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Schussler-Lenz M.,European Medicines Agency EMA | Schussler-Lenz M.,Paul Ehrlich Institute | Beuneu C.,European Medicines Agency EMA | Beuneu C.,Federal Agency for Medicines and Health Products | And 28 more authors.
European Journal of Heart Failure | Year: 2016

In the past decade, novel cell-based products have been studied in patients with acute and chronic cardiac disease to assess whether these therapies are efficacious in improving heart function and preventing the development of end-stage heart failure. Cardiac indications studied include acute myocardial infarction (AMI), refractory angina, and chronic heart failure (CHF). Increased clinical activity, experience, and multiple challenges faced by developers have been recognized at the regulatory level. In May 2014, the Committee for Advanced Therapies (CAT) discussed in an expert meeting various cell-based medicinal products developed for cardiac repair, with a focus on non-manipulated bone marrow cells, sorted bone marrow or apheresis, and expanded cells, applied to patients with AMI or CHF. The intention was to share information, both scientific and regulatory, and to examine the challenges and opportunities in this field. These aspects were considered from the quality, and non-clinical and clinical perspectives, including current imaging techniques, with a focus on AMI and CHF. The scope of this overview is to present the European regulatory viewpoint on cell-based therapies for cardiac repair in the context of scientific observations. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology. Source


Peura P.K.,Finnish Medicines Agency Fimea | Peura P.K.,University of Eastern Finland | Martikainen J.A.,University of Eastern Finland | Purmonen T.T.,University of Eastern Finland | Turunen J.H.O.,University of Eastern Finland
Medical Decision Making | Year: 2012

Background. Economic studies funded by the pharmaceutical industry are more likely to report favorable results and recommendations for the sponsor's product than are studies funded by nonindustry establishments. Purpose. To determine whether clinical outcome data obtained from the same meta-analyses are used differently in various economic studies of oral triptans and whether there is an association between the study sponsorship and the choice of clinical outcome measure. Data Sources. Economic studies of triptans were identified by updating a previously published systematic review. Study Selection. Twelve studies that used the same meta-analyses as the source of clinical outcome data were identified. Data Extraction. Two independent reviewers extracted the essential data from the identified studies. Data Synthesis. In the 12 appraised studies, 9 alternative measures of effectiveness were derived from the same meta-analyses. Eleven studies were industry-related, and in these the selected clinical outcome consistently favored the sponsor's product. Also the reported results suggested that the sponsor's product was more cost-effective than the competitors' products. Limitations. The cost-effectiveness of triptans is dependent on both the definition of clinical effectiveness and the treatment-related costs. Only bias related to the selection of the clinical outcome measure has been taken into account in this review. Conclusions. The results of published economic studies of triptans are conflicting and biased. There is a tendency to select clinical outcome measures that support the sponsor's product. This leads to concern about the possible poor applicability of these results in decision making. Source


Mantyselka P.,University of Eastern Finland | Mantyselka P.,Kuopio University Hospital | Niskanen L.,University of Eastern Finland | Niskanen L.,Finnish Medicines Agency Fimea | And 14 more authors.
Lipids in Health and Disease | Year: 2014

Background: Cross-sectional studies have suggested that serum omega-3 (n-3) and omega-6 (n-6) polyunsaturated fatty acids (PUFAs) are related to favorable lipoprotein particle concentrations. We explored the associations of serum n-3 and n-6 PUFAs with lipoprotein particle concentrations and sizes in a general population cohort at baseline and after 6 years. Findings. The cohort included 665 adults (274 men) with a 6-year follow-up. Nutritional counseling was given at baseline. Serum n-3 and n-6 PUFAs and lipoprotein particle concentrations and the mean particle sizes of VLDL, LDL, and HDL were quantified by nuclear magnetic resonance (NMR) spectroscopy for all baseline and follow-up samples at the same time. Concentrations of n-3 and n-6 PUFAs were expressed relative to total fatty acids. At baseline, n-3 PUFAs were not associated with lipoprotein particle concentrations. A weak negative association was observed for VLDL (P = 0.021) and positive for HDL (P = 0.011) particle size. n-6 PUFA was negatively associated with VLDL particle concentration and positively with LDL (P < 0.001) and HDL particle size (P < 0.001). The 6-year change in n-3 PUFA correlated positively with the change in particle size for HDL and LDL lipoproteins but negatively with VLDL particle size. An increase in 6-year levels of n-6 PUFAs was negatively correlated with the change in VLDL particle concentration and size, and positively with LDL particle size. Conclusion: Change in circulating levels of both n-3 and n-6 PUFAs, relative to total fatty acids, during 6 years of follow-up are associated with changes in lipoprotein particle size and concentrations at the population level. © 2014 Mäntyselkä et al.; licensee BioMed Central Ltd. Source


