scholarly journals Efficacy and safety of short-term therapy with indigo naturalis for ulcerative colitis: An investigator-initiated multicenter double-blind clinical trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0241337
Author(s):  
Kan Uchiyama ◽  
Shinichiro Takami ◽  
Hideo Suzuki ◽  
Kiyotaka Umeki ◽  
Satoshi Mochizuki ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Placebo Group ◽  
Adverse Events ◽  
Efficacy And Safety ◽  
Short Term ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Multicenter Randomized Controlled Trial ◽  
Highly Effective ◽  
Indigo Naturalis

Introduction Indigo naturalis (IN) is a blue pigment extracted from Assam indigo and other plants and has been confirmed to be highly effective for ulcerative colitis (UC) treatment in several clinical studies. Objective We conducted a multicenter double-blind study to confirm the efficacy and safety of short-term IN administration. Methods A multicenter, randomized controlled trial was conducted between December 2015 and October 2018 in our facilities. Forty-six patients with mild to moderate active UC (Lichtiger index: 5–10) were randomly assigned to the IN group or the placebo group and received 5 capsules (500 mg) twice a day for 2 weeks. We investigated the efficacy according to blood tests and the Lichtiger index before and after administration, and we also examined adverse events. Results The analysis included 42 patients (20 males, 22 females) with an average age of 45 years. Nineteen patients were assigned to the placebo group, and 23 were assigned to the IN group. After treatment administration, in the placebo group, no change in the Lichtiger index was observed (7.47 to 6.95, p = 0.359), and hemoglobin was significantly reduced (12.7 to 12.4, p = 0.031), while in the IN group, the Lichtiger index (9.04 to 4.48, p = 0.001) and albumin (4.0 to 4.12, p = 0.022) improved significantly. Mild headaches were observed in 5 patients and 1 patient in the IN and placebo groups, respectively. Conclusions Short-term administration of IN is highly effective without serious adverse events such as pulmonary hypertension or intussusception and may prevent the occurrence of serious adverse events.

Sertraline in the treatment of panic disorder

1998 ◽  
Vol 173 (1) ◽  
pp. 54-60 ◽  
Author(s):  
Peter D. Londborg ◽  
Robert Wolkow ◽  
Ward T. Smith ◽  
Eugene Duboff ◽  
Donald England ◽  
...  
Keyword(s):  
Panic Disorder ◽  
Adverse Events ◽  
Drop Out ◽  
Panic Attacks ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Hamilton Anxiety Scale ◽  
Higher Doses ◽  
Clinical Global Impression Improvement

BackgroundThis study compared the efficacy and safety of sertraline to placebo in treating panic disorder.Method178 out-patients with panic disorder who exhibited at least four panic attacks during the four weeks prior to screening and three during the two weeks of lead-in were randomly assigned to 12 weeks of double-blind treatment with sertraline (50, 100 or 200 mg) or placebo.ResultsSertraline was superior to placebo in reducing the number of panic attacks, situational attacks, unexpected attacks, limited symptom attacks, and time spent worrying (all P < 0.01) and the Hamilton Anxiety Scale (P < 0.05), although Clinical Global Impression (Improvement) did not significantly differentiate groups at 12 weeks and at end-point. No serious adverse events were associated with sertraline. No dose relationship was found for adverse events; overall drop-out rates were not different for sertraline or placebo, although more sertraline-treated subjects discontinued for adverse events, typically early in the study. Only dry mouth and ejaculation failure (primarily ejaculation delay) were associated significantly with sertraline. Conclusions Sertraline was effective and safe in reducing panic attacks. Higher doses were no more effective than the 50 mg dose.

scholarly journals Duloxetine in the Treatment of Stress Urinary Incontinence

2005 ◽  
Vol 1 (3) ◽  
pp. 345-358 ◽  
Author(s):  
Martin C Michel ◽  
Matthias Oelke
Keyword(s):  
Urinary Incontinence ◽  
Stress Urinary Incontinence ◽  
Adverse Events ◽  
Striated Muscle ◽  
Bladder Capacity ◽  
Efficacy And Safety ◽  
Cytochrome P450 1A2 ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Urethral Striated Muscle

