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Clinical Pharmacology and Therapeutics

Evangelia Liakoni, Kathryn C Edwards, Gideon St Helen, Natalie Nardone, Delia A Dempsey, Rachel F Tyndale, Neal L Benowitz
This study investigated the influence of the rate of nicotine metabolism, as indicated by the nicotine metabolite ratio (NMR) on tobacco dependence. We stratified 136 smokers based on saliva NMR as fast (n=65) and slow (n=71) metabolizers. Two "loading cigarettes" were smoked after overnight, and a "reward cigarette" after six hours daytime abstinence. Blood nicotine concentrations, expired carbon monoxide, withdrawal/craving and reward questionnaires were collected before/after smoking and during daytime abstinence...
September 22, 2018: Clinical Pharmacology and Therapeutics
Laurine Robert, Grégoire Ficheur, Bertrand Décaudin, Juliette Gellens, Michel Luyckx, Renaud Perichon, Sophie Gautier, François Puisieux, Emmanuel Chazard, Jean-Baptiste Beuscart
Drug-induced hyperkalemia is a frequent and severe complication in hospital setting. Other risk factors may also induce hyperkalemia but the combination of drugs and precipitating factors has not been extensively studied. The aim was to identify drug-induced hyperkalemia events in hospitalized older patients and to describe their combinations with precipitating factors. Two experts analyzed independently retrospective data of patients aged 75 years or more. Experts identified 471 hyperkalemia events and concluded that 379 (80...
September 22, 2018: Clinical Pharmacology and Therapeutics
Karen E Burke
Skin is an efficient protective barrier armed with an intricate network of antioxidants. External environmental stress diminishes and sometimes overwhelms these innate protective mechanisms; aging slows their efficacy. Topical antioxidants enhance natural endogenous defenses to create an indwelling reservoir for sustained protection with far higher concentrations than possible with oral intake. The challenge is creating formulations of these labile molecules that are stable, active, and can be effectively absorbed transdermally to deliver high concentrations...
September 21, 2018: Clinical Pharmacology and Therapeutics
Xiaoyan Chu, Aleksandra Galetin, Maciej J Zamek-Gliszczynski, Lei Zhang, Donald J Tweedie
No abstract text is available yet for this article.
September 21, 2018: Clinical Pharmacology and Therapeutics
Huan Ren, Jian-Quan Luo, Yan Shu, Hong-Hao Zhou, Wei Zhang
No abstract text is available yet for this article.
September 18, 2018: Clinical Pharmacology and Therapeutics
Davor Vukadinović, Michael Böhm
No abstract text is available yet for this article.
September 18, 2018: Clinical Pharmacology and Therapeutics
Matti K Itkonen, Aleksi Tornio, Outi Lapatto-Reiniluoto, Mikko Neuvonen, Pertti J Neuvonen, Mikko Niemi, Janne T Backman
No abstract text is available yet for this article.
September 17, 2018: Clinical Pharmacology and Therapeutics
Mohamad Shebley
No abstract text is available yet for this article.
September 17, 2018: Clinical Pharmacology and Therapeutics
Sandip Chaugai, Alyson L Dickson, Megan M Shuey, QiPing Feng, Katherine A Barker, Wei-Qi Wei, James M Luther, C Michael Stein, Cecilia P Chung
Tizanidine, a widely used muscle relaxant that can lower blood pressure, is metabolized by the cytochrome P450 1A2 (CYP1A2). We studied 1,626 patients prescribed tizanidine and 5,012 prescribed cyclobenzaprine concurrently with a strong CYP1A2 inhibitor. The primary outcome was severe hypotension, defined as systolic blood pressure (SBP)≤70 mm Hg during periods of drug co-exposure. Severe hypotension occurred more often in the tizanidine group [2.03% (n=33)] than the cyclobenzaprine group [1.28% (n=64)]; OR= 1...
