An observational study in History of Myocardial Infarction and Hypertriglyceridemia, sponsored by Abbott. Completed at 93 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-12.
Sponsored by Abbott · Observational
A prospective observational program using digital technology tools to enhance patient adherence to Omacor therapy
It is known that only 50% of patients with chronic diseases adhere to medical recommendations; at the same time, high patient adherence significantly improve the survival of patients with chronic diseases. The treatment duration required to achieve a significant reduction in the risk of cardiovascular complications is the subject of discussion, but studies demonstrate that long-term therapy for 5 years or more gives the greatest effect. Today, during the era of technological progress, there is a possibility to freely apply information and telecommunication technologies (e.g. cell phones, computer) in different fields, including medicine. Remote monitoring of patients by means of phone calls using structured questionnaires can also significantly improve clinical outcomes (mortality and cardiovascular hospitalizations) by 38%. Unfortunately, in the case of a long-term, usually lifetime, treatment, the use of such methods is still very limited on a large scale.
This prospective observational program will help to explore the use of digital technologies and evaluate their effectiveness to increase patient adherence using an example of patients whose treatment scheme includes Omacor. Physicians and patients will be granted a personal access to the electronic data capture system. The physician will enter data about patients who signed the informed consent into the electronic system. At Visit 1 the patient will be given a card providing the personal access to his/her account in the electronic system. In addition to visits to the physician, the program specifies remote completion of the electronic form by the patient. Additional objective of the program includes raising patients' awareness about the disease due to familiarization with educational materials available in patient personal account in the electronic system.
This study is a prospective observational program within the frames of which Omacor (Omega-3 triglycerides [EPA/docosahexaenoic acid (DHA) = 1.2/1 - 90%]) is prescribed to patients with a history of myocardial infarction within a routine procedure as a part of the combination therapy (in combination with statins, antiaggregants, beta-blockers, angiotensin-converting enzyme inhibitors (ACE)) and/or to patients with hypertriglyceridemia. The population of observed patients will be limited to those who were prescribed Omacor for the first time or not earlier than 3 months after the last dose of Omacor and course of administration is at least 6 months. Discontinuation of the drug product administration by the patient is not the reason for exclusion of the patient from the study. For outcome measures which are applicable, further analysis will be performed in subgroups of patients with the different medication adherence rate: \<0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3. Adherence rate will be calculated as the sum of days when patient taken the full prescribed dose of Omacor in period divided by the number of days in period.
Adult patients with myocardial infarction in anamnesis and/or diagnosis of hypertriglyceridemia who are under medical supervision in healthcare institutions of Russia and receive Omacor
Exclusion Criteria:
Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.
Drug: Omacor (Omega-3-acid ethyl esters)
Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
Mean Adherence Rate at the End of the Study (Visit 3)
Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period.
Time frame: 6 months
Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3)
The average score for the National questionnaire on therapy compliance for all study duration Visit 1 - Visit 3. The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance
Time frame: 6 months
The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination
The percentage of patients (%) who have chosen each of the suggested reason for therapy termination.
Time frame: 6 months
The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Mean difference of the average score on each of 8 scales of Short Form Survey (SF)-36 quality of life questionnaire at Visit 2 and Visit 3 versus the baseline. 36-Item Short Form Survey (SF-36) taps eight health concepts. Each of 36 items is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively, so that a high score defines a more favorable health state.
Time frame: 3 months, 6 months
Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Mean difference of lipid profile parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Time frame: 3 months, 6 months
Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program
Percentage of patients with hospitalizations due to cardiovascular disease
Time frame: 6 months
Number of New Cases of Stenocardia During 6 Months of the Program
Percentage of patients with new cases of stenocardia
Time frame: 6 months
Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program
Percentage of patients with non-fatal myocardial infarction cases
Time frame: 6 months
Number of Cases of Cardio-vascular Death During 6 Months of the Program
Percentage of patients dead due to cardio-vascular death
Time frame: 6 months
Mean Adherence Rate at Visit 2
Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period.
Time frame: 3 months
Change of Mean Adherence Rate by End of the Study (Visit 3) Versus Visit 2
Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period.
Time frame: 3 months, 6 months
The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
The percentage of patients with adherence rate \<0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
Time frame: 3 months, 6 months
Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 1, Visit 2
The average score for the National questionnaire on therapy compliance at Visit 1, Visit 2. The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance
Time frame: 0 months, 3 months
Change of Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 2 and Visit 3 Versus Baseline (Visit 1)
The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance
Time frame: Baseline, 3 Months, 6 Months
| Milestone | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Started | 3000 |
| Completed | 1975 |
| Not completed | 1025 |
Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period.
| proportion of days | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Mean Adherence Rate at the End of the Study (Visit 3) | 0.37 ± 0.38 |
The average score for the National questionnaire on therapy compliance for all study duration Visit 1 - Visit 3. The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance
| score on a scale | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3) | 12.9 ± 2.99 |
The percentage of patients (%) who have chosen each of the suggested reason for therapy termination.
| percentage of participants | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Adverse drug reactions | 0 |
| Lack of efficacy | 0.08 |
| Inconvenience of use | 0.43 |
| Absence at the pharmacy | 0.23 |
| Other reason | 1.94 |
| Total | 2.68 |
Mean difference of the average score on each of 8 scales of Short Form Survey (SF)-36 quality of life questionnaire at Visit 2 and Visit 3 versus the baseline. 36-Item Short Form Survey (SF-36) taps eight health concepts. Each of 36 items is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively, so that a high score defines a more favorable health state.
