scholarly journals Ursodeoxycholic Acid at 18–22 mg/kg/d Showed a Promising Capacity for Treating Refractory Primary Biliary Cholangitis

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Xinyu Xiang ◽  
Xiaoli Yang ◽  
Mengyi Shen ◽  
Chen Huang ◽  
Yifeng Liu ◽  
...  
Keyword(s):  
Side Effects ◽  
Ursodeoxycholic Acid ◽  
Standard Therapy ◽  
Response Rate ◽  
Standard Dose ◽  
Poor Response ◽  
Primary Biliary Cholangitis ◽  
Dosage Group ◽  
Standard Dosage ◽  
The Uk

Aim. To compare the response between the current recommended dosage 13–15 mg/kg/d and 20 mg/kg/d dose of ursodeoxycholic acid (UDCA) in primary biliary cholangitis (PBC) patients who do not respond completely to a standard dose of UDCA. Methods. We included 73 patients with poor response and randomized them into two groups to investigate whether increasing the dosage of UDCA was beneficial to nonresponders. Patients assigned to the 13–15 mg/kg/d group continued with standard therapy, and participants in the 18–22 mg/kg/d group switched to the higher dosage (18–22 mg/kg/d), with a follow-up of 12 months for both groups. The primary endpoints were the rate of response at 6 months and drug side effects. Results. According to the Paris 2 criteria, patients receiving 18–22 mg/kg/d UDCA achieved a response rate of 59.4% compared with 36.1% in the standard dosage group ( P = 0.046 ) at 6 months, respectively. At 12 months, the high-UDCA-dosage group achieved a response rate of 59.4% compared with 47.2% in the standard dosage group ( P = 0.295 ), respectively. Additionally, the risk score predicted by the UK-PBC model was lower in high-dosage UDCA-treated patients than in the standard dosage group (all P < 0.05 ). Side effects include diarrhea, nausea and vomiting, rash, and newly developed high blood pressure, which were mild and tolerated. Conclusions. Patients treated with the high UDCA dosage showed some advantages over those who continued the standard dosage in terms of biochemical remission and disease progression, indicating that standard therapy with UDCA for 6 months and then another 1 year with high UDCA dosage for nonresponders could be a treatment option before second-line therapy is recommended.

AB0578 LONG-TERM TOLERABILITY OF AMINAPHTONE IN A COHORT OF SYSTEMIC SCLEROSIS PATIENTS IN CONCOMITANT STANDARD THERAPY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1585.1-1586
Author(s):  
E. Gotelli ◽  
S. Paolino ◽  
F. Goegan ◽  
F. Cattelan ◽  
M. Patanè ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Side Effects ◽  
Standard Therapy ◽  
Control Group ◽  
Placebo Control ◽  
Research Support ◽  
Standard Dosage ◽  
Blood Tests ◽  
Term Tolerability

