Formulary Watch |
All News - Page 215
Statin therapy decreases risk of macrovascular disease and death in diabetic patients
August 1, 2003
Individuals with diabetes are more prone to cardiovascular morbidity and mortality. However, because their low-density lipoprotein (LDL) cholesterol is similar to that of the general population, they do not usually receive statin or other cholesterol-lowering therapy.
Ezetimibe labeling updated to include additional safety information
August 1, 2003
The product label for ezetimibe (Zetia, Merck/Schering-Plough) has been revised to include hypersensitivity reactions, including rash and angioedema, as part of the adverse reactions section, according to Schering-Plough. The companies submitted an updated product label to FDA in April based on post-marketing surveillance, and the new label entered the market in July.
Coxibs not always cost-effective for treating chronic arthritis
August 1, 2003
Cyclooxygenase-2 selective inhibitiors, better known as coxibs, may not be cost-effective for treatment of chronic arthritis pain in patients at average risk for ulcer complications as compared with nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), according to a study recently published in the Annals of Internal Medicine. Using a coxib versus a NSAID cost an incremental $275,809 per year to gain 1 additional quality-adjusted life-year (QALY). For patients with a history of bleeding ulcers, however, the incremental cost per QALY gained decreased to $55,803.
Fondaparinux comparable to LMWHin preventing venous thromboembolism
August 1, 2003
Fondaparinux (Arixtra, Organon/Sanofi-Synthelabo) is at least as effective and safe as the low molecular weight heparin (LMWH) dalteparin for the prevention of venous thromboembolism (VTE) following major abdominal surgery, according to results from the Pentasaccharide in General Surgery Study (PEGASUS). Fondaparinux is the first and only synthetic selective Factor Xa inhibitor indicated for the prophylaxis of deep vein thrombosis (DVT).
Ranolazine: A novel metabolic modulator for the treatment of chronic stable angina
August 1, 2003
Current medical therapy for chronic stable angina (CSA) is targeted at reducing the frequency of anginal symptoms and improving exercise tolerance by increasing myocardial oxygen supply and/or reducing myocardial oxygen demand. Pharmacological therapy for CSA is limited since traditional agents provide pain relief by reducing the work of the heart or dilating arterioles in an attempt to enhance supply. Combinations of these agents can induce profound reductions in blood pressure that limit the aggressive dosing needed in some patients. Metabolic modulators seek to overcome this issue through a novel mechanism of action. Ranolazine (Renexa, CV Therapeutics) is a partial fatty oxidase (pFOX) 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. (Formulary 2003;38:461?476)
Reducing cardiovascular risk in patients with type 2 diabetes: Management of dyslipidemia
August 1, 2003
Patients with diabetes are at extremely high risk for cardiovascular disease. Because glucose control is associated with only modest reductions in macrovascular complications, efforts must be made to specifically target other cardiovascular risk factors. Diabetes is associated with a characteristic lipid profile: low high-density lipoprotein cholesterol (HDL-C) and high triglyceride levels with or without high low-density lipoprotein cholesterol (LDL-C) levels. This profile is also found in patients with early-onset coronary heart disease and correlates with increased atherogenesis. Multiple clinical trials have demonstrated that lipid-modifying therapy in patients with diabetes decreases cardiovascular risk. Management targeting all lipid abnormalities may represent the best treatment strategy since many patients with diabetes do not have elevated LDL-C levels. Combining lipid-modifying agents is also an attractive option for normalizing multiple lipid abnormalities. (Formulary 2003;38:478-497)
Review of Alzheimer's disease treamtent at 8 Omicare long-term care treatment facilities in Minnesota
July 1, 2003
Alzheimer's disease currently has no cure and is estimated to cost in excess of $100 billion per year.
Lescol and Lescol XL (Fluvastatin) Novartis
July 1, 2003
Statin indicated for reduction in the risk of recurrent cardiac events
Doxorubicin-related CHF more frequent than previously reported
July 1, 2003
The utility of doxorubicin is limited by the risk of cumulative, dose-related, progressive myocardial damage.
