7 research outputs found
Once versus three times daily dosing of oral budesonide for active Crohn's disease : A double-blind, double-dummy, randomised trial
Note: J.Pokrotnieks is in the list of the main authors of the article, as well as in the list of International Budenofalk Study Group collaboration list. His surname is made visible as the main author in this bibliographic record. Funding Information: The study was funded by Dr Falk Pharma GmbH, Freiburg, Germany . The study sponsor contributed to the design of the study in collaboration with the authors, funded the analysis of the data by an independent biostatistics company, worked in conjunction with the authors to interpret the data, and reviewed the draft manuscript. The sponsor was not involved in data collection. The final decision to publish was made by the first author (AD).Background: Oral budesonide 9. mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn's disease. However, there is no precise recommendation for budesonide dosing due to lack of comparative data. A once-daily (OD) 9. mg dose may improve adherence and thereby efficacy. Methods: An eight-week, double-blind, double-dummy randomised trial compared budesonide 9. mg OD versus 3. mg three-times daily (TID) in patients with mild-to-moderately active ileocolonic Crohn's disease. Primary endpoint was clinical remission defined as CDAI < 150 at week 8 (last observation carried forward). Results: The final intent-to-treat population comprised 471 patients (238 [9 mg OD], 233 [3 mg TID]). The confirmatory population for the primary endpoint analysis was the interim per protocol population (n = 377; 188 [9 mg OD], 189 [3 mg TID]), in which the primary endpoint was statistically non-inferior with budesonide 9. mg OD versus 3. mg TID. Clinical remission was achieved in 71.3% versus 75.1%, a difference of - 3.9% (95% CI [- 14.6%; 6.4%]; p = 0.020 for non-inferiority). The mean (SD) time to remission was 21.9 (13.8) days versus 21.4 (14.6) days with budesonide 9 mg OD versus 3. mg TID, respectively. In a subpopulation of 122 patients with baseline SES-CD ulcer score ≥ 1, complete mucosal healing occurred in 32.8% (21/64) on 9 mg OD and 41.4% (24/58) on 3 mg TID; deep remission (mucosal healing and clinical remission) was observed in 26.6% (17/64) and 32.8% (19/58) of patients, respectively. Treatment-emergent suspected adverse drug reactions were reported in 4.6% of 9 mg OD and 4.7% of 3 mg TID patients. Conclusions: Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3 mg TID dosing in mild-to-moderately active Crohn's disease.publishersversionPeer reviewe
Increased intestinal permeability in inflammatory bowel diseases assessed by iohexol test
Re-introduction of Griffon Vulture (Gyps fulvus) in the Eastern Balkan Mountains, Bulgaria – completion of the establishment phase 2010-2020
The current study presents and analyses the results from the recently completed 11-year-establishment phase, following the start of the local re-introduction of the Griffon Vulture (Gyps fulvus) in Kotlenska Planina SPA and Sinite Kamani Nature Park in the Eastern Balkan Mountains of Bulgaria in the period 2010-2020. As a result of the re-introduction efforts and release of 153 individuals, the Griffon Vulture has been successfully reproducing again in the Eastern Balkan Mountains since 2016, after more than 40-50 years of absence. At 2020, the local population consists of some 80 local and up to 80-115 birds, together with sojourn individuals. Amongst them, 23-25 breeding pairs, located in five different colonies and two more frequently used roosting sites. The current average productivity remains relatively low: 0.41 fledglings/territorial pair and fledging success of 0.61 fledglings/breeding pair between 2016 and 2020, but shows a trend to increase with time and the growing experience of the young locally re-introduced population. The mortality confirmed between 2010-2021 accounts for 33%, mostly due to electrocution as a post-release effect in the first six months following their release. Our data show that the newly established population in the Eastern Balkan Mountains mostly forages on feeding sites, having a comparatively small 95% home range: 281.88 ± 91 km2 and 50% core area: 6.6 ± 2.28 km2 (range 4.7–8.5 km2). We, therefore, consider the establishment phase of the re-introduction of Griffon Vulture in this particular site as successfully completed, but management should continue. Furthermore, the area of the Eastern Balkan Mountains can currently be regarded as a "source" for the species within the source-sink population regulation concept in the national and Balkan context
Sa1217 Once Daily Dosing of 9mg Budesonide (Budenofalk®) Is Therapeutic Equivalent to a Three-Times Daily Dosing of 3mg Budesonide for the Treatment of Active Crohn's Disease: A Randomized, Double-Blind, Double-Dummy, Multicenter Phase III Study
Corrigendum: New insight into spatial ecology of Griffon Vulture (Gyps fulvus) on the Balkans provides opportunity for focusing conservation actions for a threatened social scavenger
The knowledge in the behaviour and movement of endangered species is of key importance for the precise targeting and assessing the efficiency of nature conservation actions, especially considering vultures, which explore vast areas to locate ephemeral and unpredictable food resources. Therefore, a total of 51 Griffon Vultures (Gyps fulvus) from both the re-introduced population and the autochthonous Balkan Peninsula (Balkans) colonies have been tagged with GPS/GSM transmitters in recent years, in order to study their seasonal and spatial distribution. The current study presents the analysis of the high-resolution GPS location data, acquired between January 2016 and March 2021. A total of 1,138,383 locations (an average number of 23,716 ± 18,886 positions per bird, ranged between 2,515 and 76,431 of total fixes per bird; n=48) were used to estimate the home range size and identify the traditional foraging areas and roosting