| score on a scale | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Physical functioning (V2-V1,3 m) | 7.63 ± 13.4 |
| Role limitations due to physical health (V2-V1,3m) | 32.86 ± 48.42 |
| Role limitations due to emotional problems (V2-V1, | 25.71 ± 32.42 |
| Energy/fatique (V2-V1,3m) | 20.81 ± 14.12 |
| Emotional wellbeing (V2-V1,3m) | 22.66 ± 14.69 |
| Social functioning (V2-V1,3m) | 26.43 ± 25.68 |
| Pain (V2-V1,3m) | 8.43 ± 14.12 |
| General health (V2-V1,3m) | -6.14 ± 10.22 |
| Physical functioning (V3-V1,6m) | 6.69 ± 10.08 |
| Role limitations due to physical health (V3-V1,6m) | 29.55 ± 43.39 |
| Role limitations due to emotional problems (V3-V1, | 18.18 ± 30.39 |
| Energy/fatique (V3-V1,6m) | 18.18 ± 13.59 |
| Emotional wellbeing (V3-V1,6m) | 25 ± 14.56 |
| Social functioning (V3-V1,6m) | 16.48 ± 25.41 |
| Pain (V3-V1,6m) | 0.11 ± 0.53 |
| General Health (V3-V1,6m) | -9.83 ± 12.08 |
Mean difference of lipid profile parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
| mmol/L | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| total serum cholesterol (TSC) (V2-V1,3m) | -1 ± 1.09 |
| triglycerides (TG) (V2-V1,3m) | -0.98 ± 1 |
| low-density lipoproteins (LDLP) (V2-V1,3m) | -0.77 ± 0.92 |
| high-density lipoproteins (HDLP) (V2-V1,3m) | 0.15 ± 0.45 |
| total serum cholesterol (TSC) (V3-V1,6m) | -1.32 ± 1.28 |
| triglycerides (TG) (V3-V1,6m) | -1.32 ± 1.15 |
| low-density lipoproteins (LDLP) (V3-V1,6m) | -1.02 ± 1.02 |
| high-density lipoproteins (HDLP) (V3-V1,6m) | 0.2 ± 0.53 |
Percentage of patients with hospitalizations due to cardiovascular disease
| percentage of participants | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| The presence of hospitalizations | 0.74 |
| The absence of hospitalizations | 99.26 |
Percentage of patients with new cases of stenocardia
| percentage of participants | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| The presence of new cases of angina pectoris | 0.97 |
| The absence of new cases of angina pectoris | 99.03 |
Percentage of patients with non-fatal myocardial infarction cases
| percentage of participants | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Presence of cases of non-fatal myocardial infarcti | 0.04 |
| Absence of cases of nonfatal myocardial infarctio | 99.96 |
Percentage of patients dead due to cardio-vascular death
| percentage of participants | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Number of Cases of Cardio-vascular Death During 6 Months of the Program | 0.04 |
Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period.
| proportion of days | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Mean Adherence Rate at Visit 2 | 0.48 ± 0.4 |
Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period.
| proportion of days | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Change of Mean Adherence Rate by End of the Study (Visit 3) Versus Visit 2 | 0.24 ± 0.4 |
The percentage of patients with adherence rate \<0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
| percentage of participants | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Low (<0.5) (V2, 3 m) | 50 |
| Moderate (0.5 - 0.7) (V2, 3 m) | 15.56 |
| High (≥0.8) (V2, 3 m) | 34.44 |
| Low (<0.5) (V3, 6 m) | 75 |
| Moderate (0.5 - 0.7) (V3, 6 m) | 4.44 |
| High (≥0.8) (V3, 6 m) | 20.56 |
The average score for the National questionnaire on therapy compliance at Visit 1, Visit 2. The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance
| score on a scale | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Mean score (V 1, 0 m) | 12.55 ± 3.11 |
| Mean score (V 2, 3 m) | 12.99 ± 2.88 |
The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance
| score on a scale | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Mean difference (V 2-V 1, 3 m) | 0.47 ± 2.46 |
| Mean difference (V 3-V 1, 6 m) | 0.44 ± 2.52 |
Collected over 6 months Adverse drug reactions, serious adverse drug reactions and other safety-related information are reported to sponsor from the inclusion of the patient in the program during Visit 1 until Visit 3.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omacor (Omega-3-acid Ethyl Esters) | 4/3,000 (0.1%) | 0/3,000 (0%) | 4/3,000 (0.1%) |
| Event | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| EructationGastrointestinal disorders | 1/3000 |
| Abnormal faecesGastrointestinal disorders | 1/3000 |
| NauseaGastrointestinal disorders | 1/3000 |
| Alanine aminotransferase increasedInvestigations | 1/3000 |
A total of 3000 patients signed informed consent and were included in the program. Data of Visit 1 were available for 2572 (85.7%) patients, 1975 patients (65.8% of all who signed informed consent) completed the program per protocol.
| Age, Categorical(Participants) | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1600 |
| >=65 years | 972 |
| Sex: Female, Male(Participants) | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Female | 1182 |
| Male | 1390 |
| Race (NIH/OMB)(Participants) | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 48 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 2518 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Omacor (Omega-3-acid Ethyl Esters) |
|---|---|
| Russia | 2572 |
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