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Weekly News Round Up - August 17, 2011

New Once-A-Day HIV Treatment: Complera Wins Approval for Treatment-Naive Patients

Once-daily combination drug contains three previously approved drugs for HIV treatment Read more...

Multiple daily doses of HIV medication can be inconvenient and may encourage noncompliance, which can lead to drug resistance. Complera, a once-a-day combination treatment has gained FDA approval for use in HIV patients who have never received any prior HIV treatment (treatment-naive patients). Complera is composed of Gilead’s Truvada (emtracitabine/tenofovir) with Johnson and Johnson’s Edurant (rilpivirine). Complera is the second once-daily medication to be approved for treatment-naive HIV patients, after Atripla (efavirenz/emtricitabine/tenofovir). Gilead’s 4-drug combo, known as the Quad, is expected to be submitted for FDA approval in Q1 of 2012.

Treatment With Antipsychotics Raises Risk for Metabolic Complications

Metabolic complications with antipsychotic use may be of concern in schizophrenic patients; routine physical exams, monitoring encouraged Read more...

Continuity of care is never more important than it is with mental health patients. But are mental health patients getting adequate primary care follow-up? In 2004, the FDA mandated class labeling for all atypical antipsychotics to warn of increased risk of hyperglycemia (high blood sugar) and diabetes. Atypical antipsychotics include Zyprexa (olanzapine), Clozaril (clozapine) and Seroquel (quetiapine). Weight gain can be common side effect with atypical antipsychotics and may increase the risk for diabetes, heart disease and stroke. As shown in a recent study, these antipsychotics require monitoring that may not be taking place. Weight and blood pressure checks, blood glucose (sugar) and cholesterol monitoring should be considered as part of a routine physical exam for patients taking atypical antipsychotics. Mental health providers may need to schedule mandatory physicals as part of their patient’s routine care plan.

Nurses Health Study: Depression and Stroke Risk in Women May Have Connection

Increased risk of stroke in depressed women may be associated with unhealthy lifestyles, not use of antidepressant medications Read more...

The Nurses Health Study has revealed more important news, this time for women who have depression. The risk of stroke increased 29% in depressed women. Those who took antidepressant drugs, especially selective serotonin reuptake inhibitors (SSRIs), had a 39% increase risk of stroke. However, it is important to note that researchers have not linked SSRIs with an increased risk of stroke. Instead, they suggest antidepressant use may indicate depression severity, and patients should not stop using antidepressants to lower the risk of stroke. Researchers note that women who are depressed may have other increased stroke risks, such as smoking, weight gain and lack of medical care.

Propel Medical Device Approved: Sinus Implant Releases Anti-inflammatory Drug for Chronic Sinusitis

An implant for chronic sinusitis is first device approved for local drug delivery to reduce post-operative scarring, inflammation Read more...

Chances are that you have had acute sinusitis that may occur after a bad cold. Symptoms may include nasal swelling and difficult breathing, cough, headache, pain behind the eyes, and loss of smell. For most patients, these symptoms will usually resolve over a period of 10 days. However, some patients develop chronic sinusitis, lasting longer than 8 to 12 weeks, and possibly recurring. A new medical device has been FDA-approved that, when inserted after endoscopic sinus surgery, locally delivers the anti-inflammatory mometasone to sinus tissue to help reduce scarring, and possibly the need for additional surgery. Propel, manufactured by Intersect ENT, Inc. will launch this fall.

Zelboraf (vemurafenib) and Diagnostic Test Approved to Treat Aggressive Skin Cancer

Zelboraf targets mutated forms of BRAF protein found in 50% of melanoma cases; FDA expedited approval with priority review Read more...

Personalized medicine seems to be making daily headlines. And fast-paced strides are being made in melanoma treatment, as well. Put it all together and you have great news for patients with late-stage melanoma. Roche’s Zelboraf (vemurafenib) is the first FDA-approved drug to treat BRAF V600E mutation-positive, inoperable or metastatic melanoma. In clinical trials, the median overall survival with Zelboraf has not been reached, and 77% of patients are still living. The median survival for dacarbazine, the active comparison, was 8 months, with 64% of patients still living. In March of 2011, Yervoy (ipilimumab) was also approved for metastatic melanoma. Both treatments have shown prolonged overall survival in late-stage melanoma.