Hypertension
Conditions
Brief summary
This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.
Interventions
None listed
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diabetes mellitus * Hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months * Microalbuminuria (defined as microalbuminuria \> 30 mg/g and \< 300 mg/g by spot urine test) * Serum creatinine ≤1.5 mg/dL for men and ≤1.4mg/dL for women * Urinalysis with white blood cells (WBC) \<5 cells per high power field * Results of hemoglobin A1c (HbA1c), fasting blood glucose, serum creatinine, urine albumin/urine creatinine ratio and urinary analysis tests at baseline and 6 months after initiating the losartan therapy are available * Medical history and co-morbidities (if available) listed in medical records * Prescription information of antihypertensive regimen of losartan 50 mg or 100 mg available
Exclusion criteria
* Treated with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB) before initiated treatment with losartan 50 mg or losartan 100 mg * Enrollment in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Macroalbuminuria After 6 Months of Treatment | Baseline and Month 6 | Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) \>300 mg/g and ≥30% increase from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) | Baseline and Month 6 | SBP at baseline and month 6. |
| Diastolic Blood Pressure (DBP) | Baseline and Month 6 | DBP at baseline and month 6. |
Participant flow
Recruitment details
All the medical charts of the targeted study patients were reviewed. The study index period (when patients had to have received treatment for 6 months) was from June 1st 2007 to December 31st 2008. Data were collected retrospectively.
Pre-assignment details
211 patients were enrolled in this study. Among these patients, 136 patients were eligible after excluding 75 patients.
Participants by arm
| Arm | Count |
|---|---|
| Losartan 50 mg Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008. | 99 |
| Losartan 100 mg Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008. | 37 |
| Total | 136 |
Baseline characteristics
| Characteristic | Losartan 50 mg | Losartan 100 mg | Total |
|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 8.1 | 59.7 years STANDARD_DEVIATION 6 | 59.0 years STANDARD_DEVIATION 7.5 |
| Sex: Female, Male Female | 39 Participants | 16 Participants | 55 Participants |
| Sex: Female, Male Male | 60 Participants | 21 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 99 | 0 / 37 |
| serious Total, serious adverse events | 0 / 99 | 0 / 37 |
Outcome results
Primary
Number of Participants With Macroalbuminuria After 6 Months of Treatment
Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) \>300 mg/g and ≥30% increase from baseline.
Time frame: Baseline and Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Losartan 50 mg | Number of Participants With Macroalbuminuria After 6 Months of Treatment | 7 participants |
| Losartan 100 mg | Number of Participants With Macroalbuminuria After 6 Months of Treatment | 6 participants |
Secondary
Diastolic Blood Pressure (DBP)
DBP at baseline and month 6.
Time frame: Baseline and Month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Losartan 50 mg | Diastolic Blood Pressure (DBP) | Baseline (n=85; n=36) | 85.6 mmHg | Standard Deviation 12.4 |
| Losartan 50 mg | Diastolic Blood Pressure (DBP) | Month 6 (n=72; n=22) | 78.2 mmHg | Standard Deviation 8.8 |
| Losartan 50 mg | Diastolic Blood Pressure (DBP) | Change from Baseline at Month 6 (n=72; n=22) | -9.3 mmHg | Standard Deviation 1.2 |
| Losartan 100 mg | Diastolic Blood Pressure (DBP) | Baseline (n=85; n=36) | 84.0 mmHg | Standard Deviation 8.7 |
| Losartan 100 mg | Diastolic Blood Pressure (DBP) | Month 6 (n=72; n=22) | 80.1 mmHg | Standard Deviation 8.2 |
| Losartan 100 mg | Diastolic Blood Pressure (DBP) | Change from Baseline at Month 6 (n=72; n=22) | -4.4 mmHg | Standard Deviation 2.2 |
Comparison: Between-group comparison of Change from Baseline at Month 6p-value: 0.0566t-test, 2 sided
Secondary
Systolic Blood Pressure (SBP)
SBP at baseline and month 6.
Time frame: Baseline and Month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Losartan 50 mg | Systolic Blood Pressure (SBP) | Baseline (n=85; n=36) | 149.5 mmHg | Standard Deviation 16 |
| Losartan 50 mg | Systolic Blood Pressure (SBP) | Month 6 (n=72; n=22) | 136.9 mmHg | Standard Deviation 14 |
| Losartan 50 mg | Systolic Blood Pressure (SBP) | Change from Baseline at Month 6 (n=72; n=22) | -14.0 mmHg | Standard Deviation 1.6 |
| Losartan 100 mg | Systolic Blood Pressure (SBP) | Baseline (n=85; n=36) | 145.5 mmHg | Standard Deviation 11.1 |
| Losartan 100 mg | Systolic Blood Pressure (SBP) | Month 6 (n=72; n=22) | 138.4 mmHg | Standard Deviation 11.3 |
| Losartan 100 mg | Systolic Blood Pressure (SBP) | Change from Baseline at Month 6 (n=72; n=22) | -7.0 mmHg | Standard Deviation 3 |
Comparison: Between-group comparison of Change from Baseline at Month 6p-value: 0.0374t-test, 2 sided