Background:Aminaphtone (AMI) is a bioflavonoid compound, classically used for “capillary disorders”.In vitroAMI interferes with adhesion molecules (sELAM-1 and sVCAM-1) and with vascular endothelial cadherin degradation thus defending vessels permeability. Moreover, it counteracts vasoconstriction, downregulating endothelin-1 production at a gene level (1-3).In vivoAMI ameliorates clinical symptoms of several clinical conditions, above all Raynaud’s phenomenon (RP), either primary or secondary to systemic sclerosis (SSc), as demonstrated by a recent six-month study (4).Objectives:To evaluate long-term tolerability of standard dosage of AMI in a real-life cohort of SSc patients with secondary RP.Methods:Seventy-eight SSc patients (mean age 65±13 years; mean disease duration 9±7 years) treated with AMI due to active RP were enrolled (ACR/EULAR 2013 criteria). They were taking various concomitant treatments, including aspirin, calcium-channel blockers, cyclic intravenous iloprost, immunomodulators, endothelin receptor antagonists. SSc patients performed periodic clinical assessments and blood tests on average every four months per clinical practice. Duration of AMI administration, side effects, and self-assessment of Raynaud Condition Score (RCS) in a scale from 0 (absence of pain) to 10 (intolerable pain) were retrospectively taken into account.Results:Duration of AMI administration was between six and sixty-seven months (mean 31±20 months). AMI was administered at 75 mgbis in diedosage, as standard initial posology. At baseline, mean RCS was 7.3±0.8. After 3 months of treatment sixty-four patients (82%) yet referred a subjective improvement of RCS (3.5±0.8, p=0.03), whereas 14 patients (18%) were clinically unsatisfied (RCS 6.1±0.4, p=1.12). In this last group, posology was increased to 75 mgtris in die, with a satisfactory amelioration in further nine patients (93,6%) (RCS 4.0±0.6 p=0.04), while five patients (6,4%) definitively discontinued therapy for subjective ineffectiveness within six months. Patients referred a sustained improvement of RCS along the observational period (31±20 months) (last RCS 3.7±0.7, p=0.03 vs baseline). During the follow-up, five patients (6,4%) referred headache as side effect: three of them had to reduce AMI posology to 75 mg per day, while maintaining clinical benefits. Periodic blood tests did not reveal any significant alteration attributable to AMI. No other side effects related to the drug appeared during the treatment period.Conclusion:AMI shows an acceptable medium-long-term tolerability along with sustained efficacy in the management of SSc-related RP, without disabling side effects. However, the retrospective design, the absence of a placebo-control group and the concomitant standard therapy limit the results, and a randomized controlled trial for AMI use in the management of SSc-related RP is desirable.References:[1]Scorza R et al. 2008.Clin Ther30(5):924-9.[2]Felice F et al. 2018.Phlebology33(9):592-599.[3]Scorza R et al. 2008.Drugs R D9(4):251-7.[4]Ruaro B et al. 2019.Front Pharmacol10:293.Disclosure of Interests:Emanuele Gotelli: None declared, Sabrina Paolino: None declared, Federica Goegan: None declared, Francesco Cattelan: None declared, Massimo Patanè: None declared, Carmen Pizzorni: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Alberto Sulli Grant/research support from: Laboratori Baldacci

Worse Response to Ursodeoxycholic Acid in Primary Biliary Cholangitis Patients with Autoimmune Hepatitis Features

2020 ◽  
Author(s):  
Maoyao Wen ◽  
Ruoting Men ◽  
Xiaoli Fan ◽  
Yi Shen ◽  
Ping Ni ◽  
...  
Keyword(s):  
Autoimmune Hepatitis ◽  
Ursodeoxycholic Acid ◽  
Total Bilirubin ◽  
Response Rate ◽  
Immunosuppressive Agents ◽  
Biochemical Response ◽  
Primary Biliary Cholangitis ◽  
Lower Response Rate ◽  
One Year ◽  
Glutamyl Transpeptidase

Background: There is limited evidence on the treatment response of primary biliary cholangitis (PBC) with autoimmune hepatitis (AIH) features but not meet the criteria of PBC-AIH syndromes. This study was to elucidate the clinical characteristics of PBC patients with features of AIH. Methods: We included patients with diagnostic criteria of PBC. All patients were treated with ursodeoxycholic acid (UDCA) and without immunosuppressive agents for more than one year. The biochemical response was evaluated at one year after treatment of UCDA. Results: Among 432 patients with PBC, 166 (38.4%) patients did not achieve biochemical response within one year of UDCA treatment. Non-responders had lower albumin (ALB) level and higher immunoglobulin G (IgG), alanine transaminase (ALT), alanine aminotransferase (AST), alkaline phosphatase (ALP), glutamyl transpeptidase (GGT) and total bilirubin (TB) levels (P < 0.05). The response rates were significantly lower in patients with elevated level of IgG or ALT or AST. Moreover, the higher the IgG or AST level was, the lower the response rate was in patients with PBC regardless of cirrhosis. For patients with cirrhosis, there was no differences among patients with different level of ALT. Patients in the PBC with AIH features group had a significant lower response rate than patients in the PBC-only group. Among the 139 patients who underwent liver biopsy, 54 were non-responsive to UDCA and 48 (88.9%) shown mild interface hepatitis. Conclusion: In conclusion, PBC patients with AIH features had a worse response to UDCA therapy.

scholarly journals Obeticholic acid—a new therapy in PBC and NASH

2020 ◽  
Vol 133 (1) ◽  
pp. 95-104 ◽  
Author(s):  
Roger W Chapman ◽  
Kate D Lynch
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Ursodeoxycholic Acid ◽  
Farnesoid X Receptor ◽  
Primary Biliary Cholangitis ◽  
Second Line ◽  
Obeticholic Acid ◽  
Second Line Therapy ◽  
Line Therapy

