scholarly journals Long-term benefits of targeted micronutrition with the holoBLG lozenge in house dust mite allergic patients

2022 ◽  
Author(s):  
Karl-Christian Bergmann ◽  
Jennifer Raab ◽  
Linda Krause ◽  
Sylvia Becker ◽  
Sebastian Kugler ◽  
...  
Keyword(s):  
Lung Function ◽  
Primary Endpoint ◽  
House Dust Mite ◽  
Temporal Evolution ◽  
Well Being ◽  
Dust Mite ◽  
Symptom Scores ◽  
Secondary Endpoints

Summary Purpose The long-term effects of targeted micronutrition with the holoBLG lozenge in house dust mite (HDM) allergic rhinoconjunctivitis (ARC) patients were evaluated at a follow-up visit in an allergen exposure chamber (AEC). Methods Patients who were supplemented for 3‑months with the holoBLG lozenge in a previous study with two controlled HDM-AEC challenges [visits: V1, V3] were recruited for a third AEC challenge (V5) 7–8 months after cessation of supplementation. Symptoms (nose, conjunctival, bronchial, others), well-being, and lung function parameters were recorded exactly as in the previous study. Primary endpoint was change in median Total Nasal Symptom Score (TNSS) at V5 compared to V1. Secondary endpoints included e.g. change in median Total Symptom Score (TSS) and the exploratory analysis of temporal evolution of symptom scores using linear mixed effects models. Results Of the 32 patients included in the original study, 27 could be recruited for the follow-up visit with a third AEC challenge. An improvement of 20% (p = 0.15) in the primary endpoint TNSS [V1: 2.5 (interquartile range [IQR]: 1–4), V5: 2.0 (IQR: 1–3)] was observed; 40% (p = 0.04) improvement was seen for the TSS [V1: 5.0 (IQR: 3–9), V5: 3.0 (IQR: 2–5.5)]. Analysis of temporal evolution of all symptom scores, and the personal well-being revealed sustained, clinically meaningful improvement at V5 compared to V1. No relevant lung function parameter differences were observed. Conclusions Sustained long-term reduction of TNSS (primary endpoint) and sustained long-term improvement of secondary endpoints (temporal evolution of all symptom scores and well-being) were demonstrated 7–8 months after cessation of holoBLG supplementation, indicative of a long-lasting nature of immune resilience induced by holoBLG. Trial registration The study was registered at clinicaltrials.gov (NCT04872868).

scholarly journals Targeted micronutrition via holo-BLG based on the farm effect in house dust mite allergic rhinoconjunctivitis patients – first evaluation in a standardized allergen exposure chamber

2021 ◽  
Author(s):  
Karl-Christian Bergmann ◽  
Anke Graessel ◽  
Jennifer Raab ◽  
Werner Banghard ◽  
Linda Krause ◽  
...  
Keyword(s):  
Lung Function ◽  
Symptom Score ◽  
Primary Endpoint ◽  
House Dust ◽  
House Dust Mite ◽  
Temporal Evolution ◽  
Allergen Exposure ◽  
Allergic Rhinoconjunctivitis ◽  
Dust Mite ◽  
Symptom Scores

Abstract Purpose Evaluation of a lozenge for targeted micronutrition (holo-BLG), a new invention based on the farm effect, in house dust mite (HDM) allergic rhinoconjunctivitis (ARC) patients in a standardized allergen exposure chamber (AEC). Methods Eligible HDM allergic patients were exposed to HDM raw material in an AEC for 120 min before (V1) and after (V3) 3 months of holo-BLG supplementation. Nasal, conjunctival, bronchial and other symptoms were rated by the patients every 10 min and, wellbeing, peak nasal inspiratory flow (PNIF), and lung function parameters every 30 min. Primary endpoint was the change in median Total Nasal Symptom Score (TNSS) at V3 compared to V1 at 120 min of exposure. Secondary endpoints consisted of the exploratory analysis of the temporal evolution of symptom scores using linear mixed effects models. Results A total of 32 patients were included in the analysis. A significant improvement of 60% (p = 0.0034) in the primary endpoint TNSS (V1 2.5 [interquartile range, IQR 1–4], V3 1.0 [IQR 1–3]) was observed. 40% improvement was seen for the Total Symptom Score (V1 5.0 [IQR 3–9], V3 3.0 [IQR 2–4]; [Wilcoxon test: confidence interval 1.5–4.0, p < 0.0003]). The analysis of the temporal evolution of all symptom scores and the personal wellbeing revealed clinically meaningful improvement over time, manifested in a lower symptom increase during the final HDM exposure. No relevant differences were observed for PNIF and lung function parameters. Safety and tolerability were rated as excellent. Conclusions The effect of holo-BLG resulting in immune resilience might help to fight the allergy epidemic on a new front based on targeted micronutrition of immune cells. Trial registration The study was retrospectively registered at clinicaltrials.gov (NCT04477382).

