FDA's Pulmonary-Allergy Drugs Advisory Committee voted unanimously that the long-acting beta 2-agonists salmeterol (Serevent and Advair, GlaxoSmithKline) and formoterol (Foradil, Novartis) should remain on the market despite concern over reports of asthma-related deaths associated with the use of salmeterol.
Muraglitazar (Bristol-Myers Squibb/Merck) is a new agent under investigation for the treatment of patients with type 2 diabetes. It belongs to a novel class of drugs that target the peroxisome proliferator-activated receptors, both alpha and gamma subtypes. Available clinical data describe improvements in glycemic parameters similar to available thiazolidinediones. In addition to improvements in blood glucose and hemoglobin A (HbA 1c), muraglitazar treatment is associated with a substantial reduction in triglycerides (TGs), an increase in HDL-C, and a modest decrease in LDL-C levels. Safety data are limited, but in available abstracts, there are reports of moderately elevated rates of edema, weight gain, and hypoglycemia with muraglitazar compared with placebo or pioglitazone. When used in combination with metformin or glyburide, chronic heart failure events have been reported with muraglitazar. If approved, muraglitazar will provide a convenient alternative for the treatment of type 2 diabetes. (Formulary. 2005;40:285–293.)
Revised labeling was issued for tadalafil (Cialis, Lilly ICOS), vardenafil (Levitra, Bayer/GlaxoSmithKline/Schering-Plough), and sildenafil (Viagra, Pfizer) to reflect a small number of post-marketing reports of sudden vision loss, attributed to non-arteritic ischemic optic neuropathy (NAION).
One year of bisphosphonate therapy maintains the gains in bone mineral density (BMD) experienced after 1 year of full-length parathyroid hormone (1–84) in postmenopausal women at risk of osteoporotic fracture. The findings were published in the New England Journal of Medicine (2005;353:555–565).
This study compares the cost-effectiveness of the 4 most common empiric antimicrobial regimens used for the treatment of adults with community-acquired pneumonia (CAP) at a community health system during a 6-month period. Associations between initial antimicrobials and total hospital costs were determined. Cost-effectiveness ratios were determined by dividing the total hospital costs by the percent survival. A total of 415 patients met criteria for the Pneumonia Severity Index (PSI) risk class IV or V. Costs (adjusted for inflation) were as follows (median, 25th and 75th percentile): total hospital costs ($5,078 [$3,218–$8,144]), pharmacy costs ($753 [$455–$1,357]), and antibiotic costs ($139 [$82–$229]). The most favorable cost-effectiveness ratio was observed for patients who received levofloxacin monotherapy ($4,635 per life saved), followed by ceftriaxone plus a macrolide ($5,278), ceftriaxone monotherapy ($5,368), and ceftriaxone plus levofloxacin ($6,317).
Desmopressin tablets 0.1 and 0.2 mg (equiv to DDAVP tablets).
Pioglitazone acts primarily by decreasing insulin resistance, while metformin improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose.
Valsartan (Diovan, Novartis) received an expanded indication for reducing cardiovascular mortality in patients who are at high risk due to left ventricular failure or dysfunction after myocardial infarction.
This NSAID is believed to exert its therapeutic effect through inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2). Celecoxib was approved on July 29, 2005, for the relief of the signs and symptoms of ankylosing spondylitis (AS).
Phase 3 clinical trial results have demonstrated that the dual alpha/gamma peroxisome proliferator-activated receptor (PPAR) agonist muraglitazar achieves significant beneficial lipid effects compared with pioglitazone, and the agent also provides long-term glycemic control in type 2 diabetics. The results were reported during the American Diabetes Association (ADA) 65th Annual Meeting in San Diego, Calif.
A review of antipsychotic agents in late-stage development (August 2005).
A study was conducted to evaluate the clinical and economic burden of overactive bladder (OAB) among patients <60 years of age in a managed care population, especially with regard to the prevalence of related comorbidities and associated annual medical costs.
The human monoclonal antibody adalimumab induces significant Crohn's disease remission compared with placebo, according to trial results presented during Digestive Disease Week (DDW) in Chicago, Ill. Adalimumab is approved for the treatment of rheumatoid arthritis.
