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All News - Page 216
Medication safety in the limelight
May 1, 2003
FDA proposes bar codes and new error reporting standards as part of an initiative to reduce medication errors
The application of pharmacodynamicsin the optimization of antibiotic therapy (PDF)
May 1, 2003
Pharmacodynamics, the relationship between drug exposure and physiologic effect, helps to differentiate the killing activity of antibiotic classes through various markers of outcome. Antibiotics are characterized by time-dependent or concentration-dependent bacterial killing activity. With antibiotic therapy, pharmacodynamics consists of an intricate relationship between drug exposure, bacterial susceptibility, and the antimicrobial effect of the drug. Due to increasing reports of resistance, many investigators and healthcare institutions are focused on the optimal use of antibiotic therapy. Studies on antimicrobial pharmacodynamics have been increasing in the hope of defining and establishing break points that are associated with various outcome markers to optimize therapy, but the application of these studies in clinical practice is still limited. Incorporating pharmacodynamics into the study of antibiotic therapy can enhance the design of rational and optimal dosing regimens and improve the understanding of the emergence of resistance.
Adalimumab: A fully human monoclonal anti-tumor necrosis factor-alpha antibody (PDF)
May 1, 2003
Adalimumab is the newest addition to a class of medications called tumor necrosis factor-alpha (TNF-a) inhibitors. Adalimumab (Humira, Abbott) is the first fully human monoclonal antibody approved to treat rheumatoid arthritis, distinguishing it from the other TNF inhibitors. FDA approval was received in December 2002, which was earlier than expected, based on clinical trial results that demonstrated a slowed progression of joint damage in addition to an improved quality of life in adalimumab-treated RA patients. Adalimumab has been found to be effective when used alone or in combination with methotrexate and/or other disease-modifying antirheumatic drugs. Existing TNF inhibitors for RA are associated with inconvenient or complicated dosing schedules. Adalimumab offers patients the convenience of an infrequent dosing schedule. In the absence of clinical trials directly comparing adalimumab with other biologic therapies, choice will largely depend on patient factors. Pricing information places adalimumab in line with its competitors.
Coreg (Carvedilol) GlaxoSmithKline
May 1, 2003
b-blocker indicated for reducingcardiovascular mortality
Somavert (Pegvisomant for injection) Pharmacia
May 1, 2003
Growth hormone receptor antagonist to treat acromegaly
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.
Update on the treatment of osteoporosis
April 1, 2003
Osteoporosis affects more than 10 million Americans and accounts for 1.5 million fractures annually. Several treatment options have been shown to prevent fractures and improve outcomes in patients with osteoporosis. Alendronate and risedronate clearly reduce fractures and are good initial choices in many patients. Raloxifene and calcitonin reduce the risk of vertebral fractures and may be appropriate in certain patients. Teriparatide was recently approved by FDA for the treatment of osteoporosis and may offer another treatment option. Combination therapy has been shown to increase bone mineral density; however, a reduction in the risk of fractures remains to be established. Zoledronic acid may offer an advantage of reduced frequency of administration.
Omalizumab appears effective in patients with poorly controlled allergic asthma
April 1, 2003
Omalizumab appears effective in patients with poorly controlled allergic asthma.
New agent reduces PTH levels in hemodialysis patients with secondary hyperparathyroidism
April 1, 2003
New agent reduces PTH levels in hemodialysis patients with secondary hyperparathyroidism.
Prescription coverage debate moves to Capitol Hill (PDF)
April 1, 2003
Congress to weigh Medicare reform plan and patient safety; FDA addresses product risk and quality
Pipeline preview for April 2003
April 1, 2003
Recommendations for approval, approvable designations, Fast-track designations
Xanax (alprazolam extended release)
April 1, 2003
Alprazolam, which was previously approved for the treatment of anxiety and panic disorder, has now received FDA approval as extended-release tablets for the treatment of panic disorder.
Avandia (rosiglitazone)
April 1, 2003
This drug from the thiazolidinedione class is now approved for use incombination therapy with insulin, expanding on the existing indicationsas monotherapy and as combination therapy with metformin or sulfonylureas.Rosiglitazone improves sensitivity to insulin in muscle and adipose tissueand inhibits hepatic gluconeogenesis.
Xalatan (latanoprost ophthalmic solution)
April 1, 2003
FDA approval of this prescription eye drop makes it the first and only prostaglandin with a first-line indication for the treatment of elevated intraocular pressure (IOP) associated with open-angle glaucoma or ocular hypertension. Initially, latanoprost was only approved for second-line use.
Fuzeon (enfuvirtide for injection)
April 1, 2003
Enfuvirtide is the first drug to be approved in a new class of anti-HIV drugs known as fusion inhibitors (see "Focus On... Enfuvirtide"). The drug interferes with the entry of HIV-1 into immune cells by inhibiting the fusion of viral and cellular membranes. This occurs when enfuvirtide prevents conformational changes required for the fusion of viral and cellular membranes by binding to the first heptad-repeat (HR1) in the gp41 subunit of the viral envelope glycoprotein. Enfuvirtide, in combination with other antiretroviral agents, is intended for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Celecoxib shows similar rates of recurrent bleeding to diclofenac plus omeprazole
April 1, 2003
Two options are available for patients requiring treatment for arthritis who are at risk for ulcer disease: nonsteroidal anti-inflammatory drugs (NSAIDs) that are selective for cyclooxygenase-2 (COX-2) or the combination of a non-selective NSAID with a proton-pump inhibitor. A recent study of representative members from these therapeutic classes has offered findings that the two alternatives are statistically similar in their efficacy with respect to the prevention of recurrent ulcer bleeding.Celecoxib, a COX-2-selective NSAID, was given to 144 patients through random assignment. Another group of patients (N=143) were randomly assigned to receive a combination of diclofenac (a nonselective NSAID) plus omeprazole (a proton-pump inhibitor) during the 6-month trial.
