Drug Pipeline

This novel echinocandin antifungal exerts its antibiotic activity by inhibiting the synthesis of 1,3-?-D-glucan, an essential component of fungal cell walls.

This novel echinocandin antifungal exerts its antibiotic activity by inhibiting the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls.

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Ziprasidone (Geodon, Pfizer) and risperidone (Risperdal, Janssen) are equally efficacious in the treatment of patients with acute exacerbation of schizophrenia and schizoaffective disorder, with ziprasidone demonstrating a lower movement disorder burden and less effect on prolactin concentrations and weight than risperidone.

A number of clinical approaches are utilized in managing the overlapping aspects of poor glycemic control in patients with type 2 diabetes. Exenatide (Amylin/Lilly), a novel drug in a new medication class known as the incretin mimetic agents, offers a new mechanism to achieve glycemic control.

Concurrent use of oral erythromycin and strong inhibitors of CYP3A should be avoided, according to research published in The New England Journal of Medicine.

Despite unanimity in the belief that the COX-2 selective nonsteroidal anti-inflammatory drugs (NSAIDs) significantly increase cardiovascular risk, FDA's Arthritis and Drug Safety and Risk Management Advisory Committees have advised FDA that the risk/benefit profile of the previously approved COX-2 inhibitors support the marketing of these agents in the United States.

President George W. Bush recently nominated Lester M. Crawford, DVM, PhD, to take the permanent role of FDA commissioner after serving as acting or deputy administrator since February 2002.

A study conducted by researchers at the University of Wisconsin, Stanford University, and several rheumatology clinics across the United States found that rheumatoid arthritis (RA) patients who do not receive sufficient benefit with etanercept may experience improved disease control by switching to infliximab.

Ziprasidone (Geodon, Pfizer) and risperidone (Risperdal, Janssen) are equally efficacious in the treatment of patients with acute exacerbation of schizophrenia and schizoaffective disorder, with ziprasidone demonstrating a lower movement disorder burden and less effect on prolactin concentrations and weight than risperidone.

Researchers have found that angiotensin-converting enzyme (ACE) inhibitors that penetrate the blood-brain barrier (BBB) appear to reduce the incidence of Alzheimer's disease (AD) in elderly patients with hypertension.

A meta-analysis demonstrates that angiotensin converting enzyme (ACE) inhibitors provide a survival benefit in patients with diabetic nephropathy, whereas no such evidence exists for angiotensin II receptor antagonists (AIIRAs).

A number of clinical approaches are utilized in managing the overlapping aspects of poor glycemic control in patients with type 2 diabetes. Exenatide (Amylin/Lilly), a novel drug in a new medication class known as the incretin mimetic agents, offers a new mechanism to achieve glycemic control.

Evidence-based medicine is the driving philosophy for pharmacy and therapeutics (P&T) committee decision-making. When the available evidence is incomplete or unclear, the decision-making process becomes complex. Evaluation of the published literature to make sound decisions regarding appropriate medication use can be a time-consuming process. The use of expert panels or subcommittees may facilitate decision-making; however, this process is often limited by the schedules and time constraints of busy clinicians. This article describes the creation and utilization of a "virtual" panel of experts utilizing anonymous electronic communications to assist the P&T committee at a university-based teaching hospital in making medication use policy. The article includes a detailed description of the P&T committee's experience in the selection of virtual panel members, methods used, advantages, potential pitfalls, and the outcomes of a virtual committee used to evaluate the appropriateness of the off-label use of nesiritide (Natrecor, Scios).

Potassium iodide oral solution 65 mg/mL

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First prescription sleep aid not limited to short-term use

First inhaled prostacyclin approved for pulmonary arterial hypertension

If approved, cilansetron (Calmactin, Solvay Pharmaceuticals) would be the second selective 5-HT3 antagonist introduced for the treatment of irritable bowel syndrome (IBS). Based on 2 main clinical trials, cilansetron 2 mg orally 3 times daily appears to be effective in the relief of IBS-D symptoms (abdominal pain/discomfort) and abnormal bowel habits in both male and female patients. Adverse effects were minor, with constipation being the most commonly reported adverse effect. No information is currently available on cilansetron's potential for drug interactions, need for dose adjustments in renal or hepatic insufficiency, long-term safety, or cost. Cilansetron was granted priority review status by FDA on September 1, 2004, for the treatment of diarrhea-predominant IBS in men and women. Currently marketed agents for the treatment of IBS are only approved for use in female patients.

Benign prostatic hyperplasia (BPH) is a common chronic disease, with the incidence of BPH increasing with age. Histopathologic features are present in almost half of all men aged >60 years. The disease can have a profoundly negative impact on patients' quality of life, often causing them to limit or avoid basic activities of daily living. Many patients who develop BPH will seek treatment for bothersome lower urinary tract symptoms (LUTS).

A community-based study confirmed that alpha antagonist monotherapy for the treatment of hypertension is associated with an increased risk of congestive heart failure (CHF) compared to thiazide diuretic monotherapy. Study authors stated that this increased risk is only partly explained by differences in blood pressure control. The increased risk was observed in women but not in men in this prospective cohort study.

The American Heart Association (AHA) Scientific Sessions comprise the largest meeting of its kind held in the cardiovascular field, with several thousand presentations given each year. The recently concluded 2004 AHA Scientific Sessions, which took place in New Orleans, included presentations of trials that evaluated potential therapeutic compounds, as well as widely used and accepted compounds in new dosages or combinations, for the treatment of cardiovascular disorders. The compilation of clinical news that follows focuses on the cardiovascular pharmacotherapy trials of greatest interest to formulary decision-makers, including: CREATE, PEACE, A-HeFT, PROTECT, CLEAR Platelets, DIPOM, GEMINI, SHIELD, and RIO-NA.

COX-2 inhibitors associated with varying risk of MI

Secretary Tommy G. Thompson resigns, EPA administrator Michael Leavitt nominated replacement; HHS purchases 1.2 million doses of flu vaccine

Serious infections due to the Aspergillus and Candida species and other filamentous fungi have emerged as an increasing cause of infectious morbidity and mortality in the United States and globally. The most notable explanation for this increase is a rise in the number of immunocompromised patients due to advances in transplantation, the emergence and prevalence of Acquired Immunodeficiency Syndrome (AIDS), and an increase in the number of invasive surgical procedures. 1-3 Treatment of these infections with currently available standard antifungal agents such as amphotericin B, itraconazole, and fluconazole still results in an unacceptably high associated mortality. 3. Furthermore, many of these antifungal agents have limitations, including dose-limiting toxicity, drug-drug interactions, and fungal resistance. 4-10

Three studies comprising more than 3,000 primary-care patients sought to demonstrate that flexible or semi-flexible dosing of zolpidem 10 mg was effective and safe in a general practice context.

There is a growing interest in the study of insomnia; this is reflected in emerging trends in clinical management and increased research. One key question is being asked: Is insomnia a symptom or a disease?

Long-term insomnia is a substantial problem. Of the 50% of the population that report sleep difficulties, up to 36% report symptoms of insomnia lasting more than 1 year.

Approximately 11%-12% of elementary school children experience daytime sleepiness, and up to 21% have fatigue during the school day.

Sleep plays an important role in energy homoeostasis. A study was conducted to test the hypothesis that circulating levels of leptin are influenced by sleep duration.