Formulary Watch |

New molecular entity: Duloxetine

SSNRI approved for the treatment of major depressive disorder

Drug-eluting stents: A pharmacy management perspective

Current treatment options for acute coronary syndromes as well as chronic stable angina often include the use of percutaneous coronary intervention (PCI) with routine stenting. The clear benefits of stents have lead to their routine use for prevention of restenosis. However, the benefits of stenting demonstrated on some aspects of restenosis are compromised by the induction of restenosis by neointimal hyperplasia that is stimulated by standard bare metal stents. FDA has approved 2 drug-eluting stents (DES). DES create a local delivery system at the vascular site to reduce restenosis by neointimal hyperplasia. Multiple clinical trials have demonstrated the safety and efficacy of the use of DES. This article reviews the use of PCI in coronary artery disease, the evolution and pathophysiology of restenosis, and multiple aspects of DES technology. While DES may not be a direct pharmacy and therapeutics committee responsibility, committee members are being called upon to provide insights into pathway processes for medical technology review committees evaluating DES since these products contain a key pharmacologic component. There are also important adjunctive antiplatelet therapy protocols that need to be developed and adhered to in conjunction with DES in order to ensure optimal outcomes.

Ezetimibe/simvastatin: A combination product for the treatment of hyperlipidemia

Although statins have been shown to reduce LDL-C and coronary heart disease (CHD) morbidity and mortality, it is not uncommon for patients to fail to reach the treatment goals recommended by the National Cholesterol Education Program (NCEP) guidelines. Some statins cannot lower LDL-C sufficiently in FDA-approved doses; other statins cannot be titrated optimally due to potential drug interactions and adverse effects. Ezetimibe/simvastatin(Vytorin, Merck/Schering-Plough) is an intestinal cholesterol absorption inhibitor and statin combination product that received FDA approval in July 2004. The combination has been found to reduce LDL-C and triglycerides by an additional 22% and17%, respectively, and to increase HDL-C by up to 5% compared to statin monotherapy. The 40 mg simvastatin/10 mg ezetimibe dose of the combination product is one of onlya few cholesterol-lowering regimens that can reduce LDL-C >55% and is also one of the most economical. Adding ezetimibe to a statin does not reduce tolerability. Since ezetimibelacks cytochrome P450 isoenzyme interactions, the additional drug interaction risk with combination therapy is low.

Officials seek electronic health information system and pathway for approving generic biotech therapies

Another activity that will support FDA's e-labeling initiative is the establishment of a "paperless label" system.

Glycemic control and pulmonary function sustained throughout long-term use of inhalable insulin

Two studies evaluating the efficacy and long-term safety of the inhalable, rapid-acting dry powder insulin formulation (Exubera, Pfizer/Aventis) demonstrate that the drug was able to sustain glycemic control and pulmonary function in patients with type 2 diabetes

Etanercept/anakinra RA combination therapy has increased risk compared to etanercept monotherapy

Etanercept/anakinra combination therapy for the treatment of rheumatoid arthritis (RA) provides no added benefit and has an increased risk compared to etanercept alone, according to a study published in Arthritis & Rheumatism, the journal of the American College of Rheumatology (ACR).

Initial days of antidepressant therapy associated with greatest risk of suicidal behavior

Four commonly prescribed antidepressants carry an equal risk of quadrupling the chance of suicidal behavior during the first 9 days of treatment, according to a study from the United Kingdom published in the Journal of the American Medical Association. The authors cautioned, however, that the risk is likely only temporary and may be attributed to the time period in which the drugs have not yet taken effect in those patients already considering suicide.

E-prescribing and generic drug access aimed at curbing health-care costs

FDA's paperless e-labeling initiative will allow manufacturers to transmit labeling information electronically to prescribers, pharmacists, and patients.

Imiquimod for superficial basal cell carcinoma

Although the mechanism of action of imiquimod is unknown, an open-label study suggests that the drug may act by increasing the filtration of lymphocytes, dendritic cells, and macrophages into the tumor lesion. Imiquimod was approved on July 14, 2004, for an expanded indication to include the treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults.

