Hypertension
Conditions
Keywords
Hypertension, valsartan
Brief summary
This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.
Interventions
DRUGValsartan and hydrochlorothiazide (HCTZ) - monotherapy
Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally
From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally
DRUGUsual care
As directed by investigator
DRUGValsartan
Valsartan 160mg per day to 320mg per day orally
DRUGValsartan and hydrochlorothiazide (HCTZ) - combination arm
Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally
Sponsors
Baker Heart and Diabetes Institute
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* newly diagnosed or currently treated hypertensive patients who have not attained their blood pressure target and require active pharmacological treatment as recommended by the local guidelines as judged by the general practitioner
Exclusion criteria
* significantly elevated blood pressure (severe hypertension) * requiring 3 or more antihypertensive drugs * severe kidney disease or dialyses * clinical diagnosis requiring concomitant therapy with antihypertensive treatment that would be outside the therapies allowed under study protocol Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target | 26 weeks | BP target groups were: \<= 125/75mmHg, \<= 130/80mmHg and \<= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure | Baseline and 26 weeks | The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization. |
| Change in Absolute Cardiovascular Risk Score | Baseline and 26 weeks | The absolute cardiovascular risk assessment uses the Framingham Risk Equation to predict risk of a cardiovascular event over the next 5 years. A score of \<10% is a low risk, 10 to 15% is a moderate risk, and \>15% is a high risk. A decrease indicates improvement. |
| Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy | 26 weeks | The rate of all adverse events by preferred terms as determined by the General Practice investigators to be related to study intervention therapy was reported. Percentage of adverse events was calculated based on the number of participants analyzed. 41 adverse events were not reported as inadequate information was supplied to allow determination of drug treatment at onset. |
| Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | 26 weeks | A comparison of the early responders was made based on the blood pressure measurements taken at the week 6 visit window according to gender and guideline targets. The guideline targets were: patients with renal impairment: 125/75 mmHg; patients with end-organ damage/cardiovascular disease: 130/80 mmHg; others: 140/90 mmHg. |
| Change in the EQ-5D Score | Baseline and 26 weeks | The EQ-5D total indexed score (AUS) measures self-reported quality of life with the following 5 dimensions: mobility (range 1,2,3), self-care (range 1,2,3), usual activity (range 1,2,3), pain/discomfort (range 1,2,3) and anxiety/depression (range 1,2,3), where a 1 indicates no problems, a 2 indicates moderate problems, and a 3 indicates severe problems. The range of possible utility scores are between -0.217 (derived from worse responses from all 5 dimensions with severe problems ie 3,3,3,3,3) and 1.000 (no problems for all 5 dimensions) for each dimension. An increase in EQ-5D indexed score (AUS) indicates improvement. |
| Change in Mean Sitting Systolic Blood Pressure | Baseline and 26 weeks | The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization. |
| Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26 | Baseline and week 26 | The CES-D score was from 0 to 30, with a higher score indicating a higher level of depression. The categories for the score are: 0 to 9 suggests no depression; 10 to 15 suggests mild depression; 16 to 24 suggests moderate depression; 24 or above suggests severe depression. |
| Participants With End Organ Disease at Baseline and Week 26 | Baseline and week 26 | A patient was considered to have end organ damage with either of the following: 1) proteinuria (dipstick = 1+ or more or protein/creatinine ratio \> 30mg/mol or 24h urine protein \> 0.3g); 2) no proteinuria, but presence of microalbuminuria (urine albumin/creatinine ratio 3.6 to 25mg/mol(male) or 3.6 to 35mg/mol (female) detected; 3) no proteinuria or microalbuminuria, but presence of macroalbuminuria (urine albumin/creatinine ratio \> 25mg/mol(male) or \>35mg/mol (female) detected OR 4) ECG evidence of LVH (Sokolow-Lyon voltage criteria values \>= 38mm). Baseline potential for end organ damage was calculated in all 1562 randomised patients based on the criteria outlined above. If no investigation/data available, assumed no end-organ damage. It is important to note that given the limited number of ECGs at 26 weeks, between group comparisons should be limited to the two time points (baseline and 26 weeks). |
