Sanofi (Finland)

OBJECTIVE: Insulin is often postponed for years because initiation is time-consuming. We sought to compare initiation of insulin individually and in groups with respect to change in A1C and several other parameters in type 2 diabetic patients. RESEARCH DESIGN AND METHODS: A randomized (1:1), multicenter, two-arm, parallel design study with a recruiting period of up to 14 weeks and a 24-week treatment period. Either in groups of 4-8 or individually, using the same personnel and education program, 121 insulin-naive type 2 diabetic patients with an A1C of 7.0-12.0% were randomized to initiate bedtime insulin glargine. The patients visited the treatment center before and at the time of insulin initiation and at 6, 12, and 24 weeks. Patients self-adjusted the insulin dose to achieve a fasting plasma glucose 4.0-5.5 mmol/l. RESULTS: At 24 weeks, mean +/- SE A1C had decreased from 8.7 +/- 0.2 to 6.9 +/- 0.1% in those treated individually and from 8.8 +/- 0.2 to 6.8 +/- 0.1% in those in groups (not significant [NS]). Insulin doses averaged 62 +/- 5 IU and 56 +/- 5 IU at 24 weeks (NS), respectively. The frequency of hypoglycemia was similar. The total time (visits and phone calls) spent in initiating insulin in the patients in groups (2.2 +/- 0.1 h) was 48% less than in those treated individually (4.2 +/- 0.2 h). Diabetes treatment satisfaction improved significantly in both sets of patients. CONCLUSIONS: Similar glycemic control and treatment satisfaction can be achieved by initiating insulin in groups and individually. Starting insulin in groups takes one-half as much time as individual initiation.

BACKGROUND: Weight lost by obese patients is almost always regained over time. Extended treatment may improve maintenance, but solid evidence is lacking. PURPOSE: We determined effectiveness of maintenance therapy after a weight loss program. METHODS: Together 201 patients (mean age 47 years and BMI 42 kg/m(2), 71% women) were randomly assigned to either a 17-week weight loss program followed by a one-year maintenance program or to a weight loss program without subsequent maintenance intervention. The weight loss program included behavior modification and a very-low-calorie diet, and maintenance program behavior modification. The primary outcome measure was percentage of patients with 5% or more weight loss at the end of maintenance (week 69) and one year later (week 121). Secondary outcomes were weight related changes in lifestyle and quality of life. RESULTS: At week 69, 52% of the patients with and 44% of those without maintenance program had lost weight ≥5%, P = 0.40, and, at week 121, 33% and 34%, P = 0.77, respectively. At week 121 secondary outcomes did not differ between the groups among those successfully followed up. CONCLUSIONS: This one-year maintenance program was not effective in preventing weight regain in severely obese patients. Trial Registration. This trial is registered under clinicaltrials.gov Identifier: NCT00590655.

Background Seasonal influenza may result in severe outcomes, resulting in a significant increase of hospitalizations during the winter. To improve the protection provided by the standard dose influenza quadrivalent vaccine (SDQIV), a high-dose vaccine (HDQIV) has been developed specifically for adults aged 60 and older who are at higher risk of life-threatening complications,Objectives The aim of this study was to determine the cost-effectiveness of HD QIV vs SD-QIV in the recommended population of three European countries: Belgium, Finland and Portugal.Methods A cost-utility analysis comparing HDQIV versus SDQIV was conducted using a decision tree estimating health outcomes conditional on influenza: cases, general practitioner and emergency department visits, hospitalizations and deaths. To account for the full benefit of the vaccine, an additional outcome – hospitalizations attributable to influenza – was also evaluated. Demographic, epidemiological and economic inputs were based on the respective local data. HDQIV relative vaccine efficacy versus SDQIV was obtained from a phase IV efficacy randomized clinical trial. The incremental cost-effectiveness ratios (ICER) were computed for each country, and a probabilistic sensitivity analysis (1,000 simulations per country) was performed to assess the robustness of the results.Results In the base case analysis, HDQIV resulted in improved health outcomes (visits, hospitalisations and deaths) compared to SDQIV. The ICERs computed were 1,397 €/QALY, 9,581 €/QALY and 15,267 €/QALY, whereas the PSA yielded 100%, 100% and 84% of simulations being cost-effective at their respective willingness-to-pay thresholds, for Belgium, Finland, and Portugal respectively.Conclusion In three European countries with different healthcare systems, HD-QIV would contribute to a significant improvement in the prevention of influenza health outcomes while being cost-effective.

