Hypercholesterolemia, Hypertension
Conditions
Keywords
hypertension, hypercholesterolemia, family physicians, fixed dose combination therapy, cluster randomized controlled trial
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.
Interventions
OTHERTreatment algorithm:caduet, Amlodipine, ACEI-ARB combo dose, a-blocker, b-blocker or spironolactone, dyslipidemic therapy with ezetamide
initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination followed by a low dose DHP-CCB/statin combination
Sponsors
Pfizer
University of Western Ontario, Canada
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed