Formulary Watch |

Early, intensive statin therapy reduces risk of death and cardiac events in patients hospitalized for ACS

Intensive statin therapy administered to patients within 14 days of hospitalization for acute coronary syndrome (ACS) can reduce the risk of death and certain cardiovascular events by nearly 20%, according to a meta-analysis by Eddie Hulten, MD, MPH, and colleagues recently published in Archives of Internal Medicine.

Focus on 2006: A year of novel pharmacologic agents in review

So far this year, Formulary has examined 10 newly approved or investigational drugs of interest to pharmacy and therapeutics committee members through our "Focus on" articles. Because many readers have expressed that this information is useful when making formulary decisions for their hospitals, health systems, or managed care organizations, Formulary has compiled this late-year review of these new and emerging agents, along with updates on the regulatory status of each.

FDA advises about potential attenuation of anti-platelet effect of low-dose aspirin with concomitant use of ibuprofen

FDA recently released an information sheet advising healthcare professionals about a potential pharmacodynamic interaction between low-dose aspirin (81 mg/d) and ibuprofen 400 mg when they are dosed concomitantly. This interaction may attenuate aspirin's anti-platelet cardioprotective effect in patients taking aspirin for secondary prevention of myocardial infarction.

Rimonabant: A novel CB1 receptor antagonist for the treatment of obesity

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.

New meta-analyses evaluate effect of COX-2 inhibitors on renal and CV events, including arrhythmia

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.

Pipeline Preview (November 2006)

Lisdexamfetamine (NRP104, Shire/New River Pharmaceuticals) for the treatment of pediatric attention-deficit/hyperactivity disorder (ADHD)

FDA Actions in Brief

FDA granted 2 additional indications for rituximab (Rituxan, Genentech/Biogen Idec) in the treatment of patients with CD-20-positive, B-cell non-Hodgkin's lymphoma (NHL). The agent is now approved as first-line treatment of previously untreated patients with follicular NHL in combination with cyclophosphamide, vincristine, and prednisolone (CVP) chemotherapy, and in the treatment of patients with low-grade NHL with stable disease, or in those with partial or complete response following first-line treatment with CVP chemotherapy.

First-time generic approvals (November 2006)

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

Infliximab

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.

Vorinostat

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.

Von Eschenbach a step closer to confirmation

Von Eschenbach a step closer to confirmation

Chicago dining guide

Chicago Dining Guide

AMCP images

Images for AMCP show daily

Faculty scheduled to attend AMCP Educational Conference, Oct. 2006

Faculty scheduled to attend AMCP Educational Conference, Oct. 2006

Tips can aid Medicare beneficiaries in 'doughnut hole'

Recent reports of Medicare Part D beneficiaries who have been caught in the doughnut hole have related how some have cut back on medications.

Pharmacy benefit trends, other industry topics to be explored at AMCP Educational Conference

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.

Less CABG bleeding observed with enoxaparin compared with unfractionated heparin after PCI

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.

High-dose statin therapy displays benefit in preventing cardiovascular events compared with standard doses

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.

High-dose statin therapy displays benefit in preventing cardiovascular events compared with standard doses

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.

Valsartan appears more effective than amlodipine in preventing HF, diabetes in patients with hypertension

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.

Oral isotretinoin therapy linked to abnormalities in serum lipid, transaminase levels

Abnormality of triglyceride values was most severe in patients during treatment compared with baseline measures.

Infliximab

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

Von Eschenbach closer to approval as FDA head; CMS Administrator McClellan departing

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.

Clozapine patients exhibit higher risk for metabolic syndrome

Patients taking clozapine for schizophrenia should be regularly monitored because of an increased risk for metabolic abnormalities, according to a study published in the American Journal of Psychiatry.

Isotretinoin may trigger IBD in subgroup of patients

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.

Topical calcipotriol/betamethasone dipropionate achieves quicker response against psoriasis compared with biological therapies

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 demonstrates reduction of stroke incidence in patients experiencing recent stroke or TIA

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.

DMARD treatment reduces risk of acute MI in RA patients, but current biologic use carries increased risk

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.

Effect of a medication assistance program on clinical outcomes in patients with diabetes

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: Emerging efficacy and safety data and clinical considerations

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.