Drug-induced Adverse Events

Off-Label Medication in Children: Responsibilities of Pediatrician and Neonatologist.

Fri, 2019-06-07 14:17
Related Articles

Off-Label Medication in Children: Responsibilities of Pediatrician and Neonatologist.

Mymensingh Med J. 2018 Oct;27(4):912-916

Authors: Das JC, Hossain MA, Shahidullah M, Mannan MA

Abstract
Use of drug in pediatrics and neonatology should be rational. There are clinical situations when the use of unlicensed medicines or use of medicines outside the terms of license (i.e., 'off-label') may be judged by prescriber in the best interest of the patient. Off-label prescribing is clinically appropriate when the benefits outweigh the potential risks. Such practice is particularly common in pediatrics and neonatology where development of age-appropriate formulations is difficult. Before going to prescribe a drug on off-label basis, the clinician should be satisfied that an alternative medicine would not meet the patient's needs. The clinician should be satisfied that there is sufficient evidence base safety and efficacy on off-label drug use. Communication with legal guardian with sufficient information about proposed treatment is needed. The clinician has a responsibility to monitor the off-label use of drug. He should submit a report on suspected adverse drug reactions if he observes to the authorized body.

PMID: 30487515 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Applying DoTS adverse drug reactions classification to reports from hospital stimulated reporting.

Fri, 2019-06-07 14:17
Related Articles

Applying DoTS adverse drug reactions classification to reports from hospital stimulated reporting.

Eur J Clin Pharmacol. 2019 Mar;75(3):433-435

Authors: Farcas A, Bulik NB, Popa A, Mensah Achampong A, Bucsa C, Mogosan C

Abstract

PMID: 30415300 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Medication errors resulting in harm: Using chargemaster data to determine association with cost of hospitalization and length of stay.

Fri, 2019-06-07 14:17
Related Articles

Medication errors resulting in harm: Using chargemaster data to determine association with cost of hospitalization and length of stay.

Am J Health Syst Pharm. 2017 Dec 01;74(23 Supplement 4):S102-S107

Authors: McCarthy BC, Tuiskula KA, Driscoll TP, Davis AM

Abstract
PURPOSE: Results of an analysis of the economic impact of adverse drug events (ADEs) resulting in patient harm on hospitalization costs and length of stay (LOS) are reported.
METHODS: In a retrospective single-site study, medication errors among patients admitted to an academic medical center during the period April 2014-May 2015 were identified using voluntary event reporting system data and diagnosis codes. Hospitalization cases involving documented ADEs resulting in harm, as defined on a widely used medication error classification index, were matched with control cases by admission period, diagnosis-related group, and patient age and sex. Total hospitalization costs and LOS in the study groups were analyzed using an independent 2-sample Mann-Whitney U test.
RESULTS: Among 416 hospitalization cases evaluated for inclusion in the study, 242 were matched with 3,279 control cases for analysis. The primary drug classes implicated in the evaluated medication errors included chemotherapy agents (38%), corticosteroids (14%), and opioids (11%). Total hospitalization costs differed significantly (p = 0.044) between patients who experienced ADEs resulting in harm (median, $19,444; interquartile range [IQR], $13,481-$40,580) and those who did not (median, $17,173; IQR, $12,500-$27,125); the former group also had a significantly (p = 0.005) longer median LOS.
CONCLUSION: Chargemaster data for an academic medical center revealed that the median total hospitalization cost and LOS were significantly greater for hospitalizations during which a harm-causing medication error was recorded versus hospitalizations during which harm-causing medication errors were not recorded.

PMID: 29167147 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Workshop on evaluation of pediatric long-term neurocognitive development and medical products.

Fri, 2019-06-07 14:17
Related Articles

Workshop on evaluation of pediatric long-term neurocognitive development and medical products.

Pharmacoepidemiol Drug Saf. 2017 11;26(11):1428-1430

Authors: McMahon AW, Kapcala LP, Sheridan PH

PMID: 28924994 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Iatrogeniа in internist practice.

Thu, 2019-06-06 07:30
Related Articles

Iatrogeniа in internist practice.

