Incidence Of Minor Adverse Events Research Articles

Immediate Sequential Bilateral Implantable Collamer Lens Surgery Is Safe and Effective.

To assess the clinical outcomes and safety profiles of patients who underwent immediate sequential bilateral phakic lens surgery. This retrospective multicenter study included 254 consecutive patients (508 eyes) who underwent bilateral same-day Implantable Collamer Lens (ICL) (STAAR Surgical) surgery. The authors focused on 1-year postoperative clinical outcomes and adverse events. In the initial cohort, 176 patients (352 eyes) met inclusion criteria. Of these, 335 eyes underwent myopic ICL placement, and 17 eyes received a hyperopic ICL. Notably, 87% of eyes achieved ±0.50 diopters (D) and 95% achieved ±1.00 D of the intended refraction. One year postoperatively, 78% of eyes demonstrated optimal vaulting (250 to 750 µm), with a significant 19% reduction in vaulting observed over the 12 months (P < .001). Only minor adverse events, including early cataract formation (1 case), secondary toric ICL rotation (3 cases), and ICL exchange due to inappropriate vaulting (6 cases), were noted. The findings corroborate the safety and efficacy of immediate sequential bilateral phakic lens surgery and indicate its potential as a treatment option. The low incidence of minor adverse events further reinforces its favorable safety profile. [J Refract Surg. 2024;40(5):e313-e320.].

Acupuncture for treating overactive bladder in adults.

Overactive bladder is a common, long-term symptom complex, which includes frequency of micturition, urgency with or without associated incontinence and nocturia. Around 11% of the population have symptoms, with this figure increasing with age. Symptoms can be linked to social anxiety and adaptive behavioural change. The cost of treating overactive bladder is considerable, with current treatments varying in effectiveness and being associated with side effects. Acupuncture has been suggested as an alternative treatment. To assess the effects of acupuncture for treating overactive bladder in adults, and to summarise the principal findings of relevant economic evaluations. We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (including In-Process, Epub Ahead of Print, Daily), ClinicalTrials.gov and WHO ICTRP (searched 14 May 2022).We also searched the Allied and Complementary Medicine database (AMED) and bibliographic databases where knowledge of the Chinese language was necessary: China National Knowledge Infrastructure (CNKI); Chinese Science and Technology Periodical Database (VIP) andWANFANG (China Online Journals), as well as the reference lists of relevant articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs and cross-over RCTs assessing the effects of acupuncture for treating overactive bladder in adults. Four review authors formed pairs to assess study eligibility and extract data. Both pairs used Covidence software to perform screening and data extraction. We assessed risk of bias using Cochrane's risk of bias tool and assessed heterogeneity using the Chi2 testand I2 statistic generated within the meta-analyses. We used a fixed-effect model within the meta-analyses unless there was a moderate or high level of heterogeneity, where we employed a random-effects model. We used the GRADE approach to assess the certainty of evidence. We included 15 studies involving 1395 participants in this review (14 RCTsand one quasi-RCT). All included studies raised some concerns regarding risk of bias. Blinding of participants to treatment group was only achieved in 20% of studies, we considered blinding of outcome assessors and allocation concealment to be low risk in only 25% of the studies, and random sequence generation to be either unclear or high risk in more than 50% of the studies. Acupuncture versus no treatment One study compared acupuncture to no treatment. The evidence is very uncertain regarding the effect of acupuncture compared to no treatment in curing or improving overactive bladder symptoms and on the number of minor adverse events (both very low-certainty evidence). The study report explicitly stated that no major adverse events occurred. The study did not report on the presence or absence of urinary urgency, episodes of urinary incontinence, daytime urinary frequency or episodes of nocturia. Acupuncture versus sham acupuncture Five studies compared acupuncture with sham acupuncture.The evidence is very uncertain about the effect of acupuncture on curing or improving overactive bladder symptoms compared to sham acupuncture (standardised mean difference (SMD) -0.36, 95% confidence interval (CI) -1.03 to 0.31; 3 studies; 151 participants; I2 = 65%; very low-certainty evidence). All five studies explicitly stated that there were no major adverse events observed during the study. Moderate-certainty evidence suggests that acupuncture probably makes no difference to the incidence of minor adverse events compared to sham acupuncture (risk ratio (RR) 1.28, 95% CI 0.30 to 5.36; 4 studies; 222 participants; I² = 0%). Only one small study reported data for the presence or absence of urgency and for episodes of nocturia. The evidence is of very low certainty for both of these outcomes and in both cases the lower confidence interval is implausible. Moderate-certainty evidence suggests there is probably little or no difference in episodes of urinary incontinence between acupuncture and sham acupuncture (mean difference (MD) 0.55, 95% CI -1.51 to 2.60; 2 studies; 121 participants; I2 = 57%). Two studies recorded data regarding daytime urinary frequency but we could not combine them in a meta-analysis due to differences in methodologies (very low-certainty evidence). Acupuncture versus medication Eleven studies compared acupuncture with medication. Low-certainty evidence suggests that acupuncture may slightly increase how many people's overactive bladder symptoms are cured or improved compared to medication (RR 1.25, 95% CI 1.10 to 1.43; 5 studies; 258 participants; I2 = 19%). Low-certainty evidence suggests that acupuncture may reduce the incidence of minor adverse events when compared to medication (RR 0.34, 95% CI 0.26 to 0.45; 8 studies; 1004 participants; I² = 51%). The evidence is uncertain regarding the effect of acupuncture on the presence or absence of urinary urgency (MD -0.40, 95% CI -0.56 to -0.24; 2 studies; 80 participants; I2 = 0%; very low-certainty evidence)and episodes of urinary incontinence (MD -0.33, 95% CI -2.75 to 2.09; 1 study; 20 participants; very low-certainty evidence) compared to medication. Low-certainty evidence suggests there may be little to no effect of acupuncture compared to medication in terms of daytime urinary frequency (MD 0.73, 95% CI -0.39 to 1.85; 4 studies; 360 participants; I2 = 28%). Acupuncture may slightly reduce the number of nocturia episodes compared to medication (MD -0.50, 95% CI -0.65 to -0.36; 2 studies; 80 participants; I2 = 0%, low-certainty evidence). There were no incidences of major adverse events in any of the included studies. However, major adverse events are rare in acupuncture trials and the numbers included in this review may be insufficient to detect these events. The evidence is very uncertain about the effect acupuncture has on cure or improvement of overactive bladder symptoms compared to no treatment. It is uncertain if there is any difference between acupuncture and sham acupuncture in cure or improvement of overactive bladder symptoms. This review provides low-certainty evidence that acupuncture may result in a slight increase in cure or improvement of overactive bladder symptoms when compared with medication and may reduce the incidence of minor adverse events. These conclusions must remain tentative until the completion of larger, higher-quality studies that use relevant, comparable outcomes. Timing and frequency of treatment, point selection, application and long-term follow-up are other areas relevant for research.