Background: The rapid development of multiple myeloma (MM) management underscores the value of real-world data. In our study we examined 509 adult MM patients treated with immunochemotherapy (ICT) with/without stem cell transplantation (SCT) from 2013 to 2019 in the Hospital District of Helsinki and Uusimaa, Finland. Materials & methods: Our study was based on computational analyses of data integrated into the hospital data lake. Results: After 2017, treatment pattern diversity increased with improved access to novel treatments. 5-year survivals were 74.4% (95% CI: 65.5–84.5) in SCT-eligible and 44.0% (95% CI: 37.6–51.4) in non-SCT subgroups. In the SCT-eligible subgroup, high first-year hospitalization costs were followed by stable resource requirements. Conclusion: Hospital data lakes can be adapted to carry out complex analysis of large MM cohorts.

Most cases of keratinocyte cancer can be treated effectively with surgery. However, survival is reduced in patients with advanced disease. This retrospective cohort study evaluated overall survival of patients with invasive keratinocyte cancers, and high-risk features for progression of the disease and mortality in Finnish patients in a real-world setting. A total of 43,143 patients with keratinocyte cancer types of basal cell carcinoma and 10,380 with cutaneous squamous cell carcinoma were identified nationwide. More detailed patient records were available for a subset of patients (basal cell carcinoma n = 5,020 and cutaneous squamous cell carcinoma n = 1,482) from a regional database. Fifty percent of patients with advanced cutaneous squamous cell carcinoma died approximately 4.5 years after diagnosis. Multivariable models suggested that risk factors for keratinocyte cancer progression were male sex, presence of comorbidities, immunosuppression, and pre-cancerous lesions, while risk factors for disease-specific mortality were advanced disease stage with immunosuppression, other malignancies, and consecutive surgical excisions. These results suggest that identifying patient and tumour factors associated with poor disease outcome could be important when determining appropriate treatment and follow-up; however, further studies are necessary.

Anti-hepatitis B (HBs) antibody persistence and hepatitis B challenge were evaluated at 6 years of age following vaccination of fully liquid DTaP-IPV-HB-PRP~T or reconstituted DTaP-IPV-HB//PRP~T at 3, 5, 11-12 months of age. At 6 years, 53.8% and 73.5% had seroprotective anti-HBs antibodies (≥10 mIU/mL), increasing to 96.7% and 95.9% postchallenge, confirming a strong anamnestic response in primed vaccinees.

AIMS: To describe the clinical characteristics and medication purchases of insulin-treated adults in Finland at index (January 1, 2012 or first insulin purchase) and December 31, 2019. Additionally, to describe basal insulin (BI) treatment patterns and associated changes in hemoglobin A1c (HbA1c) values. MATERIALS AND METHODS: In this descriptive study using nationwide registries, we included adults with at least two reimbursed insulin purchases within 12 months of the first purchase between January 1, 2012 and December 31, 2019. We formed four study groups: type 1 diabetes (T1D) and type 2 diabetes (T2D)-diagnosed people who were further divided into prevalent or naïve users (start of insulin use before or after January 1, 2012). Insulin treatment patterns were estimated from medication purchase data and glycemic control from HbA1c results. RESULTS: Out of 145 020 people included, 34 359 had T1D and 110 661 T2D. By 2019, in parallel with the adaptation of new noninsulin medications, second-generation basal insulin (BI) analogues were adopted by 45.9% and 21.1% of prevalent T1D and T2D users. At index, HbA1c target (≤53 mmol/mol) was reached by 17% and 35% of T2D naïve and prevalent users, respectively, and by 17% of T1D prevalent users. At study end, the target was reached respectively by 41%, 34%, and 22% of insulin users. Insulin initiation improved and discontinuation worsened glycemic control in T2D, with lesser effects seen after treatment gaps or switches between BIs. CONCLUSIONS: Our study showed that glycemic control in insulin users has remained stable or improved between 2012 and 2019 despite aging population and in parallel with introduction of new treatment options, providing valuable insight into Finnish national diabetes care.

