Hypertension
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to estimate antihypertensive effect of azilsartan medoxomil (Edarbi®) therapy on blood pressure in participants with overweight or obesity in routine clinical practice of hypertension (HTN) treatment in the Russian Federation and in the Republic of Kazakhstan..
Detailed description
The drug being tested in this study is called azilsartan medoxomil (Edarbi®). Azilsartan medoxomil is being tested to treat people who have hypertension. This study looks at the clinic systolic and diastolic blood pressure (SBP, DBP) in obese participants who were prescribed azilsartan medoxomil by physicians. The study enrolled 1945 patients. All participants were asked to take azilsartan medoxomil as prescribed by their physician according to local SmPC. This multi-center trial was conducted in the Russian Federation and the Republic of Kazakhstan. The overall duration of study for observation was approximately 6 months. Participants made multiple visits to the clinics as assigned by each physician according to their routine practice, in every 3 months.
Interventions
Azilsartan medoxomil tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female participants ≥ 18 years of age with hypertension 1-2 grade. 2. Participants with: * newly diagnosed arterial HTN or * inadequately controlled previously prescribed monotherapy with Renin-Angiotensin-Aldosterone System (RAAS) blocker or * inadequately controlled previously prescribed combination therapy with RAAS blocker + diuretic or RAAS blocker + calcium antagonist. 3. The physician decides to prescribe Edarbi® * as monotherapy or * as a part of combination therapy including diuretics or calcium antagonists; 4. Overweight or obesity of any degree (body mass index\> 25 kg/m\^2); 5. Is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. In case the participant is blind or unable to read, informed consent will also be witnessed.
Exclusion criteria
1. Confirmed secondary HTN; 2. Contraindications for Edarbi® of respective approved local summary of product characteristics (SmPC) of Edarbi®; 3. Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study. 4. Is an employee or family member of the investigator or study site personnel. 5. Is currently participating in a clinical trial. Participation in non-interventional registries is permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6 | Baseline and Month 6 | The change in clinic sitting SBP measured at Month 6 relative to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6 | Baseline and Month 6 | The change in clinic sitting DBP measured at Month 6 relative to baseline. |
| Percentage of Participants With Response at Month 6 | Month 6 | Response was defined as a decrease of SBP ≥20 mm Hg or a decrease of DBP ≥10 mm Hg. |
| Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg | Month 6 | — |
| Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Baseline and Month 6 | The change in clinic sitting SBP measured at Month 6 relative to baseline. Subgroups included overweight, obesity I (basic metabolic rate \[BMI\] 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance, normal glucose metabolism, diabetes mellitus (Yes/No), metabolic syndrome, neither diabetes mellitus (DM) nor metabolic syndrome. |
| Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Baseline and Month 6 | The change in clinic sitting DBP measured at Month 6 relative to baseline. Subgroups included overweight, obesity I (basic metabolic rate \[BMI\] 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance, normal glucose metabolism, diabetes mellitus (Yes/No), metabolic syndrome, neither diabetes mellitus nor metabolic syndrome. |
| Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | Month 6 | Target BP was SBP\<140 mm Hg and DBP\<90 mm Hg. Subgroups included BMI, overweight, Obesity I (BMI 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance (Yes/No), metabolic syndrome (Yes/No) and diabetes mellitus (Yes/No). |
Countries
Kazakhstan, Russia
Participant flow
Recruitment details
Participants took part at 65 sites in the study in Russian Federation and the Republic of Kazakhstan from 18-Jul-2016 to 08-May-2018.
Pre-assignment details
Participants with a diagnosis of hypertension and who were obese, prescribed azilsartan medoxomil in accordance with local summary of product characteristics (SmPC) were enrolled in this observational study.
Participants by arm
| Arm | Count |
|---|---|
| Azilsartan Medoxomil Overweight or obese participants with hypertension who received azilsartan medoxomil tablets, orally, as prescribed by physician according to local SmPC were observed for approximately 6 months. | 1,945 |
| Total | 1,945 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Insufficient efficacy | 2 |
| Overall Study | Lost for observation | 23 |
| Overall Study | Patient's unwillingness | 16 |
| Overall Study | Reason not Specified | 9 |
Baseline characteristics
| Characteristic | Azilsartan Medoxomil | — |
|---|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 11.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Race/Ethnicity, Customized Asian | 158 Participants | — |
| Race/Ethnicity, Customized European | 1787 Participants | — |
| Region of Enrollment Kazakhstan | 186 Participants | — |
| Region of Enrollment Russia | 1759 Participants | — |
| Sex: Female, Male Female | 1103 Participants | — |
| Sex: Female, Male Male | 842 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,934 |
| other Total, other adverse events | 39 / 1,934 |
| serious Total, serious adverse events | 6 / 1,934 |
Outcome results
Primary
Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6
The change in clinic sitting SBP measured at Month 6 relative to baseline.
