The SCCS Polypill Pilot Trial

Vanderbilt University

Status and phase: Completed; Phase 2

Conditions: Hypertension; Hyperlipidemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02278471

141583

Details and patient eligibility

About

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.

Full 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.

Enrollment: 303 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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303 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Subjects in this arm will not receive any investigational medications. They will remain on the same care that they are use to receiving.

Polypill

Experimental group

Description:

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.

Treatment:

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