This manuscript reviews the pharmacodynamics and pharmacokinetics of duloxetine and its efficacy and safety in women with stress urinary incontinence. Duloxetine is a selective inhibitor of neuronal serotonin and norepinephrine uptake which increases urethral striated muscle activity and bladder capacity. Duloxetine is readily absorbed and extensively metabolized; cytochrome P450 1A2 (CYP1A2) inhibiting drugs can markedly increase duloxetine exposure. The clinical efficacy of duloxetine has consistently been demonstrated in several randomized, double-blind studies in women with moderate-to-severe stress urinary incontinence, but the additional benefit relative to placebo was moderate. Duloxetine treatment is frequently associated with adverse events such as nausea, dry mouth, fatigue, insomnia and constipation, but serious adverse events are rare. Therefore, duloxetine appears suitable for the treatment of stress urinary incontinence.

scholarly journals P.027 Efficacy and Safety of Eptinezumab Initiated During a Migraine Attack: Results from the RELIEF Study

2021 ◽  
Vol 48 (s3) ◽  
pp. S27-S28
Author(s):  
PK Winner ◽  
P McAllister ◽  
G Chakhava ◽  
J Ailani ◽  
L Mehta ◽  
...  
Keyword(s):  
Adverse Events ◽  
Migraine Attack ◽  
Rapid Onset ◽  
Migraine Treatment ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Bothersome Symptom ◽  
Post Infusion ◽  
Headache Pain

Background: Eptinezumab is approved for migraine prevention, with demonstrated rapid onset of preventive benefit. RELIEF evaluated the efficacy and safety of eptinezumab initiated during a migraine attack. Methods: RELIEF (NCT04152083; parallel-group, double-blind, placebo-controlled) randomized adults with migraine (4-15d/mo in 3mo prior to screening) to eptinezumab 100mg or placebo, administered IV within 1-6h of qualifying migraine onset. Co-primary efficacy endpoints were time to headache pain freedom and time to absence of most bothersome symptom (MBS). Results: Eptinezumab (n=238) compared with placebo (n=242) achieved significantly faster headache pain freedom (median 4h vs 9h; hazard ratio=1.54, P=0.0006) and absence of MBS (2h vs 3h; 1.75, P<0.0001). At 2h, 23.5% and 12.0% (P=0.0009) of eptinezumab-treated and placebo patients, respectively, reported headache pain freedom, and 55.5% and 35.8% (P<0.0001) reported absence of MBS. Significantly fewer eptinezumab-treated patients used rescue medication within 24h (31.5% vs 59.9%; P<0.0001). Treatment-emergent adverse events occurred in 10.9% eptinezumab-treated and 10.3% placebo patients; no serious adverse events occurred. Conclusions: Infusion of the preventive migraine treatment, eptinezumab, during a migraine resulted in rapid and sustained freedom from headache pain and MBS vs placebo, starting 2h post-infusion, decreasing need for acute medication within 24h post-infusion. No notable safety findings were identified.

Efficacy and safety of lipegfilgrastim compared with pegfilgrastim in patients with breast cancer who are receiving chemotherapy.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19587-e19587
Author(s):  
Igor Bondarenko ◽  
Oleg Gladkov ◽  
Reiner Elaesser ◽  
Anton Buchner ◽  
Peter Bias
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Adverse Events ◽  
Stage Ii ◽  
Severe Neutropenia ◽  
Study Medication ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Increased Risk

