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1.
Introduction
The objective of this prospective, multicenter, parallel-group, non-interventional clinical trial (NIT) was to characterize the effectiveness of a treatment with the phytomedicines ELOM-080 and BNO 1016 in patients with acute rhinosinusitis (ARS).Methods
A total of 228 patients suffering from ARS took part in this NIT and were treated for a maximum of 14 days with either BNO 1016 or ELOM-080. Focus was on improvement of rhinosinusitis-associated pain/discomfort and nasal congestion in real-life conditions of primary care setting, as assessed by numeric and verbal rating scale, and five-point Likert scale.Results
The course of the key ARS symptom facial pain demonstrated a faster recovery in patients with ELOM-080, when compared to BNO 1016. ELOM-080 tended to be superior for several ancillary criteria and induced significantly higher patient satisfaction with regard to the improvement of feeling of general illness. Physicians assessed both products to be very effective and well tolerated. Adverse drug reactions classified as gastrointestinal disorders occurred in both groups to a comparable extent.Conclusion
This trial demonstrated comparable effectiveness of a therapy of ARS with the phytomedicines ELOM-080 and BNO 1016, although the treatment with ELOM-080 resulted in a more rapid and more complete recovery in ARS key symptoms and tended to be superior for several ancillary criteria. Both treatments were well tolerated.Trial registration number
NIS-6471.Funding
G. Pohl-Boskamp GmbH & Co. KG.2.
Objective
To compare the safety and estimate the response profile of olanzapine, a second-generation antipsychotic, to haloperidol in the treatment of delirium in the critical care setting.Design
Prospective randomized trialSetting
Tertiary care university affiliated critical care unit.Patients
All admissions to a medical and surgical intensive care unit with a diagnosis of delirium.Interventions
Patients were randomized to receive either enteral olanzapine or haloperidol.Measurements
Patient’s delirium severity and benzodiazepine use were monitored over 5 days after the diagnosis of delirium.Main results
Delirium Index decreased over time in both groups, as did the administered dose of benzodiazepines. Clinical improvement was similar in both treatment arms. No side effects were noted in the olanzapine group, whereas the use of haloperidol was associated with extrapyramidal side effects.Conclusions
Olanzapine is a safe alternative to haloperidol in delirious critical care patients, and may be of particular interest in patients in whom haloperidol is contraindicated.3.
Ken P. EhrhardtJr Susan M. Mothersele Andrew J. Brunk Jeremy B. Green Mark R. Jones Craig B. Billeaud Alan David Kaye 《Current pain and headache reports》2018,22(4):26
Purpose of Review
Chronic pain is a highly prevalent condition affecting millions of individuals.Recent Findings
In recent years, newer treatments have emerged that are changing the way clinicians treat pain pathogenesis, including novel nonopioid strategies. In this regard, spinal cord stimulation, the MILD procedure, and regenerative medicine have shown promise. This review summarizes recent literature on these three emerging treatment strategies.Summary
The results of this review suggest that under certain conditions, spinal cord stimulation, the MILD procedure, and regenerative medicine can be effective treatment modalities.4.
Introduction
The purpose of the present study was to examine the potential ocular and systemic toxicity and toxicokinetics/pharmacokinetics of sustained-release dexamethasone in canines.Methods
In this non-randomized study, intracanalicular depots (dexamethasone-loaded or placebo vehicle) were inserted into both eyes of 33 beagles. Tear fluid and plasma were collected for toxicokinetic/pharmacokinetic analysis of dexamethasone, ophthalmic examinations were performed for signs of toxicity, and urine and blood samples were collected for urinalysis, hematology, clinical chemistry, and coagulation analysis. Animals were observed daily for signs of toxicity. Macroscopic and microscopic evaluations were performed.Results
Mean dexamethasone tear fluid concentration from the dexamethasone group decreased from 4245 ng/mL 6-h post-insertion to 1044 ng/mL on Day 35. All plasma dexamethasone levels were below the limit of quantitation. No systemic or ocular toxicities were attributed to the dexamethasone depot.Conclusion
Sustained-release dexamethasone produced no identifiable ocular or systemic toxicity in this animal model, and pharmacokinetics demonstrated a tapered, sustained drug release.Funding
Ocular Therapeutix.5.