Ter Arkh. 2019 Mar 14;91(1):129-136

Authors: Dvoretsky LI

Abstract
The article presents the history of the issue, the concept of iatrogenia, possible negative consequences of the interaction of the doctor and the patient in modern conditions. The main forms of iatrogenic (psychogenic, hospital, iatrogenic diagnostic procedures, medicinal, etc.) are given. An important place is occupied by implantation of iatrogenic (patients with artificial heart valves, cardio-implanted electronic devices, coronary stents, articular endoprostheses). The most vulnerable to the development of iatrogenic are elderly and senile patients. The interdisciplinarity of the iatrogenic problem and its educational significance for therapists, general practitioners, clinical pharmacologists, pathologists. Keywords: iatrogeniа, iatrogenic events, undesirable drug reactions, мedical error.

PMID: 31090383 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Role of healthcare databases and registries for surveillance of orphan drugs in the real-world setting: the Italian case study.

Thu, 2019-06-06 07:30
Related Articles

Role of healthcare databases and registries for surveillance of orphan drugs in the real-world setting: the Italian case study.

Expert Opin Drug Saf. 2019 Jun;18(6):497-509

Authors: Crisafulli S, Sultana J, Ingrasciotta Y, Addis A, Cananzi P, Cavagna L, Conter V, D'Angelo G, Ferrajolo C, Mantovani L, Pastorello M, Scondotto S, Trifirò G

Abstract
Introduction: Orphan drugs are medicines intended to treat, prevent, or diagnose a rare and serious condition. The collection of pre-marketing safety and efficacy data for orphan drugs is very challenging for several reasons related to the rarity of the diseases. This highlights the need for robust post-marketing evidence generation. Real-world data sources, such as claims databases, electronic healthcare records, and disease and drug registers, have an important role in studying orphan drugs. The availability and usefulness of such resources vary from country to country. Areas covered: A detailed description of the available real-world data sources and their contribution to generating post-marketing evidence on orphan drug benefit-risk profile in Italy is provided. Expert opinion: Despite their considerable potential for rare disease research, the available Italian data sources are currently under-used and require further harmonization of data collection. The establishment of large structured and integrated nationwide data sources, tailored to respond to both research as well as regulatory requirements, is necessary to provide clinically useful information on orphan drugs as well. Such data sources should also be more accessible at the loco-regional, national and international level.

PMID: 31059293 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Fifteen years of patient reporting -what have we learned and where are we heading to?

Thu, 2019-06-06 07:30
Related Articles

Fifteen years of patient reporting -what have we learned and where are we heading to?

Expert Opin Drug Saf. 2019 Jun;18(6):477-484

Authors: van Hunsel F, Härmark L, Rolfes L

Abstract
Introduction: In April 2003, the Netherlands Pharmacovigilance Centre Lareb successfully implemented patient reporting to their spontaneous reporting system. The number of reports by patients rapidly grew, prompting the need to evaluate the value of the patient reporting scheme and to compare experiences with other countries. The aim of this article is to summarize our 15-year experience of working with direct patient reporting in pharmacovigilance and to discuss necessary steps in order to optimize the use of patient reports in the future. Areas covered: This article is based on Lareb studies on patient reporting from 2004 onwards and covers the evolution of the Dutch patient reporting system, the value of patient participation in pharmacovigilance, the impact of patient reporting on the spontaneous reporting system and future steps to strengthen patient reporting. Expert opinion: After 15 years of experience with patient reporting we conclude that patients can add value to pharmacovigilance. We recognize that there is a big leap between allowing patients to report and actual patient involvement in pharmacovigilance. It is our belief that increased patient involvement in pharmacovigilance is a way to improve pharmacovigilance, enhancing the general public's trust in medicines.

PMID: 31030578 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Analysis of Pleiotropic Effects of Nivolumab in Pretreated Advanced or Recurrent Non-small Cell Lung Cancer Cases.

Thu, 2019-06-06 07:30
Related Articles

Analysis of Pleiotropic Effects of Nivolumab in Pretreated Advanced or Recurrent Non-small Cell Lung Cancer Cases.

