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In Is placed and Hard Facts.
There are even immunological, genetic and epigenetic effects (due to heredity and uneven gene dosing located in the X and Y chromosomes) that can influence these differences by sex. Finally, through cases of hormonal therapy clinical trials, a drug for women's inhibited sexual desire and a contraceptive for men, gender bias and stereotypes are shown to influence a potential generation of inequalities, especially in adverse drug reactions to the detriment of women. In conclusion, health professionals frequently attribute physical symptoms to women's emotionality, influencing their greater prescription of symptomatic drugs. Whether the same reason influences the lower prescription of therapeutic drugs in women than in men should be analyzed. There are biological determinants to consider due to their influence on a greater pharmacological toxicity in women. Clinical trials should improve according to the gender recommendations by the Food and Drugs Administration.The approval pathway for biosimilars of monoclonal antibodies in the European Union is aimed at ruling out the presence of significant differences with the original biological in quality attributes, efficacy, immunogenicity and safety. It also provides the rationale for extrapolating the evidence obtained with a biosimilar in at least one indication to the rest of the approved indications of its original biological, thus simplifying the development programme of biosimilars. Biosimilars of monoclonal antibodies available in the European Union for the treatment of inflammatory diseases and cancer have fulfilled all the requirements for approval, and many of them have additional evidence available. Moreover, real world data confirms the safety and efficacy of these drugs in the indications they are being used for. In Spain, many scientific societies endorse the regulatory pathway of biosimilars and acknowledge their role in the efficiency of the healthcare system. Even so, some barriers remain that limit their use. The implementation of different measures at the patient, prescriber, institutional, and national levels might increase the penetration of biosimilars, freeing up resources that may be invested in other therapies and, potentially, boost innovation.Objective The primary objective of the study is to compare the effectiveness of trastuzumab-chemotherapy with and without pertuzumab. As a secondary objective, we seek to evaluate the cardiac safety of the treatment. Method Retrospective observational study including all patients treated with either pertuzumab-trastuzumab-chemotherapy (n = 10) or trastuzumab-chemotherapy (n = 13) (January 2015-December 2018) in a specialty hospital, which met the criteria established by the Commission Central for the Optimization and Harmonization of the pharmacotherapy of the Andalusian Health Service for the use of pertuzumab in neoadjuvance HER2 positive tumor, negative hormonal receptors, with high risk of relapse (tumor > 2 cm or lymph node involvement). JNJ-54781532 To assess effectiveness, the complete pathological response was used. For cardiac safety, the decrease in left ventricular ejection fraction greater than 10% was employed. Results Complete pathological response was superior in the pertuzumab group (70.0% vs. 30.8%). Cardiac safety was similar in both. Conclusions For patients with HER2 positive tumors and negative hormonal receptors with high risk criteria that receive pertuzumab, the complete pathological response is superior, with no increase in cardiac toxicity.Objective To determine type 2 diabetes mellitus prevalence, clinical features, specific pharmacologic treatment and problems faced in nursing home patients. Method Observational, cross-sectional study conducted in March 2019 in six nursing homes, examining persons diagnosed with type 2 diabetes mellitus. Demographic, clinical and biochemical variables, specific pharmacologic therapy and hypoglycemia events as well as falls during the previous year were collected. Results Prevalence of type 2 diabetes mellitus was 21.7%. 70.90% of the patients had glycated hemoglobin ≤ 7% last year, with 92% of the patients having a moderate-severe frailty. 0.4 hypoglycemia/resident-year were found, being more frequent in patients receiving insulinization and in those with impaired renal function. However, no further falls were found in insulinized patients (p > 0.05). Diabetes therapy was adequate according to treatment recommendations for the elderly. Conclusions Prevalence of type 2 diabetes is slightly lower than that found in the literature, finding a strict control of the disease and an appropriate pharmacotherapeutic adequacy according to the recommendations by the European Diabetes Working Party for Older People. Insulinized patients and those with impaired renal function have a higher risk of hypoglycemia.Objective A review of the literature about the anti-programmed death 1 monoclonal antibody nivolumab permits to verify the existence of several issues still unresolved about their dosing schedule. The aim of the present work was to explore possibilities of nivolumab treatment personalization through therapeutic drug monitoring, in order to improve their effectiveness and efficiency. Method Observational, prospective study carried out from May 2017 through June 2019 in patients with different tumor diagnoses treated with nivolumab. Blood samples were obtained in the routine clinical practice, once nivolumab steady state was reached. Serum nivolumab levels were determined by means of quantitative ELISA. The standard schedule of 3 mg/kg every two weeks (Q2W) was modified in some patients due to different circumstances, and resulting serum concentrations were compared with those from the non-modified patients and the published data. Results Blood samples from 19 patients in treatment with nivolumab were analyzed. A total of 39 samples of nivolumab were analyzed between 6th and 27th cycles. The standard schedule of 3 mg/kg every two weeks was modified in 12/19 (60%) patients, with intervals of 3, 4, 5, 6 or 7 weeks, once the steady state was reached. No statistically significant differences were detected when comparing every two weeks and every four week intervals. When the intervals were six or seven weeks, mean plasma concentration showed a statistically significant difference compared with every two weeks. Conclusions Current data contribute to confirm former suspects about the possibilities of exploring new scenarios to improve and personalize nivolumab dosage. Additional studies to confirm it in bigger series and correlate it with clinical results, and to better define the role of therapeutic drug monitoring in the treatment, are warranted, not only by financial concerns but also for improving quality of life of patients and clinical management aspects.
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