Current Issue : April - June Volume : 2017 Issue Number : 2 Articles : 5 Articles
The present study aimed to compare pharmacokinetic parameters of two pramipexole\n0.25 mg formulations in order to show bioequivalence. The study was conducted in a randomized,\nopen-label, two-period, two-sequence, and crossover design, involving 23 healthy volunteers. One of\nthe 0.25 mg formulations of pramipexole evaluated in the study was manufactured by PT Dexa\nMedica, Palembang, Indonesia, the other, used as the reference, by Boehringer Ingelheim Pharma\nGmbH & Co. KG, Ingelheim am Rhein, Germany. All eligible subjects were required to fast\nbefore each drug administration period, which was separated by a one-week washout period.\nPramipexole concentrations in plasma were assayed using a validated ultra performance liquid\nchromatography with mass spectrometry (UPLC-MS/MS) detector. The evaluated pharmacokinetic\nparameters included the area under the plasma concentration curve from time zero to the last observed\nmeasurable concentration (AUC0-t), the area under the plasma concentration curve extrapolated to\ninfinite time (AUC0-âË?ž), the maximum plasma concentration (Cmax), the time to reach Cmax (tmax),\nand the plasma concentration half-life (t1/2). To evaluate the bioequivalence of those two pramipexole\nformulations, 90% confidence intervals (CIs) for geometric mean ratios of both formulations were\ncalculated for AUC and Cmax parameters, while tmax and t1/2 differences were analyzed on the\nnon-transformed data using Wilcoxon matched-pairs and a Studentââ?¬â?¢s paired t-test, respectively.\nThe 90% CIs for the geometric mean ratios of the two pramipexole formulations were 95.89%\n(90.73%ââ?¬â??101.34%), 95.53% (89.75%ââ?¬â??101.68%), and 92.11% (84.35%ââ?¬â??100.58%) for AUC0-t, AUC0-âË?ž,\nand Cmax, respectively. There were no statistically significant differences for tmax and t1/2 between\nthe two pramipexole formulations. It is concluded that two pramipexole formulations in this study\nwere bioequivalent....
Access to bevacizumab, an important component of oncology treatment regimens, may be\nlimited. This survey of oncologists in the US (n = 150), Europe (n = 230), and emerging markets\n(EM: Brazil, Mexico, and Turkey; n = 130) examined use of and barriers to accessing bevacizumab as\ntreatment of advanced solid tumors. We also assessed the likelihood that physicians would prescribe\na bevacizumab biosimilar, if available. Bevacizumab was frequently used as early-line therapy in\nmetastatic colorectal cancer, metastatic non-squamous nonââ?¬â??small-cell lung cancer, and metastatic\novarian cancer (all markets), and as a second-line therapy in glioblastoma multiforme (US, EM).\nA greater percentage of EM-based physicians cited access-related issues as a barrier to prescribing\nbevacizumab versus US and EU physicians. Lack of reimbursement and high out-of-pocket costs\nwere cited as predominant barriers to prescribing and common reasons for reducing the number of\nplanned cycles. Overall, ~50% of physicians reported they ââ?¬Å?definitelyââ?¬Â or ââ?¬Å?probablyââ?¬Â would prescribe\na bevacizumab biosimilar, if available. Efficacy and safety data in specific tumor types and lower\ncost were factors cited that would increase likelihood to prescribe a bevacizumab biosimilar. A lower\ncost bevacizumab biosimilar could address the unmet needs of patients and physicians worldwide,\nand may have the greatest impact on patient outcomes in EM....
Background: We compared the effectiveness of abatacept (ABA) vs tocilizumab (TCA) in tumor necrosis factor\ninhibitor (TNFi) experienced patients.\nMethods: We identified rheumatoid arthritis (RA) patients from a large observational US cohort (1 January 2010ââ?¬â??31\nMay 2014) who had discontinued at least one TNFi and initiated ABA or TCZ in moderate or high disease activity based\non the Clinical Disease Activity Index (CDAI) and had no prior exposure to the comparator drug. Using propensity score\nmatching (1:1) stratified by prior TNF use (1 TNFi vs ââ?°Â¥2 TNFis), effectiveness at 6 months after initiation was evaluated.\nMean change in CDAI over 6 months following initiation was the primary outcome, with secondary outcomes of\nachievement of low disease activity/remission (CDAI ââ?°Â¤ 10) and mean change in modified Health Assessment\nQuestionnaire (mHAQ) score.\nResults: The 264 pairs of propensity score-matched ABA and TCZ initiators were well matched with no substantial\ndifferences in the baseline characteristics, defined as standardized differences >0.1 in the stratification. Both treatment\ngroups had similar mean change in CDAI at 6 months (ââ?¬â??11.3 in ABA vs ââ?¬â??9.9 in TCZ; mean difference ââ?¬â??1.27, 95% CI ââ?¬â??3.\n65, 1.11). Similar proportions of both treatment groups achieved low disease activity/remission (adjusted odds ratio for\nABA vs TCZ 0.99, 95% CI 0.69, 1.43). Mean change in mHAQ was ââ?¬â??0.12 in ABA initiators vs ââ?¬â??0.11 in TCZ initiations (mean\ndifference ââ?¬â??0.01, 95% CI ââ?¬â??0.09, 0.06).\nConclusions: Patients receiving either ABA or TCZ had substantial improvement in clinical disease activity. In this\npropensity score-matched sample, similar outcomes were observed for both treatment cohorts...
