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Weekly Drug News Round-Up: June 22, 2016

Rayaldee Gains Approval to Treat Secondary Hyperparathyroidism

Rayaldee is the first treatment approved to address this condition in patients with chronic kidney disease Read More...

In March the FDA did not initially approve OPKO Health’s Rayaldee (extended-release calcifediol) due to concerns over manufacturing issues. However, after resubmission, Rayaldee, a vitamin D3 analogue, was approved this week as a treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. SHPT can result in debilitating bone disease. In Phase 3 studies, more than 80% of stage 3 or 4 CKD patients with SHPT who received Rayaldee has a correction in vitamin D insufficiency as compared to less than 7% of those receiving placebo. The most common side effects included anemia, dyspnea, congestive heart failure and constipation.

Are You Getting the Right Treatment for Your Atrial Fibrillation? Study

Aspirin alone is not effective in preventing strokes in patients with atrial fibrillation Read More...

More than one-third of U.S. patients with atrial fibrillation, an irregular heartbeat that can lead to blood clots and subsequent stroke, are prescribed aspirin alone rather than the guideline recommended blood thinners such as Xarelto (rivaroxaban) or warfarin. As published in Journal of the American College of Cardiology this week, researchers reviewed medical records in two groups of at-risk atrial fibrillation patients totaling over 500,000 people. In both of these high-risk groups, roughly 40 percent were inappropriately treated with aspirin and about 60 percent were prescribed a recommended blood thinner, the investigators found. Besides Xarelto, newer drugs include dabigatran (Pradaxa), apixaban (Eliquis) and edoxaban (Savaysa).

Oral Antibiotic for “Superbug” MRSA Under Research

MRSA can cause a number of problems including skin infections, sepsis and pneumonia Read More...

The studies are early, but a new antibacterial agent has shown promise against the potentially deadly "superbug" called MRSA -- methicillin-resistant staphylococcus aureus.  A combination of the experimental antibiotic TXA709 and the cephalosporin antibiotic cefdinir (Omnicef) - already FDA-approved to treat other infections like strep throat and pneumonia - successfully treated animals infected with MRSA. Another plus - both drugs can be given orally on an outpatient basis. While TXA709 is effective on it’s own, combining with cefdinir lowers the chance the MRSA bacteria will become resistant. MRSA infections result in 19,000 deaths a year and account for $3 billion in annual health care costs.

Statins and Dosing: How Much is Too Much?

Statin side effects -- such as muscle pains, fatigue, memory loss and diabetes -- increase with increasing statin doses Read More...

The data is clear - statins lower levels of LDL ("bad") cholesterol and can save lives. But what dose is the right dose to ensure maximal heart protection with limited drug side effects? Research in JAMA Internal Medicine finds no evidence at present that increasing the intensity of treatment to LDL levels below 100 mg/dL adds further benefit. Researchers found that lowering LDL levels into the 70 mg/dL range did not translate into any further benefit. According to the FDA, millions of Americans currently take statins, including well-known brands such as Crestor (rosuvastatin), Lipitor (atorvastatin), and Zocor (simvastatin), among others. Disputes continue in the U.S. about the ideal cholesterol level target.

10 Common Sleep Disorders: Treatments & Truths

Are you tired all day and sleepless throughout the night? Read More...

Insomnia, restless leg syndrome, teeth grinding? These sleep disorders all occur at night and can keep you from getting the adequate rest you need. Obstructive sleep apnea and sleepwalking can be flat-out dangerous. Should you use treatments like benzodiazepine hypnotics, ropinirole (Requip), or melatonin for any of these conditions? Learn more about the common sleep disorders, typical symptoms and recommended treatments in our slideshow 10 Common Sleep Disorders: Treatments and Truths. Then rest a little easier.