Hypertension
Conditions
Keywords
Pharmacological therapy
Brief summary
The purpose of this survey is designed to investigate the treatment status of hypertensive patient with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.
Detailed description
This survey was designed to investigate the treatment status of hypertensive patients with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner. For adults, 4-8 mg of candesartan cilexetil is typically administered orally once daily. The dose is increased up to 12 mg, as necessary. For patients with complications of renal damage, however, administration of candesartan cilexetil should be started at 2 mg once daily, and, as necessary, the dose increased up to 8 mg.
Interventions
DRUGcandesartan cilexetil
candesartan cilexetil tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Hypertensive patients with at least one of the following risk factors: * Waist circumference greater than or equal to (≥) 85 centimeter (cm) for male and ≥ 90 cm for female * Fasting triglyceride level ≥ 150 milligram per deciliter (mg/dL) * High-density lipoprotein (HDL) cholesterol level less than (\<) 40 mg/dL * Fasting blood glucose level ≥ 110 mg/dL * Body-mass index (BMI) ≥ 25.0 \* Patients currently taking medications for hypertriglyceridemia, hypo-HDL-cholesterolemia, or diabetes mellitus are also regarded as meeting the criteria for inclusion in the surveillance
Exclusion criteria
Hypertensive patients who meet all of the following conditions (\[1\] to \[3\]): 1. Patients receiving continuous therapy with Blopress Tablets 2. Patients aged \< 20 years or ≥ 75 years 3. Patients with a history of cerebrovascular or coronary artery disease within 6 months before the start of the surveillance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions (ADR) | Baseline up to 3 years | ADR are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. |
| Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR) | Baseline up to 3 years | SADR are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cerebrovascular/Cardiovascular Events | Baseline up to 3 years | Cerebrovascular/cardiovascular events reported to be associated with Blopress were reported. The composite events classified under primary major adverse cardiac Events (MACE) 1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). |
| Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Baseline up to 3 years | Participants reporting cerebrovascular/cardiovascular events who had either obesity, blood glucose abnormalities, or lipid abnormalities as any one of the underlying risk factors associated with Blopress at the time of enrollment were reported.The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). |
| Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Baseline up to 3 years | Participants reporting cerebrovascular/cardiovascular events who had multiple underlying risk factors which included either obesity + blood glucose abnormalities, obesity + lipid abnormalities OR blood glucose + lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). |
| Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Baseline up to 3 years | Participants reporting cerebrovascular/cardiovascular events who had obesity, blood glucose and lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). |
Participant flow
Recruitment details
Participants took part in the study at 1,126 investigative sites in Japan from 7 June 2006 to 30 November 2010.
Pre-assignment details
Participants with a historical diagnosis of hypertension with metabolic syndrome-related risk factors were observed in a single treatment group to receive candesartan cilexetil 4 milligrams (mg).