Abstract Introduction Obeticholic acid (OCA) is a semi-synthetic hydrophobic bile acid (BA) analogue that is highly selective agonist of farnesoid X receptor (FXR), a key nuclear BA receptor, which induces expression of gut-derived hormones, in particular fibroblast growth factor 19. The resulting beneficial effects of OCA on glucose and lipid metabolism and particularly hepatic inflammation make it a candidate for the treatment of a variety of conditions including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Sources of data In PBC patients who have not initially responded to ursodeoxycholic acid, OCA has been shown in double-blind controlled clinical trials to significantly reduce serum alkaline phosphatase. To date, OCA is the only therapy licensed by the FDA, EMA and endorsed by NICE as second line therapy for PBC. No medications are currently approved in Europe or the USA for the treatment of NASH. In recent clinical trials, OCA has been shown encouraging results by improving liver blood tests and reducing liver fibrosis with no worsening of NASH. Areas of agreement OCA is the established second line therapy for PBC in those patients who fail to adequately respond to ursodeoxycholic acid. Areas of controversy The main side effects of OCA treatment in both PBC and NASH is that of dose-dependent pruritis which can lead to treatment discontinuation in ~1–10% of patients. In addition, OCA-treated patients may also exhibit (reversible) alterations in serum lipid levels; most notably a small decrease in high density lipoprotein cholesterol. It is not yet known whether these changes carry a long-term cardiovascular risk in NASH. In addition, the relatively high cost of OCA may limit its use in cash-limited health systems. Growing Points Additional clinical trials are in progress to ascertain the long-term effects of OCA on survival in PBC and NASH. Areas timely for developing research New FXR agonists with a lower rate of side effects are being developed and trialed. Combination therapy with other agents may offer increased efficacy.

scholarly journals Successful Treatment of Intralesional Bleomycin in Keloids of Vietnamese Population

2019 ◽  
Vol 7 (2) ◽  
pp. 298-299 ◽  
Author(s):  
Nghi Dinh Huu ◽  
Sau Nguyen Huu ◽  
Xuan Le Thi ◽  
Thuong Nguyen Van ◽  
Phuong Pham Thi Minh ◽  
...  
Keyword(s):  
Side Effects ◽  
High Risk ◽  
Successful Treatment ◽  
Response Rate ◽  
Poor Response ◽  
The Poor ◽  
Vietnamese Population ◽  
Systemic Side Effects ◽  
Lesion Treatment ◽  
Local Side

BACKGROUND: Keloid is an overactive condition of the skin tissue to early lesions characterised by proliferation of fibroblasts, excessive collagen production in the lesion. Treatment of keloids is a big challenge because of the poor response rate and high risk of recurrence after treatment. We found that bleomycin offers promise in the treatment of keloids. AIM: To evaluate the efficacy of bleomycin injected in the injury for keloids treatment. METHODS: The treatment was carried out in 55 patients having 120 keloids of different sizes and locations. Average treatments were 4 times. RESULTS: Complete flattening was 70.8%, highly significant flattening was 8.3%, no patient of minimal flattening. Systemic side-effects of bleomycin were not evaluated, but local side-effects were mainly pains (100%), blisters (78.3%), ulceration (5.8%), and hyperpigmentation (56.7%). CONCLUSION: The percentage of patients recurring 6, 12, 15, 18 months after the last treatment were 3.8, 15.4, 45.5, 50%, respectively.

scholarly journals Primary Biliary Cholangitis: Predictors of Poor Response to Ursodeoxycholic Acid after 1 Year of Treatment in Moroccan Patients

2021 ◽  
pp. 990-995
Author(s):  
Hakima Abid ◽  
Inssaf Akoch ◽  
Maria Lahlali ◽  
Nada Lahmidani ◽  
Mounia El Yousfi ◽  
...  
Keyword(s):  
Ursodeoxycholic Acid ◽  
Biological Response ◽  
Poor Response ◽  
Overlap Syndrome ◽  
Response To Therapy ◽  
Response To Treatment ◽  
Decompensated Cirrhosis ◽  
Primary Biliary Cholangitis ◽  
Biliary Cirrhosis ◽  
Average Value

