Formulary Watch |

International Index of Erectile Function questionnaire (US version) (PDF)

Addendum questionnaire to June Focus On: Tadalafil

Sexual Encounter Profile (SEP) Patient and Partner Diaries (PDF)

Addendum to June Focus On: Tadalafil

Inhaled insulin regimen looks equal to or better than shots alone for type 1 diabetes

The 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.

FDA Actions in Brief

FDA actions in Brief as reported June 1, 2002

House approves Medicare Rx benefit while states struggle to expand coverage

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.

Pipeline Preview for June

as reported June 1, 2002

Vioxx (Rofecoxib tablets and oral suspension) Merck & Co., Inc.

New Indication: COX-2 inhibitor gains rheumatoid arthritis indication

Acova (Argatroban injection) GlaxoSmithKline

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

Faslodex (Fulvestrant injection) AstraZeneca

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

Benicar (Olmesartan medoxomil) Sankyo Pharma/Forest Laboratories

NME: 7th ARB approved for hypertension

Few CHF patients achieve target dosages of beta blockers, risking hospitalizations and death

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.

Long-term trials show good response to new anti-RA biologic

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.

Introduction: Considering Your Quinolone Formulary Options: An overview of Ciprofloxacin and Moxifloxacin

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.

Part 2: Beyond depression: Evaluation of newer indications and off-label uses for SSRIs (PDF)

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: An oral selective phosphodiesterase type 5 inhibitor for treatment of erectile dysfunction (PDF)

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.

Rheumatoid arthritis: Update on the newest DMARDs and their potential place in therapy (PDF)

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.

General safety of moxifloxacin

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.

The potency/efficacy of the fluoroquinolones in community-acquired pneumonia

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.

The appropriate use of the fluoroquinolones: factors affecting quinolone use versus other agents: uses and indications

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

Antimicrobial agent resistance

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.

Pharmacodynamics of the quinolones

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

Overview of the fluoroquinolones focus on moxifloxacin

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.

Moxifloxacin: a once-daily, fourth-generation fluoroquinolone antibiotic

Product Profile

Ciprofloxacin: a highly active fluoroquinolone with a wide range of gram-negative and gram-positive activity

Product Profile

Avinza (morphine sulfate extended-release capsules), Ligand

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

Serevent Diskus (salmeterol xinafoate inhalation powder)

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

Risperdal (risperidone tablets/oral solution), Janssen

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

Plavix (clopidogrel bisulfate tablets), Sanofi-Synthelabo/Bristol-Myers Squibb

New Indication: Antiplatelet approved for acute coronary syndrome

Stavudine: Lactic acidosis, motor weakness warnings

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

Revised rofecoxib labeling adds GI safety benefit, cardiovascular risk

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.