Mipomersen passes hurdle in two trials
The new and upcoming anti-cholesterol drug mipomersen performed quite well in two phase 3 trials. Mipomersen is an antisense inhibitor of apolipoprotein B (apoB) synthesis and was shown to be able to lower LDL-cholesterol significantly compared to placebo (36 vs 13%). The trials demonstrated a good efficacy profile but drop out rates were rather partly because of adverse events that include elevations in liver enzymes. The manufacturer Isis Pharmaceuticals is expected to apply for drug approval next year.
Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
The drug midodrine hydrochloride (ProAmatine), on the other hand, is under threat of being withdrawn from the US market. ProAmatine, which is indicated for low blood pressure was approved by the FDA in 1996 under the accelerated approval system which require postmarketing studies to verify efficacy and safety. However, no studies have been performed. Shire, the drug maker currently holding patent to the drug declared “it had already intended to voluntarily withdraw the drug, long before the FDA went public with the proposal.” Shire acquired ProAmatine when they took over Roberts Pharma in 1999. The drug is also manufactured by other companies in generic form. The withdrawal will take effect on September 30, 2010. The FDA recommends: Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.
NIH Genomic Mapping Study Finds Largest Set of Genes Related to Major Risk Factor for Heart Disease
National Institutes of Health researchers report they have identified largest set of genes underlying high cholesterol and high triglycerides. This major feat was made possible by scanning the genomes of over 100,000 worldwide. The research team consisted of scientists from 17 countries. According to study co-author and NIH Director Dr. Francis S. Collins
“Genetic studies that survey a wide variety of human populations are a powerful tool for identifying hereditary factors in health and disease. These results help refine our course for preventing and treating heart disease, a health problem that affects millions of Americans and many more people worldwide.”
Telemonitoring of HF patients reduces deaths, costs
Australian researchers report success of a telemonitoring and structured telephone support program to reduce “risk of all-cause mortality and heart-failure-related hospitalizations.” Particularly interesting is the fact that most participants were quick in learning the use of the technology.
“Structured telephone support and telemonitoring reduced healthcare costs, were acceptable to patients, improved prescribing of evidence-based pharmacotherapies, improved patient heart-failure knowledge and self-care behaviors, and even improved NYHA functional class in those studies that assessed it.”