Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose–response trial

2020 ◽  
Vol 11 (1) ◽  
pp. 370-377 ◽  
Author(s):  
Song Lin ◽  
Shanliang Zhao ◽  
Jiahong Liu ◽  
Jianwen Zhang ◽  
Chao Zhang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Treatment Failure ◽  
Lactobacillus Casei ◽  
Adverse Reactions ◽  
Open Label ◽  
Label Dose ◽  
Gastrointestinal Adverse Events ◽  
Response Trial

Anti-tuberculosis (TB) drugs can induce a series of gastrointestinal adverse events, which can seriously affect patients’ quality of life and may lead to treatment failure.

scholarly journals Correction: Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose–response trial

2020 ◽  
Vol 11 (4) ◽  
pp. 3751-3751
Author(s):  
Song Lin ◽  
Shanliang Zhao ◽  
Jiahong Liu ◽  
Jianwen Zhang ◽  
Chao Zhang ◽  
...  
Keyword(s):  
Dose Response ◽  
Lactobacillus Casei ◽  
Adverse Reactions ◽  
Adult Patients ◽  
Open Label ◽  
Label Dose ◽  
Response Trial

Correction for ‘Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose–response trial’ by Song Lin et al., Food Funct., 2020, 11, 370–377.

scholarly journals Safety of Denervation Following Targeted Lung Denervation Therapy for COPD: AIRFLOW-1 Three-year Outcomes

2020 ◽  
Author(s):  
Christophe Pison ◽  
Pallav Shah ◽  
Dirk-Jan Slebos ◽  
Vincent Ninane ◽  
Wim Janssens ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Function ◽  
Adverse Events ◽  
Late Onset ◽  
Open Label ◽  
Serious Adverse Events ◽  
Copd Exacerbations ◽  
Clinical Consequences

Abstract Background: Targeted lung denervation (TLD) is a novel bronchoscopic therapy that disrupts parasympathetic pulmonary nerve input to the lung reducing clinical consequences of cholinergic hyperactivity. The AIRFLOW-1 study assessed safety and TLD dose in patients with moderate-to-severe, symptomatic COPD. This analysis evaluated the long-term impact of TLD on COPD exacerbations, pulmonary function, and quality of life over three years of follow up.Methods: TLD was performed in a prospective, energy-level randomized (29 W vs 32 W power), multicenter study (NCT02058459). Additional patients were enrolled in an open label confirmation phase to confirm improved gastrointestinal safety after procedural modifications. Durability of TLD was evaluated at one, two, and three years post-treatment and assessed through analysis of COPD exacerbations, pulmonary lung function, and quality of life. Results: Three-year follow-up data were available for 73.9% of patients (n=34). The annualized rate of moderate to severe COPD exacerbations remained stable over the duration of the study. Lung function (FEV1, FVC, RV, and TLC) and quality of life (SGRQ-C and CAT) remained stable over three years of follow-up. No new gastrointestinal adverse events and no unexpected serious adverse events were observed. Conclusion: TLD in COPD patients demonstrated a positive safety profile out to three years, with no late-onset serious adverse events related to denervation therapy. Clinical stability in lung function, quality of life, and exacerbations were observed in TLD treated patients over three years of follow up.

scholarly journals Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL’HIV trial

PLoS Medicine ◽  
2020 ◽  
Vol 17 (11) ◽  
pp. e1003421
Author(s):  
Delphine Sculier ◽  
Gilles Wandeler ◽  
Sabine Yerly ◽  
Annalisa Marinosci ◽  
Marcel Stoeckle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Viral Suppression ◽  
Safety Data ◽  
Risk Difference ◽  
Hiv Treatment ◽  
Efficacy And Safety ◽  
Open Label ◽  
Hiv 1

