Weekly Drug News Round-Up: December 7, 2016
Jardiance Shown to Reduce Cardiovascular Death in Type 2 Diabetes
Death from cardiovascular disease is 70% higher in diabetics compared to those without diabetes Read More...
The U.S. Food and Drug Administration (FDA) has approved a new indication for Jardiance (empagliflozin), from Boehringer Ingelheim and Eli Lilly, to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and heart disease. Jardiance is a sodium glucose co-transporter-2 (SGLT2) inhibitor, and was originally approved in 2014 to improve blood sugar control in adults with type 2 diabetes alongside diet and exercise. For the new indication, Jardiance was studied in a Phase 4 study of more than 7,000 patients, and was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies.
FDA Clears Avastin Plus Chemotherapy for Platinum-Sensitive Ovarian Cancer
Avastin is also approved for platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer Read More
The FDA has approved Genentech's Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube or primary peritoneal cancer. In clinical trials, adding Avastin to chemotherapy showed an overall survival difference of five months compared to chemotherapy alone, and a significant improvement in progression-free survival. However, overall survival, one of the secondary endpoints in one pivotal study, was not significantly improved with the addition of Avastin to chemotherapy.
Pradaxa Blood Thinner May Beat Warfarin After Bleeding Episode: Study
Researchers looked at data from 90,000 patients who filled prescriptions for Pradaxa or warfarin Read More...
Bleeding episodes, sometimes quite serious, can occur in patients using blood thinners like warfarin, Pradaxa, Eliquis, and Xarelto, often used to prevent clotting in atrial fibrillation. A recent observational study asked “What, if any, blood thinner should patients take after a bleeding episode?” Over 1,500 of these patients suffered a major bleeding event while taking the drugs, and half resumed taking a blood thinner. Stopping the blood thinner use altogether was clearly less-safe, as the risk of death or stroke was 23 to 34 percent higher. Those who restarted Pradaxa instead of warfarin after a major bleed cut their risk of another major bleeding event within one year by 50%.
Marijuana Derivative Cannabidiol Shown Effective for Tough-to-Treat Epilepsy
GW Pharmaceuticals said it expects to submit the product to the FDA for approval in 2017 Read More...
Researchers have found that the experimental compound cannabidiol (CBD), a derivative of marijuana that does not lead to a “high”, helped reduce seizure frequency in children and adults with two hard-to-treat forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome. However, researchers noted that the CBD used in the trials is a "purified, pharmaceutical-grade" pill, not medical marijuana. In studies, researchers randomly added either CBD or placebo to standard anti-seizure medication in patients with either Dravet syndrome or Lennox-Gastaut syndrome. After 14 weeks, those on CBD in both groups saw a 39 to 44% reduction in seizures, compared to 13 to 22% in the placebo group.
The Facts on Bipolar Disorder and FDA-Approved Treatments
According to FDA, if you take atypical antipsychotics, your doctor should monitor your weight, blood sugar, and cholesterol Read More...
Fluctuating back and forth between a depressed feeling and then feeling very excited or “hyper” could be signs of bipolar disorder, a type of mental health disorder. However, as noted by the FDA in a December Consumer Article update, today, people with bipolar disorder have several approved and effective medications. Treatments for bipolar disorder can include mood stabilizers like lithium, and antipsychotic drugs, which may include atypical antipsychotics such as Abilify (aripiprazole) and Zyprexa (olanzapine). In fact, atypical antipsychotics are often used as the first-line treatment in severely manic patients because they work quickly and are, in several ways, safer than the older antipsychotic drugs.