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A year of novel pharmacologic agents in review
November 1st 2005In each issue, Formulary's "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 so far in 2005, along with updates on the status of each agent.
Pre-meal inhaled insulin lowers HbA1c levels more effective than rosiglitazone
November 1st 2005Inhaled insulin (Exubera, Pfizer/Sanofi-Aventis) could be an effective therapy and alternative to rosiglitazone (Avandia, GlaxoSmithKline) for individuals who are early into the course of type 2 diabetes, according to a study published in Diabetes Care.
A pharmacotherapeutic review of treatment options for infertility in women
October 1st 2005The growing trend for women to wait later in life before having their first child has placed many women at a higher risk for difficult conception. There are numerous classes of medications available to assist women who have been diagnosed with infertility.Agents that are used in the treatment of infertility include: clomiphene citrate, aromatase inhibitors, gonadotropins, chorionic gonadotropins, gonadotropin-releasing hormone, gonadotropin-releasing hormone agonists, gonadotropin-releasing hormone antagonists, follitropins, and other miscellaneous agents. Medications chosen for a patient will vary depending on the identified cause of the infertility. Additionally, economic factors will play a role. It is important for healthcare professionals to be aware of treatment options and have a basic understanding of the role these medications play in the treatment of infertility. (Formulary. 2005;40:329–341.)
Ranolazine: An update on the novel antianginal agent
October 1st 2005Ranolazine (Ranexa, CV Therapeutics) is a partial fatty acid oxidase inhibitor that increases the amount of ATP produced from glucose and increases the ability of the myocardium to retain functionality despite a reduced oxygen supply. Ranolazine is under FDA review for the treatment of chronic stable angina (CSA). Ranolazine was first reviewed in the August 2003 issue of Formulary. Since the initial review of ranolazine by FDA, additional data have emerged that merit an update in this journal. Clinical trials have demonstrated the efficacy of ranolazine as both monotherapy and combination therapy in patients with CSA. Recently published clinical trials (MARISA and CARISA) have shown an improvement in symptom-limited exercise duration. The results of the ERICA trial demonstrated a reduction in weekly anginal attacks when ranolazine was added to maximum-dose amlodipine therapy. Headache and generalized weakness were the most commonly reported adverse events in clinical trials. Prolongation of the QT interval has raised concerns; however, a lack of development of ventricular tachyarrhythmias-specifically Torsade de Pointes-remains an important safety finding. (Formulary. 2005;40:323–328.)
Muraglitazar: A dual peroxisome proliferator-activated receptor agonist
September 1st 2005Muraglitazar (Bristol-Myers Squibb/Merck) is a new agent under investigation for the treatment of patients with type 2 diabetes. It belongs to a novel class of drugs that target the peroxisome proliferator-activated receptors, both alpha and gamma subtypes. Available clinical data describe improvements in glycemic parameters similar to available thiazolidinediones. In addition to improvements in blood glucose and hemoglobin A (HbA 1c), muraglitazar treatment is associated with a substantial reduction in triglycerides (TGs), an increase in HDL-C, and a modest decrease in LDL-C levels. Safety data are limited, but in available abstracts, there are reports of moderately elevated rates of edema, weight gain, and hypoglycemia with muraglitazar compared with placebo or pioglitazone. When used in combination with metformin or glyburide, chronic heart failure events have been reported with muraglitazar. If approved, muraglitazar will provide a convenient alternative for the treatment of type 2 diabetes. (Formulary. 2005;40:285–293.)
Bisphosphonate maintains BMD gains achieved with parathyroid hormone
September 1st 2005One year of bisphosphonate therapy maintains the gains in bone mineral density (BMD) experienced after 1 year of full-length parathyroid hormone (1–84) in postmenopausal women at risk of osteoporotic fracture. The findings were published in the New England Journal of Medicine (2005;353:555–565).
Cost-effectiveness of 4 empiric antimicrobial regimens in patients with community-acquired pneumonia
September 1st 2005This study compares the cost-effectiveness of the 4 most common empiric antimicrobial regimens used for the treatment of adults with community-acquired pneumonia (CAP) at a community health system during a 6-month period. Associations between initial antimicrobials and total hospital costs were determined. Cost-effectiveness ratios were determined by dividing the total hospital costs by the percent survival. A total of 415 patients met criteria for the Pneumonia Severity Index (PSI) risk class IV or V. Costs (adjusted for inflation) were as follows (median, 25th and 75th percentile): total hospital costs ($5,078 [$3,218–$8,144]), pharmacy costs ($753 [$455–$1,357]), and antibiotic costs ($139 [$82–$229]). The most favorable cost-effectiveness ratio was observed for patients who received levofloxacin monotherapy ($4,635 per life saved), followed by ceftriaxone plus a macrolide ($5,278), ceftriaxone monotherapy ($5,368), and ceftriaxone plus levofloxacin ($6,317).
Dual peroxisome proliferator-activated receptor agonist demonstrates significant lipid benefits
August 1st 2005Phase 3 clinical trial results have demonstrated that the dual alpha/gamma peroxisome proliferator-activated receptor (PPAR) agonist muraglitazar achieves significant beneficial lipid effects compared with pioglitazone, and the agent also provides long-term glycemic control in type 2 diabetics. The results were reported during the American Diabetes Association (ADA) 65th Annual Meeting in San Diego, Calif.