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).
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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).
Surfactant replacement therapy (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants
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).
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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
A review of select agents in late-stage development for the treatment of arrhythmia, congestive/chronic heart failure, and pulmonary hypertension (PDF) (January 2005)
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.
Researchers conducted a study to determine if self-reported sleep deprivation is associated with an increased risk of coronary events.
In each issue, the Focus On article reviews a newly approved or investigational drug of interest to pharmacy and therapeutics committee members. Because so many readers have told the editors of Formulary that they reference this column frequently when making formulary decisions for their hospitals, health-systems, or managed-care organizations, the editors have compiled this review of all the Focus On articles published in 2004, along with updates on the status of each agent.
As initiatives to legalize the importation of prescription drugs draw more attention, the concern over counterfeit drugs is growing. The possibility of receiving counterfeit drugs has created an emerging dilemma for health-care professionals. FDA is relying on pharmacists to help ensure the integrity of drug products before they reach health-care consumers. Pharmacy and therapeutics committees can play a key role in achieving this goal by reviewing policies for medication acquisition and ensuring that necessary controls are in place to help prevent the acquisition of counterfeit drugs. FDA is also taking steps to help alleviate counterfeiting by mandating bar codes on all hospital drug packaging and implementing electronic pedigree papers to track distribution. FDA leaders project that by 2007, all prescription drugs will be tracked electronically to help ensure their authenticity. Formulary decision-makers, pharmacy directors, and clinicians must continue to be educated about the problem to help prevent counterfeit drugs from polluting the drug supply.
Government, industry provide pharmaceutical policy outlook for 2005; $139 million to advance information technology, records; Rofecoxib hearings point to failures in clinical testing design, decision-making transparency; New guidance for generic drugs clarifies protocol, increases speed to market
New molecular entities: erlotinib, solifenacin, natalizumab
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