In Vivo. 2019 Mar-Apr;33(2):507-514

Authors: Akano Y, Kuribayashi K, Funaguchi N, Koda Y, Fujimoto E, Mikami K, Minami T, Takahashi R, Yokoi T, Kijima T

Abstract
BACKGROUND/AIM: Nivolumab is an immune checkpoint inhibitor for advanced non-small cell lung cancer (NSCLC). We investigated the safety and efficacy of nivolumab by analyzing the response factor, adverse effects (AE), and the post-treatment condition of pretreated advanced or recurrent NSCLC patients.
PATIENTS AND METHODS: Nivolumab (3 mg/kg) was administered to 79 pre-treated NSCLC patients from December 2015 to January 2018. Nivolumab efficacy and AE were assessed using the Response Evaluation Criteria in Solid Tumors and the Common Terminology Criteria, respectively.
RESULTS: Progression-free survival (PFS) was significantly prolonged in cases where the therapeutic effect of the pretreatment was a partial response (p=0.0004). Five cases (6.3%) experienced grade 3-4 AEs. PFS was significantly prolonged in the skin rash group versus the non-skin rash group, and in patients where nivolumab treatment was discontinued.
CONCLUSIONS: Long-term survival was observed in patients with skin rash. Therapeutic effect of nivolumab immediately following its administration appears to be favorable for survival.

PMID: 30804134 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Factors associated with drug interactions in elderly hospitalized in high complexity hospital.

Thu, 2019-06-06 07:30
Related Articles

Factors associated with drug interactions in elderly hospitalized in high complexity hospital.

Cien Saude Colet. 2019 Jan;24(1):17-26

Authors: Veloso RCSG, Figueredo TP, Barroso SCC, Nascimento MMGD, Reis AMM

Abstract
This study aims to determine the frequency of potential drug-drug interactions (PDI) in hospitalized elderly and associated factors. This is a cross-sectional study in a teaching hospital. The dependent variable was the occurrence of potential drug interactions identified using DrugReax software. Patients with adverse drug reactions (ADR) related to clinical manifestations of PDIs were also identified. Multivariate logistic regressions was performed to analyze the association between the occurrence of PDIs and independent variables. In total, 237 older adults were included in the study. The prevalence of PDIs and interaction-related ADRs was 87.8% and 6.8%, respectively. The multivariate analysis showed a positive association between the detection of PDIs (OR 8.6; 95% CI, 2.5-30.0), and hospitalization due to a diagnosed circulatory system disease and number of medications > 14 (OR 9.8; 95% CI, 2.8-34.3%). The study showed a high prevalence of PDIs in the drug treatment of the elderly, but a lower prevalence of ADRs, as well as a positive association between PDIs and hospitalization due to a diagnosed circulatory system disease and number of medications > 14. The identification of factors associated with PDIs guides prevention measures for people that are more exposed to adverse events.

PMID: 30698236 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

A randomised controlled trial of vaporised Δ9-tetrahydrocannabinol and cannabidiol alone and in combination in frequent and infrequent cannabis users: acute intoxication effects.

Thu, 2019-06-06 07:30
Related Articles

A randomised controlled trial of vaporised Δ9-tetrahydrocannabinol and cannabidiol alone and in combination in frequent and infrequent cannabis users: acute intoxication effects.

Eur Arch Psychiatry Clin Neurosci. 2019 Feb;269(1):17-35

Authors: Solowij N, Broyd S, Greenwood LM, van Hell H, Martelozzo D, Rueb K, Todd J, Liu Z, Galettis P, Martin J, Murray R, Jones A, Michie PT, Croft R

Abstract
Access to cannabis and cannabinoid products is increasing worldwide for recreational and medicinal use. Two primary compounds within cannabis plant matter, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), are both psychoactive, but only THC is considered intoxicating. There is significant interest in potential therapeutic properties of these cannabinoids and of CBD in particular. Some research has suggested that CBD may ameliorate adverse effects of THC, but this may be dose dependent as other evidence suggests possible potentiating effects of THC by low doses of CBD. We conducted a randomised placebo controlled trial to examine the acute effects of these compounds alone and in combination when administered by vaporisation to frequent and infrequent cannabis users. Participants (n = 36; 31 male) completed 5 drug conditions spaced one week apart, with the following planned contrasts: placebo vs CBD alone (400 mg); THC alone (8 mg) vs THC combined with low (4 mg) or high (400 mg) doses of CBD. Objective (blind observer ratings) and subjective (self-rated) measures of intoxication were the primary outcomes, with additional indices of intoxication examined. CBD showed some intoxicating properties relative to placebo. Low doses of CBD when combined with THC enhanced, while high doses of CBD reduced the intoxicating effects of THC. The enhancement of intoxication by low-dose CBD was particularly prominent in infrequent cannabis users and was consistent across objective and subjective measures. Most effects were significant at p < .0001. These findings are important to consider in terms of recommended proportions of THC and CBD in cannabis plant matter whether used medicinally or recreationally and have implications for novice or less experienced cannabis users.Trial registration: ISRCTN Registry Identifier: ISRCTN24109245.

