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Clinical Pharmacology and Therapeutics

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https://www.readbyqxmd.com/read/28643861/challenges-in-the-development-of-novel-cardiovascular-therapies
#1
T J Hwang, A S Kesselheim
Cardiovascular disease accounts for nearly one in three deaths globally, but few novel therapies have reached patients and clinicians in recent years. This translational report reviews trends in the development and approval of cardiovascular drugs and evaluates recent innovation in the field of cardiovascular disease therapeutics. New policies are needed to better support the development of safe and effective therapies with the greatest potential to improve patient health outcomes.
June 23, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28643331/treatment-with-antipsychotics-in-pregnancy-changes-in-drug-disposition
#2
Andreas Austgulen Westin, Malin Brekke, Espen Molden, Eirik Skogvoll, Ingrid Castberg, Olav Spigset
Although pregnancy is known to cause changes in drug pharmacokinetics, little is known about its impact on serum levels of antipsychotics. In this study, we retrospectively assessed 201 routine serum antipsychotic therapeutic drug monitoring concentration measurements obtained from a total of 110 pregnancies in 103 women, and 512 measurements from the same women before and after pregnancy. Serum concentrations in the third trimester were significantly lower than baseline for quetiapine (-76%; CI, -83%, -66%; p<0...
June 23, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28643329/analgesic-plasma-concentrations-of-oxycodone-after-surgery-for-breast-cancer-which-factors-matter
#3
K Cajanus, M Neuvonen, O Koskela, M A Kaunisto, P J Neuvonen, M Niemi, E Kalso
We investigated factors affecting analgesic oxycodone concentrations after breast cancer surgery in 1,000 women. Preoperatively, we studied heat and cold pain sensitivities and anxiety scores. Postoperatively, rest and motion pain intensities were measured and intravenous oxycodone was administered until satisfactory analgesia. At this point, the mean oxycodone concentration (variation coefficient) was 33.3 ng/ml (66%), and it was 21.7 ng/ml (69%) when the patient requested oxycodone again. At both time points, the concentrations varied >100-fold between individuals...
June 23, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28643328/drug-repurposing-by-simulating-flow-through-protein-protein-interaction-networks
#4
M Manczinger, V Bodnár, B T Papp, B Sz Bolla, K Szabó, B Balázs, E Csányi, E Szél, G Erős, L Kemény
As drug development is extremely expensive, the identification of novel indications for in-market drugs is financially attractive. Multiple algorithms are used to support such drug repurposing, but highly reliable methods combining simulation of intracellular networks and machine learning are currently not available. We developed an algorithm that simulates drug effects on the flow of information through protein-protein interaction networks, and uses Support Vector Machine to identify potentially effective drugs in our model disease, psoriasis...
June 23, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28636269/commentary-on-r-d-trends-away-from-general-medicine-cardiovascular-drugs-can-the-fda-help-reverse-the-trend
#5
R J Meyer
In the latter part of the 20th century, drug development in cardiovascular diseases (CVDs) was a paragon of "modern" therapeutics, bringing about a substantial number of effective, well-tolerated agents targeting some of the most prevalent diseases of the Western world. These drugs were often examples of rational drug development targeting specific pathophysiologic pathways previously elucidated through basic research (e.g., targeting of the renin-angiotensin system or the cholesterol synthesis pathway). The widespread adoption of these ground-breaking medications in practice and into medical guidelines undoubtedly played a role in the fall of morbidity and mortality from CVD in the United States in recent decades...
June 21, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28636191/-fast-track-development-and-approval-process-for-heart-failure-therapeutics
#6
L Papadimitriou, J Butler
Heart failure (HF) is a global epidemic, with a high mortality and morbidity burden. In such diseases, earlier access to lifesaving therapeutic regimens is imperative, and could be accomplished by improving the drug development and approval process, without jeopardizing patient safety. The US Food and Drug Administration (FDA) has already established mechanisms facilitating the latter, but further guidance to enhance and expedite the process holds promise to further improve patient outcomes.
June 21, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28608458/biomarkers-of-renal-function-towards-clinical-actionability
#7
REVIEW
S Heleen Binnenmars, Ryanne S Hijmans, Gerjan Navis, Martin H de Borst
No abstract text is available yet for this article.
