scholarly journals P0331ASSESSMENT OF DELIVERY OF NICE APPROVED USE OF TOLVAPTAN (JINARC) IN ADULTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE IN A UK RENAL CENTRE

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Aaron Acquaye ◽  
Kate Naylor ◽  
Sunil Bhandari
Keyword(s):  
Side Effects ◽  
Liver Enzymes ◽  
Retention Rate ◽  
Pressure Control ◽  
Lifestyle Changes ◽  
University Teaching ◽  
Initial Assessment ◽  
Teaching Hospitals ◽  
Duration Of Treatment ◽  
Tract Infections

Abstract Background and Aims Until recently, the management of ADPKD has largely been limited to lifestyle changes (smoking cessation, salt avoidance and diet with weight loss) and tight blood pressure control, in addition to kidney pain management and prompt treatment of complications such as infections. The approval of Tolvaptan, a highly selective vasopressin V2 receptor antagonist, by NICE, following the pivotal TEMPO 3:4 trial provides clinicians with an opportunity to modify the progression of ADPKD and preserve kidney function. Tolvaptan works by slowing cyst growth patients with ADPKD (and therefore potentially reducing kidney pain, urinary tract infections and haematuria). During the TEMPO 3:4 trial, a reversible elevation (> 3X upper limit) of liver enzymes was observed in 4.4% patients taking tolvaptan vs 1% on placebo. The onset of liver injury was between 3 – 14 months of initiation of tolvaptan; therefore, monthly blood tests are required to mitigate the potential injury associated with the increase in liver enzymes. The main side effects are polyuria and thirst. The aims for the audit were Method We carried out a prospective questionnaire-based study on all patients who were on tolvaptan therapy. All patients received a comprehensive explanation of the merits and side-effects of Tolvaptan with written literature and a copy of their initial assessment consultation prior to commencement of therapy. In addition, we reviewed patients’ clinic attendances, relevant biochemical results and liver function test as per licence agreement tolvaptan therapy. This was approved by the Hull University Teaching Hospitals (HUTH) NHS Trust Audit department with a signed Clinical Governance Form 1. Results In total, 27 patients, consisting of 18 males and 9 females [mean age 44.5yrs] and all Caucasian on tolvaptan therapy were evaluated. The median duration of treatment was 10months. Two patients [7.4%] dropped out of treatment: one patient opted out of treatment due to the polyuria interfering with his job requirements and the other had relocated to another country; giving HUTH a retention rate of 92.6%. 55.5% of patients responded to not having missed a dose of drug at any time at any time despite a significant number experiencing side-affects (Figure1). Some purposely missed medication due to a social event. Although 100% of patients did respond to experiencing side effects of tolvaptan, 74% of patients said it did not interfere with their quality of life. 88.8% of patients were on the full dose of 90mg in the morning and 30mg after 8 hours. The Tolvaptan clinic in HUTH is run as a pharmacist led with consultant oversight. Currently no issues have arisen but the patients’ view of a pharmacist led-clinic is currently being studied. Conclusion This study demonstrates that despite a number of expected side-affects; with good patient education and follow-up, few patients stopped therapy and most patients remain compliant to tolvaptan therapy. Currently a pharmacist led, consultant backed tolvaptan clinic has not adversely affected this success.

scholarly journals P272 How well are conventional DMARDs tolerated in PsA: a real-world study

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Issrah Jawad ◽  
Muhammad K Nisar
Keyword(s):  
Side Effects ◽  
Real World ◽  
Retention Rate ◽  
Cost Effective ◽  
University Teaching ◽  
Duration Of Treatment ◽  
Real World Data ◽  
Nice Guidelines ◽  
Gi Symptoms ◽  
Conventional Dmards

