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IMS v Ayotte: NH's Prescription Information Law is constitutionalThe Federal Court of Appeals for the First Circuit in a 2 to 1 decision held that New Hampshire's Prescription Information Law "that among other things prohibited certain transfer of physicians' prescribing histories for use in detailing" regulates conduct, not speech, thereby removing "the challenged portions of the statute from the proscriptions of the First Amendment."
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IMS v Ayotte: NH's Prescription Information Law is constitutionalThe Federal Court of Appeals for the First Circuit in a 2 to 1 decision held that New Hampshire's Prescription Information Law "that among other things prohibited certain transfer of physicians' prescribing histories for use in detailing" regulates conduct, not speech, thereby removing "the challenged portions of the statute from the proscriptions of the First Amendment."
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Rivaroxaban: A direct factor Xa inhibitor for VTE prophylaxis in patients undergoing total knee or hip replacement surgeryRivaroxaban is a highly potent direct factor Xa inhibitor that is pending FDA approval for the indication of venous thromboembolism (VTE) prophylaxis in patients undergoing total knee replacement or total hip replacement surgery.
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A review of antithrombotic therapies in acute coronary syndrome: Should unfractionated heparin be replaced?Cardiovascular disease afflicts more than 71.3 million people in the United States and accounts for more deaths annually than any other cause. The estimated direct and indirect costs associated with cardiovascular disease in 2006 ($403 billion) were more than double the costs associated with cancer ($190 billion), which is the second-leading cause of death in the United States.
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A review of antithrombotic therapies in acute coronary syndrome: Should unfractionated heparin be replaced?Cardiovascular disease afflicts more than 71.3 million people in the United States and accounts for more deaths annually than any other cause. The estimated direct and indirect costs associated with cardiovascular disease in 2006 ($403 billion) were more than double the costs associated with cancer ($190 billion), which is the second-leading cause of death in the United States.
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A review of antithrombotic therapies in acute coronary syndrome: Should unfractionated heparin be replaced?Cardiovascular disease afflicts more than 71.3 million people in the United States and accounts for more deaths annually than any other cause. The estimated direct and indirect costs associated with cardiovascular disease in 2006 ($403 billion) were more than double the costs associated with cancer ($190 billion), which is the second-leading cause of death in the United States.
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Cetuximab as an add-on to leucovorin, fluorouracil, and oxaliplatin for stage 3 colon cancer adds no benefitA new study seems to indicate that adding cetuximab to the standard therapy for resected stage 3 colon cancer provides no additional benefits.
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Phthalate exposure during pregnancy increases odds of preterm deliveryPregnant women exposed to environmental phthalates are at an elevated risk of preterm delivery, according to a recent study in JAMA Pediatrics.
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72nd American Diabetes Association Scientific Sessions: Clinical updates review findings on risk of malignancy with pioglitazone, as well as various risk factors associated with insulin glargine useA review of drug therapies and research presented at the 2012 Scientific Session of the American Diabetes Association.
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Arformoterol: The first nebulized long-acting beta2-adrenergic agonistBronchodilators play an important role in the management of stable chronic obstructive pulmonary disease (COPD). Although bronchodilators do not prevent the decline in lung function in patients with COPD, their efficacy in improving disease-related symptoms, reducing the frequency and severity of disease exacerbations, and improving patients' quality of life has been demonstrated in clinical trials. Arformoterol, the (R,R)-enantiomer of the selective beta2-agonist formoterol, is a potent, highly specific, nebulized long-acting beta2-adrenergic agonist recently approved by FDA for the long-term maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. In 2 large, 12-week, phase 3 studies, arformoterol demonstrated an efficacy superior to that of placebo and comparable to that of salmeterol in patients with COPD. In these trials, arformoterol was well tolerated, with a safety profile similar to that of other inhaled long-acting beta2-agonists when used at..
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Statin use may be linked to increased cataract riskA recent study indicates that patients taking statins have a higher risk of developing cataracts.
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A drug use evaluation of amphotericin B lipid complex injection following institution of new treatment guidelines at a tertiary teaching medical centerA 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..
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Certolizumab pegol: A pegylated anti-TNF-alpha antibody fragment for the treatment of Crohn's diseaseTwo tumor necrosis factor-alpha (TNF-alpha) inhibitors, infliximab and adalimumab, are approved by FDA for the treatment of moderate-to-severe Crohn's disease (CD) in patients who have an inadequate response to conventional therapies. Certolizumab is a pegylated TNF-alpha inhibitor being investigated for the treatment of moderate-to-severe CD.
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Management of epoetin alpha use in the intensive care unit: a drug use evaluationThis 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.)
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Management of epoetin alpha use in the intensive care unit: a drug use evaluationThis 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.)
