scholarly journals Association between statin use and clinical course, microbiologic characteristics, and long-term outcome of early Lyme borreliosis. A post hoc analysis of prospective clinical trials of adult patients with erythema migrans

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0261194
Author(s):  
Daša Stupica ◽  
Fajko F. Bajrović ◽  
Rok Blagus ◽  
Tjaša Cerar Kišek ◽  
Stefan Collinet-Adler ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Lyme Borreliosis ◽  
Erythema Migrans ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Post Hoc Analysis ◽  
Associated Symptoms ◽  
Post Hoc ◽  
Statin Use

Background Statins were shown to inhibit borrelial growth in vitro and promote clearance of spirochetes in a murine model of Lyme borreliosis (LB). We investigated the impact of statin use in patients with early LB. Methods In this post-hoc analysis, the association between statin use and clinical and microbiologic characteristics was investigated in 1520 adult patients with early LB manifesting as erythema migrans (EM), enrolled prospectively in several clinical trials between June 2006 and October 2019 at a single-center university hospital. Patients were assessed at enrollment and followed for 12 months. Results Statin users were older than patients not using statins, but statin use was not associated with Borrelia seropositivity rate, Borrelia skin culture positivity rate, or disease severity as assessed by erythema size or the presence of LB-associated symptoms. The time to resolution of EM was comparable in both groups. The odds for incomplete recovery decreased with time from enrollment, were higher in women, in patients with multiple EM, and in those reporting LB-associated symptoms at enrollment, but were unaffected by statin use. Conclusion Statin use was not associated with clinical and microbiologic characteristics or long-term outcome in early LB.

scholarly journals Clinical Course, Serologic Response, and Long-Term Outcome in Elderly Patients with Early Lyme Borreliosis

2018 ◽  
Vol 7 (12) ◽  
pp. 506 ◽  
Author(s):  
Katarina Boršič ◽  
Rok Blagus ◽  
Tjaša Cerar ◽  
Franc Strle ◽  
Daša Stupica
Keyword(s):  
Lyme Borreliosis ◽  
Older Patients ◽  
Erythema Migrans ◽  
Middle Aged ◽  
Patient Age ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Incomplete Response ◽  
Patient Âgé

Infected elderly people often present with signs and symptoms that differ from those in younger adults, but data on the association between patient age and presentation of early Lyme borreliosis (LB) are limited. In this study, the association between patient age (18–44 years, young vs. 45–64 years, middle-aged vs. ≥ 65 years, elderly) and disease course, microbiologic characteristics, and the long-term outcome of treatment was investigated prospectively in 1220 adult patients with early LB manifesting as erythema migrans (EM) at a single-center university hospital. Patients were assessed at enrolment and followed-up for 12 months. Age was associated with comorbidities, previous LB, presenting with multiple EM, and seropositivity to borreliae at enrolment. The time to resolution of EM after starting antibiotic treatment was longer in older patients. At 12 months, 59/989 (6.0%) patients showed incomplete response. The odds for incomplete response decreased with time from enrolment (odds ratio (OR) of 0.49, 0.50, and 0.48 for 2-month vs. 14-days, 6-month vs. 2-month, and 12-month vs. 6-month follow-up visits, respectively), but were higher with advancing age (OR 1.57 for middle-aged vs. young, and 1.95 for elderly vs. young), in women (OR 1.41, 95% confidence interval (CI) 1.01–1.96), in patients who reported LB-associated constitutional symptoms at enrolment (OR 7.69, 95% CI 5.39–10.97), and in those who presented with disseminated disease (OR 1.65, 95% CI 1.09–2.51). The long-term outcome of EM was excellent in patients of all age groups. However, older patients had slower resolution of EM and higher odds for an unfavorable outcome of treatment (OR 1.57, 95% CI 1.05–2.34 for middle-aged vs. young; and OR 1.95, 95% CI 1.14–3.32 for elderly vs. young), manifested predominantly as post-LB symptoms. The presence of LB-associated constitutional symptoms at enrolment was the strongest predictor of incomplete response.

scholarly journals Long-Term Outcome after Joint Bleeds in Von Willebrand Disease Compared to Haemophilia A: A Post Hoc Analysis

2018 ◽  
Vol 118 (10) ◽  
pp. 1690-1700 ◽  
Author(s):  
Karin van Galen ◽  
Merel Timmer ◽  
Piet de Kleijn ◽  
Frank Leebeek ◽  
Wouter Foppen ◽  
...  
Keyword(s):  
Von Willebrand Disease ◽  
Haemophilia A ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Post Hoc Analysis ◽  
Joint Health ◽  
Post Hoc ◽  
Type 3 ◽  
Von Willebrand