Background: Only drafts of regulatory guidelines for the registration of biosimilars are available in Lebanon. We\nanalyzed the results of a regional survey conducted in Lebanon to understand the impact of different parameters on\nthe acceptance and future prescription of biosimilars. We also reviewed the current situation of biosimilars around the\nworld. The study surveyed healthcare professionals from the Arab countries, Iran, Belgium and Italy. Data about the\nparticipants� specialty, country of residence, their knowledge about biosimilars, biosimilars� prescription, price influence\nand the manufacturer�s credibility were collected.\nResults: 117 questionnaires were completed and returned: 46 (39.3%) respondents were oncologists. 72 (61.5%)\nrespondents were Lebanese, and the others from Egypt, Syria, Algeria, Iraq, Sudan, Jordan, Iran, Belgium and Italy.\n77 (65.8%) respondents had knowledge about biosimilars, of whom 48 (62.3%) considered biosimilars as biologics\nthat demonstrate bioequivalence with the original biodrug and have all preclinical and clinical trials equal to those\nalready performed with the original biodrug. 74 (63.2%) out of 117 respondents agreed that biosimilars in the Arab\nand Middle Eastern market are already marketed. Among the 48 participants who prescribe biosimilars, the main\nprescription driver was the drug�s approval by the FDA and EMA (68.8%). 71 (60.7%) respondents considered that the\nmain advantage of biosimilars is their lower price and 41 (35%) out of the 117 respondents declared that they should\nknow in which country the drug has been tested/created before using it in their own country. 35% of the respondents\nthought that the cost of a treatment should not come before its effectiveness or safety/tolerance, given that the\nbiosimilar will be less expensive than the reference drug.\nConclusions: Biosimilars� acceptance and use is increasing worldwide. Only few physicians are aware of biosimilars\npresence in the market and do prescribe them in Lebanon and the Arab region. This could be mainly explained by\nlack of confidence in efficacy, safety, manufacturing process and price of these products, and lack of clear legislation.\nThus, WHO is finalizing a new guideline for similar biotherapeutic agents. This could be a starting point for the Lebanese\ngovernment to support the authorization of biosimilars....
The present paper addresses severe asthma which is limited to 5-10% of the overall population of asthmatics.\nHowever, it accounts for 50% or more of socials costs of the disease, as it is responsible for hospitalizations and\nEmergency Department accesses as well as expensive treatments.\nThe recent identification of different endotypes of asthma, based on the inflammatory pattern, has led to the\ndevelopment of tailored treatments that target different inflammatory mediators. These are major achievements\nin the perspective of Precision Medicine: a leading approach to the modern treatment strategy.\nOmalizumab, an anti-IgE antibody, has been the only biologic treatment available on the market for severe\nasthma during the last decade. It prevents the linkage of the IgE and the receptors, thereby inhibiting mast\ncell degranulation. In clinical practice omalizumab significantly reduced the asthma exacerbations as well as\nthe concomitant use of oral glucocorticoids.\nIn the ââ?¬Å?Th2-high asthmaââ?¬Â phenotype, the hallmarks are increased levels of eosinophils and other markers (such as\nperiostin). Because anti-IL-5 in this condition plays a crucial role in driving eosinophil inflammation, this cytokine\nor its receptors on the eosinophil surface has been studied as a potential target for therapy.\nTwo different anti-IL-5 humanized monoclonal antibodies, mepolizumab and reslizumab, have been proven effective in\nthis phenotype of asthma (recently they both came on the market in the United States), as well as an anti-IL-5\nreceptor alpha (IL5RÃ?±), benralizumab.\nOther monoclonal antibodies, targeting different cytokines (IL-13, IL-4, IL-17 and TSLP) are still under evaluation,\nthough the preliminary results are encouraging.\nFinally, AIT, Allergen Immunotherapy, a prototype of Precision Medicine, is considered, also in light of the recent\nevidences of Sublingual Immunotherapy (SLIT) tablet efficacy and safety in mite allergic asthma patients.\nGiven the high costs of these therapies, however, there is an urgent need to identify biomarkers that can predict\nthe clinical responders....
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