Extended-release niacin proved better than ezetimibe in favorably changing carotid intima-media thickness, a measure of atherosclerosis, in high-risk patients who were already receiving a statin.
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New molecular entity: Ecallantide (Kalbitor) was approved in December 2009, to treat hereditary angioedema (HAE).
Middle-aged (35 to 54 years) women are gaining ground on their male counterparts in their prevalence of myocardial infarction (MI) and their cardiovascular risk factor scores, according to an examination of the National Health and Nutrition Examination Survey (NHANES) over time.
Selective serotonin uptake inhibitors present a small but notable increased risk of stroke and death in depressed post-menopausal women, according to a new study.
Researchers have found that 1 in 5 smokers of at least 10 cigarettes a day will make a serious attempt to quit when offered help by health professionals and that the most effective cessation method employs a combination of bupropion SR and nicotine lozenges.
Close to 20% of kidney dialysis patients have an increased chance of significant bleeding because they receive the wrong blood-clot medication after undergoing a procedure to open a blocked artery, the Journal of the American Medical Assn. reports.
There's a direct relationship between children using Medicaid and current and present mental health problems, according to recent federal drug research.
Anticoagulants and antiplatelet agents in late-stage development
Erectile dysfunction and premature ejaculation: underlying causes and available treatments; Focus on roflumilast; Anticoagulants and antiplatelet agents in late-stage development
Towards the end of 2009, FDA launched a new medication safety initiative.
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Heart failure (HF) guideline-recommended aldosterone antagonist therapy was received by less than one-third of eligible patients participating in a quality improvement registry who had been hospitalized for HF.
New formulation: Diclofenac sodium topical solution (Pennsaid) was approved on November 5, 2009, to treat the signs and symptoms of osteoarthritis of the knee.
In early November 2009, FDA approved revisions to the drug label for exenatide (Byetta, Amylin Pharmaceuticals), an injectable glucagon-like peptide-1 agonist for the treatment of type 2 diabetes mellitus.
Roflumilast is a novel, orally active phosphodiesterase 4 inhibitor currently under review by FDA for the treatment of patients with moderate-to-severe COPD.
Recent FDA action (through January 2010) related to testosterone undecanoate injection, telavancin, Ampligen, doxepin, everolimus, aztreonam lysine, erlotinib, TG4010, BSI-201, midazolam, Aimspro, Motorgraft, BHR-100, dextran sulfate
A systematic review into the comparative effectiveness of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), or both, for patients with stable ischemic heart disease and preserved left ventricular (LV) function found that adding an ACE inhibitor to standard treatment can improve outcomes.
New molecular entity: Pralatrexate injection (Folotyn) was approved on September 24, 2009, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
This review examines the underlying causes associated with ED and PE and evaluates currently available treatment options and those under investigation.
The new team heading up FDA will be firmly established and eager to implement new policies and programs. Payers, plans, and formulary committees will be watching key trends that will shape drug development and coverage in 2010:
Generic drugs approved by FDA (through January 2010): Nizatidine oral solution in the 15 mg/mL strength
Dabigatran, a new oral direct thrombin inhibitor, given to patients with atrial fibrillation at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.
Recent FDA approvals (through January 2010) related to Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate
Use of statins over a long period of time was associated with a decreased risk of gallstones followed by cholecystectomy.
Use of fertility drugs does not seem to generally increase uterine cancer risk, however, a Danish study identified small increases in risk from certain fertility drugs used for a longer period.
Even given implementation of information technology, FDA drug approval time has not decreased, according to researchers.
The Infectious Diseases Society of America (IDSA) is calling for development of 10 new antibiotics by 2020
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