Hypertension, Stroke
Conditions
Keywords
Stroke, Hypertension
Brief summary
The primary objective of the study is to evaluate the proportion of hypertensive patients who achieve regulation of their blood pressure (BP) levels according to the European Society of Cardiology / European School of Haematology (ESC/ESH) Guidelines, after treatment with eprosartan for 6 months under standard medical practice conditions. The absolute change in Systolic blood pressure from baseline will also be calculated. This study also aims in the evaluation of Framingham stroke risk profile score of patients treated with eprosartan under standard clinical practice conditions during the observation period. Besides the primary and the secondary objective of the study, the assessment of the percentage of patients who experienced Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) (overall and per observed event) and the percentage of patients who discontinued treatment prematurely before the advent of the 6-month observation period due to toxicity to the study medication constitutes another important objective that is related to the safety of the treatment.
Detailed description
This is an open, non-interventional, non-comparative study. Therefore, there is no control group, randomization, or blinding involved. The target subject population is hypertensive patients who are being treated with eprosartan under standard clinical conditions and the locally approved Summary of Product Characteristics (SmPCs). Treatment selection is independent of the study conduct according to the local requirements of the Health Authorities for the definition of non-interventional studies being conducted in Greece. Therefore, the inclusion/exclusion criteria of this study follow the clinical decision of the participating physician, when prescribing the study medication(s) under standard clinical practice. The study plans to enroll 600 patients from 100 participating centers (hospitals and private physicians). This number includes an additional 25% cushion compared to the required sample size to ensure that sufficient data is collected for the subsequent statistical analysis. The study has been designed to be non-interventional and subsequently follows the per center standard practice of treatment, medical care and visits. As a result a rigid visit schedule could not be imposed. However, when taking into account the overall local standard practice, an overview of the visit schedule is indicated per subject: * A baseline visit at the beginning of the 6-month observation period where the investigator will check the eligibility of the subject and will record the baseline data provided that the subject is eligible and has given the signed and dated informed consent. * A final visit at the end of the 6-month treatment period (also observation period), and * At least one interim visit (according to the standard clinical practice, within baseline and final visit)
Interventions
None listed
Sponsors
Abbott
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients (age greater or equal to 18 years) 2. Hypertensive patients, with a sitting Systolic Blood Pressure above 140 mmHg or 130 mmHg in diabetics and high/very high risk patients, according to ESC/ESH Guidelines 3. Patients being prescribed eprosartan under the terms and conditions of the local label and administered according to standard medical practice 4. Patients with at least one of the following conditions: * Newly diagnosed hypertension, * Inability to tolerate other antihypertensive medications, or * Lack of response to current antihypertensive medication(s)
Exclusion criteria
1\. Any contraindication to eprosartan or the excipients (according to the local label)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions. | Baseline up to 6 months | The percentage of hypertensive patients who achieve regulated BP levels according to the ESC/ESH (European Society of Cardiology/European Society of Hypertension) Guidelines, after they have been treated with eprosartan for 6 months under standard daily medical practice conditions. Rate of responders (%) who reach the ESH/ESC Guidelines BP levels of \<140 mmHg/90 mmHg \[systolic BP (SBP)/diastolic BP (DBP)\] for the general population of hypertensive patients OR of \<130 mmHg/80 mmHg in case of diabetics and high or very high risk patients such as those with associated clinical conditions \[stroke, myocardial infarction, coronary artery disease (CAD)\] |
| The Absolute Change in Systolic Blood Pressure From Baseline | Baseline up to 6 months | The absolute change in systolic Blood Pressure from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Framingham Stroke Risk Profile Scores of the Participating Patients | Baseline up to 6 months | The Framingham Stroke Risk Profile assesses the Probability of Stroke Within 10 Years separately for a) Women Aged 55-84 Years and Free of Previous Stroke AND b) for Men Aged 55-85 Years and Free of Previous Stroke. First the Framingham Stroke Risk Profile Score is calculated as the sum of points obtained from each of the following factors: age, treated or untreated SBP, presence of diabetes, cigarette smoking, cardiovascular disease, atrial fibrillation, hypertension, and left ventricular hypertrophy according to the gender-specific tables provided by D'Agostino et al (Stroke 1994: 40-43). Subsequently the total score obtained yields the 10-year probability of stroke from gender-specific tables provided in D'Agostino et al. The score can range from 0-38 (according to the scales of D' Agostino et al) with higher scores yielding increased 10-year probability of stroke. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypertensive Patients All eligible hypertensive patients treated with eprosartan | 533 |
| Total | 533 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Hypertensive Patients |
|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment Greece | 533 participants |
| Sex: Female, Male Female | 276 Participants |
| Sex: Female, Male Male | 257 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 533 |
| serious Total, serious adverse events | 0 / 533 |
Outcome results
Primary
The Absolute Change in Systolic Blood Pressure From Baseline
The absolute change in systolic Blood Pressure from baseline
Time frame: Baseline up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients | The Absolute Change in Systolic Blood Pressure From Baseline | -31.1 mmHg | Standard Deviation 11.9 |
Primary
The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions.
The percentage of hypertensive patients who achieve regulated BP levels according to the ESC/ESH (European Society of Cardiology/European Society of Hypertension) Guidelines, after they have been treated with eprosartan for 6 months under standard daily medical practice conditions. Rate of responders (%) who reach the ESH/ESC Guidelines BP levels of \<140 mmHg/90 mmHg \[systolic BP (SBP)/diastolic BP (DBP)\] for the general population of hypertensive patients OR of \<130 mmHg/80 mmHg in case of diabetics and high or very high risk patients such as those with associated clinical conditions \[stroke, myocardial infarction, coronary artery disease (CAD)\]
Time frame: Baseline up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypertensive Patients | The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions. | 62.8 Percentage of participants |
Secondary
Change in Framingham Stroke Risk Profile Scores of the Participating Patients
The Framingham Stroke Risk Profile assesses the Probability of Stroke Within 10 Years separately for a) Women Aged 55-84 Years and Free of Previous Stroke AND b) for Men Aged 55-85 Years and Free of Previous Stroke. First the Framingham Stroke Risk Profile Score is calculated as the sum of points obtained from each of the following factors: age, treated or untreated SBP, presence of diabetes, cigarette smoking, cardiovascular disease, atrial fibrillation, hypertension, and left ventricular hypertrophy according to the gender-specific tables provided by D'Agostino et al (Stroke 1994: 40-43). Subsequently the total score obtained yields the 10-year probability of stroke from gender-specific tables provided in D'Agostino et al. The score can range from 0-38 (according to the scales of D' Agostino et al) with higher scores yielding increased 10-year probability of stroke.
Time frame: Baseline up to 6 months
Population: Excluded from Framingham calculation were patients with either~1. a history of cerebrovascular accident~2. any of the parameters missing for the calculation of the Framingham~3. age \<54 years or \> 84 years for females \& \<54 or \> 85 years for males
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Hypertensive Patients | Change in Framingham Stroke Risk Profile Scores of the Participating Patients | Baseline | 14 score on a scale | Full Range 1.7 |
| Hypertensive Patients | Change in Framingham Stroke Risk Profile Scores of the Participating Patients | 6 months | 11 score on a scale | — |