Frequently asked questions about AIM-HIGH

1. What happens now that I am enrolled in the study?

Now that you are enrolled, your doctor and the study staff are going to explain the next steps, schedule you for follow-up visits, and provide you with a study kit that has the medications you will take.

2. What are the study medications?

During AIM-HIGH you will receive what is currently the best-proven cholesterol treatment – a statin. You may also receive a second cholesterol medication (niacin) in combination with the statin.

The two study medications used in AIM-HIGH have been approved by the U.S. FDA and Health Canada and used safely for many years.

There are two medications you will take in this study. The first is simvastatin (Zocor®) which lowers bad cholesterol. The second is extended-release niacin (Niaspan®) which raises good cholesterol and lowers levels of triglycerides.

At the end of the AIM-HIGH five-year cholesterol management program we will know whether the addition of extended-release niacin improves the already well-established treatment benefits of simvastatin.

3. How will I get the study medications?

At the first AIM-HIGH visit you will be given detailed instructions about the AIM-HIGH medications and how you should take these. You will be given additional boxes of your medicines after most of your visits. Medications can be mailed to you if you cannot come in to the AIM-HIGH center.

If you run low on study medication, contact the study physician or research coordinator’s office as soon as possible.

4. What happens if I move?

If you move or change your telephone number during the AIM-HIGH study, please inform the AIM-HIGH staff. We will try to continue our follow-up with your visits even if you move out of the area. There are over 72 U.S. and Canadian clinics/hospitals participating in this study, so there is a good chance we can find an AIM-HIGH doctor in your new area.

5. Can I leave the AIM-HIGH clinical program after it has started?

Yes. You can leave this or any clinical trial, at any time. If you choose to withdraw from the AIM-HIGH program, please let your AIM-HIGH doctor and staff know of your decision as soon as possible and provide them with your reason for leaving. If you leave the study, you must return all of the unused study drugs to the AIM-HIGH clinic as soon as possible. The AIM-HIGH staff will also ask your permission to contact you at the end of the study to see how you are doing off the study medications.

6. Is it OK to go on vacation?

Of course! Let your AIM-HIGH staff know your vacation schedule when you make your next study visit appointment.

The important thing to remember is to give the AIM-HIGH staff your vacation phone contact if you are going to be away, especially at the time of the follow-up phone calls. Also, talk with your AIM-HIGH staff to make sure you have all the medicine you will need during your vacation.

7. When will I know the results of AIM-HIGH?

AIM-HIGH will take a total of four - six years to complete. After patients have completed all their study visits the researchers will compile all the results, run a statistical analysis, and review all the findings. Your AIM-HIGH doctor will receive a copy of the final report and you will receive a letter explaining all the results of the five-year cholesterol management program. At this time you will also receive a letter letting you know if you were taking the Niaspan® or the placebo.

8. Are there any medications, herbs or vitamins I can’t take during this study?

Always talk with your AIM-HIGH doctor before you start or stop any medication, including vitamins, herbs, supplements or any over-the-counter medication. It is also very important to let your AIM-HIGH doctor know if another doctor prescribes any new medications or changes/stops any current medications.

In particular, if you are prescribed any of the following drugs, please have your physician call your AIM-HIGH doctor:

• Verapamil (a drug used to control heart rhythm and chest pain) marketed under various brand names
• Amiodarone (another drug used to control heart rhythm) marketed as Cordarone®
• Any other drug intended to lower cholesterol levels
• High dose antioxidant vitamins C, E or beta-carotene, and fish oil

9. What are some of the possible side effects from the medications?

Simvastatin (Zocor®) is a well-tolerated drug taken by millions of people worldwide. A few people (about 1 in 100) may develop elevated liver enzymes. For this reason, we will perform a blood test before you start simvastatin to make sure that your liver enzyme levels are normal and we will periodically check your liver enzymes as part of your participation in AIM-HIGH. Stomach upset may occur. If this persists or worsens, let your AIM-HIGH doctor know promptly.

This drug may infrequently cause muscle aches (which can lead to an extremely rare but very serious, possibly fatal, condition). Seek immediate medical attention if you develop: marked muscle pain, tenderness or weakness (especially with fever or unusual tiredness).

Tell your AIM-HIGH doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes and skin, dark urine, severe fatigue, stomach/ abdominal pain, persistent nausea, changes in the amount of urine. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your AIM-HIGH doctor.

Extended-release Niacin (Niaspan®): The most common side effect of extended-release niacin (a vitamin B3 preparation) is flushing (skin redness with a feeling of warmth). Taking an aspirin or non-steroidal anti-inflammatory drug (such as ibuprofen) before you take your dose of extended-release niacin can help reduce these symptoms. Avoiding alcohol or hot drinks when you take it can also help.

If you are diabetic, extended-release niacin may affect your blood glucose levels. Your AIM-HIGH doctor will work with your own doctors to make sure that your blood glucose levels are maintained.

Itching, tingling, or headache may occur. These effects should subside as your body adjusts to the medication. Stomach upset, heartburn, nausea, vomiting, and diarrhea may also occur rarely. If these continue, notify your AIM-HIGH doctor promptly.

Let your AIM-HIGH doctor know promptly if you start having the rare side-effects of: vision problems, dark urine, stomach (abdominal) pain, yellowing eyes or skin, irregular heartbeat, black stools, increased urination, muscle aches/pain. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms include: rash, swelling, and dizziness. If you notice other effects not listed above, contact your AIM-HIGH doctor.

10. What happens if I need to go to the hospital or emergency room?

If you need to go to the hospital or emergency room, please make sure you or a family member shows your AIM-HIGH Participant Identification Card to the medical staff. This lets the medical staff know about your participation in the study, and will give the attending medical staff important information about your care. If you don’t have your AIM-HIGH Card with you, just let them know the name of your AIM-HIGH doctor and ask the medical staff to contact them.

At your next study visit, the AIM-HIGH staff will review with you what happened during your hospital or emergency room visit. This includes any changes that might have been made in your medications such as adding a new one, or stopping an old one.

Do you have more questions about the study medications?

Talk with your AIM-HIGH doctor and staff. They have lots of information and are happy to help. Also, read the medication instructions for any further questions regarding dosing, potential side effects, potential drug interactions, etc. You can also call 1-800-5-NIASPAN (1-800-564-2772) for more information about Niaspan and ways to minimize any possible side effects.

The AIM-HIGH five-year cholesterol program enables patients to receive cholesterol medications and access to medical experts at no cost to them or their insurers.

If you think you might be eligible speak with your doctor or .