| Change in Self-care Behavior Score From Baseline to Week 26 | Baseline and week 26 | A modified self-care behavior tool (questionnaire) was used to calculate 2 domain scales: maintenance and confidence. Each domain has a standardized score between 0 and 100. Self-care is best represented by maintenance. Confidence is an important process that moderates the relationship between self-care and outcomes. Higher index score suggests better self-care. A score of 70 or greater can be used as the cut-point to judge self-care adequacy. |
| Rate of Treatment Compliance | 26 weeks | The rate of compliance was planned to be estimated from the quantity of unused medication returned at each scheduled visit over the entire follow-up period. Rate of compliance = (tablets supplied - tablets returned)/(tablets for 100% compliance). |
| Number of Patients With Major Clinical Endpoints | 26 weeks | Major clinical endpoints measured were all-cause mortality and fatal and non-fatal cardiovascular events (e.g. acute myocardial infarction, stroke and heart failure). |
| Number of Patients With Depression | Baseline and week 26 | Patients with depression refers to potential depressive symptoms, not clinically diagnosed depression. The 2 question Arrol screening tool was used to determine if the patient had potential depressive symptoms. The 2 questions are: During the last month have you often been bothered by feeling down, depressed or hopeless? During the past month have you often been bothered by little interest or pleasure in doing things? The presence of potential depressive symptoms was determined by a 'yes' answer to either of these questions. |
Countries
Australia, United States
Participant flow
Pre-assignment details
2337 patients were enrolled. 2185 received study medication during the 4 week run-in period. 1562 patients were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target | 524 |
| Monotherapy (Initial Monotherapy Arm) Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study. | 360 |
| Combination (Initial Combination Therapy Arm) Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study. | 678 |
| Total | 1,562 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 10 | 25 |
| Overall Study | includes pregnancy | 3 | 9 | 2 |
| Overall Study | Investigator discretion | 3 | 5 | 13 |
| Overall Study | Lost to Follow-up | 7 | 7 | 7 |
| Overall Study | Protocol Violation | 9 | 18 | 20 |
| Overall Study | Withdrawal by Subject | 32 | 22 | 43 |
Baseline characteristics
| Characteristic | Usual Care | Monotherapy (Initial Monotherapy Arm) | Combination (Initial Combination Therapy Arm) | Total |
|---|---|---|---|---|
| Age Continuous | 59 years STANDARD_DEVIATION 12 | 59 years STANDARD_DEVIATION 12 | 59 years STANDARD_DEVIATION 12 | 59 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 201 Participants | 138 Participants | 260 Participants | 599 Participants |
| Sex: Female, Male Male | 323 Participants | 222 Participants | 418 Participants | 963 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 95 / 2,185 | 47 / 524 | 36 / 360 | 105 / 678 |
| serious Total, serious adverse events | 27 / 2,185 | 24 / 524 | 15 / 360 | 22 / 678 |
Outcome results
Primary
Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target
BP target groups were: \<= 125/75mmHg, \<= 130/80mmHg and \<= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines.
Time frame: 26 weeks
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target | 27.4 percentage of participants |
| Monotherapy (Initial Monotherapy Arm) | Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target | 33.0 percentage of participants |
| Combination (Initial Combination Therapy Arm) | Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target | 37.9 percentage of participants |
Secondary
Change in Absolute Cardiovascular Risk Score
The absolute cardiovascular risk assessment uses the Framingham Risk Equation to predict risk of a cardiovascular event over the next 5 years. A score of \<10% is a low risk, 10 to 15% is a moderate risk, and \>15% is a high risk. A decrease indicates improvement.