Abstract Background NICE guidelines recommend the first line use of DMARDs in psoriatic arthritis (PsA). However, studies show that many conventional treatments like methotrexate are poorly tolerated. There is hitherto no published real-world data addressing the tolerability of DMARDs in PsA. Our objective was therefore to assess the drug management in PsA with focus on tolerability and the reasons for therapy cessation. Methods We conducted a retrospective analysis of all PsA patients enrolled in electronic database up to April 2019 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease management. Results 335 patients were identified with a formal diagnosis of PsA. Mean age of the cohort was 46 years (13-81) and 58% were female. 9% of the individuals had diabetes and 18% had concurrent cardiovascular disease. 1/10th reported to be current smokers and 8% had a diagnosis of depression. 48% of the group had clinically active disease. Same percentage were taking a single DMARD. 10% had trialled 3 or more drugs. 62% of patients had discontinued one or more DMARDs prior. The mean duration before discontinuing a DMARD was 9.9 months. Methotrexate was the best tolerated and on average discontinued after 13.4 months (range: 4 days to 10.9 years). Sulfasalazine and hydroxychloroquine were discontinued after an average of 8.4 (11 days to 4.27 years) and 12.5 months (1.3 months to 2.88 years) respectively. Leflunomide was the least tolerated DMARD and stopped after an average of 5.5 months (7 days to 2.53 years). The main reason for stopping a medication was gastro-intestinal symptoms which accounted for 42% of all the reported side effects. This applied to both methotrexate (43%) and sulfasalazine (46%) discontinuation. The leading reasons for discontinuing hydroxychloroquine were jointly GI symptoms and other side effects at 43% each. Leflunomide was stopped in 50% of cases due to neurological symptoms. Conclusion To our knowledge, this is the first report confirming poor retention rate of oral DMARDs in a real world PsA cohort managed over 20 years. In the context of chronic disease, the median duration of treatment is short. Our analysis did not include patients who suffer from side effects but continue therapy thereby impacting treatment adherence and hence the true scale of the issue is likely higher. Though NICE guidelines stipulate the need of an adequate trial of minimum two DMARDs prior to therapy escalation, these drugs are not well tolerated and thus pose a challenge to clinicians. One potential solution is earlier adoption of biological therapies, which are increasingly cost effective and have been shown to be better tolerated. Disclosures I. Jawad None. M.K. Nisar None.

scholarly journals AB0810 IMPACT OF TOLERABILITY ON RETENTION OF cDMARDs IN PSORIATIC ARTHRITIS - IS IT A CONCERN?

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1706.2-1707
Author(s):  
I. Jawad ◽  
M. K. Nisar
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Side Effects ◽  
Real World ◽  
Retention Rate ◽  
Cost Effective ◽  
University Teaching ◽  
Duration Of Treatment ◽  
Real World Data ◽  
Gi Symptoms

Background:Most guidelines recommend the first line use of DMARDs in Psoriatic Arthritis (PsA). However, studies show that many conventional treatments like methotrexate are poorly tolerated. There is hitherto no published real-world data addressing the tolerability of DMARDs in PsA.Objectives:Our objective was therefore to assess the drug management in PsA with focus on tolerability and the reasons for therapy cessation.Methods:We conducted a retrospective analysis of all PsA patients enrolled in electronic database up to April 2019 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease managementResults:335 patients were identified with a formal diagnosis of PsA. Mean age of the cohort was 46 years (13-81) and 58% were female. 48% of the group had clinically active disease. Same percentage were taking a single DMARD. 10% had trialled 3 or more drugs. 62% of patients had discontinued one or more DMARDs prior. The mean duration before discontinuing a DMARD was 9.9 months. Methotrexate was the best tolerated and on average discontinued after 13.4 months (range: 4 days to 10.9 years). Sulfasalazine and Hydroxychloroquine were discontinued after an average of 8.4 (11 days to 4.27 years) and 12.5 months (1.3 months to 2.88 years) respectively. Leflunomide was the least tolerated DMARD and stopped after an average of 5.5 months (7 days to 2.53 years). The main reason for stopping a medication was gastro-intestinal symptoms which accounted for 42% of all the reported side effects. This applied to both methotrexate (43%) and sulfasalazine (46%) discontinuation. The leading reasons for discontinuing Hydroxychloroquine were jointly GI symptoms and other side effects at 43% each. Leflunomide was stopped in 50% of cases due to neurological symptoms.Conclusion:To our knowledge, this is the first report confirming poor retention rate of oral DMARDs in a real world PsA cohort managed over 20 years. In the context of chronic disease, the median duration of treatment is short. Our analysis did not include patients who suffer from side effects but continue therapy thereby impacting treatment adherence and hence the true scale of the issue is likely higher. Though NICE guidelines stipulate the need of an adequate trial of minimum two DMARDs prior to therapy escalation, in reality these drugs are not well tolerated and thus pose a challenge to clinicians. One potential solution is earlier adoption of biological therapies, which are increasingly cost effective and have been shown to be better tolerated.Disclosure of Interests:Issrah Jawad: None declared, Muhammad Khurram Nisar Grant/research support from: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Consultant of: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Speakers bureau: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB

scholarly journals Heterogeneity of Antibiotics Multidrug-Resistance Profile of Uropathogens in Romanian Population

