scholarly journals Real-World Clinical Experience with SGLT2 Inhibitors: Use of Special Screening Tool for Type 2 Diabetes Patients to Avoid Serious Adverse Events: A Single-Centre Prospective Study

2020 ◽  
Vol 26 (1) ◽  
pp. 38-43
Author(s):  
Vishwa B. Unadkat ◽  
Sandeep Sharma ◽  
Ruchi Omar
Keyword(s):  
Adverse Effect ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Adverse Events ◽  
Real World ◽  
Common Adverse Effect ◽  
Sglt2 Inhibitors ◽  
Serious Adverse Events ◽  
Screening Protocol ◽  
Simple Screening

<b><i>Background:</i></b> Promising results of clinical trials involving SGLT2 inhibitors urge every clinician managing diabetes to use them. However, upcoming real-world data still show increased incidence of adverse events, but efficacy is comparable to clinical trials. <b><i>Objectives:</i></b> Genitourinary infection is the most commonly reported adverse effect with SGLT2 inhibitors. We evaluated effectiveness of patient screening protocol and advice of hygiene and hydration to avoid adverse effects of SGLT2 inhibitors in real-world setting. <b><i>Method:</i></b> This was a prospective observational longitudinal study which included consecutive subjects with uncontrolled T2DM recommended with SGLT2i after a simple screening protocol from December 2017 to November 2018. The adverse effects and metabolic parameters were evaluated at 1st, 3rd, 6th, and 12th months for each patient. <b><i>Results:</i></b> Of 413 patients recommended for SGLT2 inhibitors, 335 patients started the medication. At baseline, average age, glycosylated haemoglobin (HbA1c), and weight were 53 years, 9.5%, and 82 kg, respectively. Data of 332, 299, 270, and 231 patients were available at the 1st, 3rd, 6th, and 12th months for safety follow-up, respectively. Genitourinary tract infection was the most common adverse effect (8%) followed by ketosis (4%). Two patients needed to stop the drug permanently due to recurrent transient ischaemic attack and emphysematous pyelonephritis. Significant reduction in mean weight and HbA1c was observed at 6 months (<i>n</i> = 270): 2.9 kg and 1.1%, respectively, and at 12 months (<i>n</i> = 231): 3.8 kg and 1.6%, respectively. <b><i>Conclusion:</i></b> Simple screening protocol for patients considered for SGLT2i significantly reduced incidence of genitourinary adverse events.

Statin-induced adverse effects – facts and genes

2013 ◽  
Vol 154 (3) ◽  
pp. 83-92
Author(s):  
Mariann Harangi ◽  
Noémi Zsíros ◽  
Lilla Juhász ◽  
György Paragh
Keyword(s):  
Risk Factors ◽  
Single Nucleotide Polymorphisms ◽  
Adverse Effects ◽  
Adverse Events ◽  
Statin Therapy ◽  
Significant Proportion ◽  
Gene Mutations ◽  
Nucleotide Polymorphisms ◽  
Serious Adverse Events ◽  
Single Nucleotide

Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients. Orv. Hetil., 2013, 154, 83–92.

Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms

2019 ◽  
pp. 331-340
Author(s):  
Susan Churchill ◽  
◽  
Kayla Deru ◽  
Lindell K. Weaver ◽  
Steffanie H. Wilson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Hyperbaric Oxygen ◽  
Gas Flow ◽  
Randomized Trials ◽  
Symptom Improvement ◽  
Sham Control ◽  
Serious Adverse Events ◽  
Double Blind ◽  
To Receive

Safety monitoring and successful blinding are important features of randomized, blinded clinical trials. We report chamber- and protocol-related adverse events (AEs) for participants enrolled in two randomized, double-blind clinical trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as well as the success of maintaining the blind with a low-pressure sham control arm. In both studies, participants were randomized to receive HBO2 (1.5 atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres absolute, room air). In 143 participants undergoing 4,245 chamber sessions, chamber-related adverse events were rare (1.1% in the HOPPS study, 2.2% in the BIMA study). Minor, non-limiting barotrauma was the most frequently reported. Rarely, some participants experienced headache with chamber sessions. No serious adverse events were associated with chamber sessions. An allocation questionnaire completed after intervention revealed that the sham control arm adequately protected the blind in both trials. Participants based allocation assumptions on symptom improvement or lack of symptom improvement and could not discern intervention arm by pressure, smell, taste, or gas flow.

scholarly journals Efficacy of treatment with Ombitasvir, Paritaprevir / r + Dasabuvir over 8 versus 12 weeks in chronic HCV hepatitis genotype 1B

