The SCCS Polypill Pilot Trial

Vanderbilt University303 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

303

Conditions

Hypertension Hyperlipidemia

Interventions

Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)DRUG

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Franklin Primary Health Center

Mobile, Alabama, United States

Outcomes

Primary Outcomes

Systolic Blood Pressure

polypill versus usual care

Time frame: 12 months

Medication Adherence-Percentage of Pills Taken

polypill arm-evaluation via pill counts.

Time frame: 12 months

LDL Cholesterol

Polypill versus usual care

Time frame: 12 months

Secondary Outcomes

Systolic Blood Pressure

polypill versus usual care

Time frame: 2 months

Medication Adherence

polypill-percentage of pills taken, evaluated via pill counts

Time frame: 2 months

Drug Metabolite Profile

LC/MS/MS-based drug metabolite profile assay screen in the polypill arm.

Time frame: 12 months

LDL Cholesterol

polypill versus usual care

Time frame: 2 months

Insulin Resistance

Measurement of HOMA-IR using fasting glucose and insulin.

Time frame: 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.

Time frame: Baseline and 12 months

Data from ClinicalTrials.gov

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