Patient-Controlled Methylphenidate for Cancer Fatigue: A Double-Blind, Randomized, Placebo-Controlled Trial

2006 ◽  
Vol 24 (13) ◽  
pp. 2073-2078 ◽  
Author(s):  
Eduardo Bruera ◽  
Vicente Valero ◽  
Larry Driver ◽  
Loren Shen ◽  
Jie Willey ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Symptom Assessment ◽  
Assessment System ◽  
Research Nurse ◽  
Symptom Improvement ◽  
Open Label ◽  
Double Blind ◽  
Fatigue Score ◽  
Significant Difference

Purpose To evaluate the effectiveness of patient-controlled methylphenidate as compared with placebo in cancer patients with fatigue, as measured by the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F). Patients and Methods Patients with a fatigue score of at least 4 on a scale of 0 to 10 (0 = no fatigue, 10 = worst possible fatigue) and hemoglobin level of at least 10 g/dL were included. Patients were randomly assigned to receive 5 mg methylphenidate or placebo every 2 hours as needed (maximum of four capsules a day), for 7 days. Patients completed a daily diary including study drug record and fatigue intensity. A research nurse telephoned patients daily to assess toxicity and fatigue level. All patients were offered open-label methylphenidate for 4 weeks. FACIT-F and the Edmonton Symptom Assessment System (ESAS) were assessed at baseline, and days 8, 15, and 36. The FACIT-F fatigue subscore on day 8 was considered the primary end point. Results Of 112 patients randomly assigned, 52 patients in the methylphenidate and 53 in the placebo group were assessable for analysis. Fatigue intensity improved significantly on day 8 in both the methylphenidate and placebo groups. However, there was no significant difference in fatigue improvement by FACIT-F (P = .31) or ESAS (P = .14) between groups. In open-label phase, fatigue intensity maintained low as compared with baseline. No significant toxicities were observed. Conclusion Both methylphenidate and placebo resulted in significant symptom improvement. Methylphenidate was not significantly superior to placebo after 1 week of treatment. Longer study duration is justified. The role of daily telephone calls from a research nurse should be explored as a palliative care intervention.

Donepezil for Cancer Fatigue: A Double-Blind, Randomized, Placebo-Controlled Trial

2007 ◽  
Vol 25 (23) ◽  
pp. 3475-3481 ◽  
Author(s):  
Eduardo Bruera ◽  
Badi El Osta ◽  
Vicente Valero ◽  
Larry C. Driver ◽  
Be-Lian Pei ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Final Analysis ◽  
Symptom Assessment ◽  
Subscale Score ◽  
Assessment System ◽  
Open Label ◽  
Double Blind ◽  
Fatigue Score ◽  
Significant Difference ◽  
Open Label Phase

PurposeTo evaluate the effectiveness of donepezil compared with placebo in cancer patients with fatigue as measured by the Functional Assessment for Chronic Illness Therapy–Fatigue (FACIT-F).Patients and MethodsPatients with fatigue score ≥ 4 on a scale of 0 to 10 (0 = no fatigue, 10 = worst possible fatigue) for more than 1 week were included. Patients were randomly assigned to receive donepezil 5 mg or placebo orally every morning for 7 days. A research nurse contacted the patients by telephone daily to assess toxicity and fatigue level. All patients were offered open-label donepezil during the second week. FACIT-F and/or the Edmonton Symptom Assessment System (ESAS) were assessed at baseline, and days 8, 11, and 15. The FACIT-F fatigue subscale score on day 8 was considered the primary end point.ResultsOf 142 patients randomly assigned to treatment, 47 patients in the donepezil group and 56 in the placebo group were assessable for final analysis. Fatigue intensity improved significantly on day 8 in both donepezil and placebo groups. However, there was no significant difference in fatigue improvement by FACIT-F (P = .57) or ESAS (P = .18) between groups. In the open-label phase, fatigue intensity continued to be low as compared with baseline. No significant toxicities were observed.ConclusionDonepezil was not significantly superior to placebo in the treatment of cancer-related fatigue.