e19587 Background: Cancer chemotherapy frequently causes neutropenia, leading to an increased risk of infections and delays in subsequent chemotherapy treatments. Pegfilgrastim is a pegylated recombinant form of granulocyte colony stimulating factor (G-CSF) that extends the half-life and requires less frequent dosing than nonpegylated G-CSF. Lipegfilgrastim is a glycosylated and pegylated G-CSF. The objective of this study was to compare the efficacy and safety of lipegfilgrastim and pegfilgrastim in chemotherapy-naïve patients with breast cancer who are candidates to receive docetaxel/doxorubicin. Methods: In this double-blind, randomized, active-controlled, noninferiority trial, patients with high-risk stage II, III, or IV breast cancer and an absolute neutrophil count ≥1.5x109 cells/L were randomly assigned to lipegfilgrastim 6 mg (n=101) or pegfilgrastim 6 mg (n=101). Study medication was injected subcutaneously on day 2 of the chemotherapy cycle (4 cycles maximum). Primary efficacy endpoint was the duration of severe neutropenia (days with an absolute neutropenia count <0.5x109 cells/L) during cycle 1. Secondary endpoints included the incidence of febrile neutropenia. Efficacy analysis population included patients who were randomized but did not have major protocol violations. Results: Overall, 37%, 46%, and 17% of patients had stage II, III, and IV breast cancer, respectively. The mean duration of severe neutropenia in cycle 1 was 0.7 days in the lipegfilgrastim group and 0.8 days in the pegfilgrastim group (poisson regression least squares mean [95% CI] -0.218 [-0.498 to 0.062]). 56% and 49%, respectively, did not experience severe neutropenia in cycle 1. Three patients experienced febrile neutropenia; all were in the pegfilgrastim group during cycle 1. 28% of patients in the lipegfilgrastim group and 26% in the pegfilgrastim group had adverse events that the investigator considered to be related to study medication. Three and 7 patients, respectively had serious adverse events. Conclusions: The results of this study confirm that the efficacy of lipegfilgrastim is comparable with pegfilgrastim. No unexpected safety events were observed.

scholarly journals Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

2013 ◽  
Vol 29 (suppl 1) ◽  
pp. s17-s31 ◽  
Author(s):  
Cassyano Januário Correr ◽  
Inajara Rotta ◽  
Thaís de Souza Teles ◽  
Rangel Ray Godoy ◽  
Bruno Salgado Riveros ◽  
...  
Keyword(s):  
Adverse Events ◽  
Meta Analysis ◽  
Biological Agents ◽  
Severe Psoriasis ◽  
Biological Agent ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Short Term ◽  
Serious Adverse Events

We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible.

scholarly journals Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study

2016 ◽  
Vol 44 (2) ◽  
pp. 142-146 ◽  
Author(s):  
Graeme Jones ◽  
Thomas Wallace ◽  
Matthew J. McIntosh ◽  
Laura Brockwell ◽  
Juan J. Gómez-Reino ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Link Type ◽  
Serious Infection ◽  
Tocilizumab Monotherapy ◽  
Safety Signals

Objective.To report on the 5-year efficacy and safety results of the AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy) monotherapy study (ClinicalTrials.gov: NCT00109408, NCT00720798).Methods.Patients with rheumatoid arthritis for whom biologics had not failed or who did not discontinue methotrexate because of lack of efficacy or tolerability were followed up for 5 years to assess the efficacy and serious adverse events (SAE) of tocilizumab (TCZ) monotherapy.Results.Longterm efficacy results showed that efficacy was maintained or improved for up to 264 weeks in patients receiving TCZ monotherapy. Serious infection was the most frequent SAE; no new safety signals were reported.Conclusion.Longterm monotherapy with TCZ demonstrated continuing efficacy and safety.

scholarly journals P732 The clinical efficacy and safety of indigo naturalis in induction & maintenance therapy for moderate-to-severe ulcerative colitis: A single-centre prospective uncontrolled open-label study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S588-S588
Author(s):  
Y Matsuno ◽  
A Hirano ◽  
T Torisu ◽  
Y Fuyuno ◽  
Y Okamoto ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Maintenance Therapy ◽  
Mucosal Healing ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Indigo Naturalis