June 12, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28599065/the-role-of-the-kidney-in-drug-elimination-transport-metabolism-and-the-impact-of-kidney-disease-on-drug-clearance
#8
J O Miners, X Yang, K M Knights, L Zhang
Recent advances in the identification and characterization of renal drug transporters and drug metabolizing enzymes has led to greater understanding of their roles in drug and chemical elimination and in modulation of the intra-renal exposure and response to drugs, nephrotoxic compounds, and physiological mediators. Furthermore, there is increasing awareness of the potential importance of drug-drug interactions (DDIs) arising from inhibition of renal transporters, and regulatory agencies now provide recommendations for the evaluation of transporter mediated DDIs...
June 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28599060/evaluation-of-pharmacokinetic-and-pharmacodynamic-drug-drug-interaction-of-sacubitril-valsartan-lcz696-and-sildenafil-in-patients-with-mild-to-moderate-hypertension
#9
Hsiu-Ling Hsiao, Thomas H Langenickel, Jesika Petruck, Kiran Kode, Surya Ayalasomayajula, Uwe Schuehly, Michael Greeley, Parasar Pal, Wei Zhou, Margaret F Prescott, Gangadhar Sunkara, Iris Rajman
Sacubitril/valsartan (LCZ696) is indicated for the treatment of patients with heart failure and reduced ejection fraction (HFrEF). Since patients with HFrEF may receive sacubitril/valsartan and sildenafil, both increasing cGMP, the present study evaluated the pharmacokinetic and pharmacodynamic drug interaction potential between sacubitril/valsartan and sildenafil. In this open-label, 3-period, single sequence study, patients with mild-to-moderate hypertension (153.8±8.2 mm Hg mean SBP) received a single dose of sildenafil 50 mg, sacubitril/valsartan 400 mg once daily for 5 days, and sacubitril/valsartan and sildenafil co-administration...
June 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28597911/digitizing-medicines-for-remote-capture-of-oral-medication-adherence-using-co-encapsulation
#10
Sara H Browne, Charles Peloquin, Frank Santillo, Richard Haubrich, Leticia Muttera, Kathleen Moser, George Savage, Constance Benson, Terrence Blaschke
High-resolution measurement of medication adherence is essential to personalized drug therapy . An FDA-cleared device, using an edible ingestion sensor (IS), external wearable patch and paired mobile device, can detect and record ingestion events. Oral medications must be combined with an IS to generate precise 'digitized-medication' ingestion records. We developed a GMP-protocol to repackage oral medications with the IS within certified Capsugel® capsules, termed co-encapsulation (CoE). A randomized bioequivalence study of CoE-IS-Rifamate (Isoniazid/Rifampin 150/300mg) versus native-Rifamate was conducted in 12 patients with active Mycobacterium Tuberculosis (MTB) and demonstrated bioequivalence using the population method ratio test (95% CI)...
June 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28589612/renal-targeted-therapies-of-antihypertensive-and-cardiovascular-drugs-for-patients-with-stages-3-through-5d-kidney-disease
#11
REVIEW
Omar Al Dhaybi, George L Bakris
No abstract text is available yet for this article.
June 7, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28581206/upcoming-challenges-in-multidisciplinary-heart-failure-management-active-role-of-future-clinical-pharmacists
#12
J Motiejunaite, T Chouihed, A Mebazaa
In their article "Role and Value of Clinical Pharmacy in Heart Failure Management" Stough and Patterson discuss the potential benefits that clinical pharmacists could bring to heart failure management. They mostly focused on chronic stable heart failure. The objective of this commentary is to provide future perspectives for clinical pharmacist involvement in multidisciplinary heart failure team in the management of patients admitted in emergency for decompensation of their heart condition.
June 5, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28581028/measuring-the-value-of-pharmacogenomics-evidence
#13
G P Patrinos, C Mitropoulou
In recent years, there is a growing need to measure the value of pharmacogenomics testing so that policymakers are well informed to decide about adopting and reimbursing pharmacogenomics testing, prioritizing pharmacogenomics research and development, and encouraging the application of companion diagnostics. Presently, there are limited economic evaluation studies of genome-guided treatment modalities that would allow decision-makers to comparatively assess the value and clinical utility of such interventions...