Time frame: Baseline and Month 6
Population: Full analysis set (FAS) included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6 | Baseline | 156.8 mmHg | Standard Deviation 11.8 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6 | Change from baseline at Month 6 | -30.5 mmHg | Standard Deviation 13.4 |
p-value: <0.001Wilcoxon test
Secondary
Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6
The change in clinic sitting DBP measured at Month 6 relative to baseline.
Time frame: Baseline and Month 6
Population: FAS included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6 | -14 mmHg | Standard Deviation 9.4 |
p-value: <0.001Wilcoxon test
Secondary
Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6
The change in clinic sitting DBP measured at Month 6 relative to baseline. Subgroups included overweight, obesity I (basic metabolic rate \[BMI\] 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance, normal glucose metabolism, diabetes mellitus (Yes/No), metabolic syndrome, neither diabetes mellitus nor metabolic syndrome.
Time frame: Baseline and Month 6
Population: FAS included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Change at Week 6, Overweight | -13.9 percentage of participants | Standard Deviation 9.5 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Change at Week 6, BMI (Obesity class I) | -14 percentage of participants | Standard Deviation 9.3 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Change at Week 6, BMI (Obesity class II) | -14.3 percentage of participants | Standard Deviation 9.4 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Change at Week 6, BMI (Obesity class III) | -12.6 percentage of participants | Standard Deviation 11 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Change at Week 6, Normal glucose metabolism | -14 percentage of participants | Standard Deviation 9.4 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Change at Week 6, Impaired glucose tolerance | -14.2 percentage of participants | Standard Deviation 8.6 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Change at Week 6, Diabetes Mellitus (No) | -13.9 percentage of participants | Standard Deviation 9.2 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Change at Week 6, Diabetes Mellitus (Yes) | -13.7 percentage of participants | Standard Deviation 10.6 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Change at Week 6,Neither DM nor metabolic syndrome | -13.4 percentage of participants | Standard Deviation 9.5 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 | Change at Week 6, Metabolic syndrome | -14.4 percentage of participants | Standard Deviation 9.1 |
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
Secondary
Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6
The change in clinic sitting SBP measured at Month 6 relative to baseline. Subgroups included overweight, obesity I (basic metabolic rate \[BMI\] 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance, normal glucose metabolism, diabetes mellitus (Yes/No), metabolic syndrome, neither diabetes mellitus (DM) nor metabolic syndrome.
Time frame: Baseline and Month 6
Population: FAS included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Change at Week 6, Overweight | -30.2 mmHg | Standard Deviation 13.6 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Change at Week 6, BMI (Obesity class I) | -30.6 mmHg | Standard Deviation 13.2 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Change at Week 6, BMI (Obesity class II) | -31.5 mmHg | Standard Deviation 12.5 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Change at Week 6, BMI (Obesity class III) | -27.1 mmHg | Standard Deviation 15.8 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Change at Week 6, Normal glucose metabolism | -30.5 mmHg | Standard Deviation 13.3 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Change at Week 6, Impaired glucose tolerance | -30.1 mmHg | Standard Deviation 13.2 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Change at Week 6, Diabetes Mellitus (No) | -30.6 mmHg | Standard Deviation 13.3 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Change at Week 6, Diabetes Mellitus (Yes) | -30.5 mmHg | Standard Deviation 13.7 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Change at Week 6,Neither DM nor Metabolic Syndrome | -29.4 mmHg | Standard Deviation 13.6 |
| Azilsartan Medoxomil | Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 | Change at Week 6, Metabolic syndrome | -31.2 mmHg | Standard Deviation 13.1 |
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
p-value: <0.001Wilcoxon test
Secondary
Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6
Target BP was SBP\<140 mm Hg and DBP\<90 mm Hg. Subgroups included BMI, overweight, Obesity I (BMI 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance (Yes/No), metabolic syndrome (Yes/No) and diabetes mellitus (Yes/No).
Time frame: Month 6
Population: FAS included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | BMI (Overweight) | 89.8 percentage of participants |
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | BMI (Obesity Class I) | 86.7 percentage of participants |
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | BMI (Obesity Class II) | 82.5 percentage of participants |
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | BMI (Obesity Class III) | 74.2 percentage of participants |
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | Normal glucose metabolism | 88 percentage of participants |
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | Impaired glucose tolerance | 80.5 percentage of participants |
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | Diabetes Mellitus (No) | 86.4 percentage of participants |
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | Diabetes Mellitus (Yes) | 81.7 percentage of participants |
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | Neither diabetes mellitus nor metabolic syndrome | 88.4 percentage of participants |
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 | Metabolic syndrome | 86.1 percentage of participants |
Secondary
Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg
Time frame: Month 6
Population: Participants from FAS, all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy with data available for analysis at the given time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil | Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg | 86.4 percentage of participants |
Secondary
Percentage of Participants With Response at Month 6
Response was defined as a decrease of SBP ≥20 mm Hg or a decrease of DBP ≥10 mm Hg.
Time frame: Month 6
Population: Participants from FAS, all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy with data available for analysis at the given time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil | Percentage of Participants With Response at Month 6 | 92.6 percentage of participants |