News January 2014 Issue

In The News: January 2014

Postmenopausal Drug Approved by FDA Aids Osteoporosis in Some
The Food and Drug Administration (FDA) has approved a novel estrogen-based drug for women to treat moderate-to-severe vasomotor symptoms associated with menopause as well as prevent postmenopausal osteoporosis. The new drug for menopausal women (Duavee®) is the first to combine conjugated estrogens with bazedoxifene. Bazedoxifene is approved in Europe for the prevention of osteoporosis and has been shown to reduce the risk of endometrial hyperplasia, a possible precursor to cancer associated with the drug’s estrogen element. The combination of conjugated estrogens and bazedoxifene is indicated only for postmenopausal women who still have a uterus, according to the FDA. Clinicians are advised to prescribe the new drug “for the shortest duration consistent with treatment goals and risks” as they would for any other estrogen-containing product. The agency advises that doctors can also prescribe the combination drug to prevent osteoporosis. The estrogens/bazedoxifene drug will be available in the United States, the first country to approve it, in the first quarter of 2014.

Bracing Knee Eases OA Pain
Patients with knee osteoarthritis (OA) who wore a patellofemoral brace for six weeks experienced decreases in pain and bone marrow lesions, according to results presented at the annual meeting of the American College of Rheumatology (Oct. 30, 2013). Patellofemoral knee braces are commonly used to restore the natural alignment of the upper and lower leg. Based on a 100-point visual analog scale (VAS), patients who wore the brace for an average of 7.35 hours per day had a substantial decline in pain of -18.16 points. The control group had only a slight change of -1.29 points, according to researchers. Patients who wore the brace showed not only significant reduction in patellofemoral joint pain (in the front of the knee), but also a decrease in the volume of bone marrow lesions in their patellofemoral joint.

Headache Not Specific to Lupus
Although headache is a common symptom among systemic lupus erythematosus patients, it’s not a neuropsychiatrtic manifestation of the disease, according to a study reported online in Arthritis & Rheumatism (Oct. 28, 2013). Of the 1,732 lupus patients reviewed in the study, headache was reported by 17.8 percent, but only 1.5 percent had “lupus headache,” using the criteria of “severe, persistent, and nonresponsive” to treatment, even with narcotic analgesic medications. Instead, headache appeared to be an indication of other neuropsychiatric manifestations, including cerebrovascular disease and polyneuropathy (damage to nerves outside the brain or spinal cord). Among those who reported headache, the specific types were migraine in 61 percent and tension in 39 percent. Overall, 55.1 percent of the participant’s headaches resolved with treatment, including all but one of those classified as a lupus headache.

FDA Approves New Methotrexate Injection Device
The Food and Drug Administration (FDA) has approved a self-injection device for the subcutaneous administration of methotrexate. The single-use, disposable, autoinjector known as Otrexup® is intended for use by adults with active, severe rheumatoid arthritis (RA) or psoriasis who haven’t responded to or been able to tolerate first-line therapy. Approximately six million prescriptions for methotrexate were written in the United States in 2012 alone. The drug is typically given orally once a week, but many patients don’t respond or cannot tolerate the drug’s side effects, including nausea, abdominal pain and indigestion. Otrexup offers an easy and safe alternative to administering subcutaneous methotrexate, which may overcome some of the current barriers to oral administration.