FDA comes out against aspirin for primary prevention

July 10, 2014

Available data indicated "serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain."

Cardiovascular disease (CVD), including heart disease and stroke, affects tens of millions of people in the United States. Many consumers begin taking aspirin to prevent heart attacks and strokes without a diagnosis of CVD. FDA recently announced that aspirin should not be marketed for primary prevention. In its statement, FDA said it had "reviewed the available data and does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke. In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain."

The available evidence does support the use of aspirin for preventing another heart attack or stroke in patients who have CVD or who have already had a heart attack or stroke (secondary prevention). 

Of note, the American Heart Association and American Diabetes Association continue to support use of aspirin for primary prevention in high-risk patients.

Source: Use of aspirin for primary prevention of heart attack and stroke. FDA website. http://bit.ly/CVDasp. Accessed May 30, 2014.

 

AHA/ASA updates guidelines for prevention of recurrent stroke

The American Heart Association and the American Stroke Association have released updated guidelines for preventing recurrent stroke in patients who have experienced a stroke or transient ischemic attack.

Highlights of changes from the 2011 guidelines include the following:

•      Systolic blood pressure below 140 mm Hg and diastolic pressure below 90 mm Hg are reasonable goals.

•      Vitamin K antagonist therapy, apixaban, and dabigatran are indicated to prevent recurrent stroke in patients who have nonvalvular atrial fibrillation, while rivaroxaban is considered a reasonable option.

•      For patients over age 70, carotid endarterectomy may have better outcomes than carotid angioplasty with stenting. In younger patients, the two approaches are similar in their risks for perioperative complications and long-term ipsilateral stroke.

•      Addition of new class I recommendations for the use of apixaban and dabigatran to prevent recurrent strokes in patients with nonvalvular atrial fibrillation as alternatives to warfarin. Rivaroxaban received a class II recommendation.

Greater emphasis was placed in the updated guidelines on lifestyle factors, including diet, exercise, and weight management.

The importance of diet was underscored with a new nutrition section, which included the following points:

·      Patients should be assessed for signs of overnutrition or undernutrition; those with signs of undernutrition should be referred for nutritional counseling.

·      The use of routine supplementation with a single vitamin or vitamin combinations is not recommended.

·      Sodium intake should be reduced to less than 2.4 grams per day, even to less than 1.5 grams per day.

·      Patients should adhere to a Mediterranean-type diet that includes vegetables, fruits, whole grains, low-fat dairy, poultry, fish, legumes, olive oil, and nuts, and limits sweets and red meats.

Source: Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack. Stroke 2014;May 1:[Epub ahead of print].

 

USPSTF draft advises aspirin for women at risk of preeclampsia

The U.S. Preventive Services Task Force is recommending the use of low-dose aspirin (81 mg/day) to prevent preeclampsia in high-risk women. Previously, the group found insufficient evidence to recommend its routine use.

In a draft recommendation statement, the task force advises daily, low-dose aspirin after 12 weeks' gestation if a woman has one or more high-risk conditions, such as a history of preeclampsia, chronic hypertension, or diabetes, or has several moderate risk factors, including obesity, family history, and an age of 35 years or above.

The panel added that its review of new research finds aspirin maintenance therapy can reduce the risk of pre-term birth by 14%. Low-dose aspirin was also found to cut rates of premature birth and intrauterine growth restriction (IUGR).

Preeclampsia symptoms, which occur in pregnancy at around 20 weeks, include dangerously high blood pressure and protein deposits in urine. If left untreated, preeclampsia can develop into eclampsia, a life-threatening condition that causes seizures late in pregnancy.

There was no evidence that aspirin harms mother or fetus.

Source: Henderson JT, Whitlock EP, O’Connor E, et al. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: A systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014;160(10):695–703. doi:10.7326/M13–2844.