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By Carlos Adanero Pharmacist
Young Bin Choy, Mark R Prausnitz
The Rule of Five predicts suitability of drug candidates, but was developed primarily using orally administered drugs. Here, we test whether the Rule of Five predicts drugs for delivery via non-oral routes, specifically ophthalmic, inhalation and transdermal. We assessed 111 drugs approved by FDA for those routes of administration and found that >98% of current non-oral drugs have physicochemical properties within the limits of the Rule of Five. However, given the inherent bias in the dataset, this analysis was not able to assess whether drugs with properties outside those limits are poor candidates...
May 2011: Pharmaceutical Research
Alexei Kharitonenkov, Andrew C Adams
Since the discovery of insulin in 1921, protein therapeutics have become vital tools in the treatment of diabetes mellitus. This heritage has been extended with the comparatively recent introduction of recombinant and re-engineered insulins, in addition to the advent of GLP1 agonists. FGF21 represents an example of a novel experimental protein therapy which is able to induce favorable metabolic effects in various species ranging from rodents to man. The aim of this review is to communicate the story of the FGF21 drug discovery path from identification in a functional in vitro screen, to the eventual evaluation of its utility in patients...
June 2014: Molecular Metabolism
J Michael Gaziano, Howard D Sesso, William G Christen, Vadim Bubes, Joanne P Smith, Jean MacFadyen, Miriam Schvartz, JoAnn E Manson, Robert J Glynn, Julie E Buring
CONTEXT: Multivitamin preparations are the most common dietary supplement, taken by at least one-third of all US adults. Observational studies have not provided evidence regarding associations of multivitamin use with total and site-specific cancer incidence or mortality. OBJECTIVE: To determine whether long-term multivitamin supplementation decreases the risk of total and site-specific cancer events among men. DESIGN, SETTING, AND PARTICIPANTS: A large-scale, randomized, double-blind, placebo controlled trial (Physicians" Health Study II) of 14 641 male US physicians initially aged 50 years or older (mean [SD] age, 64...
November 14, 2012: JAMA: the Journal of the American Medical Association
Channa R Jayasekera, Michele Barry, Lewis R Roberts, Mindie H Nguyen
Just two decades after the identification of hepatitis C virus (HCV), an improved understanding of the viral lifecycle has led to several new classes of highly promising therapies. By as early as 2015, sustained virologic response rates will be in the 90% range for most HCV genotypes, and this..
May 15, 2014: New England Journal of Medicine
Harm J Gijsman, John R Geddes, Jennifer M Rendell, Willem A Nolen, Guy M Goodwin
OBJECTIVE: This study reviewed the evidence from randomized, controlled trials on the efficacy and safety of antidepressants in the short-term treatment of bipolar depression. METHOD: The authors performed a systematic review and meta-analysis of randomized, controlled trials. They searched the Cochrane Collaboration Depression, Anxiety, and Neurosis Controlled Trials Register, incorporating results of searches of MEDLINE, EMBASE, CINAHL, PsycLIT, PSYNDEX, and LILACS...
September 2004: American Journal of Psychiatry
Jonathan J Darrow, Jerry Avorn, Aaron S Kesselheim
U.S. pharmaceutical regulations are based on the principle that patients should not be exposed to new prescription drugs until their efficacy and safety have been shown. Since 1962, the Food and Drug Administration (FDA) and Congress have balanced the efficient review of investigational drugs with..
March 27, 2014: New England Journal of Medicine
S Denford, J Frost, P Dieppe, Chris Cooper, N Britten
OBJECTIVES: Patients and policy makers advocate that drug treatments should be individualised. However, the term is used in a variety of ways. We set out to identify the range of related terminology and concepts in the general field of individualisation, map out the relationships between these concepts and explore how patients' perspectives are considered. DESIGN: We consulted members of an established patient and public involvement group about their experience of medicine taking for long-term conditions and their ideas about individualisation...
2014: BMJ Open
Moshe Vardi, Marcella Debidda, Deepak L Bhatt, Laura Mauri, Christopher P Cannon
BACKGROUND: Many patients treated with oral anticoagulants for atrial fibrillation undergo percutaneous stent implantation, where dual antiplatelet therapy (DAPT) is also recommended. The current evidence to support triple oral antithrombotic therapy (TOAT) in these patients is limited, and new strategies are being discussed to optimize outcomes. HYPOTHESIS: There will be variation in antithrombotic strategies in patients with atrial fibrillation needing stenting...
February 2014: Clinical Cardiology
Ira M Jacobson, Stuart C Gordon, Kris V Kowdley, Eric M Yoshida, Maribel Rodriguez-Torres, Mark S Sulkowski, Mitchell L Shiffman, Eric Lawitz, Gregory Everson, Michael Bennett, Eugene Schiff, M Tarek Al-Assi, G Mani Subramanian, Di An, Ming Lin, John McNally, Diana Brainard, William T Symonds, John G McHutchison, Keyur Patel, Jordan Feld, Stephen Pianko, David R Nelson
BACKGROUND: Patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3 for whom treatment with peginterferon is not an option, or who have not had a response to prior interferon treatment, currently have no approved treatment options. In phase 2 trials, regimens including the oral nucleotide polymerase inhibitor sofosbuvir have shown efficacy in patients with HCV genotype 2 or 3 infection. METHODS: We conducted two randomized, phase 3 studies involving patients with chronic HCV genotype 2 or 3 infection...
