Did naproxen's cardioprotective effect skew safety data on rofecoxib?
July 1st 2002Three case-controlled studies published in the Archives of Internal Medicineshow naproxen sodium has cardioprotective effects that other NSAIDs don't.An accompanying editorial says that no evidence indicates that the COX-2inhibitor rofecoxib increases (or decreases) MI risk. It simply fell victimto being compared with the only NSAID (ie, naproxen) shown to have a cardioprotectivebenefit. (None of these new studies directly compared non-naproxen NSAIDswith COX-2 inhibitors.)
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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.
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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.
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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.
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The evidence supporting a role for the angiotensin II receptor blockers (ARBs) in patients with nephropathy and/or heart failure continues to evolve. Currently, the FDA is in late-stage review of the first ARB for a heart failure indication and is reviewing another ARB for a diabetic nephropathy indication. The authors of this article present and interpret the clinical evidence for ARB use in these two disease states. Included in their discussion are the most recent recommendations on ARBs’ place in therapy according to the American Diabetes Association, the American College of Cardiology, and the American Heart Association.
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Anoka Regional Treatment Facility, Anoka, MN-This 150-bed regional treatment facility was spending over half its annual budget on atypical antipsychotic medications. In an effort to better control rising drug class costs, a market share shift analysis of the products currently in use at the facility was conducted.
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The ruckus over designer babies, human cloning and genetic discrimination has colored much of the debate and perception of genetic services, but the discipline is gaining momentum as research propels new tests to determine the susceptibility to more common diseases, as well as a slew of rare ones.
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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.
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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.
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Long-term trials show good response to new anti-RA biologic
June 1st 2002In 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.
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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.
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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.
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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.
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The potency/efficacy of the fluoroquinolones in community-acquired pneumonia
June 1st 2002This 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.
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