Drug Pipeline

Obesity is on the rise in the United States, with 60.5% of the adult population overweight and 23.9% obese as of 2005. Up to 10% of an industrialized country's healthcare budget often can be spent on obesity and associated comorbidities.

Two recent analyses published in the Journal of the American Medical Association (JAMA) evaluating the adverse risks of cyclooxygenase-2 (COX-2) inhibitors offered continued support for the 2004 decision to remove rofecoxib from world markets. The research also demonstrated a lack of association between celecoxib and adverse cardiovascular and renal effects.

Levonorgestrel and ethinyl estradiol tablets, 0.15/0.03 mg (equiv to Seasonale tablets)

Infliximab acts through the inhibition of tumor necrosis factor (TNF)-alpha, which is responsible for the induction of inflammatory cytokines, the enhancement of leukocyte migration, and the activation of neutrophil and eosinophil functional activity. Infliximab was approved on September 27, 2006, for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

This agent targets the overexpression of histone deacetylase (HDAC) or the aberrant recruitment of HDACs to oncogenic transcription factors in cancer cells. Vorinostat was approved on October 6, 2006, for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease following 2 systemic therapies.

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The Academy of Managed Care Pharmacy's (AMCP) 2006 Educational Conference begins at noon Oct. 4 at the Hyatt Regency, Chicago. Attendees from healthcare organizations, government agencies, academia and the pharmacy industry will be exploring the fast-changing issues driving pharmacy benefit design.

A 0.5-mg/kg dose of a low molecular weight heparin, enoxaparin, resulted in less non-coronary-artery bypass grafting (CABG) bleeding compared with unfractionated heparin in the first 48 hours after elective percutaneous coronary intervention (PCI), according to a prospective, open-label, multicenter, randomized trial reported in the New England Journal of Medicine.

Intensive lipid lowering with high-dose 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) provides a significant benefit over standard-dose statin therapy in preventing nonfatal cardiovascular outcomes and also may reduce the incidence of cardiovascular death, according to results of a meta-analysis published in the Journal of the American College of Cardiology.

Intensive lipid lowering with high-dose 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) provides a significant benefit over standard-dose statin therapy in preventing nonfatal cardiovascular outcomes and also may reduce the incidence of cardiovascular death, according to results of a meta-analysis published in the Journal of the American College of Cardiology.

An angiotensin receptor blocker (ARB) valsartan-based regimen offered advantages over a calcium channel blocker (CCB) amlodipine-based regimen in preventing heart failure (HF) and diabetes in patients with hypertension, according to results of an analysis published in Hypertension.

TNF inhibitor approved for inhibiting joint damage, improving physical function in psoriatic arthritis

Although acting FDA Commissioner Andrew von Eschenbach, MD, has been on the job since September 2005, it was only last month that he received approval from the Senate's Health, Education, Labor and Pension (HELP) committee for his nomination as FDA commissioner to be considered by the full Senate. However, the step was an incremental one at best for Dr von Eschenbach and the agency, which has been without an officially appointed commissioner for all but 18 months over the past 5? years.

A review of adverse event data associated with the synthetic vitamin A retinoid isotretinoin between 1997 and 2002 suggests that the acne treatment is a "probable" cause of inflammatory bowel disease (IBD) and may precipitate its presentation within a certain subset of patients who are either predisposed to the disease or have subclinical symptoms.

An ointment containing calcipotriol (50mcg/g) plus betamethasone diproprionate (0.5mg/g) demonstrated significant efficacy against psoriasis within 4 weeks compared with 12 weeks of biological therapy, regardless of disease severity, as measured by the Psoriasis Area and Severity Index (PASI), according to a meta-analysis recently reported in the International Journal of Dermatology.

Atorvastatin reduced the overall incidence of strokes and cardiovascular events in patients without known coronary disease who had recently experienced a stroke or a transient ischemic attack (TIA), according to a randomized, placebo-controlled, double-blind study of 4,731 patients. Results from the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study, however, also demonstrated an increase in the incidence of hemorrhagic strokes among those receiving atorvastatin compared with placebo.

Disease-modifying antirheumatic drugs (DMARDs) reduce the risk of acute myocardial infarction (MI) in patients with rheumatoid arthritis (RA), according to results of an observational study published in the journal Arthritis & Rheumatism.

Approximately 17 million people in the United States have type 2 diabetes, and the prevalence continues to rise.1 More than 45% of patients with end-stage renal disease have type 2 diabetes as an etiology, and a patient with type 2 diabetes has the same risk of developing an acute coronary syndrome (unstable angina, myocardial infarction [MI]) over the next 10 years as someone who has had an acute coronary syndrome in the past.2 In addition to these complications, type 2 diabetes also increases the risk of blindness, neuropathy, and amputation.3

Drug-eluting stents (DES) represent an innovative application of pharmaceutical technology that has piqued the interest of hospital and managed care decision-makers. Since their introduction to the US market in 2004, the sirolimus- and paclitaxel-eluting stents have featured drugs employing different mechanisms of action to reduce the risk of restenosis following percutaneous coronary intervention (PCI) in an attempt to improve cardiovascular outcomes.

