Drug Pipeline

The House leadership succeeded in toting up just enough votes in late June to approve a Medicare reform bill that provides some coverage of pharmaceuticals for seniors.

New Indication: COX-2 inhibitor gains rheumatoid arthritis indication

New Indication: GlaxoSmithKline Indication broadened to include HIT prevention during PCI

NME:Once monthly IM injection; treats metastatic breast cancer after tamoxifen fails

NME: 7th ARB approved for hypertension

Albert 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.

In studies reported this month at the European League Against Rheumatism meeting in Stockholm, the anti-TNF antibody adalimumab (D2E7) for rheumatoid arthritis is showing good long-term results, even in patients for whom other disease modifying antirheumatic drugs (DMARDs) have failed.

This Formulary supplement was produced through an unrestristed educational grant from Bayer Corporation. The views and opinions in this supplement are those of the faculty and do not necessarily reflect the views of Formulary, Advanstar Communications Inc., or Advanstar Medical Education Services. Copyright 2002 Advanstar Communications Inc. All rights reserved.

In 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.

Tadalafil (Cialis) was recently deemed approvable for the treatment of erectile dysfunction (ED). When approved, it will join the widely used PDE5 inhibitor sildenafil citrate as an oral therapy for ED management. Among tadalafil?s characteristics are its rapid onset of action, a duration of action of up to 24 hours, and lack of food influence on the drug?s pharmacokinetics. In this Focus article, the pharmacologic, pharmacokinetic, and therapeutic aspects of tadalafil are reviewed and compared, when possible, with sildenafil and another investigational agent, vardenafil.

Leflunomide, 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.

Moxifloxacin (Avelox®) is a relatively new fluoroquinolone available in both oral and intravenous formulations. Extensive clinical analysis and postmarketing surveys suggest that moxifloxacin is safe and well tolerated.

This article reviews the efficacy of fluoroquinolones for treating community-acquired pneumonia (CAP) and discusses clinical advantages of fluoroquinolones relative to other drug classes. Of 19 randomized, controlled trials comparing a fluoroquinolone with another agent or combination of agents in CAP, 6 trials have demonstrated superiority of the fluoroquinolone with respect to clinical and/or bacteriologic efficacy.

A roundtable discussion with Vincent T. Andriole, MD, Chairperson; Paul B. Iannini, MD; Lionel A. Mandell, MD, FRCPC; Charles H. Nightingale, PhD; Lance R. Peterson, MD

The emergence of antibiotic resistance to Streptococcus pneumoniae and other bacterial pathogens is, in part, responsible for the increase in infectious-disease–related mortality occurring between 1980 and 1992.

Pharmacokinetic and pharmacodynamic parameters serve as guidelines for selecting antimicrobial agents and dose regimens that will maximize efficacy and suppress resistance.

The history of the newer quinolone agents began with the discovery of nalidixic acid in 1962. This ultimately led to the development of many newer quinolones, some of which have unique properties.

Product Profile

Product Profile

New formulation: Once daily administration for continuous Tx of chronic moderate-to-severe pain

New indication: Long-term, twice-daily treatment of bronchospasm associated with COPD

New indication: For delaying relapse in long-term treatment of schizophrenia

New Indication: Antiplatelet approved for acute coronary syndrome

Bristol-Myers Squibb has issued a "Dear Healthcare Provider" letter and revised labeling to inform of the potential for lactic acidosis and severe hepatomegaly with steatosis-including some fatal cases-when nucleoside analogue therapy is used alone or in combination with other antiretrovirals

Merck has issued revised labeling for its COX-2 inhibitor rofecoxib (Vioxx) that incorporate findings from the 8,000-patient VIGOR (Vioxx Gastrointestinal Outcomes Research) study.

New contraindications and precautions have been added to the labeling of methylphenidate HCl tablets (Ritalin and Ritalin-SR, Novartis)-approved for treatment of attention deficit/hyperactivity disorder (ADHD).

Pfizer has issued a "Dear Healthcare Professional" letter to clarify and strengthen contraindications with its antipsychotic agent ziprasidone HCl (Geodon).

Ratherthan shortening the hospital stay and improving clinical outcomes, a 48-hour infusion of milrinone was associated with increased early treatment failure-particularly due to the development of arrhythmias and hypotension-in patients hospitalized with acute exacerbations of chronic heart failure (CHF).

Enoxaparin (Lovenox) is typically used during hospitalization after orthopedic or abdominal surgery. Recent studies of its use after orthopedic surgery have shown that extending administration of the low-molecular-weight heparin after hospital discharge significantly reduces the frequency of deep-vein thrombosis (DVT). A new study confirms this is also the case for abdominal surgery for cancer, which carries a high risk of this complication.

Neither extracts of Hypericum perforatum (St. John's Wort) nor sertraline (Zoloft) tested in patients with major depressive disorder performed better than placebo in reducing patients' scores on a standard assessment of depression severity.