Latest:
Management of epoetin alpha use in the intensive care unit: a drug use evaluationThis 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.)
Latest:
Arformoterol: The first nebulized long-acting beta2-adrenergic agonistBronchodilators play an important role in the management of stable chronic obstructive pulmonary disease (COPD). Although bronchodilators do not prevent the decline in lung function in patients with COPD, their efficacy in improving disease-related symptoms, reducing the frequency and severity of disease exacerbations, and improving patients' quality of life has been demonstrated in clinical trials. Arformoterol, the (R,R)-enantiomer of the selective beta2-agonist formoterol, is a potent, highly specific, nebulized long-acting beta2-adrenergic agonist recently approved by FDA for the long-term maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. In 2 large, 12-week, phase 3 studies, arformoterol demonstrated an efficacy superior to that of placebo and comparable to that of salmeterol in patients with COPD. In these trials, arformoterol was well tolerated, with a safety profile similar to that of other inhaled long-acting beta2-agonists when used at..
Latest:
Pramipexole: A nonergot-derived dopamine agonist for the treatment of restless legs syndromeDrugs that act to increase dopamine activity are the mainstay of pharmacologic treatment for restless legs syndrome (RLS), a sensomotor disorder that usually manifests as an urge to move the legs, with or without other uncomfortable sensations.
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Apixaban: An orally active factor Xa inhibitor to prevent strokes and systemic embolism in patients with nonvalvular atrial fibrillationApixiban (Eliquis) is an orally active factor Xa inhibitor. Its manufacturers are seeking FDA approval to market apixaban to reduce risk of stroke and systemic embolism in patients with nonvalvular AF (NVAF).
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FDA takes steps to automate drug registration; Plan B OTC availability still an area of contentionFDA 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.
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Performing a pharmacoeconomic analysis of a disease management pathway or guidelineIn these tight economic times, hospitals and managed care organizations are looking to eliminate unnecessary costs.
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The treatment of acute severe asthma in the adult: an overviewAsthma is a chronic inflammatory disease of the airways affecting 5%–7% of the US and European populations. It accounts for nearly 400,000 hospitalizations and 5,000 deaths per year. Acute asthma comprises those asthmatics with severe symptoms, despite attempts at appropriate control. Typically these patients will present to a local emergency department for evaluation and treatment. This review examines the pharmaceutical treatment options made available to these patients in emergency settings, including their risks, benefits, side effects and overall effectiveness. (Formulary 2003;38:537–543.)
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The treatment of acute severe asthma in the adult: an overviewAsthma is a chronic inflammatory disease of the airways affecting 5%–7% of the US and European populations. It accounts for nearly 400,000 hospitalizations and 5,000 deaths per year. Acute asthma comprises those asthmatics with severe symptoms, despite attempts at appropriate control. Typically these patients will present to a local emergency department for evaluation and treatment. This review examines the pharmaceutical treatment options made available to these patients in emergency settings, including their risks, benefits, side effects and overall effectiveness. (Formulary 2003;38:537–543.)
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Lumiracoxib A COX-2 inhibitor for the treatment of arthritis and acute painLumiracoxib (Prexige, Novartis) appears to be the next COX-2 specific inhibitor that will be marketed in the United States. Currently, lumiracoxib is being studied for the treatment of osteoarthritis, rheumatoid arthritis, and acute pain. Lumiracoxib has been shown in vitro to be more selective for the COX-2 isoenzyme compared to rofecoxib and celecoxib, but clinical head-to-head studies between these agents are lacking. Small controlled trials, presented in abstract form, have shown lumiracoxib to have comparable efficacy to diclofenac and celecoxib in osteoarthritis. It has an adverse effect profile similar to other COX-2 inhibitors and superior to traditional NSAIDs concerning gastrointestinal safety, but cardiovascular and renal safety data are still not available. While existing clinical data on lumiracoxib are minimal and only published in abstract form, research is ongoing, including comparing lumiracoxib to ibuprofen and naproxen in the largest arthritis trial undertaken to date. When the results of this study are published, lumiracoxib?s efficacy and safety profile will be better understood. (Formulary 2003;38:528?536.)
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Panic Disorder: A pharmacological armamentariumPanic 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.)
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Panic Disorder: A pharmacological armamentariumPanic 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.)
Latest:
Panic Disorder: A pharmacological armamentariumPanic 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.)
Latest:
Panic Disorder: A pharmacological armamentariumPanic 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.)
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Palonosetron: A novel 5-HT3 receptor antagonist for chemotherapy-associated nausea and vomitingNausea 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.)
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Palonosetron: A novel 5-HT3 receptor antagonist for chemotherapy-associated nausea and vomitingNausea 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.)
