Guidelines
and Prevalence

Guidelines and Prevalence

National Guidelines and Prevalence Data

NCEP Guidelines Prevalence Data and Analysis

NCEP ATP III Guidelines, Including 2004 Update: Goals for Lipid-lowering Therapy^2,3
NCEP recommends initiating treatment with lifestyle changes such as diet and exercise, which continue during drug treatment²

(a) CHD risk equivalent: patients with multiple risk factors and 10-year risk for CHD >20%; those diagnosed with diabetes or a form of clinical atherosclerotic disease, including peripheral arterial disease, abdominal aortic aneurysm, or carotid artery disease.

(b) The LDL-C goal for persons with multiple risk factors and 10-year risk >20% is <100 mg/dL. Major risk factors (exclusive of LDL-C) that modify LDL goals include cigarette smoking, hypertension (BP ≥140/90 mm Hg or on antihypertensive medication), low HDL-C (<40 mg/dL), family history of premature CHD (CHD in male first-degree relative <55 years of age and in female first-degree relative <65 years of age), and age (men ≥45 years, women ≥55 years).

NCEP recommends an optional LDL-C goal of <70 mg/dL for very high-risk patients, such as patients with
established cardiovascular disease (CVD) plus multiple risk factors (especially diabetes).
According to NCEP, HDL-C ≥60 mg/dL counts as a "negative" risk factor; its presence removes 1 risk factor from that total count of risk factors.²
NCEP does not specify a goal for HDL-C raising or triglyceride (TG) lowering.
The independent effect of raising HDL-C or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.

Percent of patients achieving optional NCEP LDL-C goal of <70 mg/dL and non-HDL-C goal
of <100 mg/dL

NCEP recommends an optional LDL-C goal of <70 mg/dL and non-HDL-C goal of <100 mg/dL for very high-risk patients, such as patients with established cardiovascular disease (CVD) plus multiple risk factors (especially diabetes)²

A retrospective analysis of 3 large independent claims and epidemiology databases indicated that 20-26% of high-risk statin-treated patients reached LDL-C levels of <70 mg/dL and only 13.3-19% reached both LDL-C and non–HDL-C goals. This represents only 8-11% of the overall treated population.⁴

Data Analysis:

GE Healthcare's Medical Quality Improvement Consortium Database Protocol (GEMQICD): A retrospective, observational, cross-sectional analysis conducted using electronic medical records (EMR) data provided by GEMQICD of patient records collected from January 2003 to September 2010. As of September 2010, this database captured approximately 700,000 patients aged ≥18 years with dyslipidemia, (prescribed a cholesterol medication with all 3 lipid values recorded [LDL-C, HDL-C, and TG]). 359,681 of these were high-risk dyslipidemia patients. Low HDL is defined as <40 mg/dL in men and <50 mg/dL in women. Elevated TGs are defined as ≥200 mg/dL.
Limitations: Analysis was limited by: sociodemographic, cultural, and other factors beyond study scope; use of lipid data from a single visit; no data on TG levels and “fasting” state; prescribed therapy, not dispensed, data captured.

NHANES Population (Survey) Protocol: Data analyzed from adults aged ≥18 years who had fasted for 8 or more hours (n=2,679, weighted to a US population of 218.4 million) in NHANES 2007-2008 nationally representative, cross-sectional survey. The number of adults at NCEP-recommended levels for LDL-C, non–HDL-C, HDL-C, TGs, and combined lipids was determined by using NHANES total US adult population projected in 2007-2008 (218.4 million) and subtracting the NHANES-reported number of 123.0 million without lipid disorders = projected 95.4 million with dyslipidemia in 2007.
Limitations: Analysis was limited by: reliance on self-report for treatment information; absence of adequate documentation of diet or exercise used to control lipid levels; numerous sociodemographic, cultural, and other factors beyond study scope; use of lipid data from a single visit; lack of inclusion of nonfasting TGs.