MO167: SAFETY OF SGLT2 INHIBITORS (SGLT2I) IN PEOPLE OVER 75 YEARS

Abstract BACKGROUND AND AIMS The use of iSGLT2 in people over 75 years was initially associated with a higher rate of adverse effects (AEs). Subsequent clinical trials have consistently demonstrated no increase of serious adverse effects in this group of patients, but the incidence of minor adverse events remains to be analysed in this group of patients The objective of this study is to evaluate in real life the incidence of adverse effects attributable to this family of drugs in patients aged 75 years (75+) or more at the beginning of treatment with iSGLT2 taking as reference population patients aged less than 75 years (&amp;lt;75). The incidence of cardiovascular events and death was also analysed. METHOD Observational study, one-centre. We selected all the patients undergoing iSGLT2 treatment at our centre since 2015 till 2021, grouping them according to their age at the start (75 + versus &amp;lt;75 years). RESULTS A total of 153 patients started treatment with iSGLT2 in our centre, 33 (21.6%) were 75 or older. Follow-up time was 19.0 months, interquartile range [8.9–30.3]. Mean age 67.3 years (SD 10.5), m: f ratio was 3:1 and type of SGLT2i was dapagliflozin 49%, canagliflozin 29% and empagliflozin 22%. A total of 28 patients (18.3%) had some side effect of the drug, without significant differences between + 75 and &amp;lt;75. The most frequent AEs in both groups were genitourinary (GU) infections (10.3%) and falls (9.2%), Eight patients discontinued treatment (five due to any AEs) with similar distribution in both groups. GU tract infections were more frequent in the first year of treatment treatment (100% during first year in 75+ and 46.7% in &amp;lt;75 years).  We did not found any difference in older patients in the rate of CV events or death (Log rank 0.6) CONCLUSION Side effects of iSGLT2 were uncommon in our population, and age above 75 years was not associated with a higher incidence of AEs. GU tract infections, which were the most prevalent AE, were more frequent in the first year of treatment indicating the need of a more careful monitoring in this period of time.

A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products

Nicotine replacement therapies (NRTs) are intended for short-term use to help cigarette smokers to quit. Some smokers find NRTs ineffective or seek a more satisfactory source of nicotine. Tobacco-free oral nicotine pouch (NP) products have emerged as a potential reduced risk product compared with cigarettes and other tobacco products. In a randomised crossover clinical study, thirty-four healthy adult smokers were enrolled and their nicotine Cmax and AUC0-T determined for three 4 mg nicotine products (NP, gum, lozenge) under fasting conditions. The NP, lozenge and gum mean Cmax values were 8.5, 8.3 and 4.4 ng/mL, AUC0-T values were 30.6, 31.5 and 14.3 ng*h/mL, respectively. The NP showed similar nicotine bioavailability to the lozenge (p = 0.6526 (Cmax), p = 1.0000 (AUC0-T)), and superior bioavailability to the gum (p  < 0.0001 for Cmax and AUC0-T). Compared with the lozenge, the NP demonstrated greater product satisfaction with a higher number of positive responses to subjective satisfaction questions. All products were judged to be well-tolerated; the incidence of minor adverse events was lower for the NP (18.2%) than the lozenge (33.3%) or gum (18.8%). In summary, NPs may provide smokers with a more satisfying alternative nicotine source as compared to the reference NRTs.Study Registry/Registered Trial No: ISRCTN/ISRCTN65708311.