Donepezil for cancer-related fatigue: A double-blind, randomized, placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9003-9003
Author(s):  
E. Bruera ◽  
B. El Osta ◽  
V. Valero ◽  
L. Driver ◽  
J. Palmer ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Subscale Score ◽  
Assessment System ◽  
Phone Call ◽  
Controlled Study ◽  
Fatigue Improvement ◽  
Open Label ◽  
Double Blind ◽  
Significant Difference

9003 Background: Fatigue is the most frequent symptom in advanced cancer. No standard treatment is available. We previously found that open-label donepezil significantly improved fatigue by day 3 and 7 in patients (pts) on opioids for cancer pain (Fisch et al, ASCO 2003). The purpose of this study was to compare donepezil (D) with placebo (P) for fatigue in pts with advanced cancer. Methods: In this randomized, double-blind, placebo-controlled trial, pts with fatigue score = 4 on a 0 to 10 scale (10 = worst fatigue) for > 1 week, hemoglobin = 10g/dl for = 4 weeks, and no major contraindication to D were randomized to receive D 5 mg or P orally every morning for 7 days. All pts were offered open-label D during week 2. Assessment included: research nurse daily phone call for fatigue and toxicity evaluation, Edmonton Symptom Assessment System (ESAS), Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F), Sleeping Pattern Assessment, and overall effectiveness of the treatment. The FACIT-F fatigue subscale score on day 8 was considered the primary endpoint. Results: 103 pts were evaluable for final analysis. Mean difference in scores for symptoms intensity between baseline and day 8 are shown in Table 1 . FACIT-F fatigue subscale score at day 8 decreased a mean of 6 (10.6 SD) in the D arm (p < 0.001) and 7.2 (9.5 SD) in the P arm (p < 0.001). There was no significant difference in fatigue improvement between both arms according to the FACIT-F subscale (p = 0.57) and ESAS fatigue (p = 0.18) scores, and no significant difference in sleep quality score between D and P. On day 15 of the open-label phase, mean fatigue intensity remained significantly improved as compared to baseline on FACIT-F fatigue subscale (p < 0.001) and ESAS fatigue (p < 0.001) scores. No significant toxicities were observed. Conclusions: Both donepezil and placebo resulted in significant fatigue improvement. Donepezil was not significantly superior to placebo after one week. Our pilot findings are probably due to placebo effect. No significant financial relationships to disclose. [Table: see text]

The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients

2009 ◽  
Vol 29 (5) ◽  
pp. 562-567 ◽  
Author(s):  
Daniel O. Young ◽  
Steven C. Cheng ◽  
James A. Delmez ◽  
Daniel W. Coyne
Keyword(s):  
Peritoneal Dialysis ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Treatment Options ◽  
Study Drug ◽  
Phosphate Binders ◽  
Open Label ◽  
Double Blind ◽  
Phosphorus Levels ◽  
Plasma Phosphorus

Background Hyperphosphatemia remains a significant problem for patients requiring dialysis and is associated with increased mortality. Current treatment options include dietary restriction, dialysis, and phosphate binders. Treatment using the latter is frequently limited by cost, tolerability, and calcium loading. One open-label trial found niacinamide to be effective at decreasing serum phosphorus values in hemodialysis patients. Niacinamide may effectively reduce phosphorus levels in peritoneal dialysis (PD) patients already receiving standard phosphorus-lowering therapies. Methods An 8 week, randomized, double blind, placebo-controlled trial to evaluate the effectiveness of niacinamide to reduce plasma phosphorus levels in PD patients. Patients had to demonstrate a baseline phosphorus value > 4.9 mg/dL. Patients were randomized to niacinamide or placebo and prescribed 250 mg twice daily, with titration to 750 mg twice daily, as long as safety parameters were not violated. Phosphate binders, active vitamin D, and cinacalcet were kept constant during the study. The primary end point was change in plasma phosphorus. Secondary end points included changes in lipid parameters. Results 15 patients started on the study drug (8 niacinamide, 7 placebo) and 7 in each arm had at least one on-study phosphorus measurement. The niacinamide treatment group experienced an average 0.7 ± 0.9 mg/dL decrease in plasma phosphorus and the placebo-treated group experienced an average 0.4 ± 0.8 mg/dL increase. The treatment effect difference (1.1 mg/dL) was significant ( p = 0.037). No significant changes in high- or low-density lipoproteins or triglycerides were demonstrated. Two of the 8 patients randomized to the niacinamide treatment arm had to withdraw from the study due to drug-related adverse effects. Adverse effects may limit the use of niacinamide in PD patients. Conclusion Niacinamide, when added to standard phosphorus-lowering therapies, resulted in a modest yet statistically significant reduction in plasma phosphorus levels at 8 weeks. [ClinicalTrials.gov number NCT00508885 (ClinicalTrials.gov)]

Dexamethasone (DM) for cancer-related fatigue: A double-blinded, randomized, placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9002-9002 ◽  
Author(s):  
Sriram Yennurajalingam ◽  
Susan Frisbee-Hume ◽  
Marvin Omar Delgado-Guay ◽  
Janet Bull ◽  
Alexandria T. Phan ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Symptom Assessment ◽  
Primary Objective ◽  
Controlled Study ◽  
Advanced Cancer Patients ◽  
Double Blind ◽  
Cancer Related Fatigue ◽  
Significant Difference ◽  
Edmonton Symptom Assessment Scale