PMID: 30661105 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Early Detection of Adverse Drug Reactions in Social Health Networks: A Natural Language Processing Pipeline for Signal Detection.

Wed, 2019-06-05 09:57
Related Articles

Early Detection of Adverse Drug Reactions in Social Health Networks: A Natural Language Processing Pipeline for Signal Detection.

JMIR Public Health Surveill. 2019 Jun 03;5(2):e11264

Authors: Nikfarjam A, Ransohoff JD, Callahan A, Jones E, Loew B, Kwong BY, Sarin KY, Shah NH

Abstract
BACKGROUND: Adverse drug reactions (ADRs) occur in nearly all patients on chemotherapy, causing morbidity and therapy disruptions. Detection of such ADRs is limited in clinical trials, which are underpowered to detect rare events. Early recognition of ADRs in the postmarketing phase could substantially reduce morbidity and decrease societal costs. Internet community health forums provide a mechanism for individuals to discuss real-time health concerns and can enable computational detection of ADRs.
OBJECTIVE: The goal of this study is to identify cutaneous ADR signals in social health networks and compare the frequency and timing of these ADRs to clinical reports in the literature.
METHODS: We present a natural language processing-based, ADR signal-generation pipeline based on patient posts on Internet social health networks. We identified user posts from the Inspire health forums related to two chemotherapy classes: erlotinib, an epidermal growth factor receptor inhibitor, and nivolumab and pembrolizumab, immune checkpoint inhibitors. We extracted mentions of ADRs from unstructured content of patient posts. We then performed population-level association analyses and time-to-detection analyses.
RESULTS: Our system detected cutaneous ADRs from patient reports with high precision (0.90) and at frequencies comparable to those documented in the literature but an average of 7 months ahead of their literature reporting. Known ADRs were associated with higher proportional reporting ratios compared to negative controls, demonstrating the robustness of our analyses. Our named entity recognition system achieved a 0.738 microaveraged F-measure in detecting ADR entities, not limited to cutaneous ADRs, in health forum posts. Additionally, we discovered the novel ADR of hypohidrosis reported by 23 patients in erlotinib-related posts; this ADR was absent from 15 years of literature on this medication and we recently reported the finding in a clinical oncology journal.
CONCLUSIONS: Several hundred million patients report health concerns in social health networks, yet this information is markedly underutilized for pharmacosurveillance. We demonstrated the ability of a natural language processing-based signal-generation pipeline to accurately detect patient reports of ADRs months in advance of literature reporting and the robustness of statistical analyses to validate system detections. Our findings suggest the important contributions that social health network data can play in contributing to more comprehensive and timely pharmacovigilance.

PMID: 31162134 [PubMed]

Categories: Literature Watch

Contrast media and cutaneous reactions. Part 2: Delayed hypersensitivity reactions to iodinated contrast media.

Wed, 2019-06-05 06:52

Contrast media and cutaneous reactions. Part 2: Delayed hypersensitivity reactions to iodinated contrast media.