The utilization of procedural sedation and analgesia at the University Teaching Hospital of Kigali, Rwanda

Introduction: In the Emergency Department (ED), safe and effective Procedural Sedation and Analgesia (PSA) is essential. The professional performing procedural sedation has to be prepared to handle any potential adverse effects. Medications are used according to their availability and based on the physician’s experience and preference. Despite the common occurrence of procedural sedation in the ED, it has not previously been studied in Rwanda. The study aimed to describe procedural sedation and analgesia utilization and common adverse events at Rwanda's University Teaching Hospital of Kigali (UTH-K) ED.Methods: This study is a prospective observational study of procedural sedations done at UTH-KED. The effectiveness of sedation was evaluated using the Richmond Agitation Sedation Score (RASS) during sedation. The pain scale was assessed before and after the procedure. Categorical data were analyzed for significant differences using Chi-squared (X) tests and continuous data with Mann-Whitney (MW) tests.Results: Two hundred fifty-one patients were recruited. Seventy-two percent (72%) of patients were male with a median age of 32 years (IQR 23to 40). The most commonly used analgesics included morphine (78%) and tramadol (17%), with ketamine least used (1%). A common adverse event was hypoxia (36%), followed by hallucination (8%). No adverse events were observed in 47% of procedures. Conclusion: Our study findings suggest that although sedation in our low-resource setting did not result in serious adverse outcomes for patients, there was a much higher incidence of minor adverse events (especially hypoxia) than in higher-resource settings.

Incidence of Early Adverse Events Following Covishield (ChAdOx1 nCoV-19) Vaccination: A Prospective Study.

Minor adverse event following immunizations (AEFIs) are often underreported and self-treated. This study aimed to collect information regarding any and every probable adverse event experienced by the recipient of Covishield vaccine up to 10 days following the first and second dose of vaccine. To find the incidence of minor adverse events following Covishield vaccination; draw an association between adverse events and individuals' demographic factors and comorbidities; and report new adverse events, if any. A descriptive observational study was conducted among 409 participants randomly sampled from the Vaccination Centre at a Tertiary Care Hospital, Mumbai. Participants were followed up post their first and second doses to enquire about adverse events. Most commonly reported adverse events included injection site pain, tenderness, chills, fatigue, fever, and myalgia. Females reported more adverse events compared to men (p < 0.05). Younger individuals (18-24) experienced adverse events more as compared to individuals above 40 years of age (p < 0.005). Reported adverse events were lesser after the second dose in comparison with the first dose. Few participants reported dysgeusia. Covishield vaccination has a mild AEFI profile, most commonly: injection site pain, tenderness, chills, and fatigue. It is hoped that the findings of this study will dispel anxiety around the adverse events of vaccination and reduce any persisting vaccine hesitancy. Effective communication with the population on vaccination will enable individuals to make educated and informed decisions.

Non-invasive positive airway pressure therapy for improving erectile dysfunction in men with obstructive sleep apnoea.