Savolainen J.,University of Eastern Finland | Savolainen J.,Kuopio University Hospital | Kautiainen H.,University of Turku | Miettola J.,University of Eastern Finland | And 3 more authors.
Scandinavian Journal of Public Health | Year: 2014

Background: The Lapinlahti 2005 study was carried out to explore cardiovascular disease risk factors, lifestyle and quality of life in Lapinlahti residents in eastern Finland. Our aim was to study the association between lifestyle and health-related quality of life (HRQoL) in the community. Subjects and methods: The present study is based on the baseline data of the followed up (2005-2010) population-based cohort (N = 376, n of males = 184). A trained research nurse measured weight, height, waist circumference and blood pressure. Self-reported HRQoL was measured using a 15D questionnaire. A BDI-21 inventory was used to assess the presence of self-reported depressive symptoms. Lifestyle factors (nutrition, exercise, smoking and alcohol use) were examined with a structured questionnaire. Each lifestyle item was valued as -1, 0 or 1, depending on how well it corresponded to the recommendations. Based on the index the participants were divided into three lifestyle sum tertiles: I = unhealthy, II = neutral and III = healthy. The age- and sex-adjusted linear trend between the tertiles was tested. Results: The 15D score had a positive linear relationship with the lifestyle tertiles (P =.0048 for linearity, age- and sex-adjusted). Respectively, self-reported depressive symptoms were less frequent among subjects with a healthier lifestyle (P =.038). Conclusions: People who are expected to strive most to change their lifestyle have the lowest quality of life and psychological welfare, which should be taken into account in both clinical work and health promotion. © 2013 the Nordic Societies of Public Health. Source


Koskela H.O.,Kuopio University Hospital | Koskela H.O.,University of Eastern Finland | Salonen P.H.,Kuopio University Hospital | Romppanen J.,Eastern Finland Laboratory Center | And 2 more authors.
BMJ Open | Year: 2014

Objectives: Community-acquired pneumonia is associated with a significant long-term mortality after initial recovery. It has been acknowledged that additional research is urgently needed to examine the contributors to this long-term mortality. The objective of the present study was to assess whether diabetes or newly discovered hyperglycaemia during pneumonia affects long-term mortality. Design: A prospective, observational cohort study. Setting: A single secondary centre in eastern Finland. Participants: 153 consecutive hospitalised patients who survived at least 30 days after mild-to-moderate community-acquired pneumonia. Interventions: Plasma glucose levels were recorded seven times during the first day on the ward. Several possible confounders were also recorded. The surveillance status and causes of death were recorded after median of 5 years and 11 months. Results: In multivariate Cox regression analysis, a previous diagnosis of diabetes among the whole population (adjusted HR 2.84 (1.35-5.99)) and new postprandial hyperglycaemia among the non-diabetic population (adjusted HR 2.56 (1.04-6.32)) showed independent associations with late mortality. New fasting hyperglycaemia was not an independent predictor. The mortality rates at the end of follow-up were 54%, 37% and 10% among patients with diabetes, patients without diabetes with new postprandial hyperglycaemia and patients without diabetes without postprandial hyperglycaemia, respectively (p<0.001). The underlying causes of death roughly mirrored those in the Finnish general population with a slight excess in mortality due to chronic respiratory diseases. Pneumonia was the immediate cause of death in just 8% of all late deaths. Conclusions: A previous diagnosis of diabetes and newly discovered postprandial hyperglycaemia increase the risk of death for several years after community-acquired pneumonia. As the knowledge about patient subgroups with an increased late mortality risk is gradually gathering, more studies are needed to evaluate the possible postpneumonia interventions to reduce late mortality. Source

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