March 1st 2022
Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
The application of pharmacodynamics in the optimization of antibiotic therapy
May 1st 2003Antibiotic 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 1st 2003Osteoporosis 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.
Xalatan (latanoprost ophthalmic solution)
April 1st 2003FDA 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 1st 2003Enfuvirtide 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.
Enfuvirtide: The first fusion inhibitor for the treatment of patients with HIV-1 infection (PDF)
April 1st 2003Enfuvirtide (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.
From the literature: Selective serotonin reuptake inhibitors linked to upper GI tract bleeding
March 1st 2003Selective 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.
New insights into the treatment of pulmonary arterial hypertension (PDF)
March 1st 2003Pulmonary 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.
An overview of the pathophysiology and treatment of secondary peritonitis
February 1st 2003Intraabdominal infection was first thoroughly described by Hippocrates. Centuries later, despite advances in surgical and supportive therapies, this disease state continues to be associated with significant morbidity and mortality. This article reviews the literature on intraabdominal infections. It describes the pathophysiology, classification, and etiology of intraabdominal infections, focusing primarily on secondary peritonitis. The bacteriology of the gastrointestinal tract in both the normal and infected host is reviewed. Treatment options, including newly approved antimicrobial agents and agents under clinical investigation, are reviewed.