Antibiotics ◽  
2021 ◽  
Vol 10 (5) ◽  
pp. 523
Author(s):  
Răzvan-Cosmin Petca ◽  
Silvius Negoiță ◽  
Cristian Mareș ◽  
Aida Petca ◽  
Răzvan-Ionuț Popescu ◽  
...  
Keyword(s):  
General Medicine ◽  
Multidrug Resistant ◽  
University Teaching ◽  
Teaching Hospitals ◽  
Resistant Bacteria ◽  
Multiple Drug ◽  
Drug Resistant ◽  
Amoxicillin Clavulanate ◽  
Romanian Population ◽  
Tract Infections

Urinary tract infections (UTIs) are a leading cause of morbidity for both males and females. The overconsumption of antibiotics in general medicine, veterinary, or agriculture has led to a spike in drug-resistant microorganisms; obtaining standardized results is imposed by standard definitions for various categories of drug-resistant bacteria—such as multiple-drug resistant (MDR), extensive drug-resistant (XDR), and pan drug-resistant (PDR). This retrospective study conducted in three university teaching hospitals in Romania has analyzed urine probes from 15,231 patients, of which 698 (4.58%) presented multidrug-resistant strains. Escherichia coli was the leading uropathogen 283 (40.54%), presenting the highest resistance to quinolones (R = 72.08%) and penicillin (R = 66.78%) with the most important patterns of resistance for penicillin, sulfonamides, and quinolones (12.01%) and aminoglycosides, aztreonam, cephalosporins, and quinolones (9,89%). Klebsiella spp. followed—260 (37.24%) with the highest resistance to amoxicillin-clavulanate (R = 94.61%) and cephalosporins (R = 94.23%); the leading patterns were observed for aminoglycosides, aminopenicillins + β-lactams inhibitor, sulfonamides, and cephalosporins (12.69%) and aminoglycosides, aztreonam, cephalosporins, quinolones (9.23%). The insufficient research of MDR strains on the Romanian population is promoting these findings as an important tool for any clinician treating MDR-UTIs.

scholarly journals Sexual risk behaviour in a cohort of HIV-negative and HIV-positive Rwandan women

2018 ◽  
Vol 147 ◽  
Author(s):  
M. F. Mukanyangezi ◽  
O. Manzi ◽  
G. Tobin ◽  
S. Rulisa ◽  
E. Bienvenu ◽  
...  
Keyword(s):  
Sexual Risk ◽  
Reproductive Tract ◽  
Risk Behaviour ◽  
University Teaching ◽  
Teaching Hospitals ◽  
Death Sentence ◽  
Sexual Risk Behaviour ◽  
Reproductive Tract Infections ◽  
Hiv Women ◽  
Tract Infections

AbstractHere we wanted to assess whether sexual risk behaviour differs dependent by human immunodeficiency virus (HIV) status by following 100 HIV− and 137 HIV+ women recruited at two university teaching hospitals in Rwanda. Women were tested for sexually transmitted infections (STIs; trichomoniasis, syphilis, hepatitis B and C) and for reproductive tract infections (RTIs; candidiasis, bacterial vaginosis (BV)) and were interviewed at baseline and 9 months later. BV was the most prevalent infection, while syphilis was the most common STI with a 9-month incidence of 10.9% in HIV+ women. Only 24.5% of women positive for any RTI/STI contacted their health facility and got treatment. More HIV− women than HIV+ women had had more than one sexual partner and never used condoms during the follow-up period. The use of condoms was affected neither by marital status nor by concomitant STIs besides HIV. Our data highlight the importance of public education regarding condom use to protect against STIs in an era when HIV no longer is a death sentence.

scholarly journals TNF-Alpha Inhibitors for Chronic Urticaria: Experience in 20 Patients

2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Freja Lærke Sand ◽  
Simon Francis Thomsen
Keyword(s):  
Side Effects ◽  
Chronic Urticaria ◽  
Treatment Options ◽  
Significant Proportion ◽  
Response Duration ◽  
Immunosuppressive Drugs ◽  
Tnf Alpha ◽  
High Dose ◽  
Duration Of Treatment ◽  
Durable Response

