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Pipeline Preview for November, 2002

Pipeline Preview for November

From ICAAC: Microbial resistance, preventing herpes transmission at conference forefront

Microbial resistance is a concern in treating urinary tract infection (UTI) and bacteremia. But analysis of data from more than 200 US hospitals in the Surveillance Network Database-USA from 1999 to 2001 demonstrated bloodstream and urinary tract isolates with the potential to cause urosepsis to be very susceptible in vitro to broad-spectrum b-lactams and aminoglycosides. The study results were reported at the 42nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego, CA.

From the ESC Congress: Combination therapy improves LV remodeling in CHF better than monotherapy

Patients with mild chronic heart failure who are treated early on with the beta blocker carvedilol (Coreg) along with the angiotensin-converting enzyme (ACE) inhibitor enalapril demonstrated a significantly greater improvement in left ventricular remodeling than patients receiving either drug alone, according to a 572-patient study presented at the European Society of Cardiology (ESC) Congress in September in Berlin. The results reinforce current treatment recommendations.

From the Stanley Conference: Options expand for bipolar disorder

Studies presented at the Third European Stanley Foundation Conference on Bipolar Disorder in September in Freiburg, Germany, show two newer antipsychotics are each more effective than standard therapy for preventing mania relapse or reducing symptoms.

Inspra (Eplerenone) Pharmacia

NME: Aldosterone blocker approved to treat hypertension

Path still not clear for marketing generic omeprazole

Although a New York court ruled last month that the generic manufacturer KUDCO did not infringe on two AstraZeneca patents relating to the formulation of the antiulcer drug omeprazole (Prilosec), KUDCO cannot move forward because Andrx and Genpharm hold 180-day exclusive marketing rights for various strengths. The court also ruled that Andrx and Genpharm, as well as Cheminor, did infringe on the patents--so the path is not yet clear for generic omeprazole.

From the MTIRS: Anticonvulsant reduces migraine headache frequency

A phase III study presented at the 14th annual meeting of the Migraine Trust International Research Symposium (MTIRS) in September in London showed that topiramate (Topamax) significantly reduced migraine frequency at doses as low as 100 mg/d. The onset of efficacy was observed as early as the first month of treatment. Topiramate is already approved in the United States and worldwide as an

Hepsera (Adefovir dipivoxil) Gilead Sciences

NME: Antiviral approved to treat hepaptitis B

Aripiprazole: First of a new class of antipsychotics (PDF)

Aripiprazole is an investigational atypical antipsychotic that received an approvable status from FDA in September 2002 for the treatment of schizophrenia. The decision on approval could be made as early as the end of this year. Aripiprazole offers a unique mechanism of action as a dopamine system stabilizer. Aripiprazole has been found to be effective in both short-term (4?6 wk) and long-term (26?52 wk) treatment trials. It appears to produce less hyperprolactinemia, weight gain, and extrapyramidal symptoms than other antipsychotics.

HMG CoA reductase inhibitor-induced muscle toxicity: risks, monitoring, and management (PDF)

Although the commonly used HMG CoA reductase inhibitors (statins) are well tolerated and relatively safe, muscle toxicity and rhabdomyolysis can occur with administration and can be severe. This risk is higher with more bioavailable and lipophilic statins. This article summarizes what is known about the etiology of statin-associated muscle toxicity, the risks for each statin, and the current recommendations for monitoring and management.

New FDA commissioner faces major challenges

After months of speculation, in late September the White House finally nominated its lead health policy advisor, Mark B. McClellan, MD, PhD, as the next commissioner of the FDA.

Formularies and higher copays reduce drug outlays

A recent study confirms that multi-tier formularies with higher copays for certain drug categories reduce overall spending on prescription drugs by beneficiaries in employer health plans.

Charging drug representatives for physician visits: Three leadersexplain why and how

Formulary has identified three organizations that recently begancharging pharmaceutical representatives a fee to meet withphysicians. Two of the organizations-Queen City Physicians and thePolyclinic-are physician group practices based in Cincinnati, OH,and Seattle, WA, respectively.

FDA overhauls drug regulation while protecting its turf

Agency plans to consolidate oversight of drugs and biologics and revise program for ensuring high quality pharmaceutical manufacturing

Study examines economic impact of fixed-dose combination therapies for hypertension

Applied Health Outcomes, Tampa, FL-Fixed-dose combination antihypertensive agents may save money for your institution or plan as well as for your patients.