sites of the birds during the wintering, migration/roaming and summering periods. Our results reveal that Griffon Vultures movement activity and home range size varied considerably throughout the annual cycle, especially between their wintering and summering grounds, while exhibiting significant overlapping amongst the tracked individuals. Specifically, immature Griffon Vultures travel long distances across all Balkan Peninsula countries, but always gather with conspecifics, showing strong fidelity to active breeding/roosting sites. The total home range 95% area of the Griffon Vulture population on the Balkans was estimated at 39,986.4 km² and the 50% core area at 1,545.42 km² (n = 48). All tracked birds were found to either visit or frequently use (&gt; 95% of the time) the same seven vulture key zones on the Balkan Peninsula – one in Serbia, one shared between North Macedonia and Bulgaria, one shared between Bulgaria and Greece, two entirely lying in Bulgaria, one in western Greece and one shared between Kvarner Archipelago islands in Croatia and the Julian Alps - Italy, Austria and Slovenia. Several smaller sub-zones were also defined within these general ones. The seven key zones form a coherent network and are used as stepping stones for Griffon Vultures during their migration movements and roaming, but also wintering and summering. The observed concentration tendency of Griffon Vultures on the Balkans and the predictability of their temporal and spatial presence should be used to precisely target, address and substantially increase the efficiency of the conservation measures in this marginal and, thus, still vulnerable meta-population
First results from the releases of Cinereous Vultures (Aegypius monachus) aiming at re-introducing the species in Bulgaria – the start of the establishment phase 2018–2022
The current work presents the preliminary results of the Cinereous Vulture (Aegypius monachus) releases in the Balkan Mountains in 2018–2022, aiming at the species re-introduction in Bulgaria, where it was listed as locally extinct since 1985. The first imports and releases of Cinereous Vultures in Bulgaria started in 2018. Until mid-2022, 72 individuals were released in the Eastern Balkan Mountains (Kotlenska Planina SPA and Sinite Kamani Nature Park) and Vrachanski Balkan Nature Park. Of them, 63 immatures imported from Spain were released from aviaries and nine juveniles captive-bred in European zoos were released by hacking (fledging from an artificial nest). We compared the success in survival and establishment between the different release sites and methods used to adjust the ongoing technics and tactics and to support knowledge improvement for future similar projects.From the nine Cinereous Vultures released by hacking, the results were as follows: 1.00 fledging success, but only 0.22 survival in the first six months – combined period of acclimation, first migration and the first winter. All survivors from that period reached maturity into the wild, but all emigrated from the release site and settled elsewhere.Of the 63 individuals released by aviaries, 32 individuals were released in the Eastern Balkan Mountains (18 individuals are still alive – 0.56 survival; 14 individuals settled in the area, which accounts for 0.44 of all released birds and 0.78 of the survivors). Thirty-one individuals were released in Vrachanski Balkan Nature Park (23 individuals are still alive – 0.74 survival; 22 individuals settled in the area – 0.71 of all released birds and 0.96 of the survivors). Based only on aviary method comparison, the settling of the individuals in the release area was alike in the two sites. However, the Vrachanski Balkan Nature Park performed better in survival – both in acclimation and establishment periods.While comparing the release methods – hacking and release from the aviary – the following results were observed: the survival rate during acclimation was 0.86. Due to more considerable losses during the first migration and dispersal in the individuals released by hacking, the survival rate of 0.22 was significantly lower compared to 0.73 for the birds released from the aviary. Additionally, in both methods, a similar pattern in the first winter and spring migration dispersal was observed. Although the survival was equal in the released-by-hacking or aviary birds after the first year onwards, it is essential to note that the emigration of the hacked birds from the release site was 1.00. In comparison, the birds released from aviaries largely remained and settled in the release area (&gt; 0.77 of the survivors). The cost of release and related acclimation, settling, dispersal and the first winter was the greatest: 0.12–0.17 per period, or cumulatively, it was about 0.27. Survival increased and stabilised to &gt; 0.90 after the first year in the wild and reached nearly 1.00 after two years in the wild onwards.Two distinct nuclei of the Cinereous Vulture were established along the Balkan Mountains – the Eastern Balkan Mountains with 18–23 individuals and four formed pairs using a territory of about 642.74 km2 – 95% home range and 85.72 km2 – 50% core area with center being the town of Kotel; and Vrachanski Balkan Nature Park with present 23–29 individuals, of which 2–3 pairs formed so far, using a territory of about 1,143.66 km2 – 95% home range and 22.89 km2 – 50% core area with center being the village of Zgorigrad. The species readily accepted breeding in artificial nest platforms built by professional arborists on different tree species – oak, beech, sycamore and pine. The only naturally built nests were on the ground (n = 2) (unsuccessful) and in Scots Pine (n = 1) (successful). In 2021 and 2022, in each of the two sites, the first successful reproductions were recorded, which marked the return of the Cinereous Vulture as breeding species – 28 years after the last occasional record of a single breeding pair in the country and 36 years after it was officially listed as locally extinct in Bulgaria