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.
Tegaserod: A 5 HT4 agonist for women with constipation-predominant irritable bowel syndrome (PDF)
September 1st 2002Tegaserod maleate (Zelnorm) is the first selective partial 5-HT4 agonist approved by FDA for the short-term treatment of irritable bowel syndrome (IBS) in women whose primary bowel symptom is constipation. To help you prepare for P & T Committee review, this article presents tegaserod?s chemistry and pharmacology, pharmacokinetics, clinical trial results, adverse effects profile, dosing information, cost, and the author?s opinion on its place in therapy.
Anticoagulant bridging: Prosthetic heart valves, labeling changes, and limiting issues of liability
September 1st 2002With enoxaparin?s recent labeling change regarding its use in patients with prosthetic valves, clinicians may have several questions about appropriate anticoagulant selection. Specifically, what evidence prompted the labeling change, which patients are affected, what are the options and limitations for bridging patients, what?s the evidence supporting the role of low molecular weight heparins (LMWHs) in bridge therapy, and how can liability be limited should clinicians choose to use LMWH therapy? The authors of this commentary offer their insight on these issues.
Senate backs legislation easing access to generic drugs and to cheaper imports
September 1st 2002Instead of adopting a Medicare pharmacy benefit plan in July, the Senate approved legislation designed to make pharmaceuticals less expensive for all consumers. The House and Senate, however, remain far from agreement on any final legislation involving pharmaceutical coverage and regulation, and time is running out for action before the Congressional elections this November.
Voriconazole: A novel azole antifungal agent (PDF)
August 1st 2002In late May, voriconazole (Vfend) received approval for the treatment of invasive aspergillosis and as salvage therapy for treatment of Scedosporium apiospermum and Fusarium infections. In addition to these infections, voriconazole has excellent invitro activity against both Candida and Aspergillus species, including good activity against fluconazole- and itraconazole-resistant species. This Focus article reviews the antifungal's pharmacology, pharmacokinetics, efficacy in clinical trials, safety, dosing, price, and place in therapy.
Understanding the costs and treatments of alcohol abuse and dependence (PDF)
August 1st 2002Effective decision-making in benefit management requires an understanding of the economic burden of an illness - in this case, the economic burden and treatment of alcoholism. This article provides an understanding of the true costs of the disease, what has been found to be effective in its treatment, and what treatments may lessen the economic burden of the disease.
Tegaserod meta-analysis: Global relief of IBS symptoms, no increase in abdominal surgery
July 1st 2002Tegaserod, an investigational serotonin receptor agonist, provides global relief of the symptoms of constipation-predominant irritable bowel syndrome (IBS) with an acceptable incidence of adverse events, according to the results of meta-analysis of four phase III trials presented at Digestive Disease Week in San Francisco.
NEW WARNING: Uterine sarcoma linked with long-term tamoxifen use
July 1st 2002Cases of uterine sarcoma in women receiving tamoxifen citrate (Nolvadex, AstraZeneca) have prompted a "Dear Health Professional" letter, black-box warnings on labeling, and publication of a letter to the editor in the New England Journal of Medicine from FDA officials.
Liver toxicity risk low with rosiglitazone
July 1st 2002Ever since troglitazone was pulled from the market because of hepatotoxicity,clinicians has been concerned that this may be a class effect. But a newstudy of rosiglitazone (Avandia), funded by manufacturer SmithKlineBeecham,indicates this drug is not associated with heptatotoxic effects.
No link between hepatitis B vaccine and neurologic disorders
July 1st 2002The evidence doesn't support a link between administration of hepatitis B (HPB) vaccine and demyelinating disorders, such as multiple sclerosis (MS) and Guillain-Barré syndrome, so no change in immunization policy is warranted, according to an Institute of Medicine (IOM) report.
Multiple studies show eplerenone to be a potent antihypertensive agent
July 1st 2002Eplerenone, a selective aldosterone inhibitor in phase III clinical trials,is an effective agent for reducing blood pressure in a variety of patientswith hypertension, including African-Americans, said presenters at the 17thannual scientific meeting of the American Society of Hypertension in NewYork City.
The six-step process for conducting outcomes analyses using administrative databases (PDF)
July 1st 2002Administrative databases are a potentially useful source of data for conducting retrospective studies. Information in such a database can be used to evaluate the effects of organizational policy changes, new programs, or pharmaceutical therapies. This month?s column reviews the six essential steps required for conducting a simple database analysis. An example involving sepsis is used to further illustrate key points.
Alefacept: A T-cell-specific immunosuppressant to treat moderate to severe plaque psoriasis (PDF)
July 1st 2002Alefacept (Amevive) is the first immunosuppressive agent directed specifically at inhibiting the activation of, and possibly killing, T cells, which are involved in the cascade of events leading to psoriatic plaque formation and inflammation. In May, an FDA advisory committee recommended alefacept for approval as a first-line therapy against moderate to severe plaque psoriasis. The authors of this Focus article review the clinical characteristics of alefacept as well as make comparisons with other systemic drugs currently used to treat chronic psoriasis and the likely biologic competitors etanercept and infliximab.
Inhaled insulin regimen looks equal to or better than shots alone for type 1 diabetes
June 1st 2002The investigational inhaled insulin product (Exubera) could prove a boon to patients with diabetes, cutting or eliminating the need for injections. So indicate findings from a phase III trial presented at the annual meeting of the American Association of Clinical Endocrinologists (AACE). For patients with type 1 diabetes, a regimen of inhaled insulin before meals and one injection at night could control blood glucose as well as or possibly better than injections alone. These results add to some phase III data presented last June that showed a small but significant number of patients with type 2 diabetes reached recommended blood glucose levels at 6 months.
Few CHF patients achieve target dosages of beta blockers, risking hospitalizations and death
June 1st 2002Albert Einstein Healthcare Network, Philadelphia-What are the real-world consequences of inadequate beta blocker therapy in patients with congestive heart failure (CHF)? That is what this group of clinicians at Prestige Health-a 50,000 member managed care organization in Philadelphia-set out to determine.
Part 2: Beyond depression: Evaluation of newer indications and off-label uses for SSRIs (PDF)
June 1st 2002In this final installment of this series, the authors focus on the use of SSRIs in alcohol dependence, chronic pain, eating disorders, premenstrual dysphoric disorder, and sexual dysfunction. For each condition, the authors examine how well clinical trial evidence supports the application, discuss dosing and safety considerations, and provide their recommendations on preferred and alternative SSRIs, based on the weight of the evidence.
Rheumatoid arthritis: Update on the newest DMARDs and their potential place in therapy (PDF)
June 1st 2002Leflunomide, etanercept, infliximab, and anakinra represent the four latest additions to the therapeutic armamentarium for rheumatoid arthritis. All four of these DMARDs have demonstrated clinical and radiographic evidence of efficacy that is changing the therapeutic approach to treatment. The authors of this article summarize the pivotal clinical trial and efficacy data up through the perimarketing period, provide the latest efficacy and safety update on these agents, discuss the financial implications of their use, and offer insights into their place in therapy.