June 5, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28560800/emerging-targets-of-diuretic-therapy
#14
Chih-Jen Cheng, Aylin R Rodan, Chou-Long Huang
Diuretics are commonly prescribed for treatment in patients with hypertension, edema or heart failure. Studies on hypertensive and salt-losing disorders and on urea transporters have contributed to better understanding of mechanisms of renal salt and water reabsorption and their regulation. Proteins involved in the regulatory pathways are emerging targets for diuretic and aquaretic therapy. Integrative high-throughput screening, protein structure analysis, and chemical modification have identified promising agents for pre-clinical testing in animals...
May 30, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28560722/effectiveness-of-drugs-in-routine-care-a-model-for-sequential-monitoring-of-new-medicines-using-dronedarone-as-example
#15
Thomas Cars, Lars Lindhagen, Rickard Malmström, Martin Neovius, Jonas Schwieler, Björn Wettermark, Johan Sundström
Although there is no doubt about the scientific value of randomized controlled clinical trials, they are usually conducted in selected populations different from those treated in clinical practice. Therefore, it is important to optimize real-time post-marketing evaluation of effectiveness, safety, and cost of new drugs. Using electronic health records and administrative health databases from a well-defined region with universal access to healthcare, we have built a framework for real-time sequential monitoring of the effectiveness of newly marketed drugs in routine care...
May 30, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28560712/endogenous-probes-for-drug-transporters-balancing-vision-with-reality
#16
REVIEW
A David Rodrigues, Kunal S Taskar, Hiroyuki Kusuhara, Yuichi Sugiyama
No abstract text is available yet for this article.
May 30, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28555841/regulatory-consequences-of-brexit-for-the-development-of-medicinal-products
#17
LETTER
E L Jackson, P Feldschreiber, A Breckenridge
The United Kingdom voted in a referendum in June 2016 to leave the European Union (EU) after 45 years of membership. Among the many political, social, and scientific consequences are those for the regulation of health care products. No longer will the efficacy, safety, and quality of medicines in the United Kingdom be subject to an EU regulatory framework. The European Medicines Agency (EMA), which is currently located in London, will move elsewhere in Europe. The pharmaceutical industry will reassess its commitment to the UK health scene...
May 27, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28555724/population-pharmacokinetics-of-amoxicillin-in-term-neonates-undergoing-moderate-hypothermia
#18
Yuma A Bijleveld, Ron A A Mathôt, Johanna H van der Lee, Floris Groenendaal, Peter H Dijk, Arno van Heijst, Sinno H P Simons, Koen P Dijkman, Henrica L M van Straaten, Monique Rijken, Inge A Zonnenberg, Filip Cools, Alexandra Zecic, Debbie H G M Nuytemans, Anton H van Kaam, Timo R de Haan
The pharmacokinetics (PK) of amoxicillin in asphyxiated newborns undergoing moderate hypothermia were quantified using prospective data (N=125). The population PK was described by a 2-compartment model with a priori birthweight (BW) based allometric scaling. Significant correlations were observed between clearance (Cl) and postnatal age (PNA), gestational age (GA), body temperature (TEMP), and urine output (UO). For a typical patient with GA 40 weeks, BW 3000 g, 2 days PNA (i.e. TEMP 33.5°C), and normal UO, Cl was 0...
May 27, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28548223/cannabis-smoking-and-cardiovascular-health-it-s-complicated
#19
M R Piano
Many states have legalized cannabis use for treatment of certain medical conditions or have legalized cannabis for recreational use. Consequently, cannabis use prevalence has escalated, giving rise to concerns about potential health effects. Cannabis smoking remains the most prevalent route of administration and is associated with inhalation of chemical toxicants. The aim of this article is to summarize the effects of cannabis smoking on the vasculature and occurrence of cardiovascular (CV) events such as myocardial infarction (MI) and stroke...
May 26, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28548221/psilocybin-good-trip-or-bad-trip
#20
E M Sellers
Much of the history of pharmacology and therapeutics involves finding new uses for old drugs. The latest rediscovery is that of psychedelic drugs. Since they can cause profound distortions of perception and were once used as part of religious ceremonies, such research may seem unusual at this time.
May 26, 2017: Clinical Pharmacology and Therapeutics
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