Certain prescription cough syrups to be pulled from the market per FDAruling
April 1, 2003
An ingredient in dozens of cough syrups, which the FDA says is not dangerous,never underwent the current drug approval process because it was introducedbefore FDA efficacy guidelines were in place. The drug, extended-releaseguaifenesin, is marketed as an expectorant by 66 companies in prescriptioncough syrups.
Inhaled corticosteroids may carry less risk of BMD reduction in postmenopausal women
April 1, 2003
Corticosteroid therapy is an effective treatment for asthma sufferers, but the use of systemic corticosteroids is known to increase the risk of osteoporotic fractures. A recent study published in the Journal of Allergy and Clinical Immunology suggests that moderate doses of inhaled corticosteroids (ICs) carry less risk than traditional oral corticosteroid (OC) therapy with respect to reduction of bone mineral density (BMD) in postmenopausal women. This assertion is based on the premise that the lowest daily dose of IC sufficient to control the patient's asthma is used.
Enfuvirtide: The first fusion inhibitor for the treatment of patients with HIV-1 infection (PDF)
April 1, 2003
Enfuvirtide (Fuzeon, Roche/Trimeris) is the first member of a unique class of antiretrovirals known as the fusion inhibitors to gain FDA approval for the treatment of human immunodeficiency virus type-1 (HIV-1) infection. Enfuvirtide is indicated for use in combination with other antiretroviral agents in the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. Phase 3 trials demonstrated that adding enfuvirtide 90 mg twice daily to an optimized background regimen chosen with genotypic and phenotypic resistance testing improved the surrogate end points of HIV ribonucleic acid (RNA) levels, CD4 cell counts, and the proportion of patients reaching clinically undetectable HIV RNA levels (<400 and <50 copies/mL) through 24 weeks. Enfuvirtide?s efficacy in treatment-experienced patients when added to an optimized background regimen makes it a promising choice for salvage therapy. Further studies will be required to support enfuvirtide?s use in treatment-naïve patients.
ANDROMEDA study of dronedarone ends due to potential excess risk of death
March 1, 2003
Sanofi-Synthélabo has decided to discontinue ANDROMEDA under advisementfrom its steering committee and the independent Data Safety and MonitoringBoard (DSMB) for the study, the company announced recently. ANDROMEDA wasa double-blind, placebo-controlled study in the process of evaluating theuse of dronedarone in high-risk patients with congestive heart failure andventricular dysfunction. A total of 627 of the intended 1,000 patients hadalready been enrolled in the study.
From the literature: Selective serotonin reuptake inhibitors linked to upper GI tract bleeding
March 1, 2003
Selective serotonin reuptake inhibitors (SSRIs) experienced increased usage in the 1990s due to their low toxicity and minimal adverse effects. Throughout this period, several clinical reports indicated a link between the use of SSRIs and various bleeding disorders. A recent study published in the Archives of Internal Medicine found a distinct correlation between the use of SSRIs and upper gastrointestinal (GI) tract bleeding. The population-based cohort study was conducted within the 490,000 residents of a northern Denmark county over a five-year period.
Singulair (Montelukast)
March 1, 2003
New indications: Leukotriene blocker approved for treatment of seasonal allergic rhinitis
Vardenafil: An oral selective phosphodiesterase 5 inhibitor for the treatment of erectile dysfunction
March 1, 2003
Vardenafil (Levitra, Bayer AG/GlaxoSmithKline) is a selective inhibitor of phosphodiesterase 5 (PDE5) currently under review by FDA for the treatment of erectile dysfunction (ED). If approved, vardenafil will become the third PDE5 inhibitor to be marketed in the United States and the fourth oral agent approved for the treatment of ED. Vardenafil has been studied in subjects of various ages (<45 and >65 years of age), with different etiologies and different baseline severity of ED. Studies evaluating vardenafil have determined it to be safe and effective at doses of 5 mg to 40 mg, including subjects with diabetes mellitus and subjects who have undergone radical prostatectomy. Vardenafil has a pharmacokinetic profile similar to that of sildenafil (Viagra, Pfizer). The drug appears to be well tolerated. In clinical trials, headache, dyspepsia, and flushing were the most common adverse effects reported by subjects taking vardenafil. No adverse hemodynamic or visual effects have been reported during clinical trials of vardenafil; however, further investigation, including post-marketing surveillance, will be required. Further research and clinical experience with the newer PDE5 inhibitors (vardenafil and tadalafil [Cialis, Lilly/ICOS]) will be needed before their roles in the treatment of ED can be determined.
New insights into the treatment of pulmonary arterial hypertension (PDF)
March 1, 2003
Pulmonary arterial hypertension (PAH) is a progressive, debilitating disorder associated with poor quality of life and shortened life span. For many years, medical therapy consisted of calcium channel blockers, warfarin, supplemental oxygen, and digitalis glycosides. A better understanding of the pathophysiology of PAH has led to the recent development of effective treatments for this disorder. Therapeutic agents target the pathophysiologic mechanisms of PAH: pulmonary vasoconstriction, pulmonary vascular remodeling, and in situ thrombosis. With better understanding of the pathogenesis of PAH, recent advances in pharmacotherapy have been introduced for the treatment of PAH. Data are presented on efficacy and safety of newer approved and investigational agents: prostacyclin analogues, oral endothelin antagonists, and phosphodiesterase 5 inhibitors.