Clin Exp Dermatol. 2019 Jun 04;:

Authors: Tasker F, Fleming H, McNeill G, Creamer D, Walsh S

Abstract
Contrast media (CM) are an indispensable part of modern medical imaging. Adverse reactions to CM are uncommon, but frequently involve cutaneous symptoms. This two-part article reviews adverse events secondary to CM that are relevant to the practising dermatologist. Part 1 covers the classification of CM, immediate hypersensitivity reactions to CM and the newly described condition, gadolinium deposition disease. Given that there has only been two case reports to our knowledge of a delayed adverse reaction to gadolinium-based CM, this second part will focus on cutaneous delayed reactions caused by iodinated CM (ICM). Delayed hypersensitivity reactions to ICM commonly present as maculopapular exanthems, but more rarely, they can manifest as fixed drug eruptions, acute generalized exanthematous pustulosis, drug-related eosinophilia and systemic symptoms, Stevens-Johnson syndrome/toxic epidermal necrolysis, symmetrical drug-related intertriginous and flexural exanthema, graft-versus-host disease, vasculitis and iododerma. Delayed reactions to ICM may be underdiagnosed, as cutaneous symptoms may be attributed to oral medications, particularly if patients are on multiple drugs.

PMID: 31162717 [PubMed - as supplied by publisher]

Categories: Literature Watch

Smoothing dense spaces for improved relation extraction between drugs and adverse reactions.

Wed, 2019-06-05 06:52
Related Articles

Smoothing dense spaces for improved relation extraction between drugs and adverse reactions.

Int J Med Inform. 2019 Aug;128:39-45

Authors: Santiso S, Pérez A, Casillas A

Abstract
BACKGROUND AND OBJECTIVE: This work aims at extracting Adverse Drug Reactions (ADRs), i.e. a harm directly caused by a drug at normal doses, from Electronic Health Records (EHRs). The lack of readily available EHRs because of confidentiality issues and their lexical variability make the ADR extraction challenging. Furthermore, ADRs are rare events. Therefore, efficient representations against data sparsity are needed.
METHODS: Embedding-based characterizations are able to group semantically related words. However, dense spaces suffer from data sparsity. We employed context-aware continuous representations to enhance the modelling of infrequent events through their context and we turned to simple smoothing techniques to increase the proximity between similar words (e.g. direction cosines, truncation, Principal Component Analysis (PCA) and clustering) in an attempt to cope with data sparsity.
RESULTS: An F-measure of 0.639 for the ADR classification was achieved, obtaining an improvement of approximately 0.300 in comparison with the results obtained by a word-based characterization.
CONCLUSION: The embbeding-based representation together with the smoothing techniques increased the robustness of the ADR characterization. It was proven particularly appropriate to cope with lexical variability and data sparsity.

PMID: 31160010 [PubMed - in process]

Categories: Literature Watch

[Efficacy and safety of tocilizumab in patients with Takayasu arteritis].

Wed, 2019-06-05 06:52
Related Articles

[Efficacy and safety of tocilizumab in patients with Takayasu arteritis].

Zhonghua Nei Ke Za Zhi. 2019 Jun 01;58(6):444-448

Authors: Liao H, Pan LL, Du J, Gao N, Wang T

Abstract
Objective: To assess the efficacy and safety of tocilizumab and cyclophosphamide in patients with Takayasu arteritis (TA). Methods: Twenty-seven TA patients treated with tocilizumab (TCZ group) and 22 treated with cyclophosphamide (CTX group) were enrolled and retrospectively analyzed. The duration of treatment was 6 months. Disease activity and side effects were compared between the two groups. Results: After treatment, the median C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and disease activity scores in TCZ group were significantly lower than those in CTX group respectively [ESR 3 mm/1h vs. 8 mm/1h; CRP 0.13 mg/L vs. 1.09 mg/L; National Institutes of Health (NIH) score 0(0,1) vs. 0(1,1); the Indian Takayasu clinical activity score (ITAS 2010) 0(0,2) vs. 2(0,3.5), and the Indian Takayasu activity score with the acute phase response (ITAS-A) 0(0,2) vs. 2.5(0,3.5); all P<0.05]. The daily prednisone doses before treatment and after treatment in TCZ group were significantly lower than those in CTX group [(20.1±15.9) mg/d vs. (39.3±16.7) mg/d;(5.1±4.2)mg/d vs. (12.1±4.6) mg/d,both P<0.05)].The incidence of drug-related side effects in TCZ group was significantly lower than that in CTX group, which was 22.2% vs. 54.5% (P<0.05). Conclusion: Compared with CTX treatment, TCZ treatment for TA with less prednisone has better efficacy and safety.