Introduction: Primary biliary cholangitis (PBC), the new dominance of primary biliary cirrhosis, is a cholestatic disease of autoimmune etiology and represents the leading cause of intra-hepatic cholestasis. Treatment is mainly based on ursodeoxycholic acid. The biological response to treatment is the main predictor of survival without liver transplantation. The Globe-score has been recently validated as the main prognostic factor. Materials and methods: This is a retrospective study carried out in our department collating all cases of PBC followed in consultation. The aim of our work is to research the predictors of poor response to UDCA. Results: 46 patients were collected. The mean age of the patients was 58.82 years, with a predominance of women (n = 43, 93.5%). 34.78% of patients were in the stage of cirrhosis. Anti-M2 mitochondria antibodies were positive in 44 patients (95.65%). An overlap syndrome was found in 11 patients (23.9%). Treatment was based on UDCA combined with corticosteroid therapy and immunosuppressant for overlap syndrome. A biochemical response at 1 year of treatment according to the Paris II criteria was found in 47.8%. The average value of the globe score was 1.35. A score greater than 0.30 was objectified in 20 cases (43.47%). Nineteen cirrhotic patients (41.30%) had a globe score> 0.30. Factors associated with poor response to therapy were: stage of decompensated cirrhosis, elevated pre-therapy total bilirubin greater than 30 g / l and hypoalbunemia less than 35 g / l. The study of the correlation between Globe score and Paris II showed a strong and significant association with a correlation coefficient estimated at 67%. The Paris II score was significantly correlated with the response to treatment (p = 0.001). Conclusion: In accordance with the data in the literature, the globe-score and Paris II are two similar predictive means for evaluating the response at 1 year of treatment in Moroccan context. Keywords: Morocco, Predictors of response, Primary biliary cholangitis, Ursodeoxycholic acid

scholarly journals Effect of S-Adenosyl-L-Methionine on Liver Biochemistry and Quality of Life in Patients with Primary Biliary Cholangitis Treated with Ursodeoxycholic Acid. A Prospective, Open Label Pilot Study

2018 ◽  
Vol 27 (3) ◽  
pp. 273-279 ◽  
Author(s):  
Ewa Wunsch ◽  
Joanna Raszeja-Wyszomirska ◽  
Olivier Barbier ◽  
Malgorzata Milkiewicz ◽  
Marcin Krawczyk ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Ursodeoxycholic Acid ◽  
Group Treatment ◽  
Standard Dose ◽  
Serum Levels ◽  
Primary Biliary Cholangitis ◽  
Open Label ◽  
Cirrhotic Patients

Background & Aims: Chronic liver disease induces an acquired deficiency of S-adenosyl-L-methionine (SAMe) leading to impairment of detoxifying processes in the liver. Ursodeoxycholic acid (UDCA) represents the standard treatment in primary biliary cholangitis (PBC). As both compounds exert their hepatoprotective effects by different mechanisms, it is conceivable that when used together their effect might be additive. The aim of this study was to analyse the effect of SAMe supplementation on liver biochemistry and health-related quality of life (HRQoL) in patients with PBC, treated with UDCA. Methods. In this prospective pilot, proof of the principle, non-randomized and open label study we enrolled 24 patients with PBC treated with UDCA for at least 6 months. They had received both UDCA in a standard dose of 13-15 mg/kg b.w. and SAMe in the dose of 1200 mg daily over a period of 6 months. A group of 24 patients with PBC treated with UDCA served as control for liver biochemistry (Study registered on the platform ClinicalTrials.gov under ID: NCT02557360). Results. We observed a significant decrease of ALP, GGT and total cholesterol in non-cirrhotic patients treated with SAMe. There was also a significant improvement of fatigue and pruritus in PBC-40 questionnaire and amelioration of anxiety in STAI 2 questionnaire in the SAMe group. Treatment with SAMe neither increased sulfation capacity of the liver nor had an effect on fibroblast growth factor-19 serum levels. Conclusions. Our pilot study demonstrates a positive effect of adding SAMe to UDCA in non-cirrhotic patients with PBC.

scholarly journals Use of atypical antipsychotics by consultant psychiatrists working in forensic settings