May 16, 2013: New England Journal of Medicine
Eric Lawitz, Alessandra Mangia, David Wyles, Maribel Rodriguez-Torres, Tarek Hassanein, Stuart C Gordon, Michael Schultz, Mitchell N Davis, Zeid Kayali, K Rajender Reddy, Ira M Jacobson, Kris V Kowdley, Lisa Nyberg, G Mani Subramanian, Robert H Hyland, Sarah Arterburn, Deyuan Jiang, John McNally, Diana Brainard, William T Symonds, John G McHutchison, Aasim M Sheikh, Zobair Younossi, Edward J Gane
BACKGROUND: In phase 2 trials, the nucleotide polymerase inhibitor sofosbuvir was effective in previously untreated patients with chronic hepatitis C virus (HCV) genotype 1, 2, or 3 infection. METHODS: We conducted two phase 3 studies in previously untreated patients with HCV infection. In a single-group, open-label study, we administered a 12-week regimen of sofosbuvir plus peginterferon alfa-2a and ribavirin in 327 patients with HCV genotype 1, 4, 5, or 6 (of whom 98% had genotype 1 or 4)...
May 16, 2013: New England Journal of Medicine
Anuoluwapo Osinusi, Eric G Meissner, Yu-Jin Lee, Dimitra Bon, Laura Heytens, Amy Nelson, Michael Sneller, Anita Kohli, Lisa Barrett, Michael Proschan, Eva Herrmann, Bhavana Shivakumar, Wenjuan Gu, Richard Kwan, Geb Teferi, Rohit Talwani, Rachel Silk, Colleen Kotb, Susan Wroblewski, Dawn Fishbein, Robin Dewar, Helene Highbarger, Xiao Zhang, David Kleiner, Brad J Wood, Jose Chavez, William T Symonds, Mani Subramanian, John McHutchison, Michael A Polis, Anthony S Fauci, Henry Masur, Shyamasundaran Kottilil
IMPORTANCE: The efficacy of directly acting antiviral agents in interferon-free regimens for the treatment of chronic hepatitis C infections needs to be evaluated in different populations. OBJECTIVE: To determine the efficacy and safety of sofosbuvir with weight-based or low-dose ribavirin among a population with unfavorable treatment characteristics. DESIGN, SETTING, AND PATIENTS: Single-center, randomized, 2-part, open-label phase 2 study involving 60 treatment-naive patients with hepatitis C virus (HCV) genotype 1 enrolled at the National Institutes of Health (October 2011-April 2012)...
August 28, 2013: JAMA: the Journal of the American Medical Association
Sarah Tischer, Robert J Fontana
Studies of boceprevir and telaprevir based antiviral therapy in liver transplant (LT) recipients with hepatitis C genotype 1 infection have demonstrated dramatic increases in tacrolimus, cyclosporine, and mTOR inhibitor exposure. In addition to empiric dose reductions, daily monitoring of immunosuppressant blood levels is required when initiating as well as discontinuing the protease inhibitors to maximize patient safety. Although improved suppression of HCV replication is anticipated, 20 to 40% of treated subjects have required early treatment discontinuation due to various adverse events including anemia (100%), infection (30%), nephrotoxicity (20%) and rejection (5 to 10%)...
April 2014: Journal of Hepatology
R S Koff
BACKGROUND: The treatment of chronic hepatitis C is changing rapidly. AIM: To review clinical studies of the efficacy and safety of sofosbuvir-containing regimens in the treatment of chronic hepatitis C. METHODS: Using PubMed and search terms 'sofosbuvir,' 'emerging HCV treatment,' and 'HCV polymerase inhibitor,' literature on the clinical development of sofosbuvir, as well as abstracts presented at the November 2013 annual meeting of the American Association for the Study of Liver Diseases (AASLD), was reviewed...
March 2014: Alimentary Pharmacology & Therapeutics
Dennis J Cada, Terri L Levien, Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line...
July 2013: Hospital Pharmacy
Astrid Wendt, Xavier Adhoute, Paul Castellani, Valerie Oules, Christelle Ansaldi, Souad Benali, Marc Bourlière
The launch of first-generation protease inhibitors (PIs) is a major step forward in HCV treatment. However, the major advance is up to now restricted to genotype 1 (GT-1) patients. The development of second-wave and second-generation PIs yields higher antiviral potency through plurigenotypic activity, more convenient daily administration, fewer side effects and, for the second-generation PIs, potential activity against resistance-associated variants. NS5B inhibitors include nucleoside/nucleotide inhibitors (NIs) and non-nucleotide inhibitors (NNIs)...
2014: Clinical Pharmacology: Advances and Applications
Jordan J Feld
Interferon has been the backbone of therapy for hepatitis C virus (HCV) infection for over 20years. Initial response rates were poor, however they have slowly but steadily improved, such that with the addition of the nucleotide analogue ribavirin and the pegylation of interferon, over 50% of infected individuals could be cured with a course of therapy. However, interferon therapy is not ideal, requiring up to a year of weekly injections and associated with numerous systemic side effects. Advances in understanding of the HCV lifecycle have led to the development of numerous highly effective, well-tolerated oral direct acting antivirals (DAAs)...
May 2014: Antiviral Research
Mohannad Dugum, Robert O'Shea
Treatment for chronic hepatitis C virus (HCV) infection is evolving rapidly. The approval in 2013 of two new direct-acting antivirals-sofosbuvir (a polymerase inhibitor) and simeprevir (a second-generation protease inhibitor)-opens the door for an all-oral regimen, potentially avoiding interferon and its harsh side effects. Other direct-acting antivirals are under development.
March 2014: Cleveland Clinic Journal of Medicine
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