Xendos study: Orlistat plus diet prevents, delays diabetes onset in obese patients

Orlistat (Xenical) in combination with diet and lifestyle changes significantly prevents obese patients from developing type 2 diabetes, say researchers involved in this 4-year study presented at the 9th International Congress on Obesity, Sao Paulo, Brazil. They add that this is the first time a weight loss drug has been shown to prevent or delay the onset of type 2 diabetes in an at-risk population.

How to communicate effectively with your organization's "C" suite - the CFO, CEO, COO (PDF)

Innovative People, Organizations, and Ideas an Interview with Vicki Crane, MBA, RPh, and Mark Teresi, MBA, CPA

Eplerenone: The first selective aldosterone receptor antagonist for the treatment of hypertension (PDF)

Eplerenone is a selective aldosterone receptor antagonist under FDA review for treatment of hypertension. With a high trough-to-peak ratio, it is suitable for once-daily dosing. It significantly reduces blood pressure in patients with mild to severe hypertension and can be used alone or in combination with other antihypertensives. Although chemically related to spironolactone, eplerenone has a lower binding affinity for androgenic and progestogenic receptors than spironolactone, which may translate into a lower incidence of endocrine-related adverse effects. In addition, eplerenone lowers blood pressure particularly well in patients with low-renin, salt-sensitive hypertension, such as African Americans.

Evidence-based medicine: What it is, why to use it, and how to incorporate it into decision-making (PDF)

Sometimes regarded with suspicion, evidence-based medicine is not just a ploy to reduce costs. Rather, it is the best approach to decision-making in modern medical practice. This internationally recognized authority on evidence-based medicine explains what it is, how to use it to make the best clinical decisions, and how to implement it in practice. Sometimes regarded with suspicion, evidence-based medicine is not just a ploy to reduce costs. Rather, it is the best approach to decision-making in modern medical practice. This internationally recognized authority on evidence-based medicine explains what it is, how to use it to make the best clinical decisions, and how to implement it in practice.

Zelnorm (tegaserod maleate)

MME:Second IBS drug approved, this time for constipation predominant illness

Rethinking approaches to reducing medication errors: An examination of 10 core processes (PDF)

Although many organizations have implemented well-intentioned medication error reduction strategies, the authors of this article argue that most approaches don?t address the underlying foundation upon which many errors occur. In this article, they present 10 core process improvements?from ?genericizing? all drug names throughout the hospital/health system to purchasing all single-dose packaging?that they believe could have a significant impact on patient safety if implemented.

Pipeline Preview for September, 2002

as reported September 1, 2002

Kytril Injection (Granisetron HCl) Hoffmann-La Roche

Serotonin 5-HT3 receptor now indicated for prevention/treatment of PONV

Aranesp (Darbepoetin alpha) Amgen

New Indication: Anemia treatment gains postchemotherapy indication

Xyrem (Sodium oxybate (gamma hydrobutyrate [GHB])) Orphan Medical Inc

NME:Abused drug approved for cataplexy in tightly controlled program

Lexapro (Escitalopram oxalate) Forest Laboratories Inc

NME: Single isomer of citalopram approved for treating major depressive disorder

Eloxati (Oxaliplatin) Sanofi-Synthelabo Inc.

NME: Chemotherapy agent to be used in combination for recurrent colorectal cancer

Facts at a Glance (PDF)

Information about Dr. David Shulkin and the Patient Safety Officer Society

New professional society launches: The Patient Safety OfficerSociety

Each month, showcasing innovative people, organizations, or ideas!This month, a new professional society launches?interview withDavid Shulkin, MD, president of the Patient Safety Officer Society

Tegaserod: A 5 HT4 agonist for women with constipation-predominant irritable bowel syndrome (PDF)

Tegaserod maleate (Zelnorm) is the first selective partial 5-HT4 agonist approved by FDA for the short-term treatment of irritable bowel syndrome (IBS) in women whose primary bowel symptom is constipation. To help you prepare for P & T Committee review, this article presents tegaserod?s chemistry and pharmacology, pharmacokinetics, clinical trial results, adverse effects profile, dosing information, cost, and the author?s opinion on its place in therapy.