Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care

In His Image100 enrolled

Overview

The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hyperlipidemia Mixed Hyperlipidemia Dyslipidemia

Interventions

Niacin Extended Release/LovastatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. \>18 years old with CAD or risk factors for CAD 2. under standard care at Family Medical Care of Tulsa 3. not at LDL goal per ATP III guidelines Exclusion Criteria: 1. pregnancy/lactating 2. liver disease 3. allergies to statin or niacin 4. active peptic ulcer disease 5. previous treatment with combination therapy for dyslipidemia

Locations (1)

Family Medical Care of Tulsa

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

Lipid parameter change at 3 and 6 months

Percent of patients achieving ATP III LDL goals at 3 and 6 months

Data from ClinicalTrials.gov

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