Abbott Statement on Interim Study Results of AIM-HIGH
ABBOTT PARK, Ill., May 26, 2011 /PRNewswire/ -- The National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), today disclosed results from an interim analysis of the AIM-HIGH clinical trial.
AIM-HIGH was designed to test whether raising HDL and lowering triglycerides in a patient population with established cardiovascular disease and very well controlled LDL levels could produce an additional 25 percent benefit on cardiovascular outcomes. The study compared extended release niacin (Niaspan®) added to simvastatin to simvastatin alone. The interim study results concluded that this study objective could not be met.
The findings are important for the type of patients who were enrolled in the trial – those who had stable, non-acute, pre-existing cardiovascular disease and very well controlled LDL on simvastatin. The relevance of these results to patients outside the study population is currently unknown and it would be premature to extrapolate these results to a broader patient population at this time. The AIM-HIGH study population does not represent all patient populations in whom the importance of treating low HDL and lowering triglycerides with Niaspan may be significant. Abbott will reflect the relevant study findings in the label after finalization of the AIM-HIGH study results and appropriate review.
The AIM-HIGH results affirmed the positive impact of Niaspan on HDL and triglyceride lipid values. Previous studies support HDL as an independent risk factor for cardiovascular disease.
There are a number of unanswered questions that remain, based on these interim study results. Some of these issues may become clearer when the study database closes this Fall and a comprehensive analysis of the complete database can be conducted.
"Lipid disorders and cardiovascular disease are complex and varied. Based on its long history of clinical evidence, Niaspan remains an important agent for patients with mixed dyslipidemia and primary hyperlipidemia," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.
Based on an interim analysis of the data, there were a small number of ischemic strokes observed in the study, and more ischemic strokes were observed in the Niaspan plus simvastatin arm of the study. This contributed to the NHLBI's decision to stop the trial before its planned conclusion.
Previous studies do not suggest that ischemic stroke is a potential complication of niacin or Niaspan. It remains unclear whether this trend in AIM-HIGH arose by chance, or was related to niacin administration or other issues, including the fact that some of the ischemic stroke events reported in the Niaspan arm occurred after patients had stopped taking the medication and that other medications may have influenced the ischemic stroke risk.
The ischemic stroke data are also inconsistent with what is known about Niaspan's action as a vasodilator, its effect on platelet aggregation and the drug's anti-coagulative properties, all of which are inconsistent with stroke causation. In addition, no stroke safety signals have been seen in post-marketing safety data over more than 6 million patient years of experience. The event rates observed in AIM-HIGH are similar to what would be expected in the comparable background population observed in other trials.
Patients with additional questions are advised to contact their health care provider or Abbott's medical information line in the U.S. 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. Full prescribing information for Niaspan (niacin extended-release) may be found at http://www.rxabbott.com/pdf/niaspan.pdf.
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's website at www.abbott.com.
Posted: May 2011