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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.

Anticoagulant bridging: Prosthetic heart valves, labeling changes, and limiting issues of liability

With enoxaparin?s recent labeling change regarding its use in patients with prosthetic valves, clinicians may have several questions about appropriate anticoagulant selection. Specifically, what evidence prompted the labeling change, which patients are affected, what are the options and limitations for bridging patients, what?s the evidence supporting the role of low molecular weight heparins (LMWHs) in bridge therapy, and how can liability be limited should clinicians choose to use LMWH therapy? The authors of this commentary offer their insight on these issues.

Senate backs legislation easing access to generic drugs and to cheaper imports

Instead of adopting a Medicare pharmacy benefit plan in July, the Senate approved legislation designed to make pharmaceuticals less expensive for all consumers. The House and Senate, however, remain far from agreement on any final legislation involving pharmaceutical coverage and regulation, and time is running out for action before the Congressional elections this November.

Diovan (Valsartan) Novartis

ARB now indicated for heart failure

Voriconazole: A novel azole antifungal agent (PDF)

In late May, voriconazole (Vfend) received approval for the treatment of invasive aspergillosis and as salvage therapy for treatment of Scedosporium apiospermum and Fusarium infections. In addition to these infections, voriconazole has excellent invitro activity against both Candida and Aspergillus species, including good activity against fluconazole- and itraconazole-resistant species. This Focus article reviews the antifungal's pharmacology, pharmacokinetics, efficacy in clinical trials, safety, dosing, price, and place in therapy.