Despite the variety of medications available to treat type 2 diabetes, the disease is inadequately controlled in many patients. In order to improve glycemic control, manufacturers are pursuing compounds that affect the incretin hormones that stimulate insulin release in response to increased glucose levels. Although stimulation of the incretin receptors by the glucagon-like peptide-1 (GLP-1) enhances the body's ability to produce insulin in response to elevated blood glucose concentrations, the clinical usefulness of GLP-1 is limited by its rapid degradation by dipeptidyl peptidase-IV (DPP-IV). Drug companies have developed compounds intended to act as inhibitors of DPP-IV. Vildagliptin (Galvus, Novartis) is the second DPP-IV inhibitor under investigation by FDA to offer this new mechanism to achieve glycemic control. An NDA for vildagliptin was submitted to FDA in March 2006, 1 month after the submission of the first DPP-IV inhibitor, sitagliptin.

Trimipramine capsules, 25, 50, and 100 mg (equiv to Surmontil capsules)

Antiepileptic approved in an injectable formulation

First antifungal approved for prevention of invasive fungal infections caused by Aspergillus species

A drug use evaluation at Wake Forest University Baptist Medical Center (WFUBMC) was initiated following a change in institution-approved guidelines for the administration of amphotericin B lipid complex injection (ABLC) (Abelcet, Enzon). This study was conducted to determine compliance with the new guidelines among prescribers and to characterize the population of patients receiving ABLC. A total of 153 patients received ABLC from April 2001 through December 2002. One hundred thirty-three patients (87%) met 1 or more of the institutional criteria for ABLC administration and 20 (13%) receiving ABLC did not meet the guidelines. The mean baseline serum creatinine (SCr) value among patients meeting institutional guidelines (n=133) was 2.0 mg/dL (range, 0.5–5.0 mg/dL). Among patients who did not meet the guidelines (n=20), the mean baseline SCr level was 1.7 mg/dL (range, 0.6–2.9 mg/dL). The use of new guidelines, which were less stringent than previous guidelines, resulted in earlier administration..

This study evaluates the appropriateness and cost implications of using epoetin alpha for transfusion reduction in Hartford Hospital's (Hartford, Conn) intensive care units (ICUs), with the goal of implementing a protocol for use in this setting. We conducted a literature review to determine the efficacy, safety, and clinical outcomes of epoetin alpha for transfusion reduction in the ICU. We also evaluated the safety and supply of red blood cell (RBC) transfusions and the cost considerations of epoetin alpha. The literature review demonstrated that epoetin alpha can reduce blood transfusions in the ICU setting but its use provided no difference in mortality or any other clinical outcome. Our epoetin alpha expenditure for transfusion reduction was $112,067 annually to theoretically save $14,349 in blood transfusion costs. The pharmacy and therapeutics (P&T) committee subsequently recommended that epoetin alpha not be used for transfusion reduction in the ICUs and requested that a drug use evaluation (DUE) be performed to monitor compliance, adverse effects, and cost avoidance. One year after implementation of the epoetin alpha DUE program, the compliance rate was >90%, there were no reported adverse events with blood transfusions or problems with blood supply, and a cost avoidance of $104,562 was realized. (Formulary. 2006;41:442?449.)

FDA issued a proposed rule late last month that would allow pharmaceutical manufacturers to register and list products electronically in an effort to minimize the paper-based element of the process, allowing the agency to host a comprehensive national database of medications and to be more flexible in its role of monitoring the safety of medications for sale, according to officials.

Intravenous (IV) moxifloxacin followed by oral (PO) moxifloxacin, both dosed once-daily, is at least as effective in the treatment of complicated intra-abdominal infections (cIAIs) as piperacillin-tazobactam and amoxicillin-clavulanate comparator regimens dosed multiple times per day, researchers reported in the Annals of Surgery.

Three studies presented at the 10th International Conference on Alzheimer's Disease and Related Disorders in Madrid, Spain, yielded new data regarding the relationship between diabetic and pre-diabetic conditions and the subsequent development and treatment of Alzheimer's disease (AD).

The selective estrogen-receptor modulator (SERM) raloxifene reduces the risks of invasive breast cancer and vertebral fracture in postmenopausal women but also increases the risks of venous thromboembolism and fatal stroke, a study in the New England Journal of Medicine (NEJM) concluded.

Raloxifene, a second-generation selective estrogen receptor modulator (SERM) approved to treat osteoporosis, fared as effectively against breast cancer as tamoxifen in 2 related comparison studies published in the Journal of the American Medical Association (JAMA).