September 17, 2018: Clinical Pharmacology and Therapeutics
Lindsey H M Te Brake, Vycke Yunivita, Resvi Livia, Nanny Soetedjo, Eleonora van Ewijk-Beneken Kolmer, Jan B Koenderink, David M Burger, Prayudi Santoso, Reinout van Crevel, Bachti Alisjahbana, Rob E Aarnoutse, Rovina Ruslami
The pharmacokinetic and clinical implications of combining metformin with rifampicin are relevant to increasing numbers of diabetic tuberculosis (TB) patients across the world and are yet unclear. We assessed the impact of rifampicin on metformin pharmacokinetics and its glucose-lowering effect in diabetic TB patients by measuring plasma metformin and blood glucose during and after TB treatment. Rifampicin increased metformin exposure: plasma AUC0-τ and Cmax geometric mean ratio (during vs after TB treatment) were 1...
September 17, 2018: Clinical Pharmacology and Therapeutics
Jackson Thomas, Gregory M Peterson, Erin Walker, Julia K Christenson, Melissa Cowley, Sam Kosari, Kavya E Baby, Mark Naunton
Mainstream broadcasting media is a potentially powerful avenue for disseminating wellness education. For example, it can be used for community-based risk management, including preparing for pandemic events. The media can have a considerable positive impact on the public by increasing their health knowledge, changing attitudes and intentions, and influencing health behavior. However, although the broadcasting media can usefully convey prosocial, healthy messages, there is also a risk of propagating incorrect and antisocial, poor public health information...
September 16, 2018: Clinical Pharmacology and Therapeutics
Anuradha Ramamoorthy, Todd C Knepper, Christine Merenda, Martin Mendoza, Howard L McLeod, Jonca Bull, Lei Zhang, Michael Pacanowski
Race, ethnicity, sex, and age are demographic factors that can influence drug exposure and/or response, and can consequently affect treatment outcome. We evaluated demographic subgroup enrollment patterns in new therapeutic products approved by the US Food and Drug Administration (FDA) for the treatment of select cancers-breast, colorectal, lung, and prostate-that have comparative differences in morbidity and/or mortality among some demographic subgroups. In submissions of products approved between 2008 and 2013, participants (n = 22,481) were white (80%), from outside the United States (74%), between 17 and 64 years old (59%), and men (56% and 53%, including and excluding sex-specific indications, respectively)...
September 14, 2018: Clinical Pharmacology and Therapeutics
Emily A F Holmes, Catrin Plumpton, Gus A Baker, Ann Jacoby, Adele Ring, Paula Williamson, Anthony Marson, Dyfrig A Hughes
Regulatory decisions may be enhanced by incorporating patient preferences for drug benefit and harms. This study demonstrates a method of weighting clinical evidence by patients' benefit-risk preferences. Preference weights, derived from discrete choice experiments, were applied to clinical trial data to estimate the expected utility of alternative drugs. In a case study, the rank ordering of antiepileptic drugs (AEDs) as indicated from clinical studies, was compared with ordering based on weighting clinical evidence by patients' preferences...
September 11, 2018: Clinical Pharmacology and Therapeutics
Craig W Hendrix
FDA approved oral daily tenofovir/emtricitabine (TruvadaTM ) for pre-exposure prophylaxis of HIV infection in 2012 on the basis of two randomized controlled trials, one in men who have sex with men (MSM) and another in HIV serodiscordant heterosexual couples. Subsequently, even greater efficacy has been demonstrated in MSM with rapid, population level incidence reductions in some locations. In contrast, studies of antiretroviral PrEP in heterosexual women showed only modest or no efficacy, largely attributed to low adherence...
