Recent medicine's news
Saturday, Mar 1, 2008
Ranolazine: A New
Option in the Management of Chronic Stable Angina
Pharmacotherapy for the management of chronic stable angina has not
changed much in the past 10-20 years. Although the use of
revascularization has increased, â-blockers, calcium channel blockers,
and long-acting nitrates are still widely used in the management of
patients with chronic stable angina. Despite the demonstrated
effectiveness of these agents, a number of patients do not achieve the
American College of Cardiology-American Heart Association goal of
freedom from exertional angina attacks. For the first time in more than
a decade, a new agent, ranolazine, is available to assist in
controlling exertional angina. Ranolazine has a novel mechanism of
action of inhibiting the late sodium current during ventricular
depolarization. This mechanism contributes to a reduction in
intracellular sodium and, therefore, a reduction in intracellular
calcium, reducing ischemic injury. Unlike currently available
pharmacotherapy for chronic stable angina, ranolazine does not produce
clinically meaningful changes in heart rate or blood pressure. A number
of clinical trials have demonstrated the ability of ranolazine to
increase exercise tolerance, decrease weekly anginal episodes, and
decrease sublingual nitroglycerin consumption for breakthrough angina.
Based on the results of these trials, ranolazine recently was approved
by the United States Food and Drug Administration for treatment of
patients with chronic stable angina. Because of ranolazine's
pharmacokinetic and pharmacodynamic profile, pharmacists will have to
play a significant role in patient selection and monitoring.
FDA Licenses Xyntha, a New Hemophilia Treatment
ROCKVILLE, Md., Feb. 21, 2008--The U.S. Food and Drug Administration
today licensed a treatment for hemophilia A, a rare, hereditary
blood-clotting disorder that affects approximately 15,000 individuals,
almost exclusively males, in the United States.
The new treatment, called Xyntha Antihemophilic Factor (Recombinant)
Plasma/Albumin Free, is a genetically engineered version of factor
VIII, a protein essential for the clotting of blood. Factor VIII,
known as an anti-hemophilic factor, is missing or decreased in
patients with hemophilia A.
Xyntha is licensed for the control and prevention of bleeding, which
can occur spontaneously or after an accident or injury in patients
diagnosed with hemophilia A. Xyntha is also licensed to help prevent
surgical bleeding in this patient population.
Xyntha is manufactured using recombinant DNA techniques that enable
scientists to create new DNA strands with specific traits, such as the
capacity to produce a specific protein.
To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are
modified to produce factor VIII. These CHO cells are free from known
infectious agents, and Xyntha undergoes an additional process of viral
inactivation. Also, the culture in which the cells are grown is free
of any human or animal material.
"This product provides an additional treatment option for hemophilia A
patients. This recombinant Factor VIII is produced without additives
from human or animal material, which further minimizes any risk of
infection from the product," said Jesse Goodman, M.D., M.P.H.,
director of FDA's Center for Biologics Evaluation and Research.
In clinical trials, Xyntha was shown to be effective at preventing or
controlling bleeding, including preventing bleeding in surgery, for
hemophilia A patients. Generally, the most frequently reported adverse
reaction was headache. For those receiving Xyntha to prevent bleeding
in surgery, the most frequently reported adverse reaction was fever.
Most adverse reactions reported in either study were considered mild
or moderate in severity.
In addition, two of 89 individuals who received 50 days of treatment
with Xyntha, developed factor VIII inhibitors, which are antibodies
that counteract treatment with factor VIII.
Xyntha is manufactured by Wyeth Pharmaceuticals Inc., located in