Maneesh Gupta 《Clin Pract Epidemiol Ment Health》2007,3(1):12
Background
Quetiapine causes less prolactin elevation and/or galactorrhoea than other atypical antipsychotics.Case Presentation
Ms AB had galactorrhoea and raised prolactin levels at only 100 mg of quetiapine daily.Conclusion
Low dose quetiapine can also cause galactorrhoea.6.
José A. Sacristán Luís Lizan Marta Comellas Pilar Garrido Cristina Avendaño Juan J. Cruz-Hernández Javier Espinosa Tatiana Dilla 《Advances in therapy》2016,33(11):2059-2068
Introduction
The purpose of this study was to explore the main factors explaining the relative weight of the different attributes that determine the value of oncologic treatments from the different perspectives of healthcare policy makers (HCPM), oncologists, patients and the general population in Spain.Methods
Structured interviews were conducted to assess: (1) the importance of the attributes on treatment choice when comparing a new cancer drug with a standard cancer treatment; (2) the importance of survival, quality of life (QoL), costs and innovation in cancer; and (3) the most worrying side effects related to cancer drugs.Results
A total of 188 individuals participated in the study. For all participants, when choosing treatments, the best rated characteristics were greater efficacy, greater safety, treatment adaptation to patients’ individual requirements and the rapid reincorporation of patients to their daily activities. There were important differences among participants in their opinion about survival, QoL and cost. In general, oncologists, patients, and the general population gave greater value to gains in QoL than healthcare policy makers. Compared to other participants healthcare policy makers gave greater importance to the economic impact related to oncology treatments.Conclusions
Gains in QoL, survival, safety, cost and innovation are perceived differently by different groups of stakeholders. It is recommended to consider the perspective of different stakeholders in the assessment of a new cancer drugs to obtain more informed decisions when deciding on the most appropriate treatment to use.Funding
Eli Lilly & Co, Madrid (Spain).7.
Introduction
Mifepristone, a competitive glucocorticoid receptor antagonist approved for Cushing syndrome, and ketoconazole, an antifungal and steroidogenesis inhibitor, are both inhibitors of and substrates for cytochrome P450 (CYP3A4). This study evaluated the pharmacokinetic effects of concomitant ketoconazole, a strong CYP3A4 inhibitor, on mifepristone.Methods
In an open-label, two-period, single-center study, healthy adult men received mifepristone 600 mg orally daily for 12 days (period 1) followed by mifepristone 600 mg daily plus ketoconazole 200 mg orally twice daily for 5 days (period 2). Serial pharmacokinetic blood samples were collected predose and over 24 h postdose on days 12 (period 1) and 17 (period 2). A cross-study comparison (using data on file) further examined whether systemic exposure to mifepristone plus ketoconazole exceeded the exposure following mifepristone 1200 mg orally administered for 7 days.Results
Sixteen subjects were enrolled and 14 completed the study. Concomitant administration with ketoconazole increased the systemic exposure to mifepristone, based on geometric least squares mean ratios, by 28% for C max and 38% for AUC0–24. This increase was 85% and 87% of the exposure observed following mifepristone’s highest label dose of 1200 mg/day for C max and AUC0–24, respectively. Adverse events (AEs) were reported in 56.3% (9/16) of subjects during administration of mifepristone alone and in 57.1% (8/14) during combination with ketoconazole. No serious AEs were reported.Conclusion
Systemic exposure to mifepristone increased following multiple doses of mifepristone 600 mg daily plus ketoconazole 200 mg twice daily. Little to no increase in AEs occurred. Dose adjustment of mifepristone may be needed when given with ketoconazole.Funding
Corcept Therapeutics.8.
Anna I. Guerdjikova Brandon Walsh Kevin Shan Amy E. Halseth Eduardo Dunayevich Susan L. McElroy 《Advances in therapy》2017,34(10):2307-2315
Introduction
Binge eating disorder (BED) is associated with obesity and major depressive disorder (MDD). Naltrexone extended-release (ER)/bupropion ER (NB) is approved as an adjunct to diet and physical activity for chronic weight management. In a prospectively designed 24-week open-label, single-arm, single-site trial of 25 women with MDD and overweight/obesity, NB reduced weight and depressive symptoms.Methods
This post hoc analysis investigated the relationship between change in self-reported binge eating behavior (evaluated with the Binge Eating Scale [BES]) and changes in weight, control of eating, and depressive symptoms.Results
At baseline, 91% of subjects had moderate or severe BES scores, suggesting BED. BES scores were significantly improved from week 4, and by week 24, 83% reported “little or no problem.” Improvement in BES scores correlated with improvement in depressive symptoms and control of eating.Conclusion
NB may be effective in reducing binge eating symptoms associated with MDD and overweight/obesity. Evaluation of NB in BED appears warranted.Funding
Orexigen Therapeutics, Inc.9.