Background Dolutegravir (DTG)–based dual therapy is becoming a new paradigm for both the initiation and maintenance of HIV treatment. The SIMPL’HIV study investigated the outcomes of virologically suppressed patients on standard combination antiretroviral therapy (cART) switching to DTG + emtricitabine (FTC). We present the 48-week efficacy and safety data on DTG + FTC versus cART. Methods and findings SIMPL’HIV was a multicenter, open-label, non-inferiority randomized trial with a factorial design among treatment-experienced people with HIV in Switzerland. Participants were enrolled between 12 May 2017 and 30 May 2018. Patients virologically suppressed for at least 24 weeks on standard cART were randomized 1:1 to switching to DTG + FTC or to continuing cART, and 1:1 to simplified patient-centered monitoring versus standard monitoring. The primary endpoint was the proportion of patients virologically suppressed with <100 copies/ml through 48 weeks. The secondary endpoints included virological suppression at 48 weeks according to the US Food and Drug Administration (FDA) snapshot analysis. Non-inferiority of DTG + FTC versus cART for viral suppression was assessed using a stratified Mantel–Haenszel risk difference, with non-inferiority declared if the lower bound of the 95% confidence interval was greater than −12%. Adverse events were monitored to assess safety. Quality of life was evaluated using the PROQOL-HIV questionnaire. Ninety-three participants were randomized to DTG + FTC, and 94 individuals to cART. Median nadir CD4 count was 246 cells/mm3; median age was 48 years; 17% of participants were female. DTG + FTC was non-inferior to cART. The proportion of patients with viral suppression (<100 copies/ml) through 48 weeks was 93.5% in the DTG + FTC arm and 94.7% in the cART arm in the intention-to-treat population (risk difference −1.2%; 95% CI −7.8% to 5.6%). Per-protocol analysis showed similar results, with viral suppression in 96.5% of patients in both arms (risk difference 0.0%; 95% CI −5.6% to 5.5%). There was no relevant interaction between the type of treatment and monitoring (interaction ratio 0.98; 95% CI 0.85 to 1.13; p = 0.81). Using the FDA snapshot algorithm, 84/93 (90.3%) participants in the DTG + FTC arm had an HIV-1 RNA viral load of <50 copies/ml compared to 86/94 (91.5%) participants on standard cART (risk difference −1.1%; 95% CI −9.3% to 7.1%; p = 0.791). The overall proportion of patients with adverse events and discontinuations did not differ by randomization arm. The proportion of patients with serious adverse events was higher in the cART arm (16%) compared to the DTG + FTC arm (6.5%) (p = 0.041), but none was considered to be related to the study medication. Quality of life improved more between baseline and week 48 in the DTG + FTC compared to the cART arm (adjusted difference +2.6; 95% CI +0.4 to +4.7). The study’s main limitations included a rather small proportion of women included, the open label design, and its short duration. Conclusions In this study, DTG + FTC as maintenance therapy was non-inferior to cART in terms of efficacy, with a similar safety profile and a greater improvement in quality of life, thus expanding the offer of 2-drug simplification options among virologically suppressed individuals. Trial registration ClinicalTrials.gov NCT03160105.

A Study on the Effect of Dietary Modifications in decreasing or delaying Radiation Induced Acute Gastrointestinal Adverse Events in patients receiving Pelvic Radiotherapy

2021 ◽  
pp. 4029-4034
Author(s):  
Devina Janeendran ◽  
Bhama Santhosh Kumar ◽  
Jiya Marium George ◽  
Ayana S. Kumar ◽  
Ram Madhavan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Adverse Events ◽  
Treatment Modality ◽  
Dietary Intervention ◽  
Gastrointestinal Side Effects ◽  
Radiation Induced ◽  
Gastrointestinal Adverse Events ◽  
Dietary Modifications

Ionizing radiotherapy is a very common treatment modality for various types of cancer. However, its uses are expected to increase drastically with several advances in screening as well as early detection of cancer. Radiation injury due to radiation to the gastrointestinal tract is an imperative factor that works against better utility of this critical treatment modality. Moreover, following radiotherapy there are a higher chances of acute as well as chronic symptoms that would significantly reduce the quality of life of patients and furthermore adding an extra burden to the patients in terms of cost of healthcare. Thus interventions to reduce these adverse events can have long term benefits. Acute radiation induced gastrointestinal adverse events can be managed by modification of diet. Dietary modification of fat, lactose or non-starch polysaccharides (fibre) or combination of these dietary modifications reduces acute gastrointestinal adverse events during radiotherapy. In our study, we observed patients diagnosed with prostate and rectal cancer and those patients receiving neo adjuvant chemo-radiotherapy of rectum. The patients were advised to follow certain dietary modifications which aid in controlling the acute gastrointestinal side effects that developed after exposing to radiation therapy. The patients were followed up on a weekly basis and recorded the severity of the gastro intestinal symptoms after each cycle of radiation therapy and the quality of life was also calculated. Our study demonstrates that the dietary intervention appears to be a promising treatment option to control these adverse events. The dietary restriction of fat, fibre and lactose also helped in reducing the grades of adverse events during the radiotherapy. The Quality of Life of patients, however, after radiotherapy was found to be decreased when compared to the baseline.