Participants by arm
| Arm | Count |
|---|---|
| Candesartan Cilexetil Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years. | 13,804 |
| Total | 13,804 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 347 |
Baseline characteristics
| Characteristic | Candesartan Cilexetil |
|---|---|
| Adiponectin | 5.80 Microgram per milliliter (mcg/mL) STANDARD_DEVIATION 6.92 |
| Age, Continuous | 60.5 Years STANDARD_DEVIATION 9.8 |
| Alcohol Consumption Alcohol Consumer | 5539 Participants |
| Alcohol Consumption Alcohol Non-Consumer | 8265 Participants |
| Apoprotein A | 145.4 mg/dL STANDARD_DEVIATION 24.5 |
| Apoprotein B | 104.1 mg/dL STANDARD_DEVIATION 27.5 |
| Blood Pressure Diastolic Blood Pressure | 90.2 Millimeter of mercury (mmHg) STANDARD_DEVIATION 12.6 |
| Blood Pressure Systolic Blood Pressure | 156.2 Millimeter of mercury (mmHg) STANDARD_DEVIATION 17.9 |
| Body Mass Index | 26.40 Kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.84 |
| Breakdown of Concomitant Antidiabetic Medications Alpha-Glucosidase Inhibitor | 1127 Participants |
| Breakdown of Concomitant Antidiabetic Medications Biguanides | 686 Participants |
| Breakdown of Concomitant Antidiabetic Medications Insulin | 364 Participants |
| Breakdown of Concomitant Antidiabetic Medications Insulin Sensitizers | 1077 Participants |
| Breakdown of Concomitant Antidiabetic Medications Other | 44 Participants |
| Breakdown of Concomitant Antidiabetic Medications Short Acting Insulin Secretagogues | 306 Participants |
| Breakdown of Concomitant Antidiabetic Medications Sulfonylurea Drugs | 1728 Participants |
| Breakdown of Concomitant Antihyperlipidemic Drugs Eicosapentaenoic Acid | 230 Participants |
| Breakdown of Concomitant Antihyperlipidemic Drugs Fibrates | 730 Participants |
| Breakdown of Concomitant Antihyperlipidemic Drugs Other | 122 Participants |
| Breakdown of Concomitant Antihyperlipidemic Drugs Statins | 3784 Participants |
| Breakdown of Concomitant Antihypertensive Medications Alpha-Beta or Beta-Blockers | 867 Participants |
| Breakdown of Concomitant Antihypertensive Medications Alpha-Blockers | 323 Participants |
| Breakdown of Concomitant Antihypertensive Medications Angiotensin2ReceptorBlockers(other than Blopress) | 131 Participants |
| Breakdown of Concomitant Antihypertensive Medications Angiotensin Converting Enzyme (ACE) Inhibitors | 262 Participants |
| Breakdown of Concomitant Antihypertensive Medications Calcium Blockers | 4886 Participants |
| Breakdown of Concomitant Antihypertensive Medications Diuretics | 705 Participants |
| Breakdown of Concomitant Antihypertensive Medications Other | 69 Participants |
| Breakdown of Medical History Angina Pectoris | 463 Participants |
| Breakdown of Medical History Atrial fibrillation | 257 Participants |
| Breakdown of Medical History Cardiac Failure | 121 Participants |
| Breakdown of Medical History Cerebral Hemorrhage | 63 Participants |
| Breakdown of Medical History Cerebral Infarction | 593 Participants |
| Breakdown of Medical History Diabetes Mellitus | 4755 Participants |
| Breakdown of Medical History Diabetic Retinopathy | 3 Participants |
| Breakdown of Medical History Hyperlipidemia | 7841 Participants |
| Breakdown of Medical History Myocardial Infarction | 153 Participants |
| Breakdown of Medical History Other Cerebrovascular/Cardiovascular Diseases | 615 Participants |
| Breakdown of Medical History Renal Dialysis | 0 Participants |
| Breakdown of Medical History Subarachnoid Hemorrhage | 22 Participants |
| Breakdown of Other Concomitant Medication Antigout Drugs or Antihyperuricemic Drugs | 903 Participants |
| Breakdown of Other Concomitant Medication Antithrombotic Drugs | 1322 Participants |
| Breakdown of Other Concomitant Medication Other | 3005 Participants |
| Consumption of Concomitant Antidiabetic Medications Had Consumption | 3310 Participants |
| Consumption of Concomitant Antidiabetic Medications Had no consumption | 10494 Participants |
| Consumption of Concomitant Antihyperlipidemic Drugs Had Consumption | 4692 Participants |