Purpose
On a regular basis, the intensivist encounters the patient who is difficult to wean from mechanical ventilatory support. The causes for failure to wean from mechanical ventilatory support are often multifactorial and involve a complex interplay between cardiac and pulmonary dysfunction. A potential application of point of care ultrasonography relates to its utility in the process of weaning the patient from mechanical ventilatory support.Methods
This article reviews some applications of ultrasonography that may be relevant to the process of weaning from mechanical ventilatory support.Results
The authors have divided these applications of ultrasonography into four separate categories: the assessment of cardiac, diaphragmatic, and lung function; and the identification of pleural effusion; which can all be evaluated with ultrasonography during a dynamic process in which the intensivist is uniquely positioned to use ultrasonography at the point of care.Conclusions
Ultrasonography may have useful application during the weaning process from mechanical ventilatory support.10.
Nalini Vadivelu Alice M. Kai Gopal Kodumudi Julie Sramcik Alan D. Kaye 《Current pain and headache reports》2018,22(1):3
Purpose of Review
The purpose of the following review is to summarize the history and current policies related to marijuana use and prevalence, basic and clinical science pharmacological literature regarding efficacy, subpopulations of concern, and varying policies regarding its use at present.Recent Findings
With the increasingly widespread utilization of marijuana, there is also a growing complexity of public health policy, regulation, and necessity to further assess the medical indications and adverse long-term effects of marijuana use.Summary
Health care providers as well as the general public must be prepared to become familiar and up-to-date with medical literature, legislation, and educational material regarding medical marijuana.11.
Introduction
The purpose of this study was to identify the key barriers to a customer-focused drug development process and develop a comprehensive framework to overcome them.Methods
The paper draws on existing literature, both academic and practitioner, across a range of disciplines (innovation management, marketing, organizational behavior, behavioral economics, health economics, industry reports). On the basis of this extensive review, a conceptual framework is developed that offers concrete suggestions on how organizations can overcome the barriers and enable a more customer-focused development process.Results
The barriers to collaboration are organized into three distinct categories (economic, behavioral, organizational), and within each category, a one-to-one mapping between barriers and solutions is developed.Conclusion
The framework is specifically designed with the objective of offering actionable and practical advice to executives who face these challenges in their organizations. The paper provides a unique theoretical contribution by synthesizing findings from several academic disciplines with concrete examples from the pharmaceutical industry.Funding
Mundipharma International Limited.12.
Background
Aim was to determine the predictive factors for polypharmacy among inpatient children and adolescents with psychiatric disorders.Methods
Blinded, case-note review of children and adolescents with ICD 10 diagnosis of psychiatric disorders on psychotropic medication was conducted. Data on demography, illness, and treatment was analyzed with univariate and multivariate techniques.Results
Proscribing non-pharmacological interventions (OR = 4.7) and pro re nata medication (OR = 3.3), increased the risk of polypharmacy. Prescribing physical restraint reduced the risk of receiving multiple medications (OR = 0.3).Conclusion
Proscribing non-pharmacological interventions, pro re nata medication and physical restraints increased polypharmacy.13.
