Hypertension
Conditions
Keywords
Essential hypertension Uric acid Retrospective Hyzaar
Brief summary
This was a retrospective, chart review, observational study to assess the effect of MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg \[Hyzaar(R)\]) treatment for a period of at least three months on serum uric acid levels.
Interventions
None listed
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participant was \>20 years and \<75 years of age on the index date (i.e., the date of initiating MK-0954A therapy) * Diagnosed with hypertension and had received MK-0954A 50/12.5 mg for at least 3 months * Had at least one serum uric acid measurements at baseline and one at 3 months after using MK-0954A 50/12.5 mg * Had the following records documented in the chart during the data collection period: * medical history and co-morbidities (if available) * sitting blood pressure, serum uric acid, lipid profile test results before and after using MK-0954A 50/12.5 mg * serum electrolytes, serum creatinine, and pre-meal sugar (if available) * prescription information of all antihypertensive regimens
Exclusion criteria
* Had been treated with diuretic or angiotensin-receptor blockers (ARBs) 2 weeks before initiated treatment with MK-0954A 50/12.5 mg * Serum creatinine \>2 mg/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Uric Acid (SUA) Level | Baseline and Month 3 | SUA at baseline and Month 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Patients With Hyperuricemia | Baseline and Month 3 | Hyperuricemia was defined as SUA \>6.6mg/dL in females and \>7.7mg/dL in males. |
| Diastolic Blood Pressure (DBP) | Baseline and Month 3 | DBP at baseline and month 3. |
| Systolic Blood Pressure (SBP) | Baseline and Month 3 | SBP at baseline and month 3. |
Participant flow
Recruitment details
All the medical charts of the eligible study patients were reviewed. The study index period (when patients had to have received treatment for 3 months) was from June 1st 2007 to December 31st 2008. Data were collected retrospectively between November 2008 and August 2010.
Pre-assignment details
1735 patients were enrolled into this study. Among them, 1705 patients were eligible after excluding 30 patients.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months | 1,705 |
| Total | 1,705 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 795 Participants |
| Sex: Female, Male Male | 910 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 1,705 |
| serious Total, serious adverse events | 0 / 1,705 |
Outcome results
Primary
Serum Uric Acid (SUA) Level
SUA at baseline and Month 3.
Time frame: Baseline and Month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Serum Uric Acid (SUA) Level | Baseline | 6.4 mg/dL | Standard Deviation 1.6 |
| All Participants | Serum Uric Acid (SUA) Level | Month 3 | 6.6 mg/dL | Standard Deviation 1.6 |
Comparison: Comparison between Month 3 and Baselinep-value: <0.01t-test, 2 sided
Secondary
Diastolic Blood Pressure (DBP)
DBP at baseline and month 3.
Time frame: Baseline and Month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Diastolic Blood Pressure (DBP) | Month 3 | 81 mmHg | Standard Deviation 9 |
| All Participants | Diastolic Blood Pressure (DBP) | Baseline | 89 mmHg | Standard Deviation 13 |
Comparison: Comparison between Month 3 and Baselinep-value: <0.01t-test, 2 sided
Secondary
Systolic Blood Pressure (SBP)
SBP at baseline and month 3.
Time frame: Baseline and Month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Systolic Blood Pressure (SBP) | Baseline | 150 mmHg | Standard Deviation 19 |
| All Participants | Systolic Blood Pressure (SBP) | Month 3 | 135 mmHg | Standard Deviation 15 |
Comparison: Comparison between Month 3 and Baselinep-value: <0.01t-test, 2 sided
Secondary
The Percentage of Patients With Hyperuricemia
Hyperuricemia was defined as SUA \>6.6mg/dL in females and \>7.7mg/dL in males.
Time frame: Baseline and Month 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | The Percentage of Patients With Hyperuricemia | Baseline | 27.0 percent of participants |
| All Participants | The Percentage of Patients With Hyperuricemia | Month 3 | 14.6 percent of participants |
p-value: <0.0001McNemar