users; OTC, over the counter.
Medication characteristics and adherence
| Warfarin users (n=204)
| Dabigatran users (n=160)
| ||||
|---|---|---|---|---|---|
| Mean | SD | Mean | SD | ||
| Doses missed | 0.63 | 1.78 | 0.65 | 1.78 | 0.916 |
| Doses taken less than the prescribed amount | 0.23 | 1.36 | 0.19 | 0.62 | 0.784 |
|
| |||||
| Frequency of medication use per day | |||||
| Once | 94 | 192 | 28 | 44 | <0.0001 |
| ≥Twice | 6 | 12 | 73 | 116 | |
| I wanted to avoid the side effects of the medication | |||||
| No | 100 | 33 | 98 | 42 | 0.378 |
| Yes | 0.0 | 0 | 2 | 1 | |
| I forgot to take my medication | |||||
| No | 24 | 8 | 33 | 14 | 0.428 |
| Yes | 76 | 25 | 67 | 29 | |
| I didn’t think my medication was working | |||||
| No | 100 | 33 | 100 | 43 | N/A |
| I had a change in routine | |||||
| No | 94 | 31 | 65 | 28 | 0.003 |
| Yes | 6 | 2 | 35 | 15 | |
| I fell asleep | |||||
| No | 91 | 30 | 79 | 34 | 0.161 |
| Yes | 9 | 3 | 21 | 9 | |
| I was too busy | |||||
| No | 91 | 30 | 84 | 36 | 0.358 |
| Yes | 9 | 3 | 16 | 7 | |
| It was recommended by my physician | |||||
| No | 88 | 29 | 100 | 43 | 0.019 |
| Yes | 12 | 4 | 0 | 0 | |
| I had a difficult time paying for the medication | |||||
| No | 100 | 33 | 100 | 43 | N/A |
| I ran out of medication | |||||
| No | 97 | 32 | 93 | 40 | 0.445 |
| Yes | 3 | 1 | 7 | 3 | |
| I was concerned about interactions with alcohol | |||||
| No | 97 | 32 | 100 | 43 | 0.251 |
| Yes | 3 | 1 | 0 | 0 | |
| I was already taking too many medications | |||||
| No | 100 | 33 | 98 | 42 | 0.378 |
| Yes | 0 | 0 | 2 | 1 | |
| I was concerned about the risk of bleeding due to an activity I was going to do | |||||
| No | 91 | 30 | 100 | 43 | 0.044 |
| Yes | 9 | 3 | 0 | 0 | |
| I was bothered by stomach-related (gastrointestinal) side effects | |||||
| No | 100 | 33 | 98 | 42 | 0.378 |
| Yes | 0 | 0 | 2 | 1 | |
| I was bothered by side effects that were not stomach-related | |||||
| No | 97 | 32 | 100 | 43 | 0.251 |
| Yes | 3 | 1 | 0 | 0 | |
| Other reasons for nonadherence | |||||
| No | 88 | 29 | 93 | 40 | 0.442 |
| Yes | 12 | 4 | 7 | 3 | |
Note:
Values are significantly different at P<0.05 in the two-sided test of equality for column proportions and equality of means.
Abbreviations: N/A, not applicable; SD, standard deviation.
Treatment decisions and switching medication
| WUs (n=204)
| NAUs (n=160)
| ||||
|---|---|---|---|---|---|
| % | n | % | n | ||
| Reason for using the current treatment | |||||
| I made the decision myself then brought it up to my doctor | 0 | 0 | 2 | 3 | 0.018 |
| A friend or family member told me to bring it up with my doctor | 0.5 | 1 | 0 | 0 | |
| My doctor told me I needed to start taking an oral anticoagulant | 74 | 150 | 61 | 97 | |
| My doctor and I discussed it, then we both agreed | 25 | 50 | 37 | 59 | |
| I should start taking an oral anticoagulant | |||||
| I don’t remember | 2 | 3 | 0.6 | 1 | |
| Have you considered switching your treatment? | |||||
| Yes, I have seriously considered it | 9 | 13 | 3 | 5 | <0.001 |
| Yes, I have somewhat considered it | 23 | 32 | 7 | 11 | |
| No, I have not considered it | 68 | 96 | 89 | 134 | |
| Reasons for switching medication | |||||
| It does not work as well as expected | |||||
| No | 100 | 41 | 100 | 16 | N/A |
| It is too expensive | |||||
| No | 93 | 38 | 38 | 6 | <0.0001 |
| Yes | 7 | 3 | 63 | 10 | |
| It is not covered by my insurance | |||||
| No | 100 | 41 | 81 | 13 | 0.004 |
| Yes | 0 | 0 | 19 | 3 | |
| It interferes with another medication I need to take | |||||
| No | 100 | 41 | 94 | 15 | 0.106 |
| Yes | 0 | 0 | 6 | 1 | |
| I am allergic/had an allergic reaction | |||||
| No | 100 | 41 | 100 | 16 | N/A |
| I have experienced stomach-related/gastrointestinal side effects (such as stomach pain, ulcers, blood in urine or stools) | |||||
| No | 98 | 40 | 94 | 15 | 0.482 |
| Yes | 2 | 1 | 6 | 1 | |
| I have experienced side effects that were not stomach-related | |||||
| No | 93 | 38 | 88 | 14 | 0.534 |
| Yes | 7 | 3 | 13 | 2 | |
| I had a serious reaction/side effect | |||||
| No | 96 | 39 | 100 | 16 | 0.368 |
| Yes | 5 | 2 | 0 | 0 | |
| It is too much of a hassle to take as prescribed | |||||
| No | 81 | 33 | 88 | 14 | 0.532 |
| Yes | 20 | 8 | 13 | 2 | |
| I am not able to monitor my blood as frequently as necessary | |||||
| No | 81 | 33 | 88 | 14 | 0.532 |
| Yes | 20 | 8 | 13 | 2 | |
| It is interfering with my lifestyle | |||||
| No | 88 | 36 | 100 | 16 | 0.144 |
| Yes | 12 | 5 | 0 | 0 | |
Note:
Values are significantly different at P<0.05 in the two-sided test of equality for column proportions and equality of means.
Abbreviations: WUs, warfarin users; NAUs, newer anticoagulant users.