Uro-Oncology

Darifenacin (Enablex, Novartis) is a muscarinic antagonist in phase 3 clinical trials for the treatment of overactive bladder (OAB). Darifenacin demonstrates relative selectivity for the M3 muscarinic receptor subtype over the M1 and M2 subtypes. In clinical trials, darifenacin has been compared to placebo for the treatment of symptoms of OAB in adult men and women. Patients treated with darifenacin experienced significantly greater reductions in the number of incontinence episodes per week, nocturnal awakenings, and warning time before micturitions. It appears to have similar efficacy to available anticholinergic agents for the treatment of OAB. Commonly reported adverse events include dry mouth and constipation, and preliminary data suggest that darifenacin may be associated with decreased impairment of salivary flow versus oxybutynin. Darifenacin has not been found to have an effect on the cardiovascular system or cognition in clinical trials. Further research is needed to determine the efficacy of darifenacin compared to other available anticholinergic agents such as oxybutynin and tolterodine, as well as emerging therapies. In addition, further investigation of the adverse effect profile in elderly patients is warranted.

Erectile dysfunction (ED) is now recognized as a common problem in men. Several medical problems, including diabetes mellitus, coronary artery disease, hypertension, and hyperlipidemia are known to increase the likelihood of developing ED. Diagnosis depends on an adequate history and physical examination. Several therapies are now available for the treatment of ED. With the advent of the phosphodiesterase type 5 (PDE5) inhibitors, therapy for ED has become more acceptable for many men. Oral therapy is usually the first-line treatment due to the ease of use and the effectiveness of this therapy. For men who do not respond to or have a contraindication to PDE5 therapy, intrapenile injection therapy, intraurethral therapy, and vacuum devices are effective alternatives.

New molecular entities, new biologics and new formulations

Our recent "ER is a Hit With Insured Americans" news item stirred up some reader response.

New PDE5 inhibitor approved for erectile dysfunction

Recent approvals and FDA actions

Phosphodiesterase inhibitor for the treatment of ED

Data allow MCOs to evalutate their pharmacy services and which drugs should or should not be covered

New HEDIS measures for 2004; President&s New Freedom Commission on Mental Health report; The Commonwealth Fund's report on eroding retiree benefits

Providers and payers benefit from efficient scheduling,vbalanced utilization and adequate staffing

Vardenafil (Levitra, Bayer AG/GlaxoSmithKline) is a selective inhibitor of phosphodiesterase 5 (PDE5) currently under review by FDA for the treatment of erectile dysfunction (ED). If approved, vardenafil will become the third PDE5 inhibitor to be marketed in the United States and the fourth oral agent approved for the treatment of ED. Vardenafil has been studied in subjects of various ages (<45 and >65 years of age), with different etiologies and different baseline severity of ED. Studies evaluating vardenafil have determined it to be safe and effective at doses of 5 mg to 40 mg, including subjects with diabetes mellitus and subjects who have undergone radical prostatectomy. Vardenafil has a pharmacokinetic profile similar to that of sildenafil (Viagra, Pfizer). The drug appears to be well tolerated. In clinical trials, headache, dyspepsia, and flushing were the most common adverse effects reported by subjects taking vardenafil. No adverse hemodynamic or visual effects have been reported during clinical trials of vardenafil; however, further investigation, including post-marketing surveillance, will be required. Further research and clinical experience with the newer PDE5 inhibitors (vardenafil and tadalafil [Cialis, Lilly/ICOS]) will be needed before their roles in the treatment of ED can be determined.

Ranked by total of all payers, 2001

Expert analysis of a debate on cancer screening reveals 63 permutations on points of view. Is it any wonder, then, that the nation has trouble achieving consensus on health care policy?

...then bring the doctors to the men. An on-site screening program at Lockheed addressed that reluctance.

Some tips on deciding which plan or network will consistently produce better outcomes in specialized care.

Addendum questionnaire to June Focus On: Tadalafil

Tadalafil (Cialis) was recently deemed approvable for the treatment of erectile dysfunction (ED). When approved, it will join the widely used PDE5 inhibitor sildenafil citrate as an oral therapy for ED management. Among tadalafil?s characteristics are its rapid onset of action, a duration of action of up to 24 hours, and lack of food influence on the drug?s pharmacokinetics. In this Focus article, the pharmacologic, pharmacokinetic, and therapeutic aspects of tadalafil are reviewed and compared, when possible, with sildenafil and another investigational agent, vardenafil.

Healthcare still has high hopes for the elusive technology

A roundtable discussion with Vincent T. Andriole, MD, Chairperson; Paul B. Iannini, MD; Lionel A. Mandell, MD, FRCPC; Charles H. Nightingale, PhD; Lance R. Peterson, MD

Product Profile

New tools that include IS, Internet processing, ASPs and outsourcing help manage transactions and free resources to focus on core competencies

New formulation: Monthly SC injection form of GnRH agonist for advanced prostate cancer

NME: 5-alpha reductase inhibitor for treatmentof benign prostatic hyperplasia

Fluoroquinolones and nitrofurantoin have surpassed trimethoprim-sulfamethoxazole (TMP-SMZ) as the most frequently prescribed antibiotics for uncomplicated urinary tract infections (UTIs) in women, according to a new national analysis. This is despite well-established recommendations (from the Infectious Disease Society of America and others) that TMP-SMZ is the drug of choice for UTIs due to cost and concerns about antibiotic resistance.

MCOs implement multi-tier benefit to slow drug-spending growth, but future fiscal controls could limit access