New NCEP cholesterol management guidelines recommend lower LDL treatment goals

A newly released update to the National Cholesterol Education Program's (NCEP) guidelines on cholesterol management recommend that clinicians consider more intensive treatment options for patients at high and moderately high risk for heart attack. These evidence-based recommendations include setting lower treatment goals for low-density lipoprotein cholesterol (LDL-C) and initiating cholesterol-lowering drug therapy at lower LDL thresholds.

Ezetimibe/simvastatin

This novel dyslipidemia therapy features a combination of 2 previously approved drugs: ezetimibe and simvastatin. Ezetimibe exerts its effect by selectively inhibiting intestinal cholesterol and related phytosterol absorption. This mechanism of action is complemented by that of simvastatin, which acts through inhibition of the HMG-CoA reductase enzyme. The ezetimibe/simvastatin combination was approved on July 23, 2004, for the treatment of hypercholesterolemia and mixed hyperlipidemia

Focus on ximelagatran: A new oral anticoagulant

Although warfarin is an effective drug in the treatment and prevention of thromboembolism, dosing complexities and drug interactions have led to its underutilization and a desire for an alternative agent. Ximelagatran (Exanta, AstraZeneca) is a novel oral anticoagulant that can be taken in standardized doses without the use of periodic blood monitoring to determine the level of anticoagulation. Large prospective clinical trials have shown ximelagatran to be similar in efficacy compared to the standard of therapy in the prevention and treatment of thromboembolism with similar or lower rates of bleed. Of concern, however, is the fact that that ximelagatran may elevate hepatic enzymes. An NDA was filed for ximelagatran on December 23, 2003, and FDA’s Cardiovascular and Renal Drugs Advisory Committee is scheduled to review the drug for the prevention of stroke and thromboembolism at a meeting on September 10, 2004. This article reviews ximelagatran’s chemistry and pharmacology, pharmacokinetics, clinical trials, adverse effects, drug interactions, and dosage and administration.

Perspectives on empiric and chronic proton pump inhibitor therapy

The number of patients presenting with typical gastroesophageal reflux disease (GERD) symptoms and the prevalence of GERD symptoms in the general population make the prescription of proton-pump inhibitors (PPIs) by primary-care physicians commonplace. An active medication use evaluation (MUE) program that places symptom control as a primary concern can help rationalize PPI drug therapy and improve patient care. A treatment guideline that follows the current practice of empiric therapy, recommends periodic monitoring, and encourages further gastroesophageal evaluation (ie, endoscopy and pH monitoring) for assessing adequacy of treatment and treatment failures is a key component of a successful program.

Incremental tier systems increase member access with less financial exposure for health plans; Innovative health plans have countered increasing drug costs with more complex co-pay structures

Consumer-driven healthcare will greatly influence benefit and co-pay structures over the next decade, HealthTrans leaders predict.

PhRMA opposes VA prices for Medicare

Proposals to allow Medicare to negotiate prices similar to those available to the VA are unjustified, according to PhRMA.

Estrogen/progestin linked with more severe colorectal cancer

According to a study published in the New England Journal of Medicine, short-term use of estrogen plus progestin significantly decreased the risk of colorectal cancer among postmenopausal women; however, for unknown reasons, the colorectal cancers that did develop in the hormone-treated group were diagnosed at a more advanced stage.

Insulin sensitizer has favorable effects on blood pressure, lipids

Pioglitazone was also significantly superior to the other 2 treatment groups in decreasing triglycerides.

Statin therapy should be considered for all patients with type 2 diabetes

A recent study found that atorvastatin at its starting dosage reduces the risk of a first major cardiovascular event in patients with type 2 diabetes, said Helen Colhoun, MD, at the 64th scientific sessions of the American Diabetes Association (ADA) in Orlando.

Incretin mimetics improve glycemic control in type 2 diabetes

Release of GLP-1 in responseto an ingested meal and glucose load plays a major role in the development of impaired insulin secretion.

