Frontiers in pharmacology
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Frontiers in pharmacology · Jan 2018
The Optimal Chinese Herbal Injections for Use With Radiotherapy to Treat Esophageal Cancer: A Systematic Review and Bayesian Network Meta-Analysis.
Ethnopharmacological relevance: Esophageal cancer is one of the most common human cancers, and its incidence is highly endemic in China. The combination of Chinese herbal injections (CHIs) and radiotherapy should be informed by the best available evidence. Aim of the study: To update and expand on previous work in order to compare and rank the efficacy and safety of CHIs in combination with radiotherapy to treat esophageal cancer. ⋯ Lentinan injection may be considered a favorable choice for reliving ADRs, and Compound kushen injection may provide treatment benefits by reducing both gastrointestinal reaction and radiation esophagitis. Conclusions: The current clinical evidence indicated that Compound kushen injection combined with radiotherapy is the most preferable and beneficial option for patients with esophageal cancer in terms of efficacy and safety. However, the results of our study should be interpreted with caution given the limitations of the sample size and the methodological quality of the included trials.
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Frontiers in pharmacology · Jan 2018
Pan-Canadian Pharmaceutical Alliance (pCPA): Timelines Analysis and Policy Implications.
This analysis follows our recent study showing that Canadian public reimbursement delays have lengthened from regulatory approval to listing decisions by public drug plans and delayed public access to innovative medicines, mainly due to processes following the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR). Public drug plans participate in a pan-Canadian Pharmaceutical Alliance (pCPA) joint negotiation process before making decisions about whether or not to reimburse a product reviewed through CDR and pCODR. This research aims to report the findings from a comprehensive analysis of pCPA process times, times to reimbursement by public payers in Canada, and to explore the opportunities to reduce total delays in public reimbursement with a specific focus on the pCPA process. ⋯ Listing rates also appear to be declining for non-oncology products, although this trend is less conclusive for oncology products. Challenges need to be addressed to improve efficiency, transparency, and ultimately reduce pCPA timelines and total timelines to public reimbursement. Suggested ways to improve and streamline the listing process are: (1) transparent target timelines and associated performance incentives for the pCPA and public plan decisions, (2) parallel HTA-pCPA processes to enable pCPA negotiations to start part-way through the HTA review and allow pCPA negotiation information to be fed back into the HTA review, and (3) innovative agreements that consider patient input and earlier coverage with real-world evidence development.
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Frontiers in pharmacology · Jan 2018
The Efficacy and Safety of Mainstream Medications for Patients With cDMARD-Naïve Rheumatoid Arthritis: A Network Meta-Analysis.
Background: The mainstream medications for rheumatoid arthritis (RA) include conventional disease-modifying antirheumatic drugs (cDMARDs), which mostly are methotrexate (MTX), and biologic agents such as adalimumab (ADA), certolizumab (CZP), etanercept (ETN), golimumab (GOL), infliximab (IFX), and tocilizumab (TCZ). This network meta-analysis was aimed at evaluating the efficacy and safety of the medications above and interventions combining cDMARDs and biologic agents for patients with RA. Methods: PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov were searched systematically for eligible randomized controlled trials (RCTs). ⋯ Conclusion: TCZ+MTX was potentially the most recommended combination of medications for RA due to its good performance in all outcomes of efficacy. ETX+MTX and IFX+MTX, which also performed well, could be introduced as alternative treatments. However, considering the adverse events, the treatments concerning should be introduced with caution.
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Frontiers in pharmacology · Jan 2018
Population Pharmacokinetic/Pharmacodynamic Model-Guided Dosing Optimization of a Novel Sedative HR7056 in Chinese Healthy Subjects.
HR7056 is a new benzodiazepine, showing more faster acting onset and recovery than currently available short-acting sedatives. To avoid inadequate anesthesia and predict return of cognition, allowing for immediate neurological evaluation, HR7056 pharmacokinetics and pharmacodynamics were characterized in Chinese healthy subjects. We report on modeling of the data and simulations of dosage regimens for future study. ⋯ The population mean pharmacodynamic parameters were as follows: BIS, E0: 95.3; IC50: 503 ng mL-1; γ: 1.5; ke0: 0.0855 min-1; Imax: 47.9 and MOAA/S, IC50: 436 ng mL-1; γ: 1.5; ke0: 0.05 min-1; Imax: 27.9. The model simulation will enable maintenance doses to be given more accurately for future study. Clinical Trial Registration: identifier: NCT01970072.
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Frontiers in pharmacology · Jan 2018
Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe.
As per the EMA definition, adaptive pathways is a scientific concept for the development of medicines which seeks to facilitate patient access to promising medicines addressing high unmet need through a prospectively planned approach in a sustainable way. This review reports the findings of activities undertaken by the ADAPT-SMART consortium to identify enablers and explore the suitability of managed entry agreements for adaptive pathways products in Europe. We found that during 2006-2016 outcomes-based managed entry agreements were not commonly used for products with a conditional marketing authorization or authorized under exceptional circumstances. The barriers and enablers to develop workable managed entry agreements models for adaptive pathways products were discussed through interviews and a multi-stakeholder workshop with a number of recommendations made in this paper.