The SCCS Polypill Pilot Trial

Study Overview
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Brief Summary
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In this study the investigators will examine the effect of the polypill on medication adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.

Detailed Description
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The purpose of this study is to assess if a polypill-based approach to primary CVD prevention is feasible in a low socioeconomic status population. The study will assess whether a polypill approach is associated with better cardiovascular risk factor control compared with usual care. The polypill will be supplied as a compounded pill containing atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg. The medications in the polypill have been extensively evaluated individually and in combination. Each of the medications in the polypill is approved by the United States Food and Drug Administration (FDA) and widely administered in the US for the treatment of and prevention of cardiovascular disease. The doses of each component medication included in the polypill are low, which should minimize the chance of any potential side-effects. In this study we assess medication adherence, systolic blood pressure, and LDL cholesterol over a 12 month span, in subjects taking the polypill versus subjects under usual care.

Official Title
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The SCCS Polypill Pilot Trial

Conditions
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Hypertension, Hyperlipidemia

Intervention / Treatment
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* Drug: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled at the SCCS site in Mobile, Alabama, obtain care at Franklin Primary Health Center, or live in the surrounding area. Aged 45-75 years Baseline systolic blood pressure ≥120 mm Hg. In this open-label trial, the study physicians are permitted to prescribe any additional medication deemed appropriate to achieve blood pressure control. Exclusion Criteria: History of coronary heart disease or stroke History of cancer, except for basal cell skin cancer History of liver disease, not including chronic, clinically-stable hepatitis Laboratory evidence of hepatic dysfunction (an alanine aminotransferase level more than two times the upper limit of the normal range) Known renal disease, estimated creatinine clearance < 60 Current use of more than 2 anti-hypertensive medications LDL cholesterol ≥190 mg/dl Insulin-dependent diabetes Known intolerance to any of the components of the polypill Potassium <3.4 or >5.5 mEq/L Use of medications that interact with statins, including those affecting the cytochrome P450 system Current use of diuretics for indications other than hypertension Comorbidities that might be expected to limit lifespan during the 12-month follow-up period Inability to provide consent.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Subjects in this arm will not receive any investigational medications. They will remain on the same care that they are use to receiving. | |
| Experimental: Polypill<br>The study medication will be a fixed-dose combination pill (polypill) containing: Atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg. Polypill will be taken once daily. | Drug: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | polypill versus usual care | 12 months | 
| Medication Adherence-Percentage of Pills Taken | polypill arm-evaluation via pill counts. | 12 months | 
| LDL Cholesterol | Polypill versus usual care | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | polypill versus usual care | 2 months | 
| Medication Adherence | polypill-percentage of pills taken, evaluated via pill counts | 2 months | 
| Drug Metabolite Profile | LC/MS/MS-based drug metabolite profile assay screen in the polypill arm. | 12 months | 
| LDL Cholesterol | polypill versus usual care | 2 months | 
| Insulin Resistance | Measurement of HOMA-IR using fasting glucose and insulin. | Baseline and 12 months | 
| Inflammatory Profile | Plasma levels of IL-17, IFN-g, IL-6, IL-10, high sensitivity C-reactive protein, TNFa, IL-4. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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combination pill, polypill, primary prevention