AIT Drug Reviews

Oseltamivir in Seasonal, Pandemic, and Avian Influenza: a Comprehensive Review of 10-Years Clinical Experience


James R. Smith, Craig R. Rayner, Barbara Donner, Martina Wollenhaupt, Klaus Klumpp, Regina Dutkowski

DOI: 10.1007/s12325-011-0072-7

Adv Ther. 2011;28(11). In press.

Abstract | Full text

Oseltamivir (TamifluĀ®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) is an orally administered antiviral for the treatment and prevention of influenza A and B infections that is registered in more than 100 countries worldwide. More than 83 million patients have been exposed to the product since its introduction. Oseltamivir is recommended by the World Health Organization (WHO) for use in the clinical management of pandemic and seasonal influenza of varying severity, and as the primary antiviral agent for treatment of avian H5N1 influenza infection in humans. This article is a nonsystematic review of the experience gained from the first 10 years of using oseltamivir for influenza infections since its launch in early 2000, emphasizing recent advances in our understanding of the product and its clinical utility in five main areas. The article reviews the pharmacokinetics of oseltamivir and its active metabolite, oseltamivir carboxylate, including information on special populations such as children and elderly adults, and the co-administration of oseltamivir with other agents. This is followed by a summary of data on the effectiveness of oseltamivir treatment and prophylaxis in patients with all types of influenza, including pandemic (H1N1) 2009 and avian H5N1 influenza. The implications of changes in susceptibility of circulating influenza viruses to oseltamivir and other antiviral agents are also described, as is the emergence of antiviral resistance during and after the 2009 pandemic. The fourth main section deals with the safety profile of oseltamivir in standard and special patient populations, and reviews spontaneously reported adverse event data from the pandemic and pre-pandemic periods and the topical issue of neuropsychiatric adverse events. Finally, the article considers the pharmacoeconomics of oseltamivir in comparison with vaccination and usual care regimens, and as a component of pandemic influenza mitigation strategies.

Survival Benefit of Eribulin Mesylate in Heavily Pretreated Metastatic Breast Cancer: What Next?


Philippe Aftimos, Ahmad Awada

DOI: 10.1007/s12325-011-0070-9

Adv Ther. 2011;28(11). In press.

Abstract | Full text

Eribulin is a synthetic analog of halichondrin B, a non-taxane microtubule inhibitor extracted from the marine sponge, Halichondria okaida. It presents a novel mechanism of action and is active on cancer cells resistant to other antimicrotubule agents. It was granted approval in the USA and Europe for the treatment of heavily pretreated metastatic breast cancer. Early trials had shown activity in this setting with main toxicities being neutropenia and neuropathy in patients where quality of life is essential. Approvals were granted after a phase 3 trial demonstrated overall survival benefit in metastatic breast cancer previously treated with anthracyclines, taxanes, and capecitabine, in a setting where most treatments are failing to demonstrate a survival benefit. Recent data suggest that this survival benefit is also consistent in the elderly with no excess toxicity. Future strategies of eribulin are being tested in ongoing trials, evaluating this drug in earlier metastatic lines as well as in the adjuvant and the neoadjuvant settings.

Biliary Stents in the Millennium


Indu Srinivasan, Michel Kahaleh

DOI: 10.1007/s12325-011-0067-4

Adv Ther. 2011;28(10). In press.

Abstract | Full text

Biliary stents have now been in use for over two decades. Although a plethora of literature has been published on them, this review article is unique in its attempt to summarize important landmark trials and their implications on the management of various pancreatico-biliary disorders. This article will cover the various types of stents currently being used, established and upcoming indications, techniques of placement, and complications associated with stent use.

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