Time frame: Baseline and 26 weeks
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change in Absolute Cardiovascular Risk Score | -2.6 percentage risk score change | Standard Deviation 4.5 |
| Monotherapy (Initial Monotherapy Arm) | Change in Absolute Cardiovascular Risk Score | -3.3 percentage risk score change | Standard Deviation 4.6 |
| Combination (Initial Combination Therapy Arm) | Change in Absolute Cardiovascular Risk Score | -3.9 percentage risk score change | Standard Deviation 4.5 |
Secondary
Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26
The CES-D score was from 0 to 30, with a higher score indicating a higher level of depression. The categories for the score are: 0 to 9 suggests no depression; 10 to 15 suggests mild depression; 16 to 24 suggests moderate depression; 24 or above suggests severe depression.
Time frame: Baseline and week 26
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26 | 1.03 change in CES-D score | Standard Deviation 9.24 |
| Monotherapy (Initial Monotherapy Arm) | Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26 | -1.12 change in CES-D score | Standard Deviation 10.95 |
| Combination (Initial Combination Therapy Arm) | Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26 | 1.19 change in CES-D score | Standard Deviation 11.09 |
Secondary
Change in Mean Sitting Diastolic Blood Pressure
The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.
Time frame: Baseline and 26 weeks
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Change in Mean Sitting Diastolic Blood Pressure | -5.45 mmHg |
| Monotherapy (Initial Monotherapy Arm) | Change in Mean Sitting Diastolic Blood Pressure | -6.9 mmHg |
| Combination (Initial Combination Therapy Arm) | Change in Mean Sitting Diastolic Blood Pressure | -8.29 mmHg |
Secondary
Change in Mean Sitting Systolic Blood Pressure
The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.
Time frame: Baseline and 26 weeks
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Change in Mean Sitting Systolic Blood Pressure | -10 mmHg |
| Monotherapy (Initial Monotherapy Arm) | Change in Mean Sitting Systolic Blood Pressure | -11.6 mmHg |
| Combination (Initial Combination Therapy Arm) | Change in Mean Sitting Systolic Blood Pressure | -14.4 mmHg |
Secondary
Change in Self-care Behavior Score From Baseline to Week 26
A modified self-care behavior tool (questionnaire) was used to calculate 2 domain scales: maintenance and confidence. Each domain has a standardized score between 0 and 100. Self-care is best represented by maintenance. Confidence is an important process that moderates the relationship between self-care and outcomes. Higher index score suggests better self-care. A score of 70 or greater can be used as the cut-point to judge self-care adequacy.
Time frame: Baseline and week 26
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Self-care Behavior Score From Baseline to Week 26 | Maintenance score | 2.59 Change in score | Standard Deviation 13.56 |
| Usual Care | Change in Self-care Behavior Score From Baseline to Week 26 | Confidence score (N = 422, 269, 520) | 0.93 Change in score | Standard Deviation 21.04 |
| Monotherapy (Initial Monotherapy Arm) | Change in Self-care Behavior Score From Baseline to Week 26 | Maintenance score | 2.27 Change in score | Standard Deviation 12.56 |
| Monotherapy (Initial Monotherapy Arm) | Change in Self-care Behavior Score From Baseline to Week 26 | Confidence score (N = 422, 269, 520) | -0.72 Change in score | Standard Deviation 20.04 |
| Combination (Initial Combination Therapy Arm) | Change in Self-care Behavior Score From Baseline to Week 26 | Maintenance score | 3.17 Change in score | Standard Deviation 12.38 |
| Combination (Initial Combination Therapy Arm) | Change in Self-care Behavior Score From Baseline to Week 26 | Confidence score (N = 422, 269, 520) | -0.71 Change in score | Standard Deviation 20.16 |
Secondary
Change in the EQ-5D Score
The EQ-5D total indexed score (AUS) measures self-reported quality of life with the following 5 dimensions: mobility (range 1,2,3), self-care (range 1,2,3), usual activity (range 1,2,3), pain/discomfort (range 1,2,3) and anxiety/depression (range 1,2,3), where a 1 indicates no problems, a 2 indicates moderate problems, and a 3 indicates severe problems. The range of possible utility scores are between -0.217 (derived from worse responses from all 5 dimensions with severe problems ie 3,3,3,3,3) and 1.000 (no problems for all 5 dimensions) for each dimension. An increase in EQ-5D indexed score (AUS) indicates improvement.