2021 ◽  
Vol 24 (1) ◽  
pp. 44-50
Author(s):  
Mircea Manuc ◽  
◽  
Carmen Monica Preda ◽  
Laura Iliescu ◽  
Doina Istratescu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Drop Out ◽  
Real World Data ◽  
Serious Adverse Events ◽  
Intention To Treat ◽  
Genotype 1B ◽  
Male Patients ◽  
Severe Adverse Events ◽  
Chronic Hcv

Background and aims. For the 8-week OPrD regimen, real world data are insufficient. This study aims to compare the efficacy of the two types of regimens (12-week versus 8-week) in a real world cohort of patients with genotype 1b. Material and methods. We analysed a multicentric retrospective cohort enrolling 1436 patients who started HCV therapy in 2018-2019. Liver fibrosis was staged in all subjects by Fibromax. Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Results. Out of the 1436 analysed patients, 112 received 8 weeks therapy and 1324 received 12 weeks. In this cohort the proportion of male patients was 25.2%, the median age 61 years, 28.2% were interferon pre-treated, and the rate of co-morbidities was 47%. 42% of the subjects had F2 fibrosis, 29% F1 fibrosis, 16% F3 and 12% F4. The SVR rate was comparable in both groups of patients (97% in those treated with OPrD 12 weeks vs 96.4% in those that received OPrD 8 weeks) (by intention-to-treat). In the 12 weeks arm, the drop-out rate was 0.8% and the rate of severe adverse events was 1%, while in the arm of 8 weeks therapy there were no severe adverse events reported and no drop-out (p = 0.25). The only predictive factor for non-response in both treatment arms was the male sex. Conclusions. OPrD 8 weeks proved to be highly efficient in our patients with a 96.4% SVR. No serious adverse events and no drop out were reported.

scholarly journals 32 Quantifying the Prevalence of Frailty in Drug Trials and the Relationship with Serious Adverse Events

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i7-i11
Author(s):  
P Hanlon ◽  
E Butterly ◽  
J Lewsey ◽  
S Siebert ◽  
F S Mair ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Disease Severity ◽  
Negative Binomial ◽  
Frailty Index ◽  
Chronic Obstructive ◽  
Drug Trials ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Increased Risk

Abstract Introduction Frailty is common in clinical practice, but trials rarely report on participant frailty. Consequently, clinicians and guideline-developers assume frailty is largely absent from trials and have questioned the relevance of trial findings to frail people. Therefore, we examined frailty in phase 3/4 industry-sponsored clinical trials of pharmacological interventions for three exemplar conditions: type 2 diabetes mellitus (T2DM), rheumatoid arthritis (RA), and chronic obstructive pulmonary disease (COPD). Methods We constructed a 40-item frailty index (FI) in 19 clinical trials (7 T2DM, 8 RA, 4 COPD, mean age 42–65 years) using individual-level participant data. Participants with a FI &gt;0.24 were considered “frail”. Baseline disease severity was assessed using HbA1c for T2DM, Disease Activity Score-28 (DAS28) for RA, and % predicted FEV1 for COPD. Using generalised gamma regression, we modelled FI on age, sex and disease severity. In negative binomial regression we modelled serious adverse event rates on FI, and combined results for each index condition in a random-effects meta-analysis. Results All trials included frail participants: prevalence 7–21% in T2DM trials, 33–73% in RA trials, and 15–22% in COPD trials. Increased disease severity and female sex were associated with higher FI in all trials. Frailty was associated with age in T2DM and RA trials, but not in COPD. Across all trials, and after adjusting for age, sex, and disease severity, higher FI predicted increased risk of serious adverse events; the pooled incidence rate ratios (per 0.1-point increase in FI scale) were 1.46 (95% CI 1.21–1.75), 1.45 (1.13–1.87) and 1.99 (1.43–2.76) for T2DM, RA and COPD, respectively. Conclusion Frailty is identifiable and prevalent among middle aged and older participants in phase 3/4 drug trials and has clinically important safety implications. Trial data may be harnessed to better understand chronic disease management in people living with frailty.

scholarly journals Achieving blood pressure control targets in hypertensive patients of rural China – A pilot randomized trial

2020 ◽  
Author(s):  
Xiao Huang ◽  
Lishun Liu ◽  
Yun Song ◽  
Lan Gao ◽  
Min Zhao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Trial ◽  
Real World ◽  
Large Scale ◽  
Rural China ◽  
Standard Group ◽  
Open Label ◽  
Target Groups ◽  
Serious Adverse Events ◽  
Hypertensive Patients