September 10, 2018: Clinical Pharmacology and Therapeutics
Hans-Georg Eichler, Brigitte Bloechl-Daum, Karl Broich, Paul Alexander Kyrle, Jillian Oderkirk, Guido Rasi, Rui Santos Ivo, Ad Schuurman, Thomas Senderovitz, Luke Slawomirski, Martin Wenzl, Valerie Paris
Judicious use of Real World Data (RWD) is expected to make all steps in the development and utilisation of pharmaceuticals more effective and efficient, including research and development, regulatory decision making, health technology assessment, pricing and reimbursement decisions and treatment. A 'learning healthcare system' based on electronic health records and other routinely collected data will be required to harness the full potential of RWD to complement evidence based on randomised controlled trials...
September 4, 2018: Clinical Pharmacology and Therapeutics
Kristina M Brooks, Peter L Anderson
No abstract text is available yet for this article.
September 4, 2018: Clinical Pharmacology and Therapeutics
Zhihua Li, Bradley J Ridder, Xiaomei Han, Wendy W Wu, Jiansong Sheng, Phu N Tran, Min Wu, Aaron Randolph, Ross H Johnstone, Gary R Mirams, Yuri Kuryshev, James Kramer, Caiyun Wu, William J Crumb, David G Strauss
The International Council on Harmonization (ICH) S7B and E14 regulatory guidelines are sensitive but not specific for predicting which drugs are pro-arrhythmic. In response, the Comprehensive In Vitro Proarrhythmia Assay (CiPA) was proposed that integrates multi-ion channel pharmacology data in vitro into a human cardiomyocyte model in silico for proarrhythmia risk assessment. Previously, we reported the model optimization and proarrhythmia metric selection based on CiPA training drugs. In this study, we report the application of the prespecified model and metric to independent CiPA validation drugs...
August 27, 2018: Clinical Pharmacology and Therapeutics
Kathleen M Giacomini, Aleksandra Galetin, Shiew Mei Huang
The past few years have ushered in a wealth of new information on transporter biology, ranging from the publication of new crystal structures of the human glucose transporters (GLUTs; SLC2A2) (1) to the discovery of the mechanism by which the monocarboxylate transporter (SLC16A11) associates with type 2 diabetes (2), to a plethora of new therapies that target transporters in the treatment of both common and rare diseases. Complementing these fundamental advances in transporter biology, great strides have been made in our understanding of the role of transporters in the pharmacokinetics and pharmacodynamics of drugs, including transporter-mediated drug-drug interactions (DDIs), nutrient-drug interactions, and in drug efficacy and safety (3-5)...
August 23, 2018: Clinical Pharmacology and Therapeutics
Ethel D Weld, Kelly E Dooley
Children and pregnant and postpartum women suffer an undue burden of HIV-associated tuberculosis (TB), but data are lacking on key aspects of their complex management. Often excluded from clinical trials, they are left with limited options for HIV-TB co-treatment. This review will focus on pharmacologic aspects of the treatment of HIV-TB coinfection in the special populations of children and pregnant and postpartum women. Pharmacogenomic considerations, rational dosing, Drug-Drug Interactions (DDIs), safety, Immune Reconstitution Inflammatory Syndrome (IRIS), and ethical and policy aspects of the inclusion of special populations in research will be surveyed...
August 23, 2018: Clinical Pharmacology and Therapeutics
Sulggi A Lee, Julian H Elliott, James McMahon, Wendy Hartogenesis, Namandje N Bumpus, Jeffrey D Lifson, Robert J Gorelick, Peter Bacchetti, Steven G Deeks, Sharon R Lewin, Radojka M Savic
Disulfiram (DSF) was well tolerated and activated viral transcription (cell-associated unspliced [CA-US] and plasma HIV RNA) in a Phase 2 dose-escalation trial in HIV+ antiretroviral therapy (ART)-suppressed participants. Here, we investigated whether exposure to disulfiram and its metabolites predicted these changes in HIV transcription. Participants were administered 500 (N=10), 1000 (N=10), or 2000 (N=10) mg of DSF for 3 consecutive days. Disulfiram and four metabolites were measured by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS)...
August 23, 2018: Clinical Pharmacology and Therapeutics
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