The SCCS Polypill Pilot Trial

Phase 2

Completed

Interventions: Drug: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Polypill	Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)	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.

Primary Outcome Measures

Name	Time	Method
Medication Adherence-Percentage of Pills Taken	12 months	polypill arm-evaluation via pill counts.
LDL Cholesterol	12 months	Polypill versus usual care
Systolic Blood Pressure	12 months	polypill versus usual care

Secondary Outcome Measures

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