AbstractLong-term outcome after joint bleeds in von Willebrand disease (VWD) (von Willebrand factor activity ≤ 30 IU/dL) could differ from moderate or severe haemophilia A (HA) (factor VIII [FVIII] 1–5 IU/dL or FVIII < 1 IU/dL). We performed a post hoc analysis on Haemophilia Joint Health Score (HJHS, 0–124), X-ray Pettersson scores (PS, 0–13/joint) and the Haemophilia Activities List (HAL, 0–100), using multivariable regression to adjust for age (rate ratio [RR] or odds ratio [OR] [95% confidence interval]). We included 48 VWD (median age, 47 years, type 3 VWD, n = 19), 39 moderate HA (median, 39 years) and 59 severe HA patients (median, 25 years) with documented joint bleeds. VWD patients suffered repeated bleeding (lifetime > 5/joint) less often than moderate and severe HA patients (52% vs. 77% vs. 98%). HJHS and PS in VWD were similar to moderate HA (median HJHS 5 vs. 6, RR 0.9 [0.5–1.4] and PS > 3 of ≥ 1 joint OR 0.3 [0.1–1.4]), but better than in severe HA patients (median HJHS 5 vs. 9, RR 1.8 [1.1–2.9]; PS > 3 in any joint OR 0.1 [0.0–0.3]). Self-reported limitations in activities were comparable across VWD, moderate HA (HAL score < 95: 67% vs. 49%; OR 1.4 [0.5–3.6]) and young adults with severe HA (67% vs. 48%; OR 1.7 [0.7–4.4]). Despite fewer joint bleeds, joint outcome after joint bleeds was similar in VWD and moderate HA patients. Type 3 VWD patients had worst joint outcome, comparable to younger intensively treated severe HA patients. Limitations in activities occurred as often in VWD as in both moderate and severe HA.

Neural respiratory drive predicts long-term outcome following admission for exacerbation of COPD: a post hoc analysis

Thorax ◽  
2019 ◽  
Vol 74 (9) ◽  
pp. 910-913 ◽  
Author(s):  
Maxime Patout ◽  
Leonor Meira ◽  
Rebecca D’Cruz ◽  
Elodie Lhuillier ◽  
Georgios Kaltsakas ◽  
...  
Keyword(s):  
Clinical Utility ◽  
Respiratory Drive ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Post Hoc Analysis ◽  
Observational Cohort ◽  
Exacerbation Of Copd ◽  
Post Hoc

Neural respiratory drive (NRD), as reflected by change in parasternal muscle electromyogram (EMGpara), predicts clinical deterioration and safe discharge in patients admitted to hospital with an acute exacerbation of COPD (AECOPD). The clinical utility of NRD to predict the long-term outcome of patients following hospital admission with an AECOPD is unknown. We undertook a post hoc analysis of a previously published prospective observational cohort study measuring NRD in 120 patients with AECOPD. Sixty-nine (57.5%) patients died during follow-up (median 3.6 years). Respiratory failure was the most common cause of death (n=29; 42%). In multivariate analysis, factors independently associated with an increased mortality included NRD (HR 2.14, 95% CI 1.29 to 3.54, p=0.003), age (HR 2.03, 95% CI 1.23 to 3.34, p=0.006), PaCO2 at admission (HR 1.83, 95% CI 1.06 to 3.06, p=0.022) and long-term oxygen use (HR 2.98, 95% CI 1.47 to 6.03, p=0.002). NRD at hospital discharge could be measured in order to assess efficacy of interventions targeted to optimise COPD and reduce mortality following an AECOPD.Original clinicaltrial.gov number:NCT01361451

scholarly journals Statin use is associated with early recovery of kidney injury after vascular surgery and improved long-term outcome

2008 ◽  
Vol 23 (12) ◽  
pp. 3867-3873 ◽  
Author(s):  
G. M. J. M. Welten ◽  
M. Chonchol ◽  
O. Schouten ◽  
S. Hoeks ◽  
J. J. Bax ◽  
...  
Keyword(s):  
Vascular Surgery ◽  
Kidney Injury ◽  
Early Recovery ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Statin Use

scholarly journals Testing non-inferiority of blended versus face-to-face Cognitive Behavioural Therapy for severe fatigue in patients with Multiple Sclerosis and the effectiveness of blended booster sessions aimed at improving long term outcome following both therapies: – study protocol for two observer-blinded randomized clinical trials

2019 ◽  
Author(s):  
Marieke Houniet- de Gier ◽  
Heleen Beckerman ◽  
Kimberley van Vliet ◽  
Hans Knoop ◽  
Vincent de Groot
Keyword(s):  
Clinical Trials ◽  
Behavioural Therapy ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Face To Face ◽  
Cognitive Behavioural ◽  
End Of Treatment ◽  
Booster Sessions ◽  
Fatigue Severity