Abstract Background Recently, several studies have shown the high efficacy of Indigo naturalis (IN) in the induction therapy for ulcerative colitis (UC). However, the efficacy and safety in the maintenance therapy remain unclear. Thus, we performed this prospective study to investigate the efficacy and safety of IN for induction and maintenance therapy in patients with moderate to severe active UC. Methods We conducted a prospective uncontrolled open-label study at Kyushu university hospital. A total of 33 patients with moderate to severe active UC (clinical activity index (CAI) ≥8) received 2 g per day of IN for 52 weeks. We assessed CAI at week 0, 4, 8, 52, and Mayo endoscopic score (MES) was evaluated at weeks 0, 4, 52. We calculated the clinical remission (CAI ≤4) rate and mucosal healing (MES ≤1) rate at each point. Overall adverse events (AEs) during the follow-up were also estimated. Results Clinical remission rates at weeks 4, 8, and 52 were 67%, 76%, and 73%, respectively. Mucosal healing rates at weeks 4 and 52 were 48% and 70%. Seventeen patients experienced adverse events (AEs) during the follow-up. Seven severe AEs, including intussusceptions, acute severe colitis, infectious colitis, portal thrombosis, appendicitis, were observed in 4 patients. Conclusion Our prospective study indicated that IN was a promising option for induction and maintenance therapy in UC. However, possible AEs of IN should be paid attention.

scholarly journals Efficacy and safety of Kami-guibi-tang for mild cognitive impairment: a pilot, randomized, double-blind, placebo-controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hee-Yeon Shin ◽  
Ha-Ri Kim ◽  
Geon-Ho Jahng ◽  
Chul Jin ◽  
Seungwon Kwon ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Placebo Group ◽  
Mild Cognitive Impairment ◽  
Adverse Events ◽  
Vital Signs ◽  
Efficacy And Safety ◽  
Mri Findings ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Abstract Background Mild cognitive impairment (MCI) is considered an intermediate phase between normal aging and dementia. As the majority of cases of amnestic MCI (aMCI) progress to Alzheimer’s disease (AD), it is considered the prodromal stage of AD, and a treatment target for prevention of further cognitive decline. However, no medications have been shown to have symptomatic or preventive benefits in MCI. Kami-guibi-tang (KGT) is a traditional herbal formula used in Korean medicine to treat amnesia, which is reported to increase acetylcholine levels via activation of choline acetyltransferase. The objective of this study was to evaluate the efficacy and safety of KGT in patients with aMCI. Methods This study was designed as a single-center, randomized, double-blind, placebo-controlled pilot study. Participants diagnosed with aMCI were randomized to receive either KGT or placebo granules for 24 weeks. The efficacy measure was a change in the Seoul Neuropsychological Screening Battery (SNSB) score. The safety measures included the occurrence of adverse events and abnormalities in vital signs and blood chemistry, electrocardiogram (ECG), and brain magnetic resonance imaging (MRI) findings. Results A total of 16 patients in the KGT group and 14 patients in the placebo group were investigated in the study. The mean score of Clinical Dementia Rating-Sum of Boxes (CDR-SB) significantly improved from 1.53 (0.64) points to 1.13 (0.62) points in the KGT group (p = 0.010), whereas it worsened from 1.61 (0.88) points to 1.75 (0.94) points in the placebo group. There was a significant difference in the CDR-SB scores between the two groups after the intervention (p = 0.045). The total SNSB-D scores and the scores in the memory domain after the treatment were significantly higher than the baseline values in the KGT group, but not in the placebo group. The frequency of adverse events was not significantly different between the two groups, and there were no abnormalities in vital signs or blood test, ECG, and brain MRI findings after the intervention. Conclusions KGT may provide a safe and effective treatment option for patients with aMCI. Further studies with a larger sample size are needed to validate the findings. Trial registration Korean Clinical Trial Registry, ID: KCT0002407; Registered on March 30, 2017, http://cris.nih.go.kr/

Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer who are receiving chemotherapy.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9125-9125 ◽  
Author(s):  
Constantin D. Volovat ◽  
Oleg Gladkov ◽  
Igor Bondarenko ◽  
Steven Barash ◽  
Anton Buchner ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Adverse Events ◽  
Severe Neutropenia ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Increased Risk ◽  
Long Acting

9125 Background: Patients receiving cancer chemotherapy are at an increased risk of neutropenia. Recombinant granulocyte colony stimulating factors (G-CSFs) have been developed to stimulate proliferation and differentiation of neutrophils. Pegfilgrastim is a pegylated recombinant G-CSF that allows for once-per-cycle dosing. Balugrastim is a long-acting G-CSF composed of a genetic fusion between recombinant human serum albumin and G-CSF. The objective of this study was to compare the efficacy and safety of balugrastim and pegfilgrastim in patients with histologically or cytologically confirmed breast cancer who were scheduled to receive doxorubicin and docetaxel. Methods: In this double-blind, randomized, active-comparator, noninferiority trial, patients with ≥1.5x109 neutrophils/L, and ≥100x109 platelets/L were randomly assigned to subcutaneous injections of balugrastim 40 mg (n=153) or pegfilgrastim 6 mg (n=151) with stratifications for weight, prior chemotherapy exposure, and global location. The primary efficacy endpoint was the duration of severe neutropenia (days with an absolute neutrophil count <0.5x109 cells/L) during the cycle 1 for the population of patients who did not have major protocol violations. Results: Mean duration of severe neutropenia in cycle 1 was 1.1 days in the balugrastim group and 1.0 days in the pegfilgrastim group (95% CI for difference between groups -0.13 to 0.37). Fifty-eight percent of patients in the balugrastim group and 59% in the pegfilgrastim group had severe neutropenia during cycle 1 (95% CI for difference between groups -11.98% to 10.41%). Two and 4 patients, respectively, had febrile neutropenia during cycle 1; no patients in either group had febrile neutropenia during cycles 2-4. Twenty percent of patients in the balugrastim group and 19% in the pegfilgrastim group had adverse events that the investigator considered to be related to study medication. Six and 7 patients, respectively, had serious adverse events. Conclusions: The results of this study support the noninferiority of balugrastim versus pegfilgrastim, demonstrating that both compounds have comparable efficacy. There were no unexpected safety events.

Abstract 4420: Results of A Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of PS433540 in Human Subjects with Hypertension

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Joel M Neutel ◽  
Wilford F Germino ◽  
Henry Punzi ◽  
Mark McBride ◽  
Catherine C Bryson ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Human Subjects ◽  
Antihypertensive Agents ◽  
Epidemiologic Studies ◽  
Controlled Study ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Link Type

Epidemiologic studies continue to demonstrate extremely disappointing blood pressure (BP) control rates. For this reason, the search for more effective antihypertensive agents continues. PS433540 is the first compound in a novel class of agents called Dual Acting Receptor Antagonists (DARA) which selectively block angiotensin (AT 1 ) and endothelin (ET A ) receptors. In this prospective, randomized, double blind, placebo controlled study, 234 men and women with a mean age of 56.0 years entered a 3– 4 week single blind placebo run-in period. Qualifying stage I or stage II hypertensive patients were randomized in a 1:1:1 ratio to either PS433540 200mg, 500mg or matching placebo for a period of 4 weeks. Ambulatory BP monitoring (ABPM) was performed at the start of the study and was repeated at the end of the treatment period. PS433540 lowered both 24HR Systolic BP (SBP) and Diastolic DBP (DBP) as well as mean office SBP and DBP to a greater extent than placebo, p<0.001. (see Table ) PS433540 was well tolerated with 2 reported serious adverse events in the placebo group and placebo lead-in period. Three patients (all from the placebo group) were discontinued from the study for adverse events. There were no significant laboratory abnormalities. This study demonstrates that PS433540 is an effective and well tolerated new class of antihypertensive agent that may prove to be a very important addition to our armamentarium for the management of hypertension.

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