Benefit of Elevation of HDL-C in Women

Phase 4CompletedNCT01921010

Cedars-Sinai Medical Center43 enrolled

Overview

The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction accomplished by the addition of niacin to statin medication would improve endothelial function as compared to LDL-C reduction alone in patients with and without coronary artery disease and the combination of low HDL-C/high triglycerides. The combination of lipid lowering therapy would have beneficial effects on markers of inflammation. These benefits would be particularly evident in women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cardiovascular Outcomes

Interventions

NiaspanDRUG

See Arm Description

PlaceboDRUG

See Arm Description

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stable CAD(coronary artery disease) patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl * Well-controlled diabetes with HbA1C \< 7.5 currently on statin therapy, able to tolerate Niacin without unstable blood glucose levels with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl * Stable patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl Exclusion Criteria: * History of MI(myocardial infarction), PTCA(percutaneous transluminal coronary angiography) or surgery within previous 3 months * Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin * Active or known gall bladder disease * Pregnant or nursing women * Significant comorbidity that precludes participation * Significant liver disease, active alcoholism, or LFT(liver function test) \>1.5x's ULN( upper limit of normal) at screening * Diabetes with Hg A1C(hemoglobin A1c) \< 7.5 * PI perceived inability to comply with protocol

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

endothelial function

Time frame: 16 weeks

Data from ClinicalTrials.gov

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