Time frame: Baseline and 26 weeks
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in the EQ-5D Score | -0.007 change in EQ-5D score |
| Monotherapy (Initial Monotherapy Arm) | Change in the EQ-5D Score | 0.017 change in EQ-5D score |
| Combination (Initial Combination Therapy Arm) | Change in the EQ-5D Score | 0.011 change in EQ-5D score |
Secondary
Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments
A comparison of the early responders was made based on the blood pressure measurements taken at the week 6 visit window according to gender and guideline targets. The guideline targets were: patients with renal impairment: 125/75 mmHg; patients with end-organ damage/cardiovascular disease: 130/80 mmHg; others: 140/90 mmHg.
Time frame: 26 weeks
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Male patients with a target of <125/75 mmHg | 3 Participants |
| Usual Care | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Male patients with a target of <130/80 mmHg | 27 Participants |
| Usual Care | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Male patients with a target of <140/90 mmHg | 31 Participants |
| Usual Care | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Female patients with a target of <125/75 mmHg | 2 Participants |
| Usual Care | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Female patients with a target of <130/80 mmHg | 16 Participants |
| Usual Care | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Female patients with a target of <140/90 mmHg | 18 Participants |
| Monotherapy (Initial Monotherapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Female patients with a target of <140/90 mmHg | 11 Participants |
| Monotherapy (Initial Monotherapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Male patients with a target of <125/75 mmHg | 3 Participants |
| Monotherapy (Initial Monotherapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Female patients with a target of <125/75 mmHg | 2 Participants |
| Monotherapy (Initial Monotherapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Female patients with a target of <130/80 mmHg | 5 Participants |
| Monotherapy (Initial Monotherapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Male patients with a target of <130/80 mmHg | 14 Participants |
| Monotherapy (Initial Monotherapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Male patients with a target of <140/90 mmHg | 22 Participants |
| Combination (Initial Combination Therapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Male patients with a target of <130/80 mmHg | 34 Participants |
| Combination (Initial Combination Therapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Male patients with a target of <140/90 mmHg | 48 Participants |
| Combination (Initial Combination Therapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Female patients with a target of <140/90 mmHg | 42 Participants |
| Combination (Initial Combination Therapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Female patients with a target of <125/75 mmHg | 2 Participants |
| Combination (Initial Combination Therapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Male patients with a target of <125/75 mmHg | 6 Participants |
| Combination (Initial Combination Therapy Arm) | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | Female patients with a target of <130/80 mmHg | 34 Participants |
Secondary
Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy
The rate of all adverse events by preferred terms as determined by the General Practice investigators to be related to study intervention therapy was reported. Percentage of adverse events was calculated based on the number of participants analyzed. 41 adverse events were not reported as inadequate information was supplied to allow determination of drug treatment at onset.
Time frame: 26 weeks
Population: Safety analysis - consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy | 70 participants |
| Monotherapy (Initial Monotherapy Arm) | Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy | 70 participants |
| Combination (Initial Combination Therapy Arm) | Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy | 169 participants |
Secondary
Number of Patients With Depression
Patients with depression refers to potential depressive symptoms, not clinically diagnosed depression. The 2 question Arrol screening tool was used to determine if the patient had potential depressive symptoms. The 2 questions are: During the last month have you often been bothered by feeling down, depressed or hopeless? During the past month have you often been bothered by little interest or pleasure in doing things? The presence of potential depressive symptoms was determined by a 'yes' answer to either of these questions.