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Arsene Mekinian ◽  
◽  
David Saadoun ◽  
Eric Vicaut ◽  
Sara Thietart ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Disease Activity ◽  
Primary Endpoint ◽  
Takayasu Arteritis ◽  
Number Of Patients ◽  
Treatment Naïve ◽  
Secondary Endpoints ◽  
Steroid Sparing

Abstract Objectives To assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK). Methods Prospective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-up. Results Thirteen patients with TAK were included, with a median age of 32 years [19–45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0–2] after 6 months; p < 0.001), ITAS-2010 score (5 [2–7] versus 3 [0–8]; p = 0.002), and ITAS-A score (7 [4–10] versus 4 [1–15]; p = 0.0001)]. During the 12-month follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab. Conclusion Tocilizumab seems an effective steroid sparing therapy in TAK, but maintenance therapy is necessary. Trial registration ClinicalTrials.gov NCT02101333. Registered on 02 April 2014.

Long-term effects of allergen-specific subcutaneous immunotherapy for house dust mite induced allergic rhinitis

2017 ◽  
Vol 131 (11) ◽  
pp. 997-1001 ◽  
Author(s):  
E Sahin ◽  
D Dizdar ◽  
M E Dinc ◽  
A A Cirik
Keyword(s):  
Allergic Rhinitis ◽  
House Dust ◽  
House Dust Mite ◽  
Specific Immunotherapy ◽  
Subcutaneous Immunotherapy ◽  
Long Term Effects ◽  
Allergen Specific Immunotherapy ◽  
Dust Mite ◽  
Symptom Scores

AbstractBackground:Allergic rhinitis is strongly associated with the presence of house dust mites. This study investigated the long-term effects of allergen-specific immunotherapy. Allergen-specific immunotherapy was applied over three years. The study was based on a 10-year follow up of patients with allergic rhinitis.Methods:The study was conducted between 2001 and 2015. Skin prick test results and symptom scores were evaluated before (26 patients) and after 3 years (20 patients) of allergen-specific immunotherapy (using data from a previously published study), and 10 years after allergen-specific immunotherapy had ended (20 of 26 patients).Results:The symptom scores before allergen-specific immunotherapy were significantly higher than those obtained after 3 years of allergen-specific immunotherapy and 10 years after allergen-specific immunotherapy (p < 0.0175). There were no significant differences between the scores obtained at 3 years and 10 years after allergen-specific immunotherapy (p > 0.0175).Conclusion:Subcutaneous immunotherapy is an effective treatment for house dust mite induced allergic rhinitis.

scholarly journals Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labelled trial

2020 ◽  
Author(s):  
Arsene Mekinian ◽  
David Saadoun ◽  
Eric Vicaut ◽  
Sarah Thietart ◽  
Bertrand Lioger ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Disease Activity ◽  
Primary Endpoint ◽  
Takayasu Arteritis ◽  
Number Of Patients ◽  
Treatment Naïve ◽  
Secondary Endpoints ◽  
Steroid Sparing

Abstract ObjectivesTo assess long term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK).MethodsProspective open-labelled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients which discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during an 18-month follow-up.ResultsThirteen patients with TAK were included, with a median age of 32 years [19-45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3-4] at baseline, versus 1 [0-2] after 6 months; p <0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)]. During the 12 months follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab.ConclusionTocilizumab seems an effective steroid sparing therapy in TAK but maintenance therapy is necessary.

Updated outcomes of POUT: A phase III randomized trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer (UTUC).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 455-455
Author(s):  
Alison Jane Birtle ◽  
John David Chester ◽  
Robert J. Jones ◽  
Ben Jenkins ◽  
Mark Johnson ◽  
...  
Keyword(s):  
Overall Survival ◽  
Primary Endpoint ◽  
Data Monitoring Committee ◽  
Phase Iii ◽  
Free Survival ◽  
Risk Of Death ◽  
Patient Reported ◽  
Secondary Endpoints