Abstract is missing (Short communication)

<bold>Background:</bold> The link between use of oral corticosteroids (OCS) and serious adverse events (SAEs) in asthma is well-described. In contrast, whether use of high-dose inhaled corticosteroids (ICS) has a risk on these is not clear. <bold>Aim:</bold> Using Swedish data from the NORdic Dataset for aSThmA Research (NORDSTAR) cohort we examined whether current high-dose ICS exposure is associated with incident CS-related SAEs <bold>Methods:</bold> This was an observational cohort study including asthma patients ≥18 years between 2009-19. We used Cox regression models to examine the association between current ICS exposure (daily µg budesonide as a time-dependent predictor) and CS-related SAEs including osteoporosis, type-2 diabetes (T2D), cataract and pneumonia with patients using no ICS as reference. Age, sex, and OCS dose were included as covariates. <bold>Results:</bold> Overall, 529,203 asthma patients were included. We found a dose-response association between SAEs and increasing daily ICS doses. HRs of osteoporosis increased if ICS dose >800 µg: HR 1.23 (95%CI 1.16-1.30) if 800-1599 µg and HR 1.4 (95%CI 1.24-1.58) with >2400µg per day. T2D HR increased from 1.11 (95%CI 1.06-1.16) if 800-1599µg to HR 1.58 (95%CI 1.42-1.77) with >2400µg daily. Likewise, cataract risk increased with higher ICS doses. Lastly, pneumonia risk increased from HR 1.65 (95%CI 1.58-1.72) to 2.91 (95%CI 2.68-3.16) if dose increased from 800-1599 to >2400µg. <bold>Conclusion:</bold> We identified a dose-dependent added risk of current high-dose ICS use on several CS-related SAEs. This highlights the importance for clinicians to consider this risk in patients treated with high-dose ICS. More studies are needed to further investigate this association.

Dear Editor,We thank S. Hadigal and his colleagues from Viatris for their interest in our paper. We are also grateful for the opportunity to address the comments their raised in their letter regard...

<bold>BACKGROUND:</bold> Oral corticosteroids (OCS) associate with increased risk of cardiovascular disease (CVD). However, it is not clear whether use of high-dose inhaled corticosteroids (ICS) also links to increased CVD risk in asthma patients <bold>AIM:</bold> Using Swedish data from the NORdic Dataset for aSThmA Research (NORDSTAR) cohort we examined whether current high-dose ICS exposure is associated with CVD <bold>METHODS:</bold> This was an observational cohort study including asthma patients ≥18 years between 2009-19. A Cox regression model was used to examine the association between current ICS exposure (daily µg budesonide equivalent as a time-dependent predictor) and incident CVD using ICS-free patients as the reference group. Covariates included age, sex, and OCS dose <bold>RESULTS:</bold> At study enrollment, 468,940 asthma patients were included. Overall, 62,971 developed CVD. A dose-response relationship was identified between overall CVD risk and high-dose ICS: Hazard ratio (HR) 1.20 (95%CI 1.17-1.24) for daily ICS dose 800-1599 µg increasing to HR 1.63 (95%CI 1.53-1.74) with >2400µg. Likewise, the risk of several CVD subtypes were associated with high-dose ICS (800-1599 µg): ischemic heart disease HR 1.21 (95%CI 1.13-1.3); atrial fibrillation HR 1.34 (95%CI 1.25-1.43) and heart failure HR 1.53 (95%CI 1.43-1.63). HRs increased further for ICS >1600 and >2400 µg daily. No increase in risk was found with ICS doses below 800 µg daily <bold>CONCLUSION:</bold> We identified a dose-dependent risk of current high-dose ICS use on CVD onset. This highlights the importance of assessing CVD risk in patients with severe asthma. Further studies exploring this association are warranted.