Current Issue : January - March Volume : 2017 Issue Number : 1 Articles : 5 Articles
Aim: Tauroursodeoxycholic acid (TUDCA) is a taurine conjugated form of ursodeoxycholic acid (UDCA) with higher hydrophility. To\nfurther evaluate the efficacy and safety of TUDCA for primary biliary cholangitis (PBC), we performed this study on Chinese patients.\nMethods: 199 PBC patients were randomly assigned to either 250mg TUDCA plus UDCA placebo or 250mg UDCA plus TUDCA\nplacebo, 3 times per day for 24 weeks. The primary endpoint was defined as percentage of patients achieving serum alkaline\nphosphatase (ALP) reduction of more than 25% from baseline.\nResults: At week 24, 75.97% of patients in the TUDCA group and 80.88% of patients in the UDCA group achieved a serum ALP\nreduction of more than 25% from baseline (P=0.453). The percentage of patients with serum ALP levels declined more than 40%\nfollowing 24 weeks of treatment was 55.81% in the TUDCA group and 52.94% in the UDCA group (P=0.699). Both groups showed\nsimilar improvement in serum levels of ALP, aspartate aminotransferase, and total bilirubin (P>0.05). The proportion of patients with\npruritus/scratch increased from 1.43% to 10.00% in UDCA group, while there�s no change in TUDCA group (P=0.023). Both drugs\nwere well tolerated, with comparable adverse event rates between the 2 groups.\nConclusions: TUDCA is safe and as efficacious as UDCA for the treatment of PBC, and may be better to relieve symptoms than\nUDCA....
Introduction: The Biosimilars Forum\nconducted a survey through an independent\norganization from November 20, 2015 to\nJanuary 4, 2016 in order to assess current\nlevels of awareness, knowledge, and\nperceptions of biosimilars among US specialty\nphysicians who already prescribe biologics. The\nsurvey was intended to provide a baseline level\nof knowledge about biosimilars and will be\nrepeated in 2ââ?¬â??3 years in order to monitor trends\nover time.\nMethods: A 19-question survey was created by\nthe Biosimilars Forum and was administered by\nan independent third party.\nResults: Responses were obtained from 1201 US\nphysicians across specialties that are high\nprescribers of biologics, including\ndermatologists, gastroenterologists, hematologistoncologists,\nmedical oncologists, nephrologists,\nand rheumatologists.\nConclusions: The results of this survey\nhighlight a significant need for evidence-based\neducation about biosimilars for physicians\nacross specialties. Five major knowledge gaps\nwere identified: defining biologics, biosimilars,\nand biosimilarity; understanding the approval\nprocess and the use of ââ?¬Ë?ââ?¬Ë?totality of evidenceââ?¬â?¢Ã¢â?¬â?¢ to evaluate biosimilars; understanding that the\nsafety and immunogenicity of a biosimilar are\ncomparable to the originator biologic;\nunderstanding the rationale for extrapolation\nof indications; and defining interchangeability\nand the related rules regarding pharmacy-level\nsubstitution....
