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Weekly News Round Up - October 12, 2011

Juvisync Approved as Fixed-Dose Combination for Diabetes and High Cholesterol

Combination tablet may offer convenience for patients who need both simvastatin (Zocor) and sitagliptin (Januvia) Read More...

The first fixed-dose combination for diabetes and high cholesterol treatment was FDA-approved this week. Juvisync contains simvastatin (Zocor) and sitagliptin (Januvia) in a convenient combination. Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor used to lower blood sugar in type 2 diabetics, while simvastatin is a popular HMG-CoA reductase inhibitor, or “statin”, used to reduce low density lipoprotein (LDL) cholesterol. The combo will be available in multiple strengths to allow greater flexibility in dosing. The 80 mg strength of simvastatin will not be available in the combo due to the recent restrictions due to myopathy (muscle damage), including rhabdomyolysis. Cost may also be an issue for some patients, as simvastatin is available generically.

Combivent Respimat Approved to Replace Combivent MDI by 2014

Propellant-free Combivent Respimat available for chronic obstructive pulmonary disease (COPD) by mid-2012 Read More...

The phasing out of chlorofluorocarbons (CFCs) as inhalant propellants has resulted in the phase out of Combivent Metered Dose Inhaler (MDI) over the next two years. Combivent MDI, approved as adjunct treatment in chronic obstructive pulmonary disease is being replaced with Combivent Respimat, which uses a spring mechanism to release a slow-moving mist. The medications contained in the new Combivent Respimat are the same as the original Combivent MDI (albuterol and ipratropium). Studies have shown that the two inhalers are clinically comparable with regards to FEV1 (the maximum amount of air that can be forcefully exhaled in one second). FEV1 is a common measure used to estimate lung function.

Sprycel May Lead to Rare But Serious Pulmonary Arterial Hypertension

FDA warns of rare occurrence of pulmonary arterial hypertension (PAH) with leukemia drug Sprycel Read More...

Pulmonary arterial hypertension (PAH) has been reported as a rare but serious side effect of the leukemia treatment Sprycel (dasatinib). PAH results in abnormally high blood pressure in the lungs with symptoms of shortness of breath, fatigue, and swelling of the extremities. The FDA reports that 12 PAH cases have been identified in the Sprycel manufacturer's database. Cases can begin at any time during treatment, including after one year. If PAH is confirmed in a patient taking Sprycel, and other causes have been ruled out, Sprycel treatment should be stopped permanently. PAH may be reversible once Sprycel is discontinued.

Investigational Agent Teriflunomide Shows Promise in Multiple Sclerosis

New oral agent shows positive results for relapsing/remitting multiple sclerosis in Phase 3 clinical trials Read More...

Multiple sclerosis (MS) is a neurological disease that results in muscle weakness, and difficulties with balance, coordination and cognition. As reported this month in the New England Journal of Medicine, the investigational oral drug teriflunomide has shown positive results in a Phase 3 clincial trial. Patients received either placebo or teriflunomide 7 or 14 milligrams once a day for over two years. Overall, researchers saw a 31 percent greater reduction in MS relapses compared to placebo. In addition, a 20 to 21 percent reduction in disease progression was noted compared to 27 percent in the placebo group. Side effects, such as diarrhea, nausea, hair thinning, and elevated liver enzymes occurred more frequently in the teriflunomide group.

NEJM Study: Vitamin E Supplement May Increase Risk for Prostate Cancer

New research suggests Vitamin E associated with elevated prostate cancer risk, but reasons remain unknown Read More...

A study published this week in the New England Journal of Medicine reports that use of vitamin E at 400 international units (IU) per day may lead to a higher chance of developing prostate cancer. In the SELECT study (Selenium and Vitamin E Cancer Prevention Trial), researchers found that among 35,000 men assigned to receive either selenium, vitamin E, both supplements or placebo over 5.5 years, the risk increased by a significant 17 percent in the group taking vitamin E alone. Practically speaking, researchers state that for every 1000 men who take 400 IU per day of vitamin E, 76 men will get prostate cancer, compared to 65 men who will get prostate cancer if they take a placebo. Why vitamin E may lead to prostate cancer is not known.