Evaluation of a Primary Treatment Algorithm Using Combination Therapy for the Management of Patients With Hypertension and Hypercholesterolemia
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- University of Western Ontario, Canada
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Proportion of subjects whose systolic BP [SBP] <140 mmHg and diastolic BP [DBP] <90 mmHg)or proportion whose cholesterol levels are at or below threshold based on their global artherosclerotic risk profile compared at the practice level.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The objective of this study is to assess if the implementation of a treatment algorithm including initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination and subsequently a low dose DHP-CCB/statin combination will improve the management of hypertension/hypercholesterolemia compared to guidelines-base management at family practices.
Detailed Description
Utilization of fixed dose combination therapy has been advocated as an adherence-enhancing strategy and has been so recommended in the 2007 Canadian Hypertension Education Program (CHEP) recommendations. Further, in a previous study (STITCH) it was demonstrated that a simplified treatment algorithm utilizing initial therapy with a low dose fixed-dose combination therapy improved blood pressure control in hypertensive patients. However, the effectiveness of either a simplified treatment algorithm or the initial use of fixed dose combination therapies for 2 risk factors in hypertensive dyslipidemic patients has yet to be determined. Therefore, the current study is designed to determine whether utilization of a fixed dose combination hypertension/hypercholesterolemia therapy results in improved adherence, patient satisfaction as well as improved rates of reaching target LDL cholesterol and blood pressure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •male or female subjects 18 years or older
- •documented diagnoses of hypertension and of hypercholesterolemia or current therapy for these conditions
- •uncontrolled hypertension (SBP \>140 mmHg or DBP \>90 mmHg) or cholesterol levels above their threshold based on their global atherosclerotic risk profile (based on ATP III assessment)
- •ability to give written informed consent
Exclusion Criteria
- •ischemic heart disease, atrial fibrillation, chronic kidney disease and significant liver disease
- •currently prescribed 3 or more drugs to control blood pressure
- •currently prescribed 2 or more drugs to control hypercholesterolemia
- •participating in other hypertension/hypercholesterolemia studies
Outcomes
Primary Outcomes
Proportion of subjects whose systolic BP [SBP] <140 mmHg and diastolic BP [DBP] <90 mmHg)or proportion whose cholesterol levels are at or below threshold based on their global artherosclerotic risk profile compared at the practice level.
Time Frame: 6 months
Secondary Outcomes
- Secondary measures include the change at 6 months in SBP and DBP and cholesterol levels. These outcomes will be compared at the practice level(6 months)