Anton Petrov Natalia Perekhvatova Maxim Skulachev Linda Stein George Ousler 《Advances in therapy》2016,33(1):96-115
Introduction
This Phase 2 clinical trial assessed the efficacy and safety of the novel antioxidative, renewable compound SkQ1 for topical treatment of dry eye signs and symptoms.Methods
In a single-center, randomized, double-masked, placebo-controlled, 29-day study, 91 subjects with mild to moderate dry eye instilled the study drug twice daily and recorded dry eye symptoms daily. Subjects were randomized 1:1:1 into one of three ophthalmic solution treatment groups: SkQ1 1.55 µg/mL, SkQ1 0.155 µg/mL, or 0.0 µg/mL (placebo). Subjects were exposed to a controlled adverse environment chamber at 3 of the 4 study visits (Day ?7, Day 1, and Day 29). Investigator assessments occurred at all study visits.Results
SkQ1 was safe and efficacious in treating dry eye signs and symptoms. Statistically significant improvements with SkQ1 compared to placebo occurred for the dry eye signs of corneal fluorescein staining and lissamine green staining in the central region and lid margin redness, and for the dry eye symptoms of ocular discomfort, dryness, and grittiness. In addition, SkQ1 demonstrated greater efficacy compared to placebo, although the differences were not statistically significant, for corneal fluorescein staining in other regions and/or time points (total staining score, central region, corneal sum score, and temporal region), lissamine green staining for the central and nasal regions, and blink rate scores.Conclusions
This Phase 2 study indicated that SkQ1 is safe and efficacious for the treatment of dry eye signs and symptoms and supported previous study results.Trial registration
Clinicaltrials.gov identifier: NCT02121301.Funding
Miotech S.A.14.
Anna Theodorou-Kanakari Spyridon Karampitianis Vasiliki Karageorgou Eleni Kampourelli Efstathios Kapasakis Panagiotis Theodossiadis Irini Chatziralli 《Advances in therapy》2018,35(10):1510-1518
Introduction
The purpose of this review is to present the current and emerging treatment alternatives for Leber’s hereditary optic neuropathy (LHON), emphasizing the most recent use of idebenone and stem cells or gene therapy.Methods
A comprehensive literature review was performed at the PubMed database regarding the various treatment modalities for LHON.Results
Treatment modalities for LHON include nutritional supplements, activators of mitochondrial biogenesis, brimonidine, and symptomatic and supportive treatment, but nowadays attention is being paid to idebenone and gene therapy or stem cells.Conclusion
The treatment of LHON remains challenging, given the nature of the disease and its prognosis.15.
Karlsson S Varpula M Ruokonen E Pettilä V Parviainen I Ala-Kokko TI Kolho E Rintala EM 《Intensive care medicine》2007,33(3):435-443
Objective
To determine the incidence and outcome of severe sepsis in the adult Finnish population and to evaluate how treatment guidelines in severe sepsis are applied in clinical practice.Study design
A prospective study in 24 closed multidisciplinary ICUs in 21 hospitals (4 university and 17 tertiary hospitals) in Finland.Patients
All 4,500 consecutive ICU admission episodes were screened for severe sepsis during a 4-month period (1 November 2004 – 28 February 2005). The referral population was 3,743,225.Results
The severe sepsis criteria were fulfilled in 470 patients, who had472 septic episodes. The incidence of severe sepsis in the ICUs in Finland was 0.38/1000 in the adult population (95% confidence interval 0.34–0.41). The mean ICU length of stay was 8.2?±?8.1?days. ICU, hospital, and 1-year mortality rates were 15.5%, 28.3%, and 40.9%, respectively. Respiratory failure requiring ventilation support was the most common organ failure (86.2%); septic shock was present in 77% and acute renal failure in 20.6% of cases. Activated protein C was given to only 15 of the 55 patients with indication (27%) and low-dose corticosteroids to 150 of 366 (41%) patients with septic shock.Conclusions
This prospective study found the incidence of ICU-treated severe sepsis in Finland to be 0.38 per 1,000 of the population. The ICU and hospital mortalities were also lower than earlier reported in United States or Australia. Evidence-based sepsis therapies were not used as often as recommended.16.