| Consumption of Concomitant Antihyperlipidemic Drugs Had no Consumption | 9112 Participants |
| Consumption of Concomitant Antihypertensive Medications Had Consumption | 5798 Participants |
| Consumption of Concomitant Antihypertensive Medications Had no Consumption | 8006 Participants |
| Consumption of Other Concomitant Medications Had Consumption | 4694 Participants |
| Consumption of Other Concomitant Medications Had no Consumption | 9110 Participants |
| Fasting Blood Glucose | 118.4 mg/dL STANDARD_DEVIATION 41.9 |
| Fasting Triglycerides | 166.1 Milligrams per deciliter (mg/dL) STANDARD_DEVIATION 101.6 |
| Glycated Hemoglobin (HbA1c) | 6.46 Hemoglobin Percent STANDARD_DEVIATION 1.36 |
| Height | 160.28 Centimeter (cm) STANDARD_DEVIATION 9.42 |
| High Density Lipoprotein (HDL) Cholesterol | 55.0 mg/dL STANDARD_DEVIATION 15.2 |
| Initial Daily Dose of Blopress 10 mg | 1 Participants |
| Initial Daily Dose of Blopress 12 mg | 1104 Participants |
| Initial Daily Dose of Blopress 4 mg | 3934 Participants |
| Initial Daily Dose of Blopress 6 mg | 38 Participants |
| Initial Daily Dose of Blopress 8 mg | 8505 Participants |
| Initial Daily Dose of Blopress Greater than (>) 12 mg | 8 Participants |
| Initial Daily Dose of Blopress Less than (<) 4 mg | 214 Participants |
| Insulin | 11.09 mcU/mL STANDARD_DEVIATION 11.38 |
| Leptin | 9.20 Nanogram per milliliter (ng/mL) STANDARD_DEVIATION 8.24 |
| Medical History Did not Have Medical History | 3833 Participants |
| Medical History Have Medical History | 9835 Participants |
| Medical History Unknown | 136 Participants |
| Microalbumin in Urine | 158.5 Milligram per day (mg/day) STANDARD_DEVIATION 653.6 |
| Predisposition to Hypersensitivity Had no Predisposition to Hypersensitivity | 12259 Participants |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 691 Participants |
| Predisposition to Hypersensitivity Unknown | 854 Participants |
| Pulse Rate | 73.9 Pulse per minute STANDARD_DEVIATION 10.7 |
| Pulse Wave Velocity | 1713.8 Centimeter per second (cm/s) STANDARD_DEVIATION 523.8 |
| Serum Creatinine | 0.76 mg/dL STANDARD_DEVIATION 0.29 |
| Sex: Female, Male Female | 6087 Participants |
| Sex: Female, Male Male | 7717 Participants |
| Smoking Status Non Smoker | 10823 Participants |
| Smoking Status Smoker | 2981 Participants |
| Total Cholesterol | 212.1 mg/dL STANDARD_DEVIATION 37.7 |
| Urinary Protein 0 mg/dL | 8365 Participants |
| Urinary Protein 100-300mg/dL | 440 Participants |
| Urinary Protein 15-30mg/dL | 1005 Participants |
| Urinary Protein 300-1000mg/dL | 185 Participants |
| Urinary Protein 30-300mg/dL | 836 Participants |
| Urinary Protein Unknown | 2973 Participants |
| Urinary Sugar 0 mg/dL | 8907 Participants |
| Urinary Sugar 1000 mg/dL | 566 Participants |
| Urinary Sugar 100 mg/dL | 406 Participants |
| Urinary Sugar 250 mg/dL | 596 Participants |
| Urinary Sugar 500 mg/dL | 330 Participants |
| Urinary Sugar Unknown | 2999 Participants |
| Waist Circumference | 90.56 cm STANDARD_DEVIATION 9.76 |
| Weight | 68.07 Kilogram (Kg) STANDARD_DEVIATION 12.84 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 230 / 13,804 |
| serious Total, serious adverse events | 320 / 13,804 |
Outcome results
Primary
Number of Participants Reporting One or More Adverse Drug Reactions (ADR)
ADR are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Time frame: Baseline up to 3 years
Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Candesartan Cilexetil | Number of Participants Reporting One or More Adverse Drug Reactions (ADR) | 230 Participants |
Primary
Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)
SADR are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline up to 3 years
Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Candesartan Cilexetil | Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR) | 320 Participants |
Secondary
Incidence of Cerebrovascular/Cardiovascular Events
Cerebrovascular/cardiovascular events reported to be associated with Blopress were reported. The composite events classified under primary major adverse cardiac Events (MACE) 1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).
