Formulary Watch |

Exenatide: A novel incretin mimetic hormone for the treatment of type 2 diabetes

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.

FDA actions in brief

A new dosage strength of the fentanyl transdermal system (Duragesic, Alza) was approved for the management of persistent, moderate-to-severe chronic pain requiring continuous opioid administration for an extended period of time that cannot be managed by other drugs. The new patch will deliver 12 mcg of fentanyl per hour.

Cardiac death risk 5x greater with concurrent oral erythromycin and CYP3A inhibitors

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

FDA advisory committees recommend marketing of COX-2 inhibitors with 'black box' warning

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.

Crawford nominated for permanent FDA commissioner role

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.

Prior lack of efficacy with etanercept does not predict lack of efficacy with infliximab

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 and risperidone equally efficacious for treatment of acute exacerbation of schizophrenia or schizoaffective disorder

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.

ACE inhibitors that penetrate the blood-brain barrier may slow Alzheimer's progress

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.

ACE inhibitors reduce all-cause mortality in diabetic nephropathy; data unclear for AIIRAs

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).

Exenatide: A novel incretin mimetic hormone for the treatment of type 2 diabetes

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.

The use of virtual expert panels: formulary decision-making in the 21st century

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).

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Surfactant replacement therapy (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants

First-time generic approvals

Potassium iodide oral solution 65 mg/mL

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New molecular entities: Lunesta

First prescription sleep aid not limited to short-term use

New molecular entities: Ventavis

First inhaled prostacyclin approved for pulmonary arterial hypertension

Cilansetron: A novel 5-HT3 receptor antagonist for the treatment of irritable bowel syndrome

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.

Update on the treatment of benign prostatic hyperplasia

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).

Alpha blockers increase CHF risk in older hypertensive patients; FDA committees to review COX-2 inhibitor risk-benefit profile

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.

Clinical news updates from the 2004 AHA Scientific Sessions

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

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

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

Drug Watch: Agents in late-stage development for the treatment of arrhythmia, congestive/chronic heart failure, and pulmonary hypertension (January 2005) (PDF)

A review of select agents in late-stage development for the treatment of arrhythmia, congestive/chronic heart failure, and pulmonary hypertension (PDF) (January 2005)

Focus on posaconazole: A novel triazole antifungal for the treatment of invasive fungal infections

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

Flexible or semi-flexible schedules of zolpidem treatment PRN are feasible

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.

Optimizing treatment outcomes dependent on appropriate categorization of insomnia

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?

Recent evidence supports safety, efficacy of nonbenzodiazepine hypnotics for long-term treatment of insomnia

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.

Sizable proportion of elementary schoolchildren sleep less than the recommended 9 hours

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

Sleep deprivation may adversely impact neuroendocrine control of appetite

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.

Short self-reported sleep duration associated with increased CHD risk in women

Researchers conducted a study to determine if self-reported sleep deprivation is associated with an increased risk of coronary events.