David J. W. Knight Dale Gardiner Amanda Banks Susan E. Snape Vivienne C. Weston Stig Bengmark Keith J. Girling 《Intensive care medicine》2009,35(5):854-861
Objective
To investigate the effect of enteral Synbiotic 2000 FORTE® (a mixture of lactic acid bacteria and fibre) on the incidence of ventilator associated pneumonia (VAP) in critically ill patients.Design
Prospective, randomised, double blind, placebo controlled trial.Setting
Tertiary referral centre, general Adult Intensive Care Unit (ICU).Patients and participants
259 enterally fed patients requiring mechanical ventilation for 48 h or more were enrolled.Intervention
All patients were enterally fed as per a standard protocol and randomly assigned to receive either synbiotic 2000 FORTE® (twice a day) or a cellulose-based placebo for a maximum of 28 days.Measurements and results
Treatment group (n = 130) was well matched with placebo group (n = 129) for age (mean 49.5 and 50 years, respectively) and APACHE II score (median 17 for both). Oropharyngeal microbial flora and colonisation rates were unaffected by synbiotics. The overall incidence of VAP was lower than anticipated (11.2%) and no statistical difference was demonstrated between groups receiving synbiotic and placebo in the incidence of VAP (9 and 13%, P = 0.42), VAP rate per 1,000 ventilator days (13 and 14.6, P = 0.91) or hospital mortality (27 and 33%, P = 0.39), respectively.Conclusions
Enteral administration of Synbiotic 2000 FORTE® has no statistically significant impact on the incidence of VAP in critically ill patients.17.
Michael Ankele Lek-Heng Lim Samuel Groeschel Thomas Schultz 《International journal of computer assisted radiology and surgery》2017,12(8):1257-1270
Purpose
Develop a multi-fiber tractography method that produces fast and robust results based on input data from a wide range of diffusion MRI protocols, including high angular resolution diffusion imaging, multi-shell imaging, and clinical diffusion spectrum imaging (DSI)Methods
In a unified deconvolution framework for different types of diffusion MRI protocols, we represent fiber orientation distribution functions as higher-order tensors, which permits use of a novel positive definiteness constraint (H-psd) that makes estimation from noisy input more robust. The resulting directions are used for deterministic fiber tracking with branching.Results
We quantify accuracy on simulated data, as well as condition numbers and computation times on clinical data. We qualitatively investigate the benefits when processing suboptimal data, and show direct comparisons to several state-of-the-art techniques.Conclusion
The proposed method works faster than state-of-the-art approaches, achieves higher angular resolution on simulated data with known ground truth, and plausible results on clinical data. In addition to working with the same data as previous methods for multi-tissue deconvolution, it also supports DSI data.18.
Aims
Create an educational program in chronic pain (EPCP).Material and methods
We used a four-step process to create the EPCP tailored to patient’s needs.Results
Five groups of patients can benefit from the program annually. Based on their own assessment, patients stated that their knowledge of chronic pain improved between 2.8 to 24%. The satisfaction with the EPCP was 8.67/10.Conclusion
Our EPCP helps patients gain and maintain the skills they need to best manage their lives with a chronic pain.19.
Namita Kumar Sophia Naz Mark Quinn John Ryan Thomas Kumke Tom Sheeran 《Advances in therapy》2018,35(9):1426-1437
Introduction
The objective of this non-interventional study was to investigate the long-term safety and effectiveness of certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) in the UK and Ireland.Methods
Patients were prescribed CZP at their physicians’ discretion and followed during routine clinical practice for up to 88 weeks. DAS28(ESR) response (defined as at least a 1.2-point reduction from baseline) was measured in the full analysis set (FAS) at week 12, and patients were categorized by week 12 responder status in all subsequent analyses. The primary outcome was DAS28(ESR) response at week 78. Secondary outcomes included change from baseline in DAS28(ESR), HAQ-DI, and RADAI scores at week 78, and EULAR response at week 78. Adverse drug reactions (ADRs) were recorded for all patients who received at least one dose of CZP.Results
A total of 149 patients were enrolled, of whom 111 (74.5%) formed the FAS. At week 12, 80 patients (72.1%) were DAS28(ESR) responders and 31 (27.9%) non-responders. Compared to non-responders, a greater proportion of week 12 responders had a DAS28(ESR) response at week 78 (43.8% versus 22.6%). Improvements in DAS28(ESR), HAQ-DI, and RADAI scores were also greater on average among week 12 responders, as was the proportion of patients meeting EULAR criteria. Overall, 9 patients (6.1%) experienced 13 ADRs during the study.Conclusion
These data demonstrate the safety and effectiveness of CZP in adult patients with RA treated during routine clinical practice in the UK and Ireland.Trial Registration
ClinicalTrials.gov identifier, NCT01288287.Funding
UCB Pharma.20.
N. López-Vilanova J. Pavía M. A. Duch A. Catafau D. Ros S. Bullich 《Molecular imaging and biology》2017,19(2):305-314