Patient-centered Research into Outcomes Stroke Patients prefer and Effectiveness Research.

Statins Study

Stroke is a major public health problem. 800,000 strokes occur each year in the US: that’s 1 every 40 seconds! Stroke is the 4th leading cause of death and a leading cause of disability. We know that common therapies like statins help avoid another stroke, but how do they affect time at home and risk of other clinical events? We also know that certain therapies have been shown to be effective for certain patients, but less data are available on patient subgroups like women, minorities, and the elderly.
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AGE: Took Statins

AGE: 65–80 years

10% fewer MACE events*
26 more home-time days**

AGE: > 80 years

9% fewer MACE events*
27 more home-time days**

The PROSPER study used data from Get-with-the-Guidelines-Stroke and Medicare claims to examine 2-year outcomes among U.S. ischemic stroke patients who were 65 and older.

*Major Adverse Cardiovascular Events (MACE) = death, stroke, or cardiovascular readmission

**Home-time = days alive and out of the hospital or a skilled nursing facility

RACE: Took Statins

RACE: Non-white

14% fewer MACE events*
36 more home-time days**

RACE: White

8% fewer Heart Attacks*
26 more home-time days**

The PROSPER study used data from Get-with-the-Guidelines-Stroke and Medicare claims to examine 2-year outcomes among U.S. ischemic stroke patients who were 65 and older.*Major Adverse Cardiovascular Events (MACE) = death, stroke, or cardiovascular readmission

**Home-time = days alive and out of the hospital or a skilled nursing facility

GENDER: Took Statins

GENDER: Female

9% fewer MACE events*
26 more home-time days**

GENDER: Male

9% fewer MACE events*
30 more home-time days**

The PROSPER study used data from Get-with-the-Guidelines-Stroke and Medicare claims to examine 2-year outcomes among U.S. ischemic stroke patients who were 65 and older.*Major Adverse Cardiovascular Events (MACE) = death, stroke, or cardiovascular readmission

**Home-time = days alive and out of the hospital or a skilled nursing facility

LDL-C : Took Statins

LDL: <100

7% fewer MACE events*
27 more home-time days **

LDL: 100-129

10% fewer MACE events*
21 more home-time days **

LDL: >=130

12% fewer MACE events*
27 more home-time days **

The PROSPER study used data from Get-with-the-Guidelines-Stroke and Medicare claims to examine 2-year outcomes among U.S. ischemic stroke patients who were 65 and older.*Major Adverse Cardiovascular Events (MACE) = death, stroke, or cardiovascular readmission

**Home-time = days alive and out of the hospital or a skilled nursing facility

SEVERITY OF STROKE: Took Statins

Mild/Moderate Stroke (NIHSS< 16)

8% fewer MACE events*
23 more home-time days**

Severe Stroke (NIHSS>= 16)

14% fewer MACE events *
44 more home-time days**

The PROSPER study used data from Get-with-the-Guidelines-Stroke and Medicare claims to examine 2-year outcomes among U.S. ischemic stroke patients who were 65 and older.

*Major Adverse Cardiovascular Events (MACE) = death, stroke, or cardiovascular readmission

**Home-time = days alive and out of the hospital or a skilled nursing facility

 

HEART DISEASE: Took Statins

NO HEART DISEASE:

10% fewer MACE events*
30 more home-time days**

WITH HEART DISEASE:

7% fewer MACE events*
16 more home-time days**

The PROSPER study used data from Get-with-the-Guidelines-Stroke and Medicare claims to examine 2-year outcomes among U.S. ischemic stroke patients who were 65 and older.*Major Adverse Cardiovascular Events (MACE) = death, stroke, or cardiovascular readmission

**Home-time = days alive and out of the hospital or a skilled nursing facility

What is a Statin?

Statins are a class of drugs prescribed by doctors to help reduce bad cholesterol in the blood. By reducing these cholesterol levels, statins can help prevent heart attacks and stroke.

Why is Statin Therapy recommended after
stroke?

Research suggests that, for most stroke patients, statins can help prevent the occurrence of another stroke. Strokes are often caused by atherosclerosis, or hardening of the arteries. This hardening affects multiple areas of the body, so stroke patients may also have silent heart disease or blockages in heart arteries. In these patients, statins can also reduce the risk of a heart attack.

What are the Risks/Side effects?

Evidence from large, well-designed studies suggests that statins are generally safe, and for most patients, the benefits outweigh the risks. However, like any medication, statins may have side effects. Serious side effects are very rare. Mild-to-moderate side effects like headache, gastrointestinal problems, and muscle weakness may be more common. These generally go away as your body adjusts. Statins may also carry a risk of raised blood sugar levels, which contributes to the development of diabetes. Memory trouble has not been found to be a statin side effect, even though many websites list it as one. Talk to your doctor about the benefits and risks so that you can make the right medication decision together.

What are the costs?

Medication costs depend on the type of statin prescribed and your insurance plan. You should talk to you doctor about costs so that you can choose the best medication for you.

Why look at real world experience data?

Clinical trials provide high-quality evidence for the benefits of statins. However, patients in clinical trials are selected very carefully, so they are usually younger and healthier than patients who use the medication in the real world. Community-based studies help us understand whether the benefits of statins are the same in different groups of patients that may not have been studied in clinical trials. They also allow us to study outcomes that are important to patients, like days alive and out of the hospital, which may not have been studied in clinical trials.

For more information, please talk to your doctor or visit the American Heart Association website for information on drug therapy for cholesterol:

www.heart.org

References

1. Jacobson TA. NLA Task Force on Statin Safety–2014 update. J Clin Lipidol 2014;8:S1-4. 2. Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 1 – executive summary. J Clin Lipidol 2014;8:473-88. 3. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7-22. 4. Corvol JC, Bouzamondo A, Sirol M, Hulot JS, Sanchez P, Lechat P. Differential effects of lipid-lowering therapies on stroke prevention: a meta-analysis of randomized trials. Arch Intern Med 2003;163:669-76. 5. Statins after ischemic stroke and transient ischemic attack: an advisory statement from the Stroke Council, American Heart Association and American Stroke Association. Stroke 2004;35:1023. 6. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006;97:52C-60C. 7. Amarenco P, Bogousslavsky J, Callahan A, 3rd, et al., on behalf of the The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med 2006;355:549-59.

Home-time does not distinguish if a patient was living in their own home, living at a relative or friend’s house, at home with home care services, at home with other community support, in assisted living or long-term care facilities, homeless, or exceeding the Medicare benefit for post-acute care.