Abbott statement on the results of the AIM-HIGH study presented at AHA 2011

Final results were presented today from the AIM-HIGH study, a National Heart, Lung and Blood Institute (NHLBI) study. The study was designed to test whether raising HDL “good” cholesterol by adding Niaspan to simvastatin would provide an additional 25 percent reduction in cardiovascular outcomes in patients with established cardiovascular disease and well-controlled LDL “bad” cholesterol levels. The study was stopped early following an interim analysis in May and found that combination therapy did not result in an additional reduction in cardiovascular events beyond treatment with simvastatin in this patient population with well-controlled LDL cholesterol and non-HDL-cholesterol (a measure of all plaque causing particles). In response, Abbott (NYSE: ABT) issued the following statement:

The AIM-HIGH study answered an important question about the benefits of additional lipid treatment for the specific type of patients enrolled in the study – those with stable established cardiovascular disease whose lipids were well-controlled at or near primary and secondary lipid goals at the start of the study. Current treatment guidelines would not have recommended that these patients receive additional lipid therapy.

According to the National Cholesterol Education Program (NCEP) guidelines, LDL cholesterol is the primary target of lipid therapy. For patients at high cardiovascular risk, such as those enrolled in the AIM-HIGH study, guidelines recommend an optional LDL goal of 70 mg/dL or less. Additionally, non-HDL cholesterol of 100 mg/dL or less is the secondary goal of lipid treatment for high-risk patients when triglycerides are elevated (greater than 200 mg/dL) and after LDL goal is reached. Ninety-four percent of patients in the AIM-HIGH study were already taking statins, with most of this group taking statins for more than a year, many for more than five years. In these patients, although baseline HDL cholesterol levels were low (35 mg/dL), they had LDL cholesterol levels of 71 mg/dL, non-HDL cholesterol levels of 106 mg/dL and triglycerides of 161 mg/dL.

The results from the AIM-HIGH study should not be applied beyond the patient population studied. The 3,414 patients in the AIM-HIGH study represent a small percentage of high-risk patients who reach their guideline-recommended lipid treatment goals and are not representative of the typical patient being treated for lipid disorders in clinical practice today.

“Niaspan remains an important treatment option to help patients reach their lipid treatment goals, many of whom require multiple medications to do so. Even when looking only at the high-risk patient group evaluated in the AIM-HIGH study, epidemiologic data tell us that in clinical practice more than three-quarters of these patients do not reach their recommended goals for lipid therapy,” said John Leonard, M.D., senior vice president, Global Pharmaceutical Research and Development, Abbott. “Physicians should consider each patient’s cardiovascular profile and the NCEP treatment guidelines when evaluating a patient for potential additional treatment with lipid lowering medicines such as Niaspan.”

In the interim data, an unexpected imbalance in ischemic stroke events in patients who received Niaspan and simvastatin as compared to simvastatin was identified. The final data showed that the difference in ischemic stroke events between the two study arms was not statistically significant. Previous studies, meta-analyses and post-marketing safety data also did not show any stroke safety signals related to niacin or Niaspan.

The findings from the AIM-HIGH study were presented at the American Heart Association Scientific Sessions 2011 and were simultaneously published online in the New England Journal of Medicine.

Patients with additional questions are advised to contact their health care provider or Abbott’s medical information line in the United States at 1‑866‑257‑8292, or visit www.niaspan.com.

Uses for Niaspan® (niacin extended-release tablets)

Niaspan is a prescription medication used along with diet when a low-cholesterol diet and exercise alone are not enough.

• Niaspan raises HDL (“good”) cholesterol and lowers LDL (“bad”) cholesterol and triglycerides in people with abnormal cholesterol levels.
• Niaspan is also used to lower the risk of heart attack in people who have had a heart attack and have high cholesterol.
• In people with coronary artery disease and high cholesterol levels, Niaspan, when used with a bile acid-binding resin (another cholesterol medicine), can slow down or lessen the build up of plaque (fatty deposits) in your arteries.
• Niaspan can be used in combination with lovastatin or simvastatin to improve abnormal cholesterol levels when taking Niaspan, simvastatin, or lovastatin alone is not enough.
• No additional benefit of Niaspan on heart disease has been demonstrated when used with simvastatin or lovastatin over that shown for niacin, simvastatin, or lovastatin alone.

Important Safety Information for Niaspan

• Niaspan is not for people with liver problems, stomach ulcers, serious bleeding problems, or those allergic to any product ingredient.
• Severe liver damage can occur when switching to a long-acting niacin (Niaspan) from immediate-release niacin. Do not switch between forms of niacin without talking to your health care provider.
• Tell your health care provider about any unexplained muscle pain, tenderness or weakness, as this could be a sign of a serious side effect. This risk may be increased when Niaspan is taken with a statin, particularly in the elderly, diabetics, and those with kidney or thyroid problems.
• Niaspan should be used with caution if you consume large amounts of alcohol and/or have a past history of liver disease.
• Your health care provider should do blood tests before and during treatment to check liver enzyme levels, as these may increase with treatment.
• Tell your health care provider if you have kidney problems, or a history of gout. Niaspan may cause an increase in uric acid levels.
• Niaspan may cause an increase in blood sugar levels. If you have diabetes, check your blood sugar levels more frequently during the first few months or with Niaspan dose changes.
• The most common side effects with Niaspan are flushing, headache, diarrhea, nausea, vomiting, increased cough and itching.
• Flushing (warmth, redness, itching and/or tingling of the skin) is a common side effect of niacin therapy that may get better after several weeks of consistent Niaspan use. It may vary in severity and is more likely to happen when starting Niaspan or during dose increases. Talk to your doctor about how the symptoms of flushing are different from symptoms of a heart attack. By dosing at bedtime, flushing will likely occur during sleep. If awakened by flushing, get up slowly, especially if feeling dizzy or faint, or taking blood pressure medications.
• If you are taking another cholesterol medication called a bile acid-binding resin (e.g., colestipol, cholestyramine) along with Niaspan, take these medicines at least 4 to 6 hours apart.
• Some medicines should not be taken with Niaspan. Tell your health care provider about all the medicines you take, including aspirin, any cholesterol medication, blood pressure medication, or blood thinner medication, or any products containing niacin or nicotinamide.

For more information, talk with your health care provider.