Atomoxetine displays long-term efficacy in adult patients with ADHD
July 1, 2003
Long-term treatment of 384 adults ADHD patients with atomoxetine (Strattera, Lilly) showed that 67% responded with at least a 30% improvement and 40% had at least a 50% improvement.
Inappropriate metformin use is common in hospitalized patients
July 1, 2003
Metformin use in hospitalized patients is inappropriate more than one-third of the time.
Inhaled insulin superior to rosiglitazone in patients with uncontrolled type 2 diabetes
July 1, 2003
Premeal dosing of inhaled insulin may represent a valuable option for patients with type 2 diabetes.
Eszopiclone treats chronic insomnia without increasing dose
July 1, 2003
Results of a 6-month phase 3 trial using the non-benzodiazepine eszopiclone in 788 patients with chronic insomnia showed improved sleep maintenance versus placebo.
Lescol and Lescol XL (fluvastatin)
July 1, 2003
Statin indicated for reduction in the risk of recurrent cardiac events
Flumist (intranasal influenza virus vaccine, live)
July 1, 2003
First nasally delivered flu vaccine approved
Panic Disorder: A pharmacological armamentarium
July 1, 2003
Panic disorder is the most common anxiety disorder in the primary-care setting. It is characterized by episodes of acute, unexpected, and unprovoked anxiety and is often associated with depression and/or agoraphobia. Symptoms may become so pervasive that many life situations may be avoided. Management of panic disorder includes cognitive behavioral therapy, patient education, and pharmacotherapy. This article focuses on the rationale of drug therapy, methods of management, and other clinical considerations such as side effects. In addition, newer formulations are available that may subsequently change how patients are managed. Selective serotonin reuptake inhibitors (SSRIs) are considered first-line therapy, with tricyclic antidepressants (TCAs) as a possible alternative if the patient fails to respond. These agents are also useful in the management of comorbid depression. Benzodiazepines offer more rapid anxiolysis and may be used in combination with an SSRI for bridging. Although monoamine oxidase inhibitors (MAOIs) have been studied, they do not have a significant role in the pharmacological management of panic disorder. (Formulary 2003;38:431?38.)
Palonosetron: A novel 5-HT3 receptor antagonist for chemotherapy-associated nausea and vomiting
July 1, 2003
Nausea and vomiting are among the serious complications of chemotherapy and can be associated with medical and psychological complications. Palonosetron (Aloxi, MGI Pharma/Helsinn) is a new agent in the class of serotonin type 3 (5-HT3) receptor antagonists that have become a standard of care for the prevention of chemotherapy-induced nausea and vomiting. Palonosetron has a much longer half-life (~40 h) than typical 5-HT3 receptor antagonists and potentially improved efficacy in the prevention of delayed nausea and vomiting associated with moderately and highly emetogenic chemotherapy. Clinical trials of palonosetron in patients with cancer demonstrate its efficacy in the control of acute nausea and vomiting and its superiority to 2 agents in this class, dolasetron and ondansetron, in the control of delayed nausea and vomiting. Palonosetron is well-tolerated, with an adverse effect profile similar to other 5-HT3 antagonists. Its efficacy in the prevention of both acute and delayed nausea and vomiting makes palonosetron an attractive option for patients receiving chemotherapy. Further studies need to be conducted to determine the role of palonosetron among its competitors. (Formulary 2003;38:414?430.)
Pharmaceutical marketing practices and generic drugs in the spotlight
July 1, 2003
Formulary committees, pharmacy benefit managers (PBMs), pharmacists, and physicians face increased scrutiny of their relationships with pharmaceutical manufacturers under a final fraud policy statement from the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS).
