Current Issue : October - December Volume : 2018 Issue Number : 4 Articles : 5 Articles
During the past decades, agents with novel mechanisms of action, such as monoclonal antibodies (MAbs) and histone deacetylase\ninhibitors (HDACis) have been applied to treat relapsed or refractory multiple myeloma (RRMM). The treatment outcomes of\nMAbs versus HDACi in combination with bortezomib or lenalidomide plus dexamethasone remain unknown. We conducted this\nmeta-analysis to compare indirectly the efficacy and safety of MAbs and HDACis in combination with bortezomib or\nlenalidomide plus dexamethasone. Six trials (eight articles) were included in the meta-analysis with 3270 RRMM patients\nenrolled. We synthesized hazard ratios (HRs) for progression-free survival (PFS) and overall survival (OS), risk ratios (RRs) for\ncomplete response (CR),very good partial response (VGPR), overall response (OR), progressive disease plus stable disease (PD\n+ SD) and common at least grade 3 adverse events, and their corresponding 95%confidence intervals (95% CI). Treatment with\nMAbs in combination with bortezomib or lenalidomide plus dexamethasone resulted in longer PFS (HR 0.83, 95% CI: 0.66ââ?¬â??0.98),\nfewer incidences of at least grade 3 thrombocytopenia (RR 0.35, 95% CI: 0.23ââ?¬â??0.53), neutropenia (RR 0.70, 95% CI: 0.51ââ?¬â??0.96),\nand sense of fatigue (RR 0.37, 95% CI: 0.17ââ?¬â??0.82) than HDACis. The daratumumab plus bortezomib or lenalidomide and\ndexamethasone might significantly improve PFS in comparison with HDACis plus bortezomib or lenalidomide and\ndexamethasone (HR 0.55, 95% CI: 0.40ââ?¬â??0.74). In conclusion, MAbs may be superior to HDACis in achieving longer PFS and may\nbe better tolerated when in combination therapy with bortezomib or lenalidomide plus dexamethasone....
Hyperthyroidism is a common endocrine disease. Although thionamide antithyroid drugs are the cornerstone of hyperthyroidism\ntreatment, some patients cannot tolerate this drug class because of its serious side effects including agranulocytosis, hepatotoxicity,\nand vasculitis. Therefore, nonthionamide antithyroid drugs (NTADs) still have an important role in controlling hyperthyroidism in\nclinical practice. Furthermore, some situations such as thyroid storm or preoperative preparation require a rapid decrease in\nthyroid hormone by combination treatment with multiple classes of antithyroid drugs. NTADs include iodine-containing\ncompounds, lithium carbonate, perchlorate, glucocorticoid, and cholestyramine. In this narrative review, we summarize the\nmechanisms of action, indications, dosages, and side effects of currently used NTADs for the treatment of hyperthyroidism. In\naddition, we also describe the state-of-the-art in future drugs under development including rituximab, small-molecule ligands\n(SMLs), and monoclonal antibodies with a thyroid-stimulating hormone receptor (TSHR) antagonist effect....