scholarly journals Safety of denervation following targeted lung denervation therapy for COPD: AIRFLOW-1 3-year outcomes

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Pison Christophe ◽  
L. Shah Pallav ◽  
Slebos Dirk-Jan ◽  
Ninane Vincent ◽  
Janssens Wim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Function ◽  
Adverse Events ◽  
Late Onset ◽  
Open Label ◽  
Serious Adverse Events ◽  
Copd Exacerbations ◽  
Clinical Consequences

Abstract Background Targeted lung denervation (TLD) is a novel bronchoscopic therapy that disrupts parasympathetic pulmonary nerve input to the lung reducing clinical consequences of cholinergic hyperactivity. The AIRFLOW-1 study assessed safety and TLD dose in patients with moderate-to-severe, symptomatic COPD. This analysis evaluated the long-term impact of TLD on COPD exacerbations, pulmonary function, and quality of life over 3 years of follow up. Methods TLD was performed in a prospective, energy-level randomized (29 W vs 32 W power), multicenter study (NCT02058459). Additional patients were enrolled in an open label confirmation phase to confirm improved gastrointestinal safety after procedural modifications. Durability of TLD was evaluated at 1, 2, and 3 years post-treatment and assessed through analysis of COPD exacerbations, pulmonary lung function, and quality of life. Results Three-year follow-up data were available for 73.9% of patients (n = 34). The annualized rate of moderate to severe COPD exacerbations remained stable over the duration of the study. Lung function (FEV1, FVC, RV, and TLC) and quality of life (SGRQ-C and CAT) remained stable over 3 years of follow-up. No new gastrointestinal adverse events and no unexpected serious adverse events were observed. Conclusion TLD in COPD patients demonstrated a positive safety profile out to 3 years, with no late-onset serious adverse events related to denervation therapy. Clinical stability in lung function, quality of life, and exacerbations were observed in TLD treated patients over 3 years of follow up.

Quality of Life in Parkinson's Disease Patients Following Adjunctive Tolcapone Therapy: Results of an Open-Label, Multicenter, Community-Based Trial

CNS Spectrums ◽  
2010 ◽  
Vol 15 (1) ◽  
pp. 27-32 ◽  
Author(s):  
Kapil Sethi ◽  
Stewart Factor ◽  
Ray Watts
Keyword(s):  
Quality Of Life ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Adverse Events ◽  
Clinical Status ◽  
Adjunctive Treatment ◽  
Reversible Inhibitor ◽  
Open Label ◽  
Community Based

ABSTRACTObjective: To examine changes in quality of life (QOL) and global clinical status after 30 days of adjunctive treatment with tolcapone, a reversible inhibitor of catechol-O-methyltransferase, in patients with fluctuating Parkinson's disease.Methods: This 30-day, multicenter, open-label, community-based study enrolled fluctuating Parkinson's disease patients to receive tolcapone 100 mg TID as an adjunct to levodopa/carbidopa. The primary end point was QOL change assessed using the Parkinson's Disease Questionnaire (PDQ)-8. Clinical change was assessed using the investigator-rated Clinical Global Impression of Improvement Scale (CGI-I).Results: Fifty-six physicians enrolled 202 patients; 138 (68%) were ≥65 years of age and 116 (57%) had Parkinson's disease for ≥5 years. The mean PDQ-8 total score improved from 42.1 to 34.8 after 30 days of tolcapone (P<.0001). Sixty-nine percent of patients improved on the CGI-I. Physicians planned to continue tolcapone beyond the 30 days in 72%, most commonly because of positive changes in motor function and overall general improvement. No patient discontinued because of liver adverse events.Conclusions: Adjunctive tolcapone treatment was associated with statistically significant improvement in QOL in fluctuating Parkinson's disease patients. A majority of patients experienced clinical benefits and continued treatment beyond the end of this study. No liver-related adverse events were reported.

scholarly journals 0764 Pitolisant In The Treatment Of Patients With Narcolepsy: A 2-year, Prospective, Observational, Single-center Study

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A290-A290
Author(s):  
A Triller ◽  
A Hof zum Berge ◽  
B Finger ◽  
U Kallweit
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Short Form ◽  
Term Treatment ◽  
Real World Data ◽  
Open Label ◽  
Long Term Treatment ◽  
Nighttime Sleep