Making the move: Bringing pharmacy benefit management in-house
July 1, 2003
Controlling the rate of growth in prescription drug expenses continues to be a challenge. The cost of offering healthcare insurance benefits, including prescription drug benefit programs, has increased to a rate of nearly 20% in 2003. Costs are expected to rise by double digits over the next 5 years. This daunting trend has influenced HMOs and other benefit providers to consider moving pharmacy benefit management in-house to cut costs.
A clinical review of montelukast in the treatment of seasonal allergic rhinitis (PDF)
June 1, 2003
Seasonal allergic rhinitis is a disease characterized by sneezing, nasal congestion, rhinorrhea, and itching, conventionally treated with intranasal corticosteroids and antihistamines. The leukotriene receptor antagonist montelukast (Singulair, Merck) recently gained FDA approval for the treatment of seasonal allergic rhinitis. While studies have shown the efficacy of montelukast in the treatment of seasonal allergic rhinitis, there are no published clinical efficacy trials to date to support the use of montelukast alone or in combination with antihistamines as a superior therapy to intranasal corticosteroids in the management of seasonal allergic rhinitis. When combined with current economic considerations, the primary role of montelukast appears to be as an adjunct agent in patients whose seasonal allergic rhinitis symptoms cannot be controlled with intranasal corticosteroids or nonsedating antihistamines alone.
Zymar (Gatifloxacin ophthalmic solution, 0.3%)
June 1, 2003
Fluoroquinolone approved for bacterial conjunctivitis
Vigamox (Moxifloxacin ophthalmic solution, 0.5%)
June 1, 2003
Broad-spectrum antibiotic available as ophthalmic solution
Velcade (Bortezomib for injection) Millennium
June 1, 2003
Multiple myeloma treatment represents new class: proteasome inhibitors
Iressa (Gefitinib) ASTRAZENECA
June 1, 2003
Treatment for lung cancer patients unresponsive to chemotherapy
Micafungin: A new echinocandin antifungal (PDF)
June 1, 2003
A new echinocandin, micafungin (Mycamine, Fujisawa), is currently under review for the treatment of systemic mycoses. If approved, micafungin would be the second agent in the echinocandin class available for use in the United States. It is believed to exhibit fungicidal or fungistatic activity against a variety of commonly encountered fungal pathogens including Candida and Aspergillus species. In addition to its broad spectrum of activity, initial clinical studies with micafungin have identified relatively few side effects and drug interactions. Micafungin exerts its antifungal activity at the level of the fungal cell wall via inhibition of 1,3 b?d-glucan synthase. Plasma concentrations follow a 2-compartment model with a half-life of 10 to 15 hours and a volume of distribution of 0.2 to 0.27 L/kg. Dose adjustments of micafungin due to hepatic or renal dysfunction appear to be unnecessary. Adverse events associated with micafungin are infrequently encountered and are generally mild in severity. Micafungin has been available in Japan since late 2002 and is also currently under review in Canada and Europe. Micafungin may offer advantages over other recently approved antifungal agents because of its excellent tolerability and minimal drug interactions.
The application of pharmacodynamics in the optimization of antibiotic therapy
May 1, 2003
Antibiotic therapy has undergone enormous changes since the discovery of penicillin by Sir Alexander Fleming in 1928. 1. Today, clinicians face increasing reports of antibiotic resistance. Optimizing antibiotic regimens can maximize effectiveness and minimize adverse effects while decreasing the likelihood of the development of resistance. The task of designing optimal antibiotic dosing regimens incorporates pharmacodynamics (PDs), pharmacokinetics (PKs), and microbiological principles. PKs consist of absorption, distribution, metabolism, and excretion, with these parameters reflecting drug exposure over time. The relationship between drug exposure and the physiologic effect of the drug encompasses the principles of PDs. With antibiotic therapy, PDs incorporate exposure to the antibiotic and antimicrobial effect. The intricate relationship between these principles enhances the understanding of the efficacy of antibiotic therapy.
