Clinical effectiveness and safety of analogue glargine in type 1 diabetes : systematic review and meta-analysis

INTRODUCTION: The use of insulin analogues for the treatment of type 1 diabetes mellitus (T1DM) is widespread; however, the therapeutic benefits still require further evaluation given their higher costs. Objective: To evaluate the effectiveness and safety of Analogue Glargine (AG) compared to Recombinant DNA insulin (rDNA) in patients with DM1 in observational studies, building on previous reviews of RCTs comparing NPH insulin and AG. METHODS: A systematic review (SR) with meta-analysis. The SR included cohort studies and registries available on PUBMED, LILACS, and CENTRAL as well as manual and gray literature searches. The meta-analysis was conducted in Review Manager ® 5.2 software. The primary outcomes were: glycohemoglobin (Hb1Ac), weight gain and hypoglycemia. Methodological quality was assessed using the Newcastle-Ottawa scale. RESULTS: Out of 796 publications, 11 studies were finally included. The meta-analysis favored AG in Hb1Ac outcomes (adult patients) and hypoglycemic episodes (p <0.05), but without reaching glycemic control (Hb1Ac to approximately 7%). The methodological quality of the studies was moderate, noting that 45% of studies were funded by pharmaceutical companies. CONCLUSION: Given the high heterogeneity of the studies, the discrete value presented by the estimated effect on effectiveness and safety, potential conflicts of interest of the studies and the appreciable higher cost of AG, there is still no support for recommending first line therapy with analogues. The role of analogues in the treatment DM1 could be better determined by further observational studies of good methodological quality to assess their long-term effectiveness, safety as well as cost-effectiveness

Budget impact analysis of medicines : estimated values versus real-world evidence and the implications

Objectives: Budget Impact Analyses (BIA) of medicines helps managers in promoting health systems’ sustainability when assessing the role and value of new medicines. However, it is not clear whether BIAs typically underestimate or overestimate the impact on real-world budgets. This retroactive analysis seeks to compare estimated values obtained by a BIA and Real-World Evidence (RWE) to guide discussions. Methods: The estimated values were obtained through a BIA concerning the incorporation of adalimumab for the treatment of Rheumatoid Arthritis into the Brazilian Unified Health System (SUS) carried out retroactively and per international guidelines. RWE data was extracted from SUS computerized systems. We subsequently compared the number of treatments, costs, and Incremental Budget Impact (IBI). Results–The total number of treatments was underestimated by 10% (6,243) and the total expenditure was overestimated by 463% (US$4.7 billion). In five years, the total difference between the estimated values and real IBI reached US$ 1.1 billion. A current expenditure of US$1.0 was observed for every US$ 5.60 of estimated expenditure. Conclusion–The higher estimates from the BIA might cause decision makers to be more cautious with the introduction of a new medicine to reduce the opportunity costs for other interventions

A cross-sectional study of quality of life among Brazilian adults with type 1 diabetes treated with insulin glargine : findings and implications

We conducted a cross-sectional study with 401 patients of type 1 diabetes mellitus treated with insulin glargine in Minas Gerais, Brazil. Health-related quality of life (HRQoL) was assessed using EQ-5D-3L and the Diabetes Quality of Life Measure. Our findings showed that a worse HRQoL was associated with a low level of education, self-perceived health reported as poor/very poor, being bedridden and not physically exercised, had seen a doctor more than four times in the past year before the interview, and had reported comorbidities and episodes of hypoglycemia

Budget impact analysis of medicines : updated systematic review and implications

This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001 to 2015 on "budget impact analysis" with "drug" interventions were assessed, selected based on their titles/abstracts and full texts, with their characteristics checked according to key criteria. Out of 1984 studies, 92 were identified. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 6 or 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions

Initiatives across countries to reduce antibiotic utilization and resistance patterns : impact and implications

Greater accessibility to antibiotics has resulted in their excessive use, leading to increasing antimicrobial resistance (AMR) and strains on healthcare systems, with only a limited number of patients in ambulatory care treated according to guidelines. High rates of AMR are now seen across countries and continents, resulting in AMR becoming one of the most critical issues facing healthcare systems. It is estimated that AMR could potentially cause over 10 million deaths per year by 2050 unless addressed, resulting in appreciable economic consequences. There are also concerns with under-treatment especially if patients are forced to fund more expensive antibiotics as a result of AMR to first line antibiotics and do not have available funds. Over-prescribing of antibiotics is not helped by patient pressure even when physicians are aware of the issues. There is also extensive dispensing of antibiotics without a prescription; although this is now being addressed in some countries. Review interventions that have been instigated across continents and countries to reduce inappropriate antibiotic prescribing and dispensing, and associated AMR, to provide future guidance. Narrative case history approach. A number of successful activities have been instigated to reduce inappropriate prescribing and dispensing of antibiotics across sectors. These include the instigation of quality indicators, suggested activities of pharmacists as well as single and multiple interventions among all key stakeholder groups. Multiple inter-linking strategies are typically needed to enhance appropriate antibiotic prescribing and dispensing. The impact of ongoing activities need to be continually analysed to provide future direction if AMR rates, and their impact on subsequent morbidity, mortality and costs, are to be reduced