Nya förutsättningar för svensk läkemedelsmarknad

Denna översikt över prissättning och konkurrens på läkemedelsmarknaden syftar till att översiktligt diskutera de nya förutsättningarna på den svenska läkemedelsmarknaden och implikationerna för hur vi i framtiden väljer att reglera läkemedelsmarknaden. Ett ökande kostnadsansvar för landsting och patienter gör att den svenska läkemedelsmarknaden allt mer börjar lika en normal marknad med kostnadskänsliga konsumenter. Detta innebär att såväl läkemedelsföretag som reglerande myndigheter bör ompröva sina respektive roller i prisbildningen. Läkemedelsbolagen måste inse att priset och inte bara kvaliteten är ett viktigt konkurrensmedel. Staten å sin sida bör se över i vilken utsträckning prisbildningen kan överlåtas till marknaden så att ett utrymme skapas för en sund konkurrenssituation.Prisreglering; läkemedel; Sverige; parallellimport; referenspriser.

An open prospective study evaluating efficacy and safety of a new medical device for rectal application of activated carbon in the treatment of chronic, uncomplicated perianal fistulas

Purpose: It has been proposed that biological/chemical substances in the intestine might play a role in the occurrence and deterioration of perianal fistulas. Elimination of such unidentified factors from the lower gastrointestinal tract might offer a new strategy for the management of anal fistulas. The aim of this study was to evaluate the clinical effects on non-Crohn’s disease perianal fistula healing, and the safety and tolerability of a new medical device that applies high-purity, high-activity granular activated carbon locally into the rectum twice daily of patients with perianal fistulas without any concomitant medication. Methods: An open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up until week 24 (ClinicalTrial.govidentifier NCT01462747) among patients with chronic, uncomplicated perianal fistulas scheduled for surgery was conducted. Results: Of 28 patients included, 10 patients (35.7%) showed complete fistula healing (closed, no discharge on palpation) after 8 weeks; seven of these patients, corresponding to 25% of the enrolled patients, remained in remission for up to 31 weeks. At week 8, there was a statistically significant reduction in the discharge visual analog scale (p = 0.04), a significant improvement in the patient-perceived quality of life for the category of embarrassment (p = 0.002), and a trend toward improvement in the other assessment categories. Conclusions: The treatment was well tolerated, and patient acceptance was high. The results support the efficacy and safety of locally administered activated carbon for the treatment of patients with chronic uncomplicated perianal fistulas not receiving any other medication for fistula problems

Formation of the Scandinavian Obesity Surgery Registry, SOReg.

Obesity surgery is expanding, the quality of care is ever more important, and learning curve assessment should be established. A large registry cohort can show long-term effects on obesity and its comorbidities, complications, and long-term side effects of surgery, as well as changes in health-related quality of life (QoL). Sweden is ideally suited to the task of data collection and audit, with universal use of personal identification numbers, nation-wide registries permitting cross-matching to analyze causes of death, in-hospital care, and health-related absenteeism

Relationship between sedentary behavior and depression: a mediation analysis of influential factors across the lifespan among 42,469 people in low- and middle-income countries

Background: Sedentary behavior (SB) is associated with diabetes, cardiovascular disease and low mood. There is a paucity of multi-national research investigating SB and depression, particularly among low- and middle-income countries. This study investigated the association between SB and depression, and factors which influence this. Methods: Cross-sectional data were analyzed from the World Health Organization's Study on Global Ageing and Adult Health. Depression was based on the Composite International Diagnostic Interview. The association between depression and SB (self-report) was estimated by multivariable linear and logistic regression analyses. Mediation analysis was used to identify influential factors. Results: A total of 42,469 individuals (50.1% female, mean 43.8 years) were included. People with depression spent 25.6 (95%CI8.5-42.7) more daily minutes in SB than non-depressed participants. This discrepancy was most notable in adults aged ≥65 y (35.6 minutes in those with depression). Overall, adjusting for socio-demographics and country, depression was associated with a 1.94 (95%CI1.31-2.85) times higher odds for high SB (i.e., ≥8 h/day). The largest proportion of the SB-depression relationship was explained by mobility limitations (49.9%), followed by impairments in sleep/energy (43.4%), pain/discomfort (31.1%), anxiety (30.0%), disability (25.6%), cognition (16.1%), and problems with vision (11.0%). Other health behaviors (physical activity, alcohol consumption, smoking), body mass index, and social cohesion did not influence the SB-depression relationship. Conclusion: People with depression are at increased risk of engaging in high levels of SB. This first multi-national study offers potentially valuable insight for a number of hypotheses which may influence this relationship, although testing with longitudinal studies is needed

Effects of total parenteral nutrition on rat enteric nervous system, intestinal morphology, and motility.

Total parenteral nutrition (TPN) is often crucial for patients not being able to feed enterally or having intestinal absorptive deficits. Enteral nutrition is, however, frequently regarded vital for maintaining functional and structural intestinal integrity. The aim of this study was to investigate possible effects of TPN on rat distal small intestine compared to enterally fed identically housed controls, regarding the enteric nervous system (ENS), motility in vitro, and morphology. This study shows that motor responses evoked by electrical stimulation or exposure to vasoactive intestinal peptide (VIP), pituitary adenylate cyclase activating peptide-27 (PACAP-27), and nitric oxide (NO) donor were unchanged. By using immunohistochemistry, the numbers of submucous (P < 0.05) and myenteric (P < 0.05) nerve cells were found to increase, expressed as numbers per unit length. The percentage of neurons expressing VIP, PACAP-27, NO-synthase, and galanin remained unchanged, however. By in situ hybridization the number of submucous neurons expressing neuropeptide Y-mRNA was found to decrease (P < 0.05); the other populations were unaltered. Morphometry revealed an increased submucosal thickness (P < 0.05), while intestinal circumference markedly decreased (P < 0.0001) in TPN-treated rats. In conclusion, TPN treatment resulted in reduced intestinal circumference leading to condensation of enteric neurons. No marked changes in neurotransmitter expression of the enteric neurons or in motor activity were noted

Mucosal in vitro permeability in the intestinal tract of the pig, the rat, and man: species- and region-related differences

BACKGROUND: The barrier properties of the gastrointestinal mucosa may be studied by measuring its permeability to different-sized marker molecules. Owing to difficulties in obtaining human tissue it is, however, often necessary to extrapolate findings from experimental animals to man. The aim of the present study was to compare regional intestinal mucosal permeability in man, the rat, and the pig, using the same marker molecules and in vitro technique. METHODS: Segments from jejunum, ileum, colon, and rectum were mounted in Ussing diffusion chambers, and the mucosa-to-serosa passage of 14C-mannitol, fluorescein isothiocyanate (FITC)-dextran 4,400, alpha-lactalbumin, ovalbumin, and FITC-dextran 70,000 was studied. RESULTS: Irrespective of species or intestinal region an inverse relationship between the molecular weight of the markers and the permeability was seen. The mannitol permeability was higher in the small intestine than in the colon in man, whereas the rat showed a higher permeability in the ileum than in the jejunum and colon. The FITC-dextran 4,400 permeability was higher in all intestinal regions in the rat than in man and the pig. The macromolecules showed low permeability with no regional differences. CONCLUSIONS: The results showed differences between intestinal regions and between species. Permeability data from the pig correlated fairly well with those of man, whereas the rat differed, making it difficult to extrapolate from the rat to man