Abstract Background This study aimed to test the feasibility and titration methods to achieve specific BP control targets in hypertensive patients of rural China. Methods A randomized, controlled, open-label trial was conducted in Rongcheng, China. We enrolled 105 hypertensive participants aged over 60 years, and who had no history of stroke and cardiovascular disease. The patients were randomly assigned to one of three systolic BP target groups: standard: 140 - < 150mmHg; moderately intensive: 130 - < 140mmHg; and intensive: <130mmHg. Patients were followed for 6 months. Discussion The optimal target for SBP lowering is still uncertain worldwide and such information is critically needed, especially in China. However, in China the rates of awareness, treatment and control are only 46.9%, 40.7% and 15.3%, respectively. It is challenging to achieve BP control in the real world and it is very important to develop population-specific BP control protocols that fully consider the population’s characteristics, such as age, sex, socio-economic status, compliance, education level and lifestyle. This randomized trial showed feasibility and safety of the titration protocol to achieve desirable SBP targets (<150, <140, and <130mmHg) in a sample of rural Chinese hypertensive patients. The three BP target groups had similar baseline characteristics. After 6 months of treatment, the mean SBP measured at an office visit was 137.2mmHg, 131.1mmHg, and 124.2mmHg in the three groups. Home BP and central aortic BP measurements were also obtained. At 6 months, home BP measurements (2 hours after drug administration) showed a mean SBP of 130.9 mmHg in the standard group, 124.9 mmHg in the moderately intense group, and 119.7 mmHg in the intensive group. No serious adverse events were recorded over the 6-month study period. Rates of adverse events including dry cough, palpitations, and arthralgia were low and showed no significant differences between the three groups. This trial gained real world experience and laid the foundation for a future large-scale BP target study.

The Ricochet of Magic Bullets: Summary of the Institute of Medicine Report, Adverse Effects of Pertussis and Rubella Vaccines

PEDIATRICS ◽  
1992 ◽  
Vol 89 (2) ◽  
pp. 318-324
Author(s):  
Christopher P. Howson ◽  
Harvey V. Fineberg
Keyword(s):  
Adverse Effects ◽  
Adverse Events ◽  
Cost Benefit ◽  
Juvenile Diabetes ◽  
Public Law ◽  
Sudden Infant ◽  
Institute Of Medicine ◽  
National Academy Of Sciences ◽  
Reye's Syndrome ◽  
Serious Adverse Events

On July 3, 1991, the National Academy of Sciences' Institute of Medicine (IOM) released a reported entitled, Adverse Effects of Pertussis and Rubella Vaccines,1 in response to a congressional request to review evidence about a set of serious adverse events and immunization with pertussis and rubella vaccines. The request originated in the 1986 National Childhood Vaccine Injury Act (Public Law 99-660), whose primary purpose was to establish a federal compensation scheme for persons potentially injured by a vaccine; Section 312 of Public Law 99-660 called for the IOM review. Over the course of its 20-month study, the 11-member interdisciplinary committee constituted by IOM to conduct the review examined altogether 18 adverse events for pertussis vaccine—infantile spasms; hypsarhythmia; aseptic meningitis; acute encephalopathy; chronic neurologic (permanent brain) damage; deaths classified as sudden infant death syndrome (SIDS); anaphylaxis, autism; erythema multiforme or other rashes; Guillain-Barré syndrome (polyneuropathy); peripheral mononeuropathy; hemolytic anemia; juvenile diabetes; learning disabilities and hyperactivity; protracted inconsolable crying or screaming; Reye's syndrome; shock and "unusual shock-like state" with hypotonicity, hyporesponsiveness, and short-lived convulsions (usually febrile); and thrombocytopenia—and 4 adverse events for rubella vaccine—acute arthritis; chronic arthritis; radiculoneuritis and other neuropathies; and thrombocytopenic purpura. In conducting its review, the committee recognized that its charge was to focus on questions of causation and not broader topics, such as cost-benefit or risk-benefit analyses of vaccination. This summary begins with a brief history of events leading to the IOM study, then reviews the methods used by the committee to evaluate the evidence, summarizes the committee's conclusions for these adverse events, and offers directions for future investigation of adverse events in connection with widely used health interventions, such as vaccination.

scholarly journals Randomized Controlled Trial between Levetiracetam and Phenobarbital in the Treatment of Neonatal Seizure due to Perinatal Asphyxia

2018 ◽  
Vol 42 (2) ◽  
pp. 67-72
Author(s):  
Abu Faisal Md Pervez ◽  
Md Fakhrul Amin Badal ◽  
SM Nurun Nabi ◽  
Mohammad Kamrul Hassan Shabuj ◽  
Sanjoy Kumer Dey ◽  
...  
Keyword(s):  
Adverse Effect ◽  
Randomized Controlled Trial ◽  
Adverse Effects ◽  
Perinatal Asphyxia ◽  
Controlled Trial ◽  
Common Adverse Effect ◽  
Neonatal Seizure ◽  
College Hospital ◽  
Antiepileptic Agent ◽  
Randomized Controlled