Phase 3 clinical trial results have demonstrated that the dual alpha/gamma peroxisome proliferator-activated receptor (PPAR) agonist muraglitazar achieves significant beneficial lipid effects compared with pioglitazone, and the agent also provides long-term glycemic control in type 2 diabetics. The results were reported during the American Diabetes Association (ADA) 65th Annual Meeting in San Diego, Calif.
Levothyroxine, a critical medication for millions of Americans, has had a long and turbulent history. In the face of tougher FDA regulations and especially its reclassification as a "new drug" in 1997, manufacturers have struggled to carve out their niche in an expansive market. The principal concern of physicians, patients, endocrinologists, manufacturers, and FDA is levothyroxine's relative bioequivalence. Even after FDA classified several products as bioequivalent, a single brand name product still holds most of the market share, despite the fact that it is more costly. Current issues surrounding levothyroxine include: controversy about research, the number and types of recalls, the lack of a single reference-listed drug for comparison, and conflicting claims about the bioequivalence of various formulations. (Formulary. 2005;40:258–271.)
After months of delay, the Senate confirmed Lester M. Crawford, DVM, PhD, in July as the official head of FDA. Despite efforts by some Senators to hold up the vote pending resolution of some FDA policies, most legislators agreed with Republican and Democratic leaders that the agency would be better off with a permanent chief than without.
Highly resistant strains of both gram-positive and gram-negative bacteria are becoming commonplace in both the inpatient and outpatient setting. Recently developed antimicrobials have targeted resistant gram-positive pathogens, but the problem of resistant gram-negative pathogens remains. Tigecycline (Tygacil, Wyeth) is an injectable antimicrobial and the first in a new class of agents (the glycylcyclines) that possesses activity against key gram-positive and gram-negative bacterial pathogens. Tigecycline overcomes common tetracycline resistance mechanisms and has shown in vitro and in vivo activity against multidrug-resistant organisms. Tigecycline treatment produced clinical and microbiologic outcomes similar to standard comparator agents in patients with complicated skin and skin structure infections and complicated intra-abdominal infections and was approved for these indications in June 2005. The most common adverse events associated with tigecycline's administration during clinical trials were..
FDA approved moxifloxacin (Avelox, Schering-Plough) tablets and injection for the once-daily treatment of adults with complicated skin and skin structure infections (cSSSIs) caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.
Efficacy. The efficacy of ramelteon in the treatment of chronic insomnia was evaluated in 2 randomized, double-blind trials employing polysomnography (PSG).
Alvimopan (Entereg, Adolor/GlaxoSmithKline) for the treatment of postoperative ileus.
A review of agents in late-stage development for the treatment of selected genitourinary disorders (July 2005).
Cyclooxygenase-2 (COX-2)-selective nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely prescribed for patients with arthritis and other conditions because of their lower risk for gastrointestinal adverse events compared with nonselective NSAIDs 1,2
Dapoxetine (Alza/Ortho-McNeil) is a novel oral medication undergoing FDA review for premature ejaculation, one of the most common disorders of sexual dysfunction in men. Dapoxetine is a fast-acting inhibitor of the serotonin reuptake transporter. It has a short half-life and is structurally related to the antidepressant fluoxetine, allowing for on-demand dosing.
Small artery elasticity improves more with coadministration of amlodipine and atorvastatin compared with either treatment alone, said Jay N. Cohn, MD, at the 20th annual meeting of the American Society of Hypertension (ASH) in San Francisco. The additive effect of amlodipine and atorvastatin on small artery compliance may explain the superior clinical cardiovascular outcomes associated with the combination versus monotherapy with either drug.
Kidney transplant recipients on an immunosuppressive regimen of sirolimus plus cyclosporine who had their cyclosporine withdrawn at an early stage had significantly better graft survival than patients who remained on cyclosporine. The advantage appeared to be related to significantly improved kidney function in the patients in whom cyclosporine was withdrawn, reported Graeme Russ, MD, at the American Transplant Congress 2005 in Seattle, Wash.
A study was conducted to determine the cost and patient adher- ence rates of lipid-lowering therapy with an extended-release niacin and lovastatin (ERNL) combination agent versus a separate extended-release niacin and statin (ERN-S) combination or statin monotherapy.
