Clinical trial NCT02278471: The SCCS Polypill Pilot Trial
Official title: The SCCS Polypill Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Hyperlipidemia
Keywords: combination pill
polypill
primary prevention
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 303
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 12 months
measure: Medication Adherence-Percentage of Pills Taken
timeFrame: 12 months
measure: LDL Cholesterol
timeFrame: 12 months
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: 2 months
measure: Medication Adherence
timeFrame: 2 months
measure: Drug Metabolite Profile
timeFrame: 12 months
measure: LDL Cholesterol
timeFrame: 2 months
measure: Insulin Resistance
timeFrame: Baseline and 12 months
measure: Inflammatory Profile
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Franklin Primary Health Center
state: Alabama
Study officials:
affiliation: Vanderbilt Univeristy
name: Thomas J Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munoz D, Uzoije P, Reynolds C, Miller R, Walkley D, Pappalardo S, Tousey P, Munro H, Gonzales H, Song W, White C, Blot WJ, Wang TJ. Polypill for Cardiovascular Disease Prevention in an Underserved Population. N Engl J Med. 2019 Sep 19;381(12):1114-1123. doi: 10.1056/NEJMoa1815359.