Time frame: Baseline and week 26
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Number of Patients With Depression | Baseline | 154 participants |
| Usual Care | Number of Patients With Depression | Week 26 | 129 participants |
| Monotherapy (Initial Monotherapy Arm) | Number of Patients With Depression | Baseline | 96 participants |
| Monotherapy (Initial Monotherapy Arm) | Number of Patients With Depression | Week 26 | 78 participants |
| Combination (Initial Combination Therapy Arm) | Number of Patients With Depression | Baseline | 185 participants |
| Combination (Initial Combination Therapy Arm) | Number of Patients With Depression | Week 26 | 151 participants |
Secondary
Number of Patients With Major Clinical Endpoints
Major clinical endpoints measured were all-cause mortality and fatal and non-fatal cardiovascular events (e.g. acute myocardial infarction, stroke and heart failure).
Time frame: 26 weeks
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Number of Patients With Major Clinical Endpoints | All-cause mortality | 0 participants |
| Usual Care | Number of Patients With Major Clinical Endpoints | Non-fatal cardiovascular events | 15 participants |
| Monotherapy (Initial Monotherapy Arm) | Number of Patients With Major Clinical Endpoints | All-cause mortality | 1 participants |
| Monotherapy (Initial Monotherapy Arm) | Number of Patients With Major Clinical Endpoints | Non-fatal cardiovascular events | 6 participants |
| Combination (Initial Combination Therapy Arm) | Number of Patients With Major Clinical Endpoints | All-cause mortality | 0 participants |
| Combination (Initial Combination Therapy Arm) | Number of Patients With Major Clinical Endpoints | Non-fatal cardiovascular events | 13 participants |
Secondary
Participants With End Organ Disease at Baseline and Week 26
A patient was considered to have end organ damage with either of the following: 1) proteinuria (dipstick = 1+ or more or protein/creatinine ratio \> 30mg/mol or 24h urine protein \> 0.3g); 2) no proteinuria, but presence of microalbuminuria (urine albumin/creatinine ratio 3.6 to 25mg/mol(male) or 3.6 to 35mg/mol (female) detected; 3) no proteinuria or microalbuminuria, but presence of macroalbuminuria (urine albumin/creatinine ratio \> 25mg/mol(male) or \>35mg/mol (female) detected OR 4) ECG evidence of LVH (Sokolow-Lyon voltage criteria values \>= 38mm). Baseline potential for end organ damage was calculated in all 1562 randomised patients based on the criteria outlined above. If no investigation/data available, assumed no end-organ damage. It is important to note that given the limited number of ECGs at 26 weeks, between group comparisons should be limited to the two time points (baseline and 26 weeks).
Time frame: Baseline and week 26
Population: Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Participants With End Organ Disease at Baseline and Week 26 | Baseline | 226 participants |
| Usual Care | Participants With End Organ Disease at Baseline and Week 26 | Week 26 (N = 433, 277, 536) | 157 participants |
| Monotherapy (Initial Monotherapy Arm) | Participants With End Organ Disease at Baseline and Week 26 | Baseline | 146 participants |
| Monotherapy (Initial Monotherapy Arm) | Participants With End Organ Disease at Baseline and Week 26 | Week 26 (N = 433, 277, 536) | 88 participants |
| Combination (Initial Combination Therapy Arm) | Participants With End Organ Disease at Baseline and Week 26 | Baseline | 315 participants |
| Combination (Initial Combination Therapy Arm) | Participants With End Organ Disease at Baseline and Week 26 | Week 26 (N = 433, 277, 536) | 177 participants |
Secondary
Rate of Treatment Compliance
The rate of compliance was planned to be estimated from the quantity of unused medication returned at each scheduled visit over the entire follow-up period. Rate of compliance = (tablets supplied - tablets returned)/(tablets for 100% compliance).
Time frame: 26 weeks
Population: This data will not be analyzed due to the poor quality of the data.