Background: Seizure occurs more frequently in neonatal period and incidence of seizure is 50%-68% in perinatal asphyxia. At present phenobarbital is the drug of choice for treating neonatal seizure, which has some adverse effects on neurodevelopment status. Levetiracetam is a novel antiepileptic agent well-tolerated and effective in focal, generalized and neonatal seizure as well and lacks the adverse effects like phenobarbital. The present study was undertaken to compare the safety and efficacy of levetiracetam to phenobarbital in the treatment of neonatal seizure due to perinatal asphyxia.Methodology: This interventional study (Randomized Controlled Trial) was conducted in Department of Neonatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka and Dhaka Medical College Hospital, Dhaka, Bangladesh from 1st January’ 2014 to 30th June’ 2015. Intravenous levetiracetam injection, 50 mg/kg loading followed by 10 mg/kg 8 hourly maintenance was used and phenobarbital intravenous 20-40 mg/kg loading and 2.5 mg/kg/dose 12 hourly maintenance was given as per institutional protocol.Results: Sixty-nine term asphyxiated neonates (intention to treat population) provided analyzable data. Seizure control was found significantly higher (p = 0.011) higher in levetiracetam group in comparison to phenobarbital group (71% vs 40%). Need for more than one drug was significantly lower in levetiracetan group (p=0.011). Adverse effects were found significantly (p=0.001) lower in levetiracetam group (9% vs 43%). No serious adverse effect was observed in any group and most common adverse effect was somnolence in both group followed by irritability. Restlessness, sedation and shallow breathing were found only in phenobarbital group.Conclusion: Levetiracetam is more effective and safe in comparison to phenobarbital in the treatment of neonatal seizure due to perinatal asphyxia.Bangladesh J Child Health 2018; VOL 42 (2) :67-72

scholarly journals SAT-418 Finding the Needles in the Haystack: Harnessing the Electronic Health Record to Find Thyroid Immune Related Adverse Events

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Zoe Quandt ◽  
Laura Trupin ◽  
Michael Evans ◽  
Gabriela Schmajuk ◽  
Mark Stuart Anderson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Electronic Health Record ◽  
Real World ◽  
Immune Checkpoint ◽  
Thyroid Disease ◽  
Thyroid Dysfunction ◽  
Health Record ◽  
The Real ◽  
New Onset

Abstract Background: Immune checkpoint inhibitors (CPIs) are being used to effectively treat a growing number of cancers but can cause immune related adverse events (irAE). Thyroid dysfunction is the most common endocrine irAE. A meta-analysis of clinical trials estimated that following CPI exposure, 6.6% will become hypothyroid and 2.9% will have hyperthyroidism1. It is unclear if this reflects the real-world incidence of these irAEs. We used electronic health record (EHR) data to identify patients who developed thyroid dysfunction after CPI to estimate the real-world incidence of these irAEs. Methods: Data were derived from the EHR of a large U.S. academic center. We identified subjects treated with CPIs between 2012 and 2018 and excluded those with thyroid cancer or pre-existing thyroid disease. Thyroid dysfunction was identified as either a TSH &gt; 10, an abnormal free T4 or a prescription for thyroid hormone replacement or anti-thyroid medication. Those with thyroid dysfunction were then categorized as having pre-existing disease or a new-onset thyroid irAE based on the timing of CPI initiation. Logistic regression was used to evaluate the association of thyroid irAE with age, gender, CPI and type of cancer. Results: In total, 1146 individuals without pre-existing thyroid disease that received CPIs were assessed. Pembrolizumab was the most common treatment (45%), followed by nivolumab (20%). Less than 10% of subjects received atezolizumab, durvalumab, ipilimumab monotherapy, combined ipilimumab/nivolumab, or other combinations of CPIs. Melanoma was the most common cancer treated (32%), followed by non-small cell lung cancer (13%). The prevalence of any other cancer was &lt; 10% each. Overall, 19% developed thyroid irAEs. After adjustment for gender and age, the type of cancer was significantly associated with new onset thyroid dysfunction (p=0.01). The rates of thyroid irAEs ranged from 10% in glioblastoma to 40% in renal cell cancer. Although there was no significant association between irAEs and specific CPIs in the overall analysis, thyroid irAEs were more common in subjects who received combined ipilimumab/ nivolumab (31%) compared to pembrolizumab (18%, p=0.03), nivolumab (18%, p&lt;0.01) and ipilimumab (15%, p=0.02). Conclusion: Thyroid irAEs are much more common in real world practice than in clinical trials and there is emerging evidence that certain cancer types incur a higher risk of thyroid irAEs even after adjustment for CPI exposure. Clinicians and patients should be educated about these risks. Future work should focus on exploring the reasons underlying the differing rates of thyroid irAEs among different cancers including effect on cancer outcomes. 1Barroso-Sousa et al. Incidence of Endocrine Dysfunction Following the Use of Different Immune Checkpoint Inhibitor Regimens. JAMA Oncol. 2017; 02215: 1–10.

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