Purpose: Somatropin [recombinant growth hormone (rGH)] is approved in children\nand adults for several conditions involving growth disturbances and the corresponding\nbiosimilar is available in Italy since 2006. No population-based data are available on the\npattern of rGH use in Italian clinical practice. This study aimed at exploring the pattern of\nbiosimilar and originator rGH use in six Italian centers, where different policy interventions\npromoted biosimilar use.\nMethods: This population-based, drug-utilization study was conducted in the years\n2009ââ?¬â??2014, using administrative databases of Umbria, Tuscany, and Lazio Regions and\nLocal Health Units of Caserta, Treviso, and Palermo. NaÃ?¯ve rGH users were characterized,\nand prevalence of use and discontinuation were assessed over time.\nResults: Among 6,785 patients treated with rGH during the study years, 4,493 (66.2%)\nwere naÃ?¯ve users (males/females = 1.3), mostly affected by GH deficiency. The prevalence\nof rGH use increased from 2009 to 2010, remaining stable thereafter, but it was\nheterogeneous across centers (twofold higher prevalence of use in center n.2 than\ncenters n.4 and 1 in 2014). Biosimilar rGH uptake increased over time but was low (7.8%\nin 2014) and heterogeneous as well. Discontinuation of rGH therapy occurred in 54.0%\nof naÃ?¯ve users, more frequently in females than males (58.1 vs. 50.9%). During the first\nyear of treatment, discontinuation was frequent (39.9%), but no statistically significant\ndifferences were observed in treatment persistence for biosimilar vs. originator rGH\n(p > 0.05). Conclusion: Geographical heterogeneity in the prevalence of rGH use was observed.\nSimilarly, the biosimilar rGH uptake was low and variable across centers. Post-marketing\nmonitoring is required to continuously monitor the benefit-risk profile of rGH, thus guaranteeing\ngreater savings than only promoting lowest cost rGH....
ackground: This study investigated the effectiveness and safety of switching from Basalin�® to Lantus�® in Chinese patients with diabetes mellitus (DM).\nMethods: A retrospective chart review conducted using the electronic medical records of patients hospitalized at the Qingdao Endocrine and Diabetes Hospital from 2005 to 2016. All patients were diagnosed with DM and underwent switching of insulin from Basalin to Lantus during hospitalization. Data collected included fasting (FBG), pre- and post-prandial whole blood glucose, insulin dose, reasons for insulin switching and hypoglycemia. Four study time points were defined as: hospital admission, Basalin initiation, insulin switching (date of final dose of Basalin), and hospital discharge. Blood glucose measurements were imputed as the values recorded closest to the dates of these four time points for each patient.\nResults: Data from 73 patients (70 patients with type 2 diabetes, 2 with type 1, and 1 undisclosed) were analyzed. At admission, mean glycated hemoglobin (HbA1c) and FBG were 8.9% (SD=1.75) and 9.98 (3.22) mmol/L, respectively. Between Basalin initiation and insulin switch, mean FBG decreased from 9.68 mmol/L to 8.03 mmol/L (p<0.0001), over a mean 10.8 (SD=6.85) days of Basalin treatment, and reduced further to 7.30 mmol/L at discharge (p=0.0116) following a mean 6.6 (7.36) days of Lantus. The final doses of Basalin and Lantus were similar (0.23 vs. 0.24 IU/kg/day; p=0.2409). Furthermore, reductions in pre- and post-prandial blood glucose were also observed between Basalin initiation, insulin switch and hospital discharge. The incidence of confirmed hypoglycemia was low during Basalin (2 [2.4%]) and Lantus (1 [1.2%]) treatment, with no cases of severe hypoglycemia.\nConclusion: In this study population, switching from Basalin to Lantus was associated with further reductions in blood glucose, although the dose of insulin glargine did not increase. Further studies are required to verify these findings and determine the reason for this phenomenon....
When the patent of a small molecule drug expires, generics may be introduced. They are\nconsidered therapeutically equivalent once pharmaceutical equivalence (i.e.,, identical active\nsubstances) and bioequivalence (i.e., comparable pharmacokinetics) have been established\nin cross-over volunteer study. However this generic paradigm cannot be applied to complex\ndrugs as biologics. For copies of biologics EMA, and FDA, have introduced a new regulatory\nbiosimilar pathway which mandate clinical trials to show therapeutic equivalence. However\nfor some complex drugs, such as iron-carbohydrate drugs, liposomal drugs, glatiramoids\n(named Non Biologic Complex Drugs [NBCD]), regulatory guidance is still mostly lacking. In\nthis paper we will discuss therapeutic experiences with these different classes of complex\ndrugs and their specificity, to provide scientific arguments for consideration for a new\nregulatory framework....
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