Obstructive sleep apnoea syndrome (OSAS) is associated with several chronic diseases, including erectile dysfunction (ED). The association of OSAS and ED is far more common than might be found by chance; the treatment of OSAS with non-invasive positive airway pressure therapy is associated with improvement of respiratory symptoms, and may contribute to the improvement of associated conditions, such as ED. To assess the effectiveness and acceptability of non-invasive positive airway pressure therapy for improving erectile dysfunction in OSAS. We identified studies from the Cochrane Airways Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, AMED EBSCO, and LILACS, the US National Institutes of Health ongoing trials register ClinicalTrials.gov, and the World Health Organisation international clinical trials registry platform to 14 June 2021, with no restriction on date, language, or status of publication. We checked the reference lists of all primary studies, and review articles for additional references, and relevant manufacturers' websites for study information. We also searched specific conference proceedings for the British Association of Urological Surgeons; the European Association of Urology; and the American Urological Association to 14 June 2021. We considered randomised controlled trials (RCTs) with a parallel or cross-over design, or cluster-RCTs, which included men aged 18 years or older, with OSAS and ED. We considered RCTs comparing any non-invasive positive airway pressure therapy (such as continuous positive airways pressure (CPAP), bilevel positive airway pressure (BiPAP), variable positive airway pressure (VPAP), or similar devices) versus sham, no treatment, waiting list, or pharmacological treatment for ED. The primary outcomes were remission of ED and serious adverse events; secondary outcome were sex-related quality of life, health-related quality of life, and minor adverse events. Two review authors independently conducted study selection, data extraction, and risk of bias assessment. A third review author solved any disagreement. We used the Cochrane RoB 1 tool to assess the risk of bias of the included RCTs. We used the GRADE approach to assess the certainty of the body of evidence. To measure the treatment effect on dichotomous outcomes, we used the risk ratio (RR); for continuous outcomes, we used the mean difference (MD). We calculated 95% confidence intervals (CI) for these measures. When possible (data availability and homogeneous studies), we used a random-effect model to pool data with a meta-analysis. We included six RCTs (all assessing CPAP as the non-invasive positive airway pressure therapy device), with a total of 315 men with OSAS and ED. All RCTs presented some important risk of bias related to selection, performance, assessment, or reporting bias. None of included RCTs assessed the ED remission rate, and we used the provided ED mean scores as a proxy. CPAP versus no CPAP There is uncertainty about the effect of CPAP on mean ED scores after 4 weeks, using the International index of erectile function (IIEF-5, higher = better; MD 7.50, 95% CI 4.05 to 10.95; 1 RCT; 27 participants; very low-certainty evidence), and after 12 weeks (IIEF-ED, ED domain; MD 2.50, 95% CI -1.10 to 6.10; 1 RCT; 57 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). There is uncertainty about the effect of CPAP on sex-related quality of life after 12 weeks, using the Self-esteem and relationship test (SEAR, higher = better; MD 1.00, 95% CI -8.09 to 10.09; 1 RCT; 57 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision); no serious adverse events were reported after 4 weeks (1 RCT; 27 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). CPAP versus sham CPAP One RCT assessed this comparison (61 participants), but we were unable to extract outcomes for this comparison due to the factorial design and reporting of this trial. CPAP versus sildenafil (phosphodiesterase type 5 inhibitors) Sildenafil may slightly improve erectile function at 12 weeks when compared to CPAP, measured with the IIEF-ED (MD -4.78, 95% CI -6.98 to -2.58; 3 RCTs; 152 participants; I² = 59%; low-certainty evidence, downgraded due to methodological limitations). There is uncertainty about the effect of CPAP on sex-related quality of life after 12 weeks, measured with the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (EDITS, higher = better; MD -1.24, 95% CI -1.80 to -0.67; 2 RCTs; 122 participants; I² = 0%; very low-certainty evidence, downgraded due to methodological limitations). No serious adverse events were reported for either group (2 RCTs; 70 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). There is uncertainty about the effects of CPAP when compared to sildenafil for the incidence of minor adverse events (RR 1.33, 95% CI 0.34 to 5.21; 1 RCT; 40 participants; very low-certainty evidence, downgraded due to methodological limitations and imprecision). The confidence interval was wide and neither a significant increase nor reduction in the risk of minor adverse events can be ruled out with the use of CPAP (4/20 men complained of nasal dryness in the CPAP group, and 3/20 men complained of transient flushing and mild headache in the sildenafil group). When compared with no CPAP, we are uncertain about the effectiveness and acceptability of CPAP for improving erectile dysfunction in men with obstructive sleep apnoea. When compared with sildenafil, there is some evidence that sildenafil may slightly improve erectile function at 12 weeks.

Clinical Outcomes of Cervical Hybrid Reconstructions: A Prospective Study.

The study design was a prospective clinical cohort study. The aim of this study was to assess the patient-reported outcome measures (PROMs), patient satisfaction, as well as complication and reoperation rate of cervical hybrid procedures for symptomatic cervical multilevel degenerative disc disease (MLDDD). Cervical total disc replacement (CTDR) has been shown to be safe and effective for the treatment of degenerative pathologies. However, there is minimal PROMs data on the outcomes of combined CTDR and anterior cervical decompression and fusion procedures, commonly referred to as cervical hybrid surgery. Prospectively collected PROMs were analyzed from patients receiving cervical hybrid surgery for symptomatic cervical MLDDD. Between 2004 and 2016, data were collected preoperatively and postoperatively at 3, 6, and 12 months, then yearly thereafter. Patient reported outcome measures included patient satisfaction, visual analog score for neck and arm, and Neck Disability Index. Complication and reoperation rates were also assessed. A total of 151 patients (80 males, 71 females) who had a minimum of 12 months follow up were included. The mean age was 53 years (range = 24-81), and median follow up was 2 years (range = 1-10). The median number of levels treated was 3, with 29.8%, 49.0%, and 21.2% of patients having 2, 3, and 4 levels treated, respectively. The most common indication for surgery was multilevel cervical spondylotic radiculopathy (52.8%), followed by combined cervical spondylotic radiculomyelopathy (16.7%), axial neck pain (16%), and cervical spondylotic myelopathy (13.9%). Improvement in pain and disability scores were both clinically and statistically significant (P < .001), and these improvements were sustained throughout the course of follow up. There was a 16% incidence of minor adverse events, and 3 (1.9%) reoperations. Cervical hybrid surgery for cervical MLDDD demonstrates favorable and sustained clinical outcomes at short-term to midterm follow up. 4. Statistically and substantial clinical benefits can be achieved by cervical hybrid surgery, in the treatment of cervical pathologies including radiculopathy and myelopathy. The key principles is to follow strict indications, and to match technology with the pathology.

Comparison of the safety and efficacy of peroral endoscopic myotomy between octogenarians and non-octogenarians.