I3 Claims Data Protocol: A retrospective, observational, cross-sectional analysis conducted using claims database provided by I3 InVision Datamart collected from 2003-September 2010. This database captured approximately 535,831 patients age 18 years and older who were prescribed a cholesterol medication and had all 3 lipid values recorded [LDL-C, HDL-C, and TG]). Of the 535,831 patients, 233,809 were high-risk patients. Low HDL is defined as <40 mg/dL in men and <50 mg/dL in women. Elevated TG is defined as ≥200 mg/dL.
Limitations: Analysis was limited by: sociodemographic, cultural, and other factors beyond the scope of this study; use of lipid data from a single visit; no data on TG levels and "fasting" state; prescribed therapy, not dispensed, data captured.

What's next? Learn About NIASPAN
Clinical Data See the studies

Indications and Important Safety Information You Should Know About NIASPAN^® (niacin extended-release tablets)⁵

INDICATIONS FOR NIASPAN^® (niacin extended-release tablets)

NIASPAN should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and other nonpharmacological measures alone has been inadequate.
NIASPAN is indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
NIASPAN in combination with simvastatin or lovastatin is indicated for the treatment of primary hyperlipidemia and mixed dyslipidemia when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate.
In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
In patients with a history of coronary artery disease and hyperlipidemia, niacin, in combination with a bile acid-binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Limitations of Use: No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.

The AIM-HIGH study (terminated due to futility) showed no cardiovascular outcome benefit in patients with well-controlled LDL-C (40-80 mg/dL) using niacin extended-release/simvastatin vs. simvastatin.¹

IMPORTANT SAFETY INFORMATION FOR NIASPAN

NIASPAN is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminases, active peptic ulcer disease, arterial bleeding, and hypersensitivity to any product ingredients.
Do not substitute NIASPAN for equivalent doses of immediate-release (crystalline) niacin. Severe hepatic toxicity, including fulminant hepatic necrosis, can occur. Patients switching from immediate-release niacin to NIASPAN should start with NIASPAN 500 mg at bedtime and then be titrated to the desired therapeutic response.
NIASPAN should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
Persistent elevations in hepatic transaminases can occur. Monitor liver enzymes before and during treatment and discontinue NIASPAN if they show evidence of progression, particularly to 3 times ULN and are persistent, or if they occur with symptoms of nausea, fever, and/or malaise.
Myopathy has been reported in patients taking NIASPAN. The risk for myopathy and rhabdomyolysis increases when a statin is coadministered with NIASPAN, particularly in elderly patients and patients with diabetes, renal failure, or uncontrolled hypothyroidism. Advise patients to report muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during upward dosage titration of either drug. Periodic serum creatine phosphokinase (CPK) and potassium determinations should be considered in such situations.
Use caution in patients with unstable angina or in the acute phase of an MI; renal impairment; a past history of jaundice, hepatobiliary disease, or peptic ulcer.
NIASPAN can increase serum glucose levels. Closely monitor glucose levels in diabetic or potentially diabetic patients, particularly during the first few months of use or during dose adjustment.
NIASPAN can reduce platelet counts and increase prothrombin time; accordingly, carefully evaluate patients undergoing surgery. Monitor prothrombin time and platelet counts in patients receiving anticoagulants.
NIASPAN can increase uric acid levels; use with caution in patients predisposed to gout. Transient, but statistically significant decreases in serum phosphorus have also been reported with NIASPAN. Phosphorus levels should be monitored periodically in patients at risk for hypophosphatemia.
Bile acid sequestrants should be taken at least 4-6 hours apart from NIASPAN administration.
The most common adverse reactions (incidence >5% and greater than placebo) are flushing, diarrhea, nausea, vomiting, increased cough, and pruritus. Flushing (warmth, redness, itching, and/or tingling of the skin) may vary in severity and is more likely to occur with initiation of therapy or during dose increases. Advise patients of the symptoms of flushing and how they differ from the symptoms of an MI.

Click here for full Prescribing Information for NIASPAN.

References:

U.S. Food and Drug Administration. FDA Statement on the AIM-HIGH Trial.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm256841.htm. Accessed September 2, 2011.
Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). National Institutes of Health. http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3full.pdf. Published September 2002. Accessed May 23, 2011.
Grundy SM, Cleeman JI, Merz CNB, et al; for the Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004;110:227-239.
Data on file, Abbott Laboratories.
NIASPAN [package insert]. North Chicago, IL: Abbott Laboratories.