2002 ◽  
Vol 26 (5) ◽  
pp. 172-174 ◽  
Author(s):  
Carol Paton ◽  
Jose A. Garcia ◽  
Deborah Brooke
Keyword(s):  
Side Effects ◽  
Serum Level ◽  
Atypical Antipsychotics ◽  
Response Rate ◽  
Postal Questionnaire ◽  
Clinical Implications ◽  
Forensic Patients ◽  
The Uk ◽  
Level Monitoring ◽  
Typical And Atypical Antipsychotics

AIMS AND METHODAtypical antipsychotics have less neurological side-effects than the older drugs but are only available as oral preparations. This may limit their use in forensic patients. We sent a postal questionnaire to all consultant psychiatrists working in forensic settings in the UK to determine their views.RESULTSThe response rate was 60%. Respondents tended to overestimate the benefits and underestimate the side-effects of the atypical antipsychotics. The majority often prescribed atypical antipsychotics and depots together. Psychoeducation and serum level monitoring were used to optimise/monitor compliance by 50%.CLINICAL IMPLICATIONSUsing atypical antipsychotics as monotherapy is problematic in forensic settings. The extent of polypharmacy means that patients may experience the side-effects of both typical and atypical antipsychotics. More could be done to facilitate and monitor compliance.

Efficacy and safety of oral dapsone in acne vulgaris – experience of a tertiary care teaching hospital in central Lahore

2020 ◽  
Vol 14 (2) ◽  
pp. 87-90
Author(s):  
Sadaf Amin Chaudhry ◽  
Nadia Ali Zafar ◽  
Rabia Hayat ◽  
Ayesha Noreen ◽  
Gulnaz Ali ◽  
...  
Keyword(s):  
Side Effects ◽  
Therapeutic Option ◽  
Acne Vulgaris ◽  
Treatment Options ◽  
Tertiary Care ◽  
Poor Response ◽  
Global Assessment Scale ◽  
Severe Acne ◽  
Hematologic Profile

Background: Acne is the eighth most prevalent disease affecting 9.4% of the population worldwide and its prevalence in our country is estimated to be around 5%. Severe inflammatory acne is most likely to leave scars and in order to prevent facial disfigurement due to acne scarring, early treatment is desirable. Various treatment options have been formulated for acne, and are tailored according to the severity of the disease. Numerous clinical trials have been conducted till now, to determine the usefulness and side effect profile of such therapies, making acne treatment a highly studied area in dermatology. Objective of this study is to highlight the fact that oral Dapsone could be used as a cheaper alternate to isotretinoin in recalcitrant severe acne, especially in females where retinoids are sometimes contraindicated. Patients and methods: 51 patients, suffering from severe nodulocystic acne, fulfilling the criteria, were enrolled from the Department of Dermatology, Sir Ganga Ram Hospital, Lahore. All the study patients were given oral Dapsone 50mg for initial two weeks and then 100mg daily for the next 10 weeks along with oral cimetidine and topical clindamycin application twice daily. Investigator Global Assessment Scale (IGAS) was employed to measure effectiveness. The treatment was considered ʽeffectiveʹ if the patient achieves 2 or more than 2-grade improvement or almost clear or clear skin at the end of 12 weeks according to IGAS scale. The lesion counts were also done before the start of therapy (day 1) and at every two weeks follow up for 12 weeks. The change in lesion count observed between the baseline number and that seen at follow up visits was also used to evaluate the effectiveness of oral Dapsone. Safety was analyzed by fortnightly visits of the patients to look for any undesirable side effects and monitoring of the hematologic profile of the patients. Final follow up was done at the end of 16 weeks. Results: The study was conducted on 51 patients, with a ratio of 1:3 for males and females and a mean age of 25.2 years (SD ±5.81). At 12th week, patients had significant reduction in their acne lesions; with 7 patients (13.7%) showing completely clear skin, 17 patients (33.3%) had almost clear skin, 5 patients (9.8%) had 3-grade improvement. Twelve patients (23.5%) had 2-grade improvement from baseline score and only 2 patients (3.9%) had 1-grade improvement from baseline. Based on percentage reduction of lesions, excellent response was seen in 32 patients (62.7%), good response in 9 patients (17.6%), moderate response in 2 patients (3.9%), while no patient showed poor response. Dapsone was discontinued in 8 patients due to derangement of hematologic profile. Conclusion: Oral Dapsone, when given carefully, is a very effective therapeutic option in severe recalcitrant acne, with limited side effects.

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