This study compared the safety and efficacy of peroral endoscopic myotomy for esophageal motility disorders between octogenarians and non-octogenarians. This retrospective observational study recruited 321 patients (28 octogenarians and 293 non-octogenarians) who underwent peroral endoscopic myotomy from two institutions. Clinical success (postoperative Eckardt score≤3), technical success (completion of gastric and esophageal myotomy), and perioperative adverse events were compared between octogenarians and non-octogenarians. Perioperative adverse events were classified into major and minor adverse events based on the International Peroral Endoscopic Myotomy Survey criteria and were subdivided into technical and non-technical adverse events according to the presence of a direct causal relationship with the procedure. There were no significant differences in the rates of clinical success 1year after treatment (100% vs. 97.3%, P=0.64) and technical success (100% vs. 99.7%, P=0.91) between octogenarians and non-octogenarians. Octogenarians had a higher incidence of perioperative adverse events (28.6% vs. 10.2%, P=0.00097), particularly major adverse events (25.0% vs. 3.0%, P<0.0001). There were no significant differences in the incidence of minor adverse events (7.1% vs. 7.9%, P=0.67). Although there was no difference in the incidence of technical adverse events (10.7% vs. 9.2%, P=0.74), octogenarians had a significantly higher incidence of non-technical adverse events (17.9% vs. 1.0%, P=0.0002). There were no significant differences in short-term clinical success and technical success between octogenarians and non-octogenarians. However, octogenarians showed a significantly higher incidence of perioperative adverse events, particularly in major adverse events and non-technical adverse events. Peroral endoscopic myotomy for octogenarians should be carefully applied.

284. The cost effectiveness of an ICU outreach program on adverse events after spine surgery

BACKGROUND CONTEXT The Spinal Surgery AdVerse Events System (SAVES) was developed in 2008 with the intention of assessing the frequency and impact of postoperative adverse events (AEs) following spinal surgery. Over the study period this system identified a number of “minor” adverse events (Grade 1 and 2) occurring frequently; electrolyte imbalance, medication related issues, postoperative ileus and nausea. In daily practice. these may often be dismissed as trivial. However, growing evidence shows the accumulation of minor AEs may have a larger than anticipated consequence. In 2012 an ICU outreach program was developed where high dependency postoperative spine patients were reviewed daily by an intensive care physician. PURPOSE The purpose of this study was to examine the efficacy and cost-effectiveness of the introduction an ICU outreach program on adverse events in postoperative high dependency spine patients. STUDY DESIGN/SETTING This prospective cohort study took place at a single quaternary spine referral center. PATIENT SAMPLE All surgical patients admitted to a quaternary spine center for the outlined study periods. OUTCOME MEASURES The frequency of postoperative AEs was recorded during each period, as identified by the SAVES framework. METHODS Data was prospectively collected during the 4-year period before (2008-2012) and after (2012-2016) the introduction of the ICU outreach program. Previous research has determined the cost of AEs which was applied to the data set. RESULTS Over the study period the mean number of patients admitted per year was 984 (912-1090). The introduction of the ICU outreach team lead to a dramatic decrease in the number of AEs reported during the postoperative period. The percentage of patients with electrolyte imbalance decreased by 35% from 46% to 30%. Medication-related events decreased by 70% from 40% to 12%, ileus/constipation 46% from 26% to 14%, nausea by 64% from 22% to 8%, cardiac complications by 55% from 18% to 8%, pulmonary by 65% from 17% to 6% and delirium/psychiatric by 62.5% from 12% to 4.5% (P-values CONCLUSIONS The introduction of an ICU outreach program to review postoperative high dependency spine patients reduces the incidence of minor adverse events and can lead to substantial cost savings. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Therapeutic Plasma Exchange in Pediatric Renal Transplantation Experience of One Decade and 389 Sessions

ObjectiveThere are no specific recommendations for therapeutic plasma exchange (TPE) in children after renal transplantation. The purpose of this study was to report the experience with TPE in a pediatric transplant setting. Materials and Methods59 patients (mean age 12.5 ± 4.5 years) undergoing renal transplantation. Indications for TPE included the recurrence of nephrotic syndrome (NS; n = 30) and atypical hemolytic uremic syndrome (n = 6), chronic antibody-mediated rejection (cAMR; n = 20), sensitization (n = 2), and immune thrombocytopenia (n = 1). The single-filtration TPE was performed in all cases. In 74.7% of patients, fresh frozen plasma was used as a replacement fluid. In 25.3% of patients, 4% albumin solution was used as a replacement fluid. Criteria for TPE efficacy included a decrease of proteinuria and normalization of renal function in NS; a normalization of platelet count, C3, and hemoglobin concentration in aHUS; improvement in renal function; and reduction of donor-specific antibodies in cAMR; and removal of antiplatelet antibodies in immune thrombocytopenia. ResultsEfficacy results for patients with NS: 59.3% achieved remission, 25.9% achieved partial remission, and 14.8% achieved no remission, respectively. For patients with atypical hemolytic uremic syndrome there was remission in 66.6% and no remission in 33.4%. For patients with cAMR there was remission in 75% and no remission in 25%. Antiplatelet antibodies disappeared after TPE in 1 patient. In 9% of TPE procedures, minor complications were noted. All patients were on posttransplant maintenance immunosuppression and several children received additional treatment (intravenous immunoglobulin therapy or rituximab) during TPE therapy. ConclusionTPE therapy (combined with immunosuppression) was an effective tool in most pediatric cases after renal transplantation with low incidence of minor adverse events.

