Formulary June 2008 BPA Statement
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Ambrisentan, a propanoic acid type-A selective endothelin receptor antagonist, improved exercise capacity and delayed clinical worsening in patients with pulmonary arterial hypertension (PAH) in phase 3 clinical trial results presented at the annual international conference of the American Thoracic Society in San Diego, Calif.
The anticonvulsant lacosamide is effective in relieving diabetic neuropathy and produces increased pain reduction with continued treatment for 22 months, according to phase 3 study results presented during the 25th Annual Scientific Meeting of APS in San Antonio, Texas. "This is a promising treatment that maintains a long-term effect," said Tibor Hidvegi, MD, Medical Department, Petz Hospital, Gyor, Hungary.
Morphine extended-release once daily significantly reduced pain among patients with chronic, moderate-to-severe low back pain compared with oxycodone controlled-release twice daily, according to results of a study presented at the 25th Annual Scientific Meeting of the American Pain Society (APS) in San Antonio, Texas. The once-daily opioid also demonstrated significant improvement in sleep scores, said Richard L. Rauck, MD, Carolinas Pain Institute, Winston-Salem, NC.
Valsartan is associated with a reduction in the levels of high-sensitivity C-reactive protein (hs-CRP), the inflammatory marker that is highly predictive of adverse cardiovascular outcomes, independent of its blood pressure-lowering effect, said Paul M. Ridker, MD, MPH, lead investigator of a trial presented at the 21st annual meeting of ASH.
The investigative agent aliskiren, the first orally active renin inhibitor, is an effective antihypertensive agent as monotherapy and in combination with hydrochlorothiazide, reported investigators at the 21st annual scientific meeting of ASH.
Phase 3 clinical trials demonstrated that the once-daily, highly selective beta blocker nebivolol lowers blood pressure in a dose-dependent manner and is well tolerated at all doses, according to presenters at the 21st annual scientific meeting of the American Society of Hypertension (ASH), in New York, NY.
FDA has announced further steps it plans to take to target the sales of counterfeit medications. The agency also rolled out a joint campaign with the Institute of Safe Medication Practices (ISMP) to discourage the use of confusing abbreviations that can potentially cause medication errors.
Diuretics are superior to both calcium channel blockers (CCBs) and, at least in the short term, angiotensin-converting enzyme (ACE) inhibitors in preventing heart failure (HF) in hypertensive patients, according to a follow-up analysis of the largest clinical trial on hypertension to date.
SSRIs demonstrate risk reduction for colorectal tumors dependent on dose level in case-control study
Investigators conducting a population-based, nested case-control study observed an association between the daily dose level of selective serotonin reuptake inhibitors (SSRIs) and a decreased risk of colorectal cancer among patients aged 5 to 85 years old. No consistent association was found between colorectal cancer risk and the use of tricyclic antidepressants (TCAs).
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A double-blind, randomized, placebo-controlled study of the ketolide telithromycin administered orally over a 10-day period to 278 asthma patients demonstrated a reduction in asthma symptoms, but did not show a significant treatment effect on patients' morning peak expiratory flow.
In 2001, off-label drug prescriptions accounted for 150 million (21%) of the estimated 725 million prescriptions written in the United States, according to the 2001 IMS Health National Disease and Therapeutic Index (NDTI). However, according to a study published in the Archives of Internal Medicine, 73% of the off-label medication prescriptions the authors researched (95% CI, 61%–84%) had little or no scientific backing.
Postmenopausal women with prior hysterectomies do not increase their risk of breast cancer incidence with the use of conjugated equine estrogen (CEE), according to a study published in the Journal of the American Medical Association (JAMA).
Focused on a diverse number of areas in the study of gastrointestinal health, Digestive Disease Week (DDW) 2006 in Los Angeles, Calif, yielded important information about the pharmacologic treatment of certain GI cancers and Crohn's disease.
Abatacept (Orencia, Bristol-Myers Squibb) is the first T-lymphocyte co-stimulation modulator to be approved by FDA. The agent is indicated for use in patients with moderate-to-severe, active rheumatoid arthritis who have not had an adequate response to methotrexate, tumor necrosis factor (TNF) inhibitors, or other disease-modifying anti-rheumatic drugs (DMARDs).
A number of clinical approaches are utilized in managing insomnia. Indiplon (Pfizer) is a selective non-benzodiazepine sedative hypnotic under consideration by FDA for the treatment of insomnia. Like other agents in its class, indiplon binds selectively to the GABA-A receptors in the brain, promoting sleep.
Colestipol for oral suspension, 5 g/packet or scoopful (equiv to Colestid)
Approvable designations
FDA approved prednisolone orally disintegrating tablets (Orapred ODT, BioMarin/Alliant) for acute exacerbations of asthma as well as for persistent, severe asthma and for inflammation associated with certain conditions. It is the first orally disintegrating tablet formulation of prednisolone available in the United States.
Quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine
A review of agents in late-stage development for the treatment of depression (July 2006).
Tiotropium use in patients with chronic obstructive pulmonary disease (COPD) exacerbation led to decreased health resource utilization (HRU) and improved airflow limitation, according to a randomized, double-blind, multicenter, parallel group study published in the European Respiratory Journal.
A review of agents in late-stage development for the treatment of atherosclerosis and thrombosis (June 2006).
The activity of varenicline in the aiding of smoking cessation is believed to be the result of the agent's action at a sub-type of the nicotinic receptor where it acts as an agonist while simultaneously preventing nicotine binding to alpha 4 beta 2 receptors. Varenicline was approved on May 10, 2006, as an aid to smoking cessation treatment.
Federal Trade Commission (FTC) officials say they are concerned about an increasing trend of pharmaceutical companies paying makers of generic medications to delay marketing competitive products. FTC commissioner Jon Leibowitz, JD, has criticized "reverse payment" settlements, which involve a branded manufacturer compensating a generic medications manufacturer for agreeing to delay marketing efforts for a generic product until the innovator's patent expires.
The blockbuster drugs of the 1990s came off-patent, became generic, and now several of them have become available OTC. Others are expected to join the ranks in the next few years.
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