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.
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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 related to medication safety and reliability (ie, boxed warnings, dear healthcare provider letters)
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In a prospective, observational study, exposure to protease inhibitors (PIs) was associated with an increased risk of myocardial infarction (MI). The authors stated that this association is partly explained by dyslipidemia.
In this multicenter, randomized, open-label trial, it was demonstrated that among patients whose diabetes was not well controlled with either a sulfonylurea or metformin alone, the addition of rosiglitazone (n=2,220) did not increase the risk of cardiac-related hospitalization or death compared with patients who received metformin plus a sulfonylurea (n=2,227).
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
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As a result of the broad spectrum and enhanced potency of the carbapenems, this class of agents has long been held in reserve in an attempt to avoid the development of pathogen resistance to this important group of antimicrobials.
As a result of the broad spectrum and enhanced potency of the carbapenems, this class of agents has long been held in reserve in an attempt to avoid the development of pathogen resistance to this important group of antimicrobials.
First-time generic drug approval: amlodipine/benazepril capsules
A review of agents in late-stage development for the treatment of asthma (July 2007).
In a nested case-control study, the use of low-to-moderate doses of aspirin (ASA) in women was associated with a significant reduction in all-cause mortality.
New research presented at the Digestive Disease Week 2007 regarding the effect of statins on hepatitis C infection.
In the Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) study, initial treatment of hypertension with a fixed-dose, dual-drug combination demonstrated "unprecedented" levels of control at 18 months.
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