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Novartis reports phase 3 results of Afinitor study
More than one-third of patients treated with everolimus (Afinitor) tablets had a 50% or greater reduction in the size of non-cancerous brain tumors associated with tuberous sclerosis complex (TSC) versus 0% who were treated with placebo, according to a company statement from the drug?s manufacturer Novartis.
More than one-third of patients treated with everolimus (Afinitor) tablets had a 50% or greater reduction in the size of non-cancerous brain tumors associated with tuberous sclerosis complex (TSC) versus 0% who were treated with placebo, according to a company statement from the drug’s manufacturer Novartis.
The phase 3 randomized, placebo-controlled, double-blind, parallel group, international, multicenter study, called EXIST-1 (Examining everolimus In a Study of TSC), examined the efficacy and safety of everolimus versus placebo for the treatment of patients with subependymal giant-cell astrocytomas (SEGAs) associated with TSC.
Patients were randomly assigned to receive either everolimus (n=78) or placebo (n=39). By the cut-off date of March 2, 2011, the median treatment duration was 9.6 months in the everolimus arm and 8.3 months in the placebo arm. The primary end point was overall SEGA response rate.
Everolimus targets the mTOR protein that acts as an important regulator of tumor cell division, blood vessel growth, and cell metabolism by inhibiting overactivity that can lead to the formation of non-cancerous tumors throughout the body.
"This study, which included SEGA patients from infancy to adulthood, provides compelling evidence of the impact of everolimus in reducing SEGA size with a tolerability profile consistent with the previous everolimus trial in this treatment setting," said Sergiusz Jozwiak, MD, PhD, a lead EXIST-1 investigator and professor, department of child neurology, The Children's Memorial Health Institute, Warsaw, Poland, in the press release. "This is very good news for patients and caregivers in many countries who currently may face brain surgery as the only treatment option for growing SEGAs."
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