Patients with severe chronic urticaria may not respond to antihistamines, and other systemic treatment options may either be ineffective or associated with unacceptable side effects. We present data on efficacy and safety of adalimumab and etanercept in 20 adult patients with chronic urticaria. Twelve (60%) patients obtained complete or almost complete resolution of urticaria after onset of therapy with either adalimumab or etanercept. Further three patients (15%) experienced partial response. Duration of treatment ranged between 2 and 39 months. Those responding completely or almost completely had a durable response with a mean of 11 months. Six patients (30%) experienced side effects and five patients had mild recurrent upper respiratory infections, whereas one patient experienced severe CNS toxicity that could be related to treatment with TNF-alpha inhibitor. Adalimumab and etanercept may be effective and relatively safe treatment options in a significant proportion of patients with chronic urticaria who do not respond sufficiently to high-dose antihistamines or in whom standard immunosuppressive drugs are ineffective or associated with unacceptable side effects.

scholarly journals Mesalazine (5-aminosalicylic acid) induced chronic hepatitis

Gut ◽  
1999 ◽  
Vol 44 (6) ◽  
pp. 886-888 ◽  
Author(s):  
P Deltenre ◽  
A Berson ◽  
P Marcellin ◽  
C Degott ◽  
M Biour ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Side Effects ◽  
Adverse Effects ◽  
Liver Dysfunction ◽  
Liver Enzymes ◽  
Slow Release ◽  
Aminosalicylic Acid ◽  
Safe Alternative ◽  
Release Formulation ◽  
Slow Release Formulation

BACKGROUNDTreatment of ulcerative colitis or Crohn’s disease with sulphasalazine causes several adverse effects, including hepatitis. Sulphasalazine is cleaved by colonic bacteria into 5-aminosalicylic acid and sulphapyridine. Received wisdom was that 5-aminosalicylic acid was topically active, whereas sulphapyridine was absorbed and caused immunoallergic side effects. Mesalazine, a slow release formulation of 5-aminosalicylic acid, was expected to be a safe alternative. However, several cases of acute hepatitis have been reported.CASE REPORTA 65 year old man had increased liver enzymes, anti-nuclear and anti-smooth muscle autoantibodies and IgG levels, and lesions of chronic hepatitis after 21 months of mesalazine treatment. Although liver dysfunction had been identified eight months earlier, simvastatin rather than mesalazine had been withdrawn, without any improvement. In contrast, liver enzyme and IgG levels became normal and autoantibodies disappeared after discontinuation of mesalazine administration.CONCLUSIONContrary to initial expectations, mesalazine can cause most of the sulphasalazine induced adverse effects, and hepatic side effects may be almost as frequent. When liver dysfunction occurs, mesalazine administration should be discontinued to avoid the development of chronic hepatitis and liver fibrosis.

Ampicillin-Associated Diarrhea: Effect of Dosage and Route of Administration

PEDIATRICS ◽  
1976 ◽  
Vol 58 (6) ◽  
pp. 869-872
Author(s):  
John A. Phillips ◽  
Frederick H. Lovejoy ◽  
Yoichi Matsumiya
Keyword(s):  
Urinary Tract ◽  
Side Effects ◽  
High Dose ◽  
Total Dosage ◽  
Pediatric Practice ◽  
Severe Diarrhea ◽  
Bowel Movements ◽  
Gastrointestinal Side Effects ◽  
Tract Infections ◽  
Mild Diarrhea

Ampicillin is one of the most frequently used antibiotics in pediatric practice.1 Its clinical efficacy has been widely studied, but its gastrointestinal side effects are poorly documented. In adults with urinary tract infections, 11% taking 1 gm/day of ampicillin orally had bowel movements which were at least twice as frequent as normal.2 Another series in adults receiving ampicillin reported an increase in stools with 16% having ≤5 and 5% having ≥5 stools per day. The change in stools increased with total dosage and was equal after oral or intravenous administration.3 In children, ampicillin ranging from 50 to the unusually high dose of 200 mg/kg/day resulted in mild diarrhea (≤5 stools per day) in 18% to 30%, moderate diarrhea (5 to 10 stools per day) in 2% to 11%, and severe diarrhea (≥10 stools per day) in 1% or less of cases.

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