End of Study Medication (Niaspan/Placebo) Phase
May 25 – August 15, 2011
The AIM-HIGH study's Data and Safety Monitoring Board (DSMB) recommended that all AIM-HIGH participants stop taking the extended-release niacin or placebo (the inactive drug) earlier than anticipated. The DSMB is an independent group of experts that monitors study progress and the safety of study participants. The study sponsor, the National Heart, Lung, and Blood Institute (NHLBI), agreed with the DSMB's recommendation.
The study medication was stopped early because:
- The number of participants who had serious heart and/or vascular problems was virtually the same for both groups of participants. In other words, in AIM-HIGH participants, niacin had no beneficial effect on reducing the number of heart and vascular problems.
- Extended-release niacin was effective in raising HDL ("good") cholesterol in the group who took it, but it did not affect the number of serious heart and/or vascular events in that group.
- While the rates were low, there was an increase in the number of strokes in the group of participants taking extended-release niacin. This was a finding that has not been seen in other studies of niacin. This information contributed to the decision to stop the study early and will continue to be examined.
In summary, we concluded that extended-release niacin provided no added benefit in reducing serious heart and/or vascular events in study participants, and because of possible safety concerns, this medication was stopped 18 months earlier than planned.
End of Blinded Study Medication Phase Clinic Visit
All AIM-HIGH participants were invited to the clinic for an "End of Blinded Study Medication Phase" visit. These visits occurred between June 1 and August 15, 2011 and included:
Off Study Medication Follow-up
- Fasting blood sample measurement of cholesterol (LDL "bad cholesterol" and HDL "good cholesterol")
- Fasting blood sample measurement of blood sugar and liver function
- ECG or heart rhythm test
- Questions about heart related illnesses
- Questions about other hospitalizations
- Review of medications you are currently taking for your health
- Discussion about who will be managing your cholesterol
- Discussion about follow-up for completion of AIM-HIGH
- Permission to call you in the future
Starting January 2012
The NHLBI requested that we continue to follow all study participants for 12-18 months after stopping Niaspan or placebo. During these 12-18 months, you will not be taking extended-release niacin or placebo. You will continue taking your cholesterol lowering medication as prescribed by your primary care doctor.
The first visit will be a telephone call between January and March, 2012. Your research coordinator will be calling you to ask about your health and to collect information about any lipid and other heart medications you are currently taking.
The final study visit will occur in the summer of 2012. The purpose of this final visit is to collect information about your health since you stopped taking extended-release niacin or placebo and any lipid and other heart medications you are currently taking.
When you first enrolled in AIM-HIGH we explained that the length of the study would be 4-7 years, depending on when you entered the study. At this time there are no changes in the length of your participation in the study. During this final phase of the study:
Changes to the Study Procedures:
- We will collect safety data and monitor your health after you have stopped taking the extended-release niacin or placebo.
- You will not be taking extended-release niacin or placebo.
- You will be asked to continue taking your cholesterol lowering medication as prescribed by your primary care doctor.
- You will no longer take the blinded study medication, either extended-release niacin or placebo (inactive pill).
- The study will no longer supply you with your cholesterol lowering medications.
- You will be expected to follow-up with your cardiologist or primary care doctor for your cholesterol management.
- The study will no longer follow you every three months either in person or by phone.
- The study will no longer test your blood every 6 months.
- The new follow-up schedule will be a phone call between January and March, 2012; and a final clinic visit between July and September, 2012.
- At the phone visit, you will be asked how you are feeling, if your have been sick or hospitalized, and what medications you are currently taking for your cholesterol. This call will take approximately 15 minutes.
- At the final visit, you will be asked to come to clinic for a final visit. This visit will take approximately 30 minutes. During this visit the following will happen:
Watch for more study updates on this web site.
- You will have an ECG to check your heart rhythm.
- You will be asked how you are feeling, if you have been sick or hospitalized, and what medications you are currently taking to manage your cholesterol.
Niaspan or Placebo?
You will be notified later this year about which study medication you were taking. Your research coordinator will contact you to tell you if you were taking extended-release niacin or the placebo.
Study Results Published
The results of the study will be made public at the American Heart Association meetings in the fall of 2011. Your research coordinator will be happy to share this information with you. You can also check the Publications / Presentations section on this website.
"I want to extend the Institute's deepest appreciation to the 3,414 study participants and the investigators in the U.S. and Canada. Without them, this trial would not have been possible and their efforts have helped us advance our knowledge in the important public health area."
- Dr. Susan B. Shurin, Acting Director, National Heart, Lung, and Blood Institute