Abstract Background: Cognitive behavioural therapy (CBT) has been found effective in reducing fatigue severity in MS patients directly following treatment. However, long-term effects are inconsistent leaving room for improvement. In addition, individual face-to-face CBT draws heavily on limited treatment capacity, and the travel distance to the treatment centre can be burdensome for patients. Therefore, we developed “MS Fit”, a blended CBT for MS-related fatigue, based on a face-to-face CBT protocol found effective in a previous study, and “MS Stay Fit”, internet-based booster sessions to improve long term effectiveness of CBT for MS-related fatigue. This paper presents the protocol of two Randomised Clinical Trials (RCTs) conducted within one study investigating 1) the non-inferiority of MS Fit compared to evidence-based face-to-face CBT for MS-related fatigue, and 2) the effectiveness of MS Stay Fit on the long-term outcome of fatigue compared to no booster sessions. Methods/design: The first part of this study is an observer-blinded non-inferiority multicentre RCT, in which 166 severely fatigued MS patients will be randomized (1:1 ratio, computer-generated sequence) to either face-to-face CBT or blended CBT (MS Fit) for fatigue. The primary endpoint is at 20 weeks after baseline. After this post-treatment assessment, patients will be randomized again (1:1 ratio, computer generated sequence) to either MS Stay Fit consisting of 2 booster sessions at 2 and 4 months after end of treatment, or no booster sessions. The primary endpoint of the second study is 52 weeks after baseline. Primary outcome measure in both studies is fatigue severity assessed with the fatigue severity subscale of the Checklist Individual Strength (CIS20r). Outcomes will be assessed at baseline (T0), end of treatment (T20), after 39 and 52 weeks (T39 and T52). Discussion: If MS Fit is found to be non-inferior to face-to-face CBT it will improve the accessibility of this treatment. In addition, the study aims to test if it is possible to improve long-term effectiveness of CBT for MS-related fatigue with MS Stay Fit.

scholarly journals Testing non-inferiority of blended versus face-to-face Cognitive Behavioural Therapy for severe fatigue in patients with Multiple Sclerosis and the effectiveness of blended booster sessions aimed at improving long term outcome following both therapies: – study protocol for two observer-blinded randomized clinical trials

2019 ◽  
Author(s):  
Marieke Houniet- de Gier ◽  
Heleen Beckerman ◽  
Kimberley van Vliet ◽  
Hans Knoop ◽  
Vincent de Groot
Keyword(s):  
Clinical Trials ◽  
Behavioural Therapy ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Face To Face ◽  
Cognitive Behavioural ◽  
End Of Treatment ◽  
Booster Sessions ◽  
Fatigue Severity

Abstract Background Cognitive behavioural therapy (CBT) has been found effective in reducing fatigue severity in MS patients directly following treatment. However, long-term effects are inconsistent leaving room for improvement. In addition, individual face-to-face CBT draws heavily on limited treatment capacity, and the travel distance to the treatment centre can be burdensome for patients. Therefore, we developed “MS Fit”, a blended CBT for MS-related fatigue, based on a face-to-face CBT protocol found effective in a previous study, and “MS Stay Fit”, internet-based booster sessions to improve long term effectiveness of CBT for MS-related fatigue. This paper presents the protocol of two Randomised Clinical Trials (RCTs) conducted within one study investigating 1) the non-inferiority of MS Fit compared to evidence-based face-to-face CBT for MS-related fatigue, and 2) the effectiveness of MS Stay Fit on the long-term outcome of fatigue compared to no booster sessions. Methods/design The first part of this study is an observer-blinded non-inferiority multicentre RCT, in which 166 severely fatigued MS patients will be randomized (1:1 ratio, computer-generated sequence) to either face-to-face CBT or blended CBT (MS Fit) for fatigue. The primary endpoint is at 20 weeks after baseline. After this post-treatment assessment, patients will be randomized again (1:1 ratio, computer generated sequence) to either MS Stay Fit consisting of 2 booster sessions at 2 and 4 months after end of treatment, or no booster sessions. The primary endpoint of the second study is 52 weeks after baseline. Primary outcome measure in both studies is fatigue severity assessed with the fatigue severity subscale of the Checklist Individual Strength (CIS20r). Outcomes will be assessed at baseline (T0), end of treatment (T20), after 39 and 52 weeks (T39 and T52). Discussion If MS Fit is found to be non-inferior to face-to-face CBT it will improve the accessibility of this treatment. In addition, the study aims to test if it is possible to improve long-term effectiveness of CBT for MS-related fatigue with MS Stay Fit.

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