Abstract Introduction Pitolisant, a selective histamine H3 receptor antagonist/inverse agonist, increases histamine release in the brain. The efficacy of pitolisant in adults with narcolepsy was demonstrated in randomized, placebo-controlled trials. This study evaluated long-term use of pitolisant in clinical practice. Methods This prospective, open-label, 2-year, observational study was conducted at a major narcolepsy center in Germany and enrolled adults with a diagnosis of narcolepsy who had no prior treatment with pitolisant. Assessments included excessive daytime sleepiness (Epworth Sleepiness Scale [ESS]), weekly rate of cataplexy (WRC), and health-related quality of life (Short-Form Veterans RAND [VR-36]). Results The study enrolled 147 patients: mean age, 29.9 years; 57.1% female, 65.3% with cataplexy, and 66.7% with disrupted nighttime sleep. In patients who were tested, CSF hypocretin-1 was &lt;110 pg/mL in 70.8% (51/72), and 79.4 % (77/97) were HLA-DQB1*0602 positive. The pitolisant dose was 35.6 mg/d in 38.1% of patients at Month 3, and 73.5% at Month 24. Most patients received concomitant narcolepsy medications (63.3% at baseline; 79.6% at month 24). Mean ESS score decreased from 16.2 at baseline to 12.4 at Month 12 and 12.6 at Month 24. Mean WRC was reduced by 31% at Month 24. Significant improvement in quality of life was noted at Months 12 and 24 on VR-36 subscales that assess general health perception, vitality, and social function. In all, 38 patients (25.8%) discontinued from the study before Month 24: 15.0% for lack of efficacy and 10.8% due to adverse events. The most common adverse events were disrupted nighttime sleep (29.3% of patients), headache (15.5%), and nausea (12.2%). Conclusion These real-world data show that long-term treatment with pitolisant (usually with 35.6 mg/d) was efficacious for reducing EDS and cataplexy and improving quality of life in patients with narcolepsy. Treatment was generally well tolerated. Support Writing support funded by Harmony Biosciences, LLC.

scholarly journals Outcome Evaluation of Gabapentin as Add-on Therapy for Partial Seizures

1998 ◽  
Vol 25 (2) ◽  
pp. 134-140 ◽  
Author(s):  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Adjunctive Therapy ◽  
Positive Impact ◽  
Outcome Evaluation ◽  
Partial Seizures ◽  
Open Label ◽  
Complex Partial Seizures ◽  
Day Range

ABSTRACT:Objective:The safety, tolerability, efficacy, and impact on quality of life of gabapentin (Neurontin®) as adjunctive therapy to carbamazepine (CBZ) and/or phenytoin (PHT) was assessed in epileptic patients with partial seizures.Methods:NEON (Neurontin Evaluation of Outcomes in Neurological Practice) was an open-label, prospective, multicentre study conducted in patients on a stable dose of CBZ and/or PHT and experiencing an average of up to 4 complex partial seizures with or without secondary generalization per month, with no seizure-free months. The treatment lasted 20 weeks. Gabapentin was started at 400 mg/day and was individually titrated to effective tolerable dose up to 2400 mg/day. Quality of life was evaluated using the QOLIE-10 questionnaire.Results:A total of 141 patients were enrolled at 36 sites; 114 patients were evaluable for efficacy analyses. The mean maintenance dose of gabapentin was 1600 mg/day (range = 300-3200). A decrease of 50% or more in frequency of complex partial + secondarily generalized seizures was observed in 81 (71 %) patients (p = 0.0001). Fifty two (46%) patients were seizure-free during the last 8 weeks of treatment. A significant improvement (p < 0.05) was observed in 5 of the 10 questions of the QOLIE-10, as well as in the composite QOL score (p = 0.0002). The most frequent adverse events included somnolence (16%), dizziness (9%), and asthenia (6%). Twenty-five (18%) patients prematurely discontinued the study, 16 (11%) of them due to adverse events.Conclusion:This study indicates that treatment with gabapentin as adjunctive therapy to standard antiepileptic drugs in this group of patients not only provides significant improvement in seizure control, but also has a positive impact on quality of life. The clinical benefits in efficacy, safety and tolerability demonstrated at 20 weeks are sustained, and no tolerance develops with gabapentin in longer term use.

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