Formulary Watch |
All News - Page 215
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.
Bush budget outlines healthcare priorities
March 1, 2003
The central healthcare initiative in the administration's $2.2 trillion budget proposal for fiscal year 2004 is to establish a Medicare prescription drug benefit. President George W Bush proposes to spend $6 billion as a "down payment" on a $400 billion/10-year Medicare drug benefit and "modernization" plan.
Evidence-based Antimicrobial Therapy: Responsible Use of Fluoroquinolones in Today?s Clinical Practice (PDF)
March 1, 2003
Treatment strategies from: Vincent T. Andriole, MD, Professor of Medicine, Yale University School of Medicine Attending Physician, Yale-New Haven Hospital, New Haven, Connecticut
Prozac (Fluoxetine hydrochloride) Eli Lilly
February 1, 2003
Antidepressant now approved for use in pediatric patients
Serious respiratory adverse events may be associated with salmeterol in patients with asthma
February 1, 2003
Glaxo-SmithKline (GSK) has advised prescribers of salmeterol (Serevent) about rare, but potentially serious, respiratory adverse events in patients with asthma.
Restasis (Cyclosporine ophthalmic emulsion, 0.05%) Allergan
February 1, 2003
New formulation: Drug increases tear production in patients with chronic dry eye due to ocular inflammation
Changes in Congress and FDA shape healthcare policy
February 1, 2003
The recent selection of Sen Bill Frist (R-Tenn), MD, to lead Senate Republicans has moved healthcare policy up the priority list in the Senate. As a physician, Dr Frist has played a lead role in assessing federal health programs and policies.
Atorvastatin may inhibit clopidogrel activity
February 1, 2003
Ann Arbor, Mich-Atorvastatin, especially at higher dosages, may preventactivation of the antiplatelet agent clopidogrel, according to researchat the University of Michigan, Ann Arbor.
Extraneal (Icodextrin peritoneal dialysis solution) Baxter
February 1, 2003
NME: New solution for home-based peritoneal dialysis
Atomoxetine: A nonstimulant therapeutic option for children and adults with attention-deficit hyperactivity disorder
February 1, 2003
Atomoxetine, a norepinephrine reuptake inhibitor, is the first nonstimulant agent approved for the treatment of ADHD (Strattera, Lilly). It has been approved for use in pediatric and adult patients. Atomoxetine improves ADHD symptom severity versus placebo, as evaluated by the ADHD Rating Scale (ADHD RS), and its efficacy appears comparable to immediate-release methylphenidate. Atomoxetine requires dosage titration and may be administered once or twice daily. Common side effects seen in both pediatric and adult patients include nausea, decreased appetite, and dizziness. Dosage adjustments are necessary for patients receiving atomoxetine and cytochrome P450 2D6 inhibitors. Based on average wholesale price (AWP), atomoxetine is more costly than existing ADHD therapies. Atomoxetine provides an alternative ADHD therapy for patients who may fail or cannot tolerate conventional treatments.
An overview of the pathophysiology and treatment of secondary peritonitis
February 1, 2003
Intraabdominal 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.
FDA to speed up DTC regulatory actions
February 1, 2003
Direct-to-consumer (DTC) advertising is boosting prescription use, pharmaceutical companies are spending more on DTC ads, and FDA needs to act more quickly to remove false or misleading commercials from the air.
Atorvastatin may inhibit clopidogrel activity
February 1, 2003
Ann Arbor, Mich-Atorvastatin, especially at higher dosages, may prevent activation of the antiplatelet agent clopidogrel, according to research at the University of Michigan, Ann Arbor.
Eye on Literature: New treatment guidelines have been released for the management of acute migraine attacks and for preventing migraine headaches.
February 1, 2003
The American Academy of Family Physicians and the American College of PhysiciansAmerican Society of Internal Medicine, with assistance from the American Headache Society, released the migraine treatment guidelines. Migraine headaches affect 18% of women and 6.5% of men in the United States and are a major cause of absenteeism and reduced productivity.
ASHP, AMA ask for federal assistance to resolve drug shortage problem
February 1, 2003
Washington, DC-Representatives from the American Society of Health-SystemPharmacists and the American Medical Association met with the Health andHuman Services assistant secretary for health Eve Slater, MD, and FDA'sdeputy commissioner Lester Crawford, DVM, PhD, in late January to discussdrug shortages and ask for federal assistance in resolving the problem.
An overview of the pathophysiologyand treatment of secondary peritonitis
February 1, 2003
Intraabdominal 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.
Incorporating an ethical template into pharmacy benefit decision-making (PDF)
January 1, 2003
J Russell Teagarden, MA, RPh, vice president of clinical practices and therapeutics at Medco Health Solutions in Franklin Lakes, NJ, explains how using an ?ethical template? for pharmacy benefit decisions can make those decisions consistent and fair, reducing patient displeasure, conflict, and litigation.
A comparison of the newer treatment options for ADHD (PDF)
January 1, 2003
Psychostimulant drugs have consistently demonstrated efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD). Innovative technology has fueled the development of novel release mechanisms and isolation of active enantiomer components with the hopes of enhancing the duration of action and improving the safety and effectiveness. As a result, several new stimulant agents have recently been added to the arsenal of ADHD treatment options. Formulary selection is complicated by the high costs and small but distinct differences among these agents. The five newest FDA-approved stimulant agents for the treatment of ADHD are detailed, and a brief summary of future treatment options, including a recently approved nonstimulant agent, is provided.
Incorporating an ethical template into pharmacy benefit decision-making
January 1, 2003
If asked, could you present the underlying rationale for your pharmacy benefit coverage decisions? When considered from the consumer or employee perspective, why should they consider the payors or providers of their drug benefit legitimate decision-makers in limiting their healthcare policies?
Duloxetine: An antidepressant that inhibits both norepinephrine and serotonin uptake
January 1, 2003
Duloxetine is a reuptake inhibitor at serotonergic and noradrenergic neurons and appears to have low affinity for other neurotransmitter systems. In three published clinical trials in patients with MDD, duloxetine was well tolerated and more effective than placebo. Further study is needed to compare its efficacy with that of other antidepressants, to prospectively assess time to onset of antidepressant effect, and to clarify effects on somatic symptoms and potential adverse cardiovascular and sexual effects. Duloxetine is also under investigation for the treatment of stress urinary incontinence in women (trade name to be determined, comarketed by Lilly and Boehringer Ingelheim). Preliminary information suggests that duloxetine therapy reduces the number of incontinence episodes. Duloxetine has been deemed ?approvable? for the treatment of MDD and will be comarketed under the trade name Cymbalta by Eli Lilly and Company and Quintiles.
Pegasys: Peginterferon alfa-2a
December 1, 2002
Chronic hepatitis C therapy for patients with compensated liver disease
Dryvax: Smallpox vaccine
December 1, 2002
With the threat of bioterrorism, there was a need to reintroduce a smallpox vaccine. FDA has now approved this dried, calf lymph-type vaccine.
Healthcare at the forefront on federal, state levels
December 1, 2002
GOP control of both the Senate and House has pushed efforts to establish a Medicare drug benefit to the top of the legislative agenda. It also has moved proposals to reimport pharmaceuticals from Canada or Mexico and reform generic drug policy down the priority list.