Adverse events following immunization with pentavalent vaccine among infants attending the immunization clinic at a tertiary hospital in Eastern India

Background: Prevention of childhood diseases of public health importance is mainly achieved by immunization. Pentavalent vaccines provide immunity and protection quickly and safely. It also reduces the cost, occupational-environmental hazards as well as distress and inconvenience for the children and their parents. Adverse events following immunization (AEFI) are well established with DPT, Hep-B and Hib vaccine separately in numerous studies but when given in combination as pentavalent vaccine, data on AEFI with this is still lacking. Does there is any reduction in proportion of various minor and major AEFI after pentavalent vaccination in comparison to separate vaccines? To fill this gap in knowledge we carried an observational epidemiological study to find out the proportion and associated factors for various adverse events following immunization with pentavalent vaccine.Methods: It was a descriptive longitudinal study carried out in immunization clinic at a tertiary care centre of Eastern India. It was done between July-September 2016. Study population constitutes all the infants who attended the immunization clinic for getting vaccines. All the infants who attended the immunization clinic and were eligible for pentavalent vaccines were selected for the study.Results: A total of 230 infants participated during study period. Incidence of minor adverse events reported very high, 67 per 100 doses across all doses. Fever was most common symptom reported. Demographic character or birth history of infant had not showed an effect on occurrence of any adverse event.Conclusions: Study showed that from clinical perspective pentavalent vaccine given in a single injection has increased reactogenicity in comparison when given separately. 

Prospective Analysis of Minor Adverse Events After Colon Polypectomy.

The risks of minor adverse events (MAEs) such as abdominal pain and bloating after colon polypectomy (CP) are less clearly documented than major adverse events. However, these complications may cause significant discomfort during the performance of normal activities. We aimed to estimate the incidence of MAE, associated risk factors, and healthcare resource utilization after CP. Patients who underwent CP were prospectively enrolled in this study. Trained nurses contacted patients by telephone at 7 and 30days after the CP and administered a standardized questionnaire to obtain information regarding the development of complications. MAEs were defined as any discomfort the patient experienced after CP excluding major bleeding, perforation, and post-polypectomy coagulation syndrome. Among a total of 2716 patients, 2253 patients completed the interview at 7 and 30days. MAEs occurred in 263 patients (11.7%) before day 7, among which the most common were abdominal pain (4.5%), rectal bleeding (2.8%), and bloating (2.6%). Cumulative incidence of MAEs was in 267 patients (11.9%) at 30days. On multivariate analysis, female sex (odds ratio [OR] 2.24, 95% confidence interval [CI] 1.58-3.18) and use of meperidine (OR 1.54, 95% CI 1.04-2.27) were risk factors for the occurrence of MAEs. Two patients (0.7%) required hospital admission, 117 patients (43.8%) were treated medically in the outpatient clinic, and the majority at 148 patients (55.4%) experienced resolution of symptoms after observation. The post-CP MAE rate was as low as 11.8%. The MAEs occurred mainly in the first seven postoperative days and resulted in little use of healthcare resources.

Study of GABA in Healthy Volunteers: Pharmacokinetics and Pharmacodynamics.

Preclinical studies show that GABA exerts anti-diabetic effects in rodent models of type 1 diabetes. Because little is known about its absorption and effects in humans, we investigated the pharmacokinetics and pharmacodynamics of GABA in healthy volunteers. Twelve subjects were subjected to an open-labeled, three-period trial involving sequential oral administration of placebo, 2 g GABA once, and 2 g GABA three times/day for 7 days, with a 7-day washout between each period. GABA was rapidly absorbed (Tmax: 0.5 ~ 1 h) with the half-life (t1/2) of 5 h. No accumulation was observed after repeated oral GABA administration for 7 days. Remarkably, GABA significantly increased circulating insulin levels in the subjects under either fasting (1.6-fold, single dose; 2.0-fold, repeated dose; p < 0.01) or fed conditions (1.4-fold, single dose; 1.6-fold, repeated dose; p < 0.01). GABA also increased glucagon levels only under fasting conditions (1.3-fold, single dose, p < 0.05; 1.5-fold, repeated dose, p < 0.01). However, there were no significant differences in the insulin-to-glucagon ratio and no significant change in glucose levels in these healthy subjects during the study period. Importantly, GABA significantly decreased glycated albumin levels in the repeated dosing period. Subjects with repeated dosing showed an elevated incidence of minor adverse events in comparison to placebo or the single dosing period, most notably transient discomforts such as dizziness and sore throat. However, there were no serious adverse events observed throughout the study. Our data show that GABA is rapidly absorbed and tolerated in human beings; its endocrine effects, exemplified by increasing islet hormonal secretion, suggest potential therapeutic benefits for diabetes.

Long-term follow-up of ultrasound-guided botulinum toxin-A injections for sialorrhea in neurological dysphagia.