455 Background: The POUT trial (CRUK/11/027; NCT01993979) previously reported (with median follow-up 30.3 months) that adjuvant chemotherapy improves disease free survival (DFS) for patients (pts) with histologically confirmed pT2-T4 N0-3 M0 UTUC. Here we present results of a pre-planned analysis updating the primary endpoint and reporting key secondary endpoints including overall survival. Methods: 261 pts with UTUC were enrolled following nephro-ureterectomy and randomised (1:1) to 4 cycles of gemcitabine-cisplatin (gemcitabine-carboplatin if GFR 30-49ml/min) or surveillance with subsequent chemotherapy if required. Pts had 6 monthly imaging and cystoscopy for 2 years, then annually to 5 years. Toxicity was assessed by CTCAE v4. Primary endpoint was DFS. Secondary endpoints included metastasis free survival (MFS), overall survival (OS), toxicity and patient reported quality of life (QoL). The trial closed to recruitment early on advice of the independent data monitoring committee due to evidence of efficacy. Time-to-event endpoints are analysed (intention-to-treat) by Cox proportional hazard models. Unadjusted and adjusted (by nodal status, planned chemotherapy type, microscopic margin status, pathological stage) hazard ratios (HR, < 1 favouring chemotherapy) are reported. Results: From May 2012 to Nov 2017, 261 pts were recruited (129 surveillance; 132 chemotherapy) at 56 UK centres. One participant withdrew consent for data usage and was excluded from analyses. Pts had median age 69 years (range 37-88), 28% pT2, 66% pT3; 91% pN0. To 09/09/2020, median follow up was 48.1 months (IQR: 36.0-60.1). The unadjusted/adjusted HR for DFS was 0.48 (95% CI: 0.33-0.71; p = 0.0003) / 0.50 (95%CI: 0.34-0.75; p = 0.001), and for MFS was 0.52 (95% CI: 0.35-0.77; p = 0.001) / 0.54 (95% CI: 0.36-0.81; p = 0.002). 93/260 (35.8%) pts have died (52/129 [40.3%] surveillance and 41/131 [31.3%] chemotherapy). Chemotherapy conferred a non-statistically significant 28% reduction in relative risk of death (HR = 0.72, 95% CI: 0.47-1.08; p = 0.11; adjusted HR = 0.79, 95% CI: 0.52-1.19; p = 0.26). 3 year OS was surveillance: 67% (95% CI: 58-74%; chemotherapy: 79% (71%-85%). There was no evidence of long-term toxicity associated with chemotherapy (Wilcoxon rank-sum test p-value for worst grade post-6 months = 0.32). Most common grade 2+ adverse events were hypertension (25/240 [10.4%]), lethargy (25/240 [10.4%]) and hearing loss (13/240 [5.4%]). There was no evidence of statistically or clinically relevant differences in QoL. 12 months after treatment (EORTC Q30 global health status mean difference 4.1 and 4.8 at 12 and 24 months respectively in favour of chemotherapy). Conclusions: With additional follow-up, the previously reported DFS benefit for chemotherapy was maintained with no detrimental long-term toxicity. No statistically significant improvement in OS was observed. Clinical trial information: NCT01993979.

scholarly journals Lipoprotein(a) and Cardiovascular Outcomes after Revascularization of Carotid and Lower Limbs Arteries

Biomolecules ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 257
Author(s):  
Marat V. Ezhov ◽  
Narek A. Tmoyan ◽  
Olga I. Afanasieva ◽  
Marina I. Afanasieva ◽  
Sergei N. Pokrovsky
Keyword(s):  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Cardiovascular Outcomes ◽  
Lower Limbs ◽  
Lipid Lowering ◽  
Lipid Lowering Therapy ◽  
Cox Regression Analysis ◽  
Lipoprotein A ◽  
Secondary Endpoints

Background: Despite high-intensity lipid-lowering therapy, there is a residual risk of cardiovascular events that could be associated with lipoprotein(a) (Lp(a)). It has been shown that there is an association between elevated Lp(a) level and cardiovascular outcomes in patients with coronary heart disease. Data about the role of Lp(a) in the development of cardiovascular events after peripheral revascularization are scarce. Purpose: To evaluate the relationship of Lp(a) level with cardiovascular outcomes after revascularization of carotid and lower limbs arteries. Methods: The study included 258 patients (209 men, mean age 67 years) with severe carotid and/or lower extremity artery disease, who underwent successful elective peripheral revascularization. The primary endpoint was the composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. The secondary endpoint was the composite of primary endpoint and repeated revascularization. Results: For 36-month follow-up, 29 (11%) primary and 128 (50%) secondary endpoints were registered. There was a greater risk of primary (21 (8%) vs. 8 (3%); hazard ratio (HR), 3.0; 95% confidence interval (CI) 1.5–6.3; p < 0.01) and secondary endpoints (83 (32%) vs. 45 (17%), HR, 2.8; 95% CI 2.0–4.0; p < 0.01) in patients with elevated Lp(a) level (≥30 mg/dL) compared to patients with Lp(a) < 30 mg/dL. Multivariable-adjusted Cox regression analysis revealed that Lp(a) was independently associated with the incidence of cardiovascular outcomes. Conclusions: Patients with peripheral artery diseases have a high risk of cardiovascular events. Lp(a) level above 30 mg/dL is significantly and independently associated with cardiovascular events during 3-year follow-up after revascularization of carotid and lower limbs arteries.

scholarly journals Long-term Follow-up in Patients Diagnosed and Treated for Pulmonary Tuberculosis: What Really Happened With the Lung Function?

CHEST Journal ◽  
2011 ◽  
Vol 140 (4) ◽  
pp. 951A
Author(s):  
Pedro Marcos ◽  
Isabel Otero ◽  
Maria Fernández-Marrube ◽  
Maria Rodriguez-Valcarcel ◽  
Luis Mariñas ◽  
...  
Keyword(s):  
Lung Function ◽  
Pulmonary Tuberculosis ◽  
Long Term Follow Up

The association between lung function in adults and the socioeconomic profile in a long-term follow-up

2021 ◽  
Author(s):  
Lene Maria Ørts ◽  
Bodil Hammer Bech ◽  
Torsten Lauritzen ◽  
Anders Helles Carlsen ◽  
Annelli Sandbæk ◽  
...  
Keyword(s):  
Lung Function ◽  
Long Term Follow Up ◽  
Socioeconomic Profile
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