Normal liver enzymes no reason to withhold antiviral therapy for chronic HCV

At Digestive Disease Week in New Orleans, Steve Flamm, MD, associate professor of medicine and medical director of liver transplantation, Northwestern University, Chicago, Ill, presented study findings indicating that patients with chronic hepatitis C virus (HCV) infection and persistently normal liver enzymes derive as much benefit from pegylated interferon-alfa 2b plus ribavirin therapy as do patients with elevations in serum alanine aminotransferase (ALT). According to Dr Flamm, lead investigator for the study, "... a fraction of patients with normal liver enzymes do have aggressive liver disease on liver biopsy despite their liver tests being normal."

AIDS drug price increase draws fire

Amidst a national focus and heated debate over rising drug costs and price hikes, Abbott Laboratories quadrupled the price in December of its widely used protease inhibitor ritonavir (Norvir) from $1.71 to $8.57 for a 100 mg capsule.

Statin use demonstrates benefits 3 months post-stroke

Three months after the stroke, recovery was significantly higher among the patients who had been taking statins.

Novel antibiotic may prevent travelers' diarrhea

Rifaximin (Xifaxan, Salix), the first nonsystemic, gastrointestinal-selective oral antibiotic to receive approval for the treatment of travelers' diarrhea, is also an effective prophylaxis for travelers' diarrhea, according to data released at Digestive Disease Week in New Orleans.

Peginterferon alfa-2a monotherapy more effective than lamivudine in treatment of chronic hepatitis B

Peginterferon alfa-2a monotherapy demonstrated superior end-of-follow-up response rates to peginterferon alfa-2 in combination with lamivudine.

Rofecoxib use increases congestive heart failure risk compared to celecoxib and nonselective NSAIDs

A study was conducted to assess hospital admission rates for congestive heart failure in patients dispensed cyclooxygenase-2 (COX-2) inhibitors or nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). Researchers at the Institute for Clinical Evaluative Sciences in Toronto, Ontario, Canada, studied patients taking rofecoxib (Vioxx, Merck), celecoxib (Celebrex, Pfizer), and nonselective NSAIDs, with a control group consisting of non-NSAID users who were not given any study drugs. Study findings indicate that, relative to non-NSAID users, patients receiving rofecoxib and nonselective NSAIDs had an increased risk of admission for congestive heart failure than patients taking celecoxib.

TNF inhibitor use associated with granulomatous infectious disease; infliximab poses greatest risk

Tumor necrosis factor (TNF) antagonists increase the risk of granulomatous infectious disease, including tuberculosis, according to a study-the largest of its kind to date-published in the journal Clinical Infectious Diseases. The risk of infection was 3.25-fold greater among patients who received infliximab (Remicade, Centocor) than among those who received etanercept (Enbrel, Wyeth/Amgen), the study found.

New molecular entity: Trospium

The parasympatholytic action of trospium reduces the tonus of smooth muscle in the bladder by antagonizing the effect of acetylcholine on muscarinic receptors. Trospium was approved on May 28, 2004, for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Key issues emerge surrounding pharmaceutical pricing: Consumer groups and politicians keep a close watch on drug prices and discounts, and on PBM Medicare pharmacy cards

Medicare officials predict that beneficiaries will realize more substantial savings as sponsors drop their prices even more.

New molecular entity: Rifaximin

This nonsystemic, gastrointestinal-selective oral antibiotic exerts its effect by binding to the beta-subunit of bacterial DNA- dependent RNA polymerase. Rifaximin was approved on May 25, 2004, for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in patients aged 12 years and older.

Calcium and phosphorus management in chronic kidney disease: Challenges and trends

Common and serious comorbidities in chronic kidney disease include bone and mineral disorders, especially hyperphosphatemia and secondary hyperparathyroidism, and cardiovascular calcification and cardiovascular disease. Managing these complications typically requires the use of phosphate-binding compounds and vitamin D analogues. The selection and use of phosphate-binding agents in particular requires careful consideration of various factors such as calcium load and increased risk of subsequent cardiovascular calcification. Currently available calcium-containing phosphate binders have been demonstrated to contribute to patient calcium loads, and their use in hemodialysis patients has been associated with significant and progressive cardiovascular calcification. Thus, there is increasing interest in the use of calcium-free products, which can effectively bind phosphate without enhancing the risk for cardiovascular calcification.