Literature provides reports only of a limited follow-up single injection of botulinum toxin-A (BoNT-A) in patients with sialorrhea. The aim of our study is to evaluate the long-lasting efficacy and safety of ultrasound-guided BoNT-A injections for severe sialorrhea secondary to neurological dysphagia. We enrolled 38 severe adult sialorrhea patients referred consecutively to the neurology unit and performed bilateral parotid and submandibular gland BoNT-A injections under ultrasound guidance. The outcomes of the study were reduction of sialorrhea, duration of therapeutic effect, and subjective patient- and caregiver-reported satisfaction. A total of 113 BoNT-A administrations were given during the study period with a mean duration of follow-up of 20.2±4.4months. We observed a significant decrease from baseline in mean number of daily aspirations and a significant improvement in patient- and caregiver-reported outcomes following ultrasound-guided BoNT-A injections (p<0.001 vs baseline for all comparisons) and the mean duration of the efficacy was 5.6±1months. No major treatment-related adverse events occurred and a low incidence of minor adverse events was reported. This study confirms the long-lasting efficacy and safety of ultrasound-guided BoNT-A injections for sialorrhea, regardless of the causative neurological disorder. These results should encourage the use of BoNT-A in the treatment of severe sialorrhea and highlight the role of ultrasound guidance to obtain optimal results in terms of safety and reproducible outcomes.

PD23-12 LONG-TERM EFFICACY AND SAFETY OF ALPHA 1-BLOCKER NAFTOPIDIL FOR PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA: 3-YEAR OUTCOME ANALYSIS OF A PROSPECTIVE MULTICENTER STUDY.

METHODS: This prospective study was conducted in 155 men 49-86 years of age who visited our hospital and opted for medical treatment consisting of BPH with dutasteride. Fifty treated with dutasteride 0.5 mg daily for at least 6 months and who had persistent OAB symptoms (OAB Symptom Score (OABSS) 5) were enrolled. These patients were treated for the OAB symptoms with either solifenacin 5 mg/day or mirabegron 50 mg/day for 12 weeks (N1⁄425 in each) and evaluated by the International Prostate Symptom Score (IPSS) and OABSS just before and 4 and 12 weeks after solifenacin or mirabegron treatment. Postvoided residual urine volume (PVR) and the incidence of adverse events were also evaluated. RESULTS: Mean values of prostate volume, PVR, IPSS, and OABSS just before administration of solifenacin or mirabegron were 39.0 ml, 53.2 ml, and 17.6, 8.1, respectively, and these parameters were not significantly different between the two groups. The changes of IPSS and OABSSwere -2.0 and -2.0 at 4 weeks and -3.1 and -2.7 at 12 weeks after solifenacin treatment, respectively, which were significantly lower than those just before the administration. Four patients treatedwith solifenacin could not continue due to adverse events; 3 caseshaddysuria and1 case hadblurred vision.Thechangesof IPSSandOABSSwere -3.3 and -1.7 at 4 weeks and -3.0 and -2.5 at 12 weeks after mirabegron treatment, respectively, which were significantly lower than those just before the administration. All patients continued the mirabegron treatment. The incidence of minor adverse events was 12 and 7 cases in solifenacin and mirabegron treatment, respectively. Two and no patients had more than 100 ml PVR after solifenacin and mirabegron treatment, respectively. CONCLUSIONS: Solifenacin and mirabegron are effective in BPH patients treated with dutasteride but having OAB symptoms.

Rates of minor adverse events and health resource utilization postcolonoscopy.

Little is known about minor adverse events (MAEs) following outpatient colonoscopies and associated health care resource utilization. To estimate the rates of incident MAE at two, 14 and 30 days postcolonoscopy, and associated health care resource utilization. A secondary aim was to identify factors associated with cumulative 30-day MAE incidence. A longitudinal cohort study was conducted among individuals undergoing an outpatient colonoscopy at the Montreal General Hospital (Montreal, Quebec). Before colonoscopy, consecutive individuals were enrolled and interviewed to obtain data regarding age, sex, comorbidities, use of antiplatelets/anticoagulants and previous symptoms. Endoscopy reports were reviewed for intracolonoscopy procedures (biopsy, polypectomy). Telephone or Internet follow-up was used to obtain data regarding MAEs (abdominal pain, bloating, diarrhea, constipation, nausea, vomiting, blood in the stools, rectal or anal pain, headaches, other) and health resource use (visits to emergency department, primary care doctor, gastroenterologist; consults with nurse, pharmacist or telephone hotline). Rates of incident MAEs and health resources utilization were estimated using Bayesian hierarchical modelling to account for patient clustering within physician practices. Of the 705 individuals approached, 420 (59.6%) were enrolled. Incident MAE rates at the two-, 14- and 30-day follow-ups were 17.3% (95% credible interval [CrI] 8.1% to 30%), 10.5% (95% CrI 2.9% to 23.7%) and 3.2% (95% CrI 0.01% to 19.8%), respectively. The 30-day rate of health resources utilization was 1.7%, with 0.95% of participants seeking the services of a physician. No predictors of the cumulative 30-day incidence of MAEs were identified. The incidence of MAEs was highest in the 48 h following colonoscopy and uncommon after two weeks, supporting the Canadian Association of Gastroenterology's recommendation for assessment of late complications at 14 days. Predictors of new onset of MAEs were not identified, but wide CrIs did not rule out possible associations. Although <1% of participants reported consulting a physician for MAEs, this figure may represent a substantial number of visits given the increasing number of colonoscopies performed annually. Postcolonoscopy MAEs are common, occur mainly in the first two weeks postcolonoscopy and result in little use of health resources.

