As Congress continues to work towards the reauthorization of the Prescription Drug User Fee Act (PDUFA), drug safety is once again at center stage after reports of serious cardiovascular problems associated with GlaxoSmithKline's diabetes drug rosiglitazone (Avandia).
Statins and fibrates reduce the risk of peripheral neuropathy in patients with type 2 diabetes independent of the agents' effects on lipids, according to results presented at the 67th annual scientific sessions of the American Diabetes Association.
The use of pioglitazone in patients with renal dysfunction, type 2 diabetes, and macrovascular disease can reduce the risk of death, nonfatal myocardial infarction (MI), and stroke according to results presented at the 67th annual scientific sessions of the American Diabetes Association.
Rosiglitazone did not demonstrate an increased risk of hospitalizations and death from cardiovascular causes (the composite end point) in an interim analysis of a prospective study.
A pooled analysis involving 1,748 patients in 4 randomized trials contradicts the results of recent trials that have demonstrated that the risks for death and myocardial infarction (MI) are potentially higher in patients receiving drug-eluting stents (particularlysirolimus-eluting stents) compared with patients receiving bare-metal stents.
In a small, retrospective, case-control study, it was demonstrated that aspirin (ASA) improved 7-day survival in patients with cancer who developed acute coronary syndrome (ACS), with or without thrombocytopenia.
The results of the Standard and New Antiepileptic Drugs (SANAD) trial, an unblinded, randomized, controlled, 2-arm study comparing the efficacy of various epilepsy drugs showed that for treatment of patients with partial seizures, lamotrigine demonstrated superior efficacy.
A greater percentage of patients at high risk for cardiovascular disease are likely to reach target low-density lipoprotein cholesterol (LDL-C) levels with initial treatment with rosuvastatin than with atorvastatin or simvastatin, according to the results of the Satisfying Optimal LDL-C ATP III Goals with Rosuvastatin (SOLAR) trial.
In a multicenter, randomized, double-blind, controlled trial, investigators demonstrated that in patients whose asthma was well controlled with the use of fluticasone twice daily, switching to fluticasone plus salmeterol once daily did not increase the rates of treatment failure, but switching to montelukast once daily resulted in a 60% increased risk of treatment failure.
In a 6-month, randomized, double-blind study, use of budesonide/formoterol as both maintenance and reliever therapy was demonstrated to provide better asthma control than either salmeterol/fluticasone plus terbutaline as needed or a fixed maintenance dose of budesonide/formoterol plus terbutaline as needed.
Use of naproxen or celecoxib does not prevent Alzheimer's disease (AD), at least within the early years after treatment initiation, according to a randomized, placebo-controlled, multicenter study.
Three-year results of the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial show that a single, annual intravenous infusion of zoledronic acid can decrease risk of vertebral fracture by 70% and the risk of hip fracture by 41% among women with osteoporosis.
Atrial fibrillation (AF) is a disorder that affects >2 million people in the United States. Firstline antiarrhythmic agents (per American College of Cardiology/American Heart Association/European Society of Cardiology guidelines) that are currently used to treat recent-onset AF work by indiscriminately blocking various ionic channels, thereby inducing a prolonged ventricular action potential duration or possibly inducing ventricular arrhythmias in the presence of myocardial ischemia because of excessive conduction slowing in diseased cardiac tissue. Vernakalant is an atrial-selective, potassium and sodium-channel-blocking agent awaiting FDA approval for the indication of conversion of recent-onset AF to normal sinus rhythm.
Andrew von Eschenbach, MD, has faced a number of tough issues since he was sworn in as FDA's commissioner in December 2006, not the least of which is drug safety. Fewer new drugs have been coming to market, and pressure continues to mount for FDA to do more with limited resources. Legislation to reauthorize user fees for pharmaceutical and medical device manufacturers has to be approved by Congress by September 30, 2007, or FDA will have to lay off hundreds of staff members. The need for speedy legislative action has focused public attention on agency operations and policies, a trend likely to continue as the nation's healthcare system and prescription drug costs become a central issue in next year's presidential elections.
Briefs of FDA actions/approvals of drugs, doses, and indications
First-time generic approvals, August 2007
The latest FDA action (through August 2007) related to rimonabant (Zimulti), guanfacine extended-release (Intuniv), risperidone (Risperdal), maraviroc, sitaxsentan (Thelin), HCV-796, docetaxel (Taxotere Injection Concentrate), raltegravir (Isentress), topotecan (Hycamtin), ixabepilone, cetuximab (Erbitux), leukocyte interleukin (Multikine), pafuramidine, ALTU-135
Amlodipine/valsartan, a combination of calcium-channel blocker and angiotensin II receptor antagonist is now approved by FDA for the treatment of hypertension
Pregabalin, an anticonvulsant agent, is now approved by FDA for the management of fibromyalgia.
Ambrisentan, an endothelin-receptor antagonist is now approved by FDA for the treatment of PAH
Rising use of digital technologies and the Internet in the past decade has led to a dramatic explosion in the collection and use of personal data. While electronic use of information provides numerous benefits, it also poses various risks, such as identity theft and security breaches.
Employers are looking for ways to improve quality and affordability. Early identification and consumer engagement strategies help minimize an employer's risk of an employee becoming a high-risk and unproductive employee.
The economics and the politics behind the major healthcare problems affecting men, such as cardiovascular disease, cancer, obesity and depression, aren't receiving the attention they deserve. It has been the rule that women make health decisions for themselves and also for their male partners and their children. In contrast, most men have a more casual attitude toward their care: "if it ain't broke, don't fix it."
For years, surgeons and other specialists working at hospitals were at the financial mercy of administrators. While it was true that these physicians were the ultimate authority on clinical care, the decisions about equipment, more staff and other important aspects of treating patients were often out of their hands. With departments wrestling each other for precious few dollars, their requests were frequently denied.
Roughly 150,000 Americans traveled abroad for care in 2005, and many more are expected to follow suit in the next few years. Medical tourism, once associated mainly with cosmetic procedures, now represents an attractive alternative for consumers to obtain hip replacement, heart procedures and other surgical interventions at a lower cost than what the United States can offer.
Newly diagnosed patients with chronic conditions wait an average of 105 days until someone reaches out to them with disease management support. Precious time is lost, affecting their health, attitude and openness to change.
Providing patients with safe, effective and affordable prescription drugs is a continuous challenge for health plans and insurers. These efforts rely heavily on the decisions made by the Food and Drug Administration (FDA) in determining which new drugs come to market and how those medicines perform when used in real-world healthcare settings.
Ahearing before a federal district court this summer will most likely conclude the 14-year Texas class action case of Frew v. Hawkins. This class action suit was filed in 1993 by a group of mothers who were dissatisfied with the medical treatment that their children received-children who qualified for, but allegedly did not receive, full preventive care and treatment under Medicaid laws. As states enact changes to ensure full compliance with these laws, MCOs will see the effects on Medicaid provider networks, reimbursement rates and reporting requirements.
Recently, there has been a slight decline in HMO enrollment, according to industry experts. PPOs are gaining share.
NATIONAL REPORTS-For chronically ill patients, increased cost sharing can be associated with lower rates of drug treatment, less adherence among existing users and more frequent d iscontinuation of therapy, according to research published in a recent issue of the Journal of the American Medical Assn.
