Until 2005, irbesartan was the only ARB available on the Veterans Affairs (VA) healthcare system's national formulary. In 2005, irbesartan was removed from the formulary and was replaced with valsartan and losartan. For those patients who were to continue ARB therapy via a switch to either losartan or valsartan, dosing guidelines were created by the Veterans Integrated System Network 7 to facilitate the change. These guidelines suggested that patients taking irbesartan 150 mg once daily be treated with either valsartan 80 mg or losartan 50 mg once daily and that patients taking irbesartan 300 mg once daily be treated with either valsartan 160 mg or losartan 100 mg once daily. To determine if the dosing guidelines resulted in equal antihypertensive effectiveness, we carried out a retrospective chart review, examining the cases of 86 patients at the William Jennings Bryan Dorn VA Medical Center in Columbia, South Carolina, who had switched from irbesartan to either losartan or valsartan.
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Two tumor necrosis factor-alpha (TNF-alpha) inhibitors, infliximab and adalimumab, are approved by FDA for the treatment of moderate-to-severe Crohn's disease (CD) in patients who have an inadequate response to conventional therapies. Certolizumab is a pegylated TNF-alpha inhibitor being investigated for the treatment of moderate-to-severe CD.
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Biologic treatment of RA associated with increased risk of nonmelanotic skin cancer and melanoma
January 1st 2008The use of biologic treatment for rheumatoid arthritis (RA) is associated with an increased risk of nonmelanotic skin cancer and melanoma, according to a large observational study published that included 13,001 patients.
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Pipeline Preview, January 2008
January 1st 2008FDA-related information through January 2008 on Extended-release ropinirole (Requip XL); Indiplon; Xience V Everolimus Eluting Coronary Stent System; tetrabenazine; vernakalant (Kynapid); gepirone extended-release; lovastatin (Mevacor); bevacizumab (Avastin); tedisamil; rabies monoclonal antibody cocktail; AVI-4658; alfimeprase; Prochymal; aripiprazole (Abilify); bendamustine (Treanda); ATIR; CDX-110; and ISIS 333611
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Wellness incentives engage Americans in their healthcare
January 1st 2008The real potential for the application of incentives, rewards and recognition programs is in the broader context of overall employee health, as well as benefit programs and retirement planning initiatives driven by consumer directed healthcare strategies.
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Wellness incentives engage Americans in their healthcare
January 1st 2008The real potential for the application of incentives, rewards and recognition programs is in the broader context of overall employee health, as well as benefit programs and retirement planning initiatives driven by consumer directed healthcare strategies.
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Only a few months ago, efforts to build a national electronic health information system appeared dead in the water. Now there is growing support on Capitol Hill for legislative action, plus strong statements from the Bush administration backing health information technology (HIT).
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Increased need for pacemaker insertion demonstrated among women treated with amiodarone for AF
December 1st 2007According to the results of a prospective cohort study of 1,005 patients with new-onset atrial fibrillation (AF), women who are treated with amiodarone are at greater risk for bradyarrhythmia requiring pacemaker insertion than men who are treated with the drug.
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Clinical news updates from the 2007 AHA Scientific Sessions
December 1st 2007The 2007 American Heart Association (AHA) Scientific Sessions took place November 3 to 7, 2007, in Orlando, Florida. Among the new data presented were the much anticipated results of a phase 3 trial of prasugrel versus clopidogrel in patients scheduled for percutaneous coronary intervention (PCI). Other clinical trials of note were the first prospective study of a statin in patients with ischemic heart disease and heart failure and a comparison of eptifibatide with abciximab on ST-segment resolution in patients with myocardial infarction (MI) who are undergoing primary PCI. This AHA Special Report details these and other trials.
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Doripenem: A new extended-spectrum carbapenem antibiotic
December 1st 2007Doripenem is a carbapenem antibiotic recently approved for the treatment of complicated intra-abdominal infections (IAIs) and complicated urinary tract infections (UTIs), including pyelonephritis. An NDA has also been submitted for the use of doripenem in the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP). Doripenem is the fourth carbapenem approved for use in the United States and exhibits many pharmacologic similarities with imipenem/cilastatin and meropenem. Doripenem has a broad spectrum of activity against various gram-positive and gram-negative aerobic and anaerobic bacteria, including many multidrug-resistant gram-negative pathogens. Improved potency against nonfermentative gram-negative bacteria has also been demonstrated with doripenem compared with other carbapenems. In clinical trials, doripenem was generally well tolerated; headache, nausea, diarrhea, and phlebitis were the most commonly reported drug-related adverse events. Because doripenem exhibits..
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The use of prophylactic granulocyte colony-stimulating factors (G-CSF) in adult patients with cancer who are receiving chemotherapy is associated with a reduced risk of early death and febrile neutropenia, according to a systematic review and meta-analysis published in the Journal of Clinical Oncology.
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In a retrospective cohort study of 162 primary care practices in the United Kingdom, the use of antibiotics was demonstrated to be effective in preventing serious complications following upper respiratory tract infection (URTI), sore throat, or otitis media; however, the authors stated that the number needed to treat (NNT) to prevent 1 such complication is too high to justify prescription of the drugs for this purpose.
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FDAAA empowers FDA to have greater control over drug safety
December 1st 2007Congress approved the FDA Amendments Act of 2007 (FDAAA) in September after a lengthy debate that resulted in compromises on many issues. The resulting law contains numerous provisions designed to better inform the public about drug safety and provides new tools for FDA to reduce risks and unsafe drug use.
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