Long-term Botulinum Toxin Treatment of Benign Essential Blepharospasm, Hemifacial Spasm, and Meige Syndrome

To report the clinical success and incidence of adverse events of repetitive botulinum toxin treatment of 15 years or greater. Retrospective cohort study. The study sample consisted of 37 patients from a clinical practice, 11 male and 26 female. Inclusion criteria consisted of patients treated a minimum of 15 consecutive years for facial dystonia. Seven patients had hemifacial spasm, 4 Meige syndrome, and 26 benign essential blepharospasm. Main outcome measures consisted of treatment efficacy and adverse events. Mean treatment duration was 19.4 years (SD 2.2) with an average of 62 (SD 22) treatments of 70.2 (SD 20.8) neurotoxin units. Mean duration of treatment efficacy was 127 days (SD 37) with a 5% physician-reported minor adverse event rate and no major adverse events over each patient's clinical course. Patients reported no major and 20% incidence of minor adverse events over the treatment course. Results suggest that long-term botulinum toxin treatment produces clinical success in the alleviation of facial dystonia symptoms. Treatment produced a low incidence of major adverse events and minor adverse events. Previous studies may under-report clinical success and over-report adverse events because of study design.

Safety of cardiac magnetic resonance and contrast angiography for neonates and small infants: a 10-year single-institution experience

With increasing applications of cardiac magnetic resonance (CMR) and magnetic resonance angiography (MRA) for evaluation of congenital heart disease (CHD), safety of this technology in the very young is of particular interest. We report our 10-year experience with CMR in neonates and small infants with particular focus on the safety profile and incidence of adverse events (AEs). We reviewed clinical, anesthesia and nursing records of all children ≤120 days of age who underwent CMR. We recorded variables including cardiac diagnosis, study duration, anesthesia type and agents, prostaglandin E1 (PGE1) dependence and gadolinium (Gd) use. Serially recorded temperature, systemic saturation (SpO(2)) and cardiac rhythm were analyzed. Primary outcome measure was any AE during or <24 h after the procedure, including minor AEs such as hypothermia (axillary temperature ≤95 °F), desaturation (SpO(2) drop ≥10% below baseline) and bradycardia (heart rate ≤100 bpm). Secondary outcome measure was unplanned overnight hospitalization of outpatients. Children (n = 143; 74 boys, 69 girls) had a median age of 6 days (1-117), and 98 were ≤30 days at the time of CMR. The median weight was 3.4 kg (1.4-6 kg) and body surface area 0.22 m(2) (0.13-0.32 m(2)). There were 118 (83%) inpatients (108 receiving intensive care) and 25 (17%) outpatients. Indications for CMR were assessment of aortic arch (n = 57), complex CHD (n = 41), pulmonary veins (n = 15), vascular ring (n = 8), intracardiac mass (n = 8), pulmonary artery (n = 7), ventricular volume (n = 4), and systemic veins (n = 3). CMR was performed using a 1.5-T scanner and a commercially available coil. CMR utilized general anesthesia (GA) in 86 children, deep sedation (DS) in 50 and comforting methods in seven. MRA was performed in 136 children. Fifty-nine children were PGE1-dependent and 39 had single-ventricle circulation. Among children on PGE1, 43 (73%) had GA and 10 (17%) had DS. Twelve children (9%) had adverse events (AEs)-one major and 11 minor. Of those 12, nine children had GA (10%) and three had DS (6%). The single major AE was respiratory arrest after DS in a neonate (resuscitated without sequelae). Minor AEs included desaturations (n = 2), hypothermia (n = 5), bradycardia (n = 2), and bradycardia with hypoxemia (n = 2). Incidence of minor AEs was 9% for inpatients (vs. 4% for outpatients), and 8% for neonates (vs. 9% for age ≥30 days). Incidence of minor AEs was similar between PGE1-dependent infants and the non-PGE1 group. There were no adverse events related to MRA. Of 25 outpatients, 5 (20%) were admitted for overnight observation due to desaturations. CMR and MRA can be accomplished safely in neonates and infants ≤120 days old for a wide range of pre-surgical cardiac indications. Adverse events were unrelated to patient age, complexity of heart disease, type of anesthesia or PGE1 dependence.

A case of subdural hematoma in patient with chronic myeloid leukemia treated with high-dose imatinib mesylate

Imatinib mesylate (IM) is used to treat a wide range of diseases, including Philadelphia chromosome-positive chronic myeloid leukemia (CML), on account of its high tolerability and low incidence of minor adverse events. Hemorrhage is thought to be a rare complication of IM. Recently, IM has been associated with reduced α2-plasmin inhibitor and platelet dysfunction. We report here the case of a 33-year-old female patient with CML who experienced subdural hematoma after an incremental increase in IM dosage due to a loss of complete molecular response. This case indicates that physicians should be alert to this atypical cause of headache in patients taking high-dose IM.