AHA and ASA issue guidelines for stroke prevention in women

The American Heart Association and American Stroke Association recently released the first woman-specific guidelines for avoiding stroke. Stroke is the third leading cause of death among women in the United States. If these guidelines are followed, estimates are that up to 80% of strokes in women could be prevented.

The new guidelines are as follows:

• Before taking birth control pills, women should be screened for high blood pressure to reduce stroke risk.

• To reduce stroke risk, women who suffer from migraine headaches with aura should stop smoking.

• To reduce preeclampsia risk, low-dose aspirin and/or calcium supplement therapy should be considered for women with a history of high blood pressure before pregnancy.

• Preeclampsia should be seen as a risk factor for stroke long after pregnancy, since women who have the condition have twice the risk of stroke and four times the risk of high blood pressure later in life.

• Women who have preeclampsia should be treated early for obesity, smoking, and high cholesterol.

• Women over the age of 75 should be screened for atrial fibrillation because of its association with increased stroke risk.

• Pregnant women with severe high blood pressure (160/110 mmHg or above) should be treated with blood pressure medication, while expectant mothers with moderately high blood pressure (150-159 mmHg/100-109 mmHg) should be considered for treatment.

Source: Bushnell C, McCullough LD, Awad IA et al. Guidelines for the prevention of stroke in women. Stroke 2014. Published online before print February 6, 2014, doi: 10.1161/01.str.0000442009.06663.48. Accessed March 2, 2014.

FDA accepts investigational NDA for REG2

FDA has accepted Regado Biosciences’ investigational new drug application for REG2. Regado previously completed a single escalating-dose phase I clinical trial of REG2 and plans to conduct additional clinical testing for subacute venous thrombosis indications.

REG2 is an early clinical-stage study evaluating an extended release formulation of pegnivacogin, the same Factor IXa inhibiting anticoagulant used in REG1. REG2 is formulated for subcutaneous depot injection and is intended to provide a controllable level of anticoagulation for up to two weeks for subacute uses, especially in cases where a patient may be unable to swallow an oral anticoagulant. It is paired with an intravenous bolus formulation of anivamersen, which is used as an active control agent, if needed.

Regado is developing REG2 for potential uses in a variety of acute- and subacute-care cardiovascular indications, such as venous thromboembolism prophylaxis in patients undergoing abdominal surgery, as treatment for transcatheter aortic valve implantation (TAVI) patients, and for bridging patients who are unable to take oral anticoagulants for a period of time before or after a surgical procedure.

Source: Regado Biosciences, Inc. announces FDA acceptance of IND for REG2. [press release] Basking Ridge, NJ. February 13, 2014. http://regadobio.investorroom.com/2014-02-13-Regado-Biosciences-Inc-Announces-FDA-Acceptance-of-IND-for-REG2. Accessed March 2, 2014.

Bayer initiates phase 3 VTE prevention study with rivaroxaban

A new phase 3 clinical trial will evaluate two doses of rivaroxaban (Xarelto) against acetylsalicylic acid (ASA) for the long-term, secondary prevention of symptomatic venous thromboembolism (VTE).

The study, EINSTEIN CHOICE, supplements the EINSTEIN trial, which established that rivaroxaban 20 mg taken once daily reduced the risk of recurrent symptomatic DVT and PE in patients who had previously completed six or 12 months of anticoagulation treatment. EINSTEIN CHOICE will include approximately 2,850 patients and will evaluate whether rivaroxaban in doses of 10 mg or 20 mg is superior to ASA at 100 mg in the prevention of fatal or nonfatal symptomatic recurrent venous thromboembolism in patients who have completed six to 12 months of anticoagulant treatment.

Many physicians stop warfarin treatment after six months and may switch patients to aspirin because of the inconvenience of warfarin management and fears about the risk of bleeding. But the risk of VTE recurrence at one year is about 10%. The EINSTEIN CHOICE study is designed to demonstrate whether reducing the dose of rivaroxaban from 20 mg once daily to 10 mg once daily maintains efficacy and lowers the risk of bleeding, and whether rivaroxaban is better than aspirin at reducing the risk of recurrence.

Source: “Bayer initiates rivaroxaban Phase III study to support dose selection according to individual benefit-risk profile in long-term VTE prevention” [press release]. Berlin, Germany. February 17, 2014. http://press.healthcare.bayer.com/en/press/news-details-page.php/15399/2014-0043. Accessed March 2, 2014.

Anna D. Garrett is a clinical pharmacist and president of Dr. Anna Garrett (www.drannagarrett.com). Her mission is to help women in midlife maximize their mojo! Contact her at info@drannagarrett.com.