A fixed dose combination of desloratadine, a long-acting tricyclic antihistamine with selective peripheral histamine\nH1 receptor antagonistic activity, and betamethasone, a glucocorticoid, can potentially provide synergistic effect\nin the treatment of severe allergic conditions and improve clinical outcomes. Co-administration of an anti-allergy\nmedication and a corticosteroid is extensively used in clinical practice, either as single drug tablets or as a fixed\ndose combination tablet. The current study was conducted to compare the pharmacokinetics of fixed combination\ntablets of desloratadine and betamethasone in 40 healthy human volunteers after a single oral dose in a randomized\ntwo-period, two-treatment, and two-sequence cross-over study. The study protocol was prepared in accordance to\nthe requirements set in the EMA guidance for conducting bioequivalence studies. Reference (Frenaler Cort 5 mg\ndesloratadine/0.6 mg betamethasone film coated tablet, Roemmers S.A.I.C.F., Argentina) and test (Oradus Ã?² 5 mg\ndesloratadine/0.6 mg betamethasone film coated tablet, Pharmaline, Lebanon) drugs were administered to fasted\nvolunteers and blood samples were collected up to 72 h and assayed for desloratadine, hydroxydesloratadine metabolite\nand betamethasone using a validated LC-MS/MS method. The pharmacokinetic parameters AUC0-t, Cmax,\nTmax, T1/2, Ke, in addition to (for betamethasone only) AUC0-âË?ž, MRTinf, and residual area (%) were determined\nfrom plasma concentration-time profile by non-compartmental analysis method using thermos Scientific Kinetica\n(version 5.1). The analysis of variance did not show any significant difference between the two formulations and 90%\nconfidence intervals fell within the acceptable range for bioequivalence (80-125%). The resulting data demonstrated\nthat when administered as fixed dose combination, the pharmacokinetics of desloratadine and betamethasone were\nbioequivalent and were well-tolerated....
Background: PATRO Children is an ongoing observational, longitudinal, non-interventional, global post-marketing\nsurveillance study, which is investigating the long-term safety and effectiveness of Omnitrope�®, a somatropin\nbiosimilar to Genotropin�®, in children with growth disturbances. The primary endpoint of PATRO Children is long-term\nsafety and the secondary endpoint is effectiveness, which is assessed by analysing auxological data such as height\n(HSDS) and height velocity (HVSDS) standard deviation scores. Here, we report the data from the Italian interim analysis\nof PATRO Children data up to August 2015.\nMethods: PATRO Children is enrolling children who are diagnosed with conditions of short stature requiring GH\ntreatment and are receiving Omnitrope�®. Adverse events (AEs) are assessed in all Omnitrope�®-treated patients.\nHeight is evaluated yearly to near-adult (final) height, and is herein reported as HSDS; height velocity is also\nassessed and reported as a standard deviation score (HVSDS).\nResults: Up to August 2015, a total of 186 patients (mean age 10.2 years, 57.5 % males) were enrolled :156 [84 %]\nhad growth hormone deficiency, 12 [6.5 %] were born small for gestational age, seven [3.8 %] had Prader-Willi\nsyndrome, one [0.5 %] had Turner syndrome and one [0.5 %] had chronic renal insufficiency; seven [3.8 %] patients had\nother indication profiles. The mean treatment duration with Omnitrope�® was 28.1 �± 19.1 months. AEs were reported in\n35.6 % of patients and included headache, pyrexia, arthralgia, abdominal pain, leg and/or arm pain and increased\nblood creatine phosphokinase. Two serious AEs in two patients were thought to be drug-related; one patient\nexperienced a minimal increase in a known residual craniopharyngioma, and another a gait disturbance with\nworsening of walking difficulties. Similar to investigational studies, Omnitrope�® treatment was associated with\nimprovements in both HSDS and HVSDS.\nConclusions: Omnitrope�® appears to be well tolerated and effective for the treatment of a wide range of paediatric\nindications, which is consistent with the outcomes from controlled clinical trials. These results need to be interpreted\nwith caution until the data from the global PATRO Children study are available....
Many biologic products have improved the outcomes of cancer patients, but the costs can substantially burden\nhealthcare systems. Biosimilar products can potentially reduce drug costs and increase patient access to beneficial\ntreatments. Approval of a biosimilar product relies on the demonstration of ââ?¬Å?comparabilityââ?¬Â or ââ?¬Å?no clinically meaningful\ndifferencesââ?¬Â as compared to its reference biologic product. Biosimilar products for erythropoietin, granulocyte colonystimulating\nfactor, trastuzumab, and rituximab are already available, and the regulatory processes in various countries\nare constantly evolving. It is important that oncologists be familiar with the potential issues surrounding the clinical\nuse of biosimilar products. In this review article, we provide background information about biosimilar products and\ntheir regulatory approval processes, followed by a discussion of individual biosimilar drugs....
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