Time frame: Baseline up to 3 years
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Primary MACE 2 | 6.29 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Sudden Death | 0.24 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Cerebral Hemorrhage | 0.57 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Cerebral Infarction | 2.34 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Subarachnoid Hemorrhage | 0.15 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Acute Myocardial Infarction | 0.99 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Hospitalization for Heart Failure | 0.27 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Intervention/Hospitalization for Angina Pectoris | 1.74 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Atrial Fibrillation | 1.35 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Transition to Dialysis | 0.30 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Renal Transplant | 0.00 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Dissecting Aortic Aneurysm | 0.06 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Diabetic Retinopathy | 0.15 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | New-Onset Diabetes | 4.35 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Primary MACE | 4.29 Number of events per 1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events | Renal Events | 0.30 Number of events per 1,000 person-years |
Secondary
Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities
Participants reporting cerebrovascular/cardiovascular events who had obesity, blood glucose and lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).
Time frame: Baseline up to 3 years
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Sudden Death | 0.35 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Cerebral Hemorrhage | 0.81 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Cerebral Infarction | 3.48 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Subarachnoid Hemorrhage | 0.23 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Acute Myocardial Infarction | 1.28 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Hospitalization for Heart Failure | 0.35 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Intervention/Hospitalization for Angina Pectoris | 2.78 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Atrial Fibrillation | 1.97 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Transition to Dialysis | 0.70 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Renal Transplant | 0.00 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Dissecting Aortic Aneurysm | 0.12 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Diabetic Retinopathy | 0.35 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | New-Onset Diabetes | 5.22 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Primary MACE | 6.14 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Primary MACE 2 | 9.27 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Renal Events | 0.70 Number of events/1,000 person-years |
Secondary
Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities
Participants reporting cerebrovascular/cardiovascular events who had multiple underlying risk factors which included either obesity + blood glucose abnormalities, obesity + lipid abnormalities OR blood glucose + lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).
Time frame: Baseline up to 3 years
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Sudden Death | 0.20 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Cerebral Hemorrhage | 0.53 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Cerebral Infarction | 2.19 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Subarachnoid Hemorrhage | 0.13 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Acute Myocardial Infarction | 1.06 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Hospitalization for heart Failure | 0.33 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Intervention/Hospitalization for Angina Pectoris | 1.33 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Atrial Fibrillation | 1.46 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Transition to Dialysis | 0.07 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Renal Transplant | 0.00 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Dissecting Aortic Aneurysm | 0.07 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Diabetic Retinopathy | 0.07 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | New-Onset Diabetes | 4.51 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Primary MACE | 4.11 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Primary MACE 2 | 5.77 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Renal Events | 0.07 Number of events/1,000 person-years |
Secondary
Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities
Participants reporting cerebrovascular/cardiovascular events who had either obesity, blood glucose abnormalities, or lipid abnormalities as any one of the underlying risk factors associated with Blopress at the time of enrollment were reported.The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).
Time frame: Baseline up to 3 years
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Sudden Death | 0.21 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Cerebral Hemorrhage | 0.41 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Cerebral Infarction | 1.55 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Subarachnoid Hemorrhage | 0.10 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Acute Myocardial Infarction | 0.62 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Hospitalization for Heart Failure | 0.10 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Intervention/Hospitalization for Angina Pectoris | 1.45 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Atrial Fibrillation | 0.62 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Transition to Dialysis | 0.31 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Renal Transplant | 0.00 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Dissecting Aortic Aneurysm | 0.00 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Diabetic Retinopathy | 0.10 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | New-Onset Diabetes | 3.32 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Primary MACE | 2.90 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Primary MACE 2 | 4.45 Number of events/1,000 person-years |
| Candesartan Cilexetil | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Renal Events | 0.31 Number of events/1,000 person-years |