9002 Background: Cancer-related-fatigue (CRF) is the most common and distressing symptoms in patients with advanced cancer. Currently, there is no standard treatment for CRF. Although corticosteroids have been used in the treatment of CRF, there are no well-powered placebo-controlled trials that used a validated CRF outcome measure. The primary objective of this prospective, randomized, double-blind, placebo-controlled study is to compare the effect of DM versus placebo on CRF. Methods: Advanced cancer patients with fatigue ≥ 4/10 on the Edmonton Symptom Assessment Scale (ESAS) and at least 2 other CRF-related symptoms (pain, nausea, appetite, depression, anxiety or sleep disturbance ≥ 4/10), normal cognition, no infections and hemoglobin ≥ 9 g/L were eligible for enrollment. Patients were randomized to either receive dexamethasone 4 mg orally twice a day for 15 days (primary end point) or matching placebo. The primary outcome was the day 15 change in Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores. Differences in the group means (normal distribution) were analyzed using the two-sample t-test. Results: In 83 evaluable patients (43 DM and 40 placebo), median age was 60 years, 61% were white, and 53% were female. There was no difference in the demographics and fatigue (FACIT-F subscale) between DM and placebo groups except for sex (p=0.02). The mean (SD) FACIT-F subscores at baseline and at day 15 for DM were 18 (11) and 27 (11) (p<0.001) and for placebo were 21 (9) and 24 (12) (p=0.06), respectively. Mean improvement in FACIT-F subscale was significantly higher in the DM group compared to placebo (9.6 (11) vs. 3.1 (9.7), p=0.005). We found a significant difference in ESAS physical distress (p=0.02), but no differences in ESAS overall symptom distress (p=0.11) and ESAS psychological distress (P=0.88) between DM and placebo. There were insignificantly higher numbers of grade ≥3 toxicities in patients who received DM than in patients who received placebo (20/42 vs. 18/47, p=0.37). Conclusions: Dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer. Long-term safety studies are needed.

scholarly journals Gastrointestinal Tract Microbiome Dynamics Following Treatment with SER-109, an Investigational Oral Microbiome Therapeutic to Reduce the Recurrence of Clostridium difficile Infection (CDI)

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S389-S390 ◽  
Author(s):  
Matthew Henn ◽  
Christopher Ford ◽  
Edward O’Brien ◽  
Jennifer Wortman ◽  
Sheri Simmons ◽  
...  
Keyword(s):  
Stock Options ◽  
Controlled Trial ◽  
Post Treatment ◽  
Oral Microbiome ◽  
Biologically Active ◽  
Open Label ◽  
Double Blind ◽  
Significant Difference ◽  
Open Label Phase ◽  
Favorable Clinical Outcome

Abstract Background Recurrence of CDI occurs within a few weeks after treatment due to antibiotic-induced dysbiosis. SER-109, an investigational, first-in-class microbiome drug, was designed to sustain a clinical response through microbiome restoration with a purified ecology of spores. In an open-label Phase 1b (Ph1b) trial of SER-109 for prevention of recurrent CDI, 26 of 30 subjects did not recur following treatment. In a Phase 2 (Ph2) double-blind controlled trial of SER-109 (n = 59) vs. placebo (n = 30), no significant difference was observed in the proportions of subjects with recurrence (44.1% vs. 53.3%, respectively). Here we contrast gut microbiome changes among subjects in both trials to understand differences in clinical outcomes observed 8-weeks after dosing. Methods We used 16S v4 and high-resolution whole metagenomic shotgun (WMS) sequencing to characterize microbiome changes from stool samples collected at baseline and 1, 4, and 8 weeks post-treatment. Microbiome analyses focused on subjects diagnosed with recurrence via EIA toxin testing (high confidence recurrence; HCR). Results Significantly greater richness of commensal spore-former species was observed in Ph2 subjects treated with SER-109 compared with PBO at weeks 1 and 4 post-treatment (Mann–Whitney P = 0.008, P = 0.044 respectively) consistent with drug engraftment. In addition, the number of spore-forming species at 1 week post-treatment was significantly greater in non-recurrent subjects vs. HCR subjects (Mann–Whitney P = 0.011). Furthermore, we identified 10 spore-former species that were significantly more prevalent in both SER-109 and non-recurrent subjects (Fig 1). In comparison to Ph1 subjects, SER-109 engraftment was significantly reduced and delayed among Ph2 subjects at all time points (Fig 2). Moreover, Ph1b subjects who received higher doses of SER-109 than that used in Ph2 had increased levels of engraftment. Conclusion In patients with recurrent CDI and dysbiosis, a focused spore-based therapeutic approach leads to engraftment of SER-109 strains. In addition, microbiome signatures of engraftment were associated with a favorable clinical outcome. Although SER-109 was biologically active, a higher dose may improve the rate and degree of microbiome repair. Disclosures M. Henn, Seres Therapeutics: Employee and Shareholder, Salary and Stock Options; C. Ford, Seres Therapeutics: Employee and Shareholder, Salary and Stock Options; E. O’Brien, Seres Therapeutics: Employee and Shareholder, Salary and Stock Options; J. Wortman, Seres Therapeutics: Employee and Shareholder, Salary and Stock Options; S. Simmons, Seres Therapeutics: Employee and Shareholder, Salary and Stock options; L. Diao, Seres Therapeutics: Employee and Shareholder, Salary and Stock; K. Litcofsky, Seres Therapeutics: Employee and Shareholder, Salary and stock options; P. Bernardo, Seres Therapeutics: Employee and Shareholder, Salary and Stock options; J. Aunins, Seres Therapeutics, Inc.: Employee and Shareholder, Salary and Stock options; D. Cook, Seres Therapeutics: Employee and Shareholder, Salary and Stock Options; M. Trucksis, Seres Therapeutics Inc.: Employee and Shareholder, Salary and stock options

Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial

2020 ◽  
pp. 27-37
Author(s):  
Suresh Durgam ◽  
Willie Earley ◽  
Rui Li ◽  
Dayong Li ◽  
Kaifeng Lu ◽  
...  
Keyword(s):  
Safety Profile ◽  
Relapse Prevention ◽  
Controlled Trial ◽  
Fixed Dose ◽  
Open Label ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Controlled ◽  
Time To Relapse

Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97 weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3—9 mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9 mg/d) or placebo for double-blind treatment (up to 72 weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n = 99) or cariprazine (n = 101). Time to relapse was significantly longer in cariprazine — versus placebo-treated patients (P = .0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI] = 0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥ 10% of patients during open-label treatment; there were no cariprazine adverse events ≥ 10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060. Key words: schizophrenia; cariprazine; long-term treatment; relapse prevention; randomized controlled trial; oral antipsychotics

scholarly journals Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ekaterina Alexeeva ◽  
Gerd Horneff ◽  
Tatyana Dvoryakovskaya ◽  
Rina Denisova ◽  
Irina Nikishina ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Controlled Trial ◽  
Randomized Study ◽  
Primary Objective ◽  
Disease State ◽  
Inactive Disease ◽  
Open Label ◽  
Standard Regimen ◽  
Double Blind ◽  
Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n = 35) or placebo+MTX (n = 33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p = 0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/−IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients. Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

scholarly journals Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽  
2021 ◽  
Vol 41 (3) ◽  
pp. 294-304 ◽  
Author(s):  
Messoud Ashina ◽  
Uwe Reuter ◽  
Timothy Smith ◽  
Judith Krikke-Workel ◽  
Suzanne R Klise ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Statistical Testing ◽  
Control Group ◽  
Double Blind ◽  
Treatment Groups ◽  
Primary Endpoints ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

scholarly journals Early and sustained symptom improvement with umeclidinium/vilanterol versus monotherapy in COPD: a post hoc analysis of the EMAX randomised controlled trial

2020 ◽  
Vol 14 ◽  
pp. 175346662092694
Author(s):  
Edward M Kerwin ◽  
Isabelle H Boucot ◽  
Claus F Vogelmeier ◽  
Francois Maltais ◽  
Ian P Naya ◽  
...  
Keyword(s):  
Rescue Medication ◽  
Controlled Trial ◽  
Medication Use ◽  
Symptom Improvement ◽  
Chronic Obstructive ◽  
Electronic Diary ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Bronchodilator Therapy ◽  
Post Hoc

Background: In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained. Methods: Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured via an electronic diary and analysed initially in 4-weekly periods. Post hoc analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1–8), and association between E-RS:COPD responder status at Weeks 1–4 and later time points. Results: In the intent-to-treat population ( n = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI versus either monotherapy plateaued by Week 4–8 and were sustained at Weeks 21–24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60–85%) retained their Weeks 1–4 E-RS:COPD responder/non-responder status at Weeks 21−24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1–4, 70% were responders at Weeks 21–24. Conclusion: Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI versus either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient’s likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care. Clinical Trial Registration: NCT03034915, 2016-002513-22 (EudraCT Number). The reviews of this paper are available via the supplemental material section.

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