PMID: 31159524 [PubMed - in process]

Categories: Literature Watch

Effect of a Pharmacist-Driven Medication Management Intervention Among Older Adults in an Inpatient Setting.

Wed, 2019-06-05 06:52
Related Articles

Effect of a Pharmacist-Driven Medication Management Intervention Among Older Adults in an Inpatient Setting.

Drugs Aging. 2019 04;36(4):371-378

Authors: Alosaimy S, Vaidya A, Day K, Stern G

Abstract
BACKGROUND: Older adults have a seven times greater risk than younger adults of being hospitalized due to an adverse drug event.
OBJECTIVE: The objective of this study was to compare the number of potentially inappropriate medications (PIMs) on admission to the number of PIMs on discharge following pharmacist intervention.
PATIENTS AND METHODS: This was a prospective, single-center pilot study performed at a tertiary medical center. Eighty-two adults aged 65 years or older on five or more medications who were admitted to the general medicine floor between December 2016 and May 2017 were included in the analysis. Pharmacists completed a review of prior admission medications and identified PIMs. Recommendations for PIMs were communicated to the medical team and documented in the patient's electronic medical record. PIMs were measured by the use of validated screening tools and an assessment of patient-specific parameters.
RESULTS: Fifty-two percent of our patients were taking at least one PIM. The average number of PIMs on admission was found to be 0.84 ± 1.12. Pharmacist intervention resulted in a statistically significant reduction to an average of 0.56 ± 0.91 PIMs (P < 0.01). The mean time to complete the medication therapy management (MTM) process was 49.39 ± 16.2 min per patient.
CONCLUSION: While pharmacist-driven MTM significantly reduced PIMs in our study, the implementation of this model in the inpatient setting faces several challenges.

PMID: 30671871 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Flushing Disorders Associated with Gastrointestinal Symptoms: Part 2, Systemic Miscellaneous Conditions.

Wed, 2019-06-05 06:52
Related Articles

Flushing Disorders Associated with Gastrointestinal Symptoms: Part 2, Systemic Miscellaneous Conditions.

Clin Med Res. 2018 06;16(1-2):29-36

Authors: Rastogi V, Singh D, Mazza JJ, Parajuli D, Yale SH

Abstract
Flushing disorders with involvement of the gastrointestinal tract represent a heterogeneous group of conditions. In part 1 of this review series, neuroendocrine tumors (NET), mast cell activation disorders (MCAD), and hyperbasophilia were discussed. In this section we discuss the remaining flushing disorders which primarily or secondarily involve the gastrointestinal tract. This includes dumping syndrome, mesenteric traction syndrome, rosacea, hyperthyroidism and thyroid storm, anaphylaxis, panic disorders, paroxysmal extreme pain disorder, and food, alcohol and medications. With the exception of paroxysmal pain disorders, panic disorders and some medications, these disorders presents with dry flushing. A detailed and comprehensive family, social, medical and surgical history, as well as recognizing the presence of other systemic symptoms are important in distinguishing the different disease that cause flushing with gastrointestinal symptoms.

PMID: 29650526 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Sacral Neuromodulation for Refractory Bladder Pain Syndrome/Interstitial Cystitis: a Global Systematic Review and Meta-analysis.

Wed, 2019-06-05 06:52
Related Articles

Sacral Neuromodulation for Refractory Bladder Pain Syndrome/Interstitial Cystitis: a Global Systematic Review and Meta-analysis.

Sci Rep. 2017 09 08;7(1):11031

Authors: Wang J, Chen Y, Chen J, Zhang G, Wu P

Abstract
Bladder pain syndrome/interstitial cystitis (BPS/IC) is a common debilitating disease and there has not been consistently effective treatment. We aimed to evaluate all available literature regarding the efficacy and safety of sacral neuromodulation (SNM) for refractory BPS/IC. A comprehensive search of Pubmed, Web of Science and Cochrane Library through May 2016 was conducted. A total of 17 studies enrolling 583 patients were identified. Pooled analyses demonstrated that SNM was associated with great reduction in pelvic pain (weighted mean difference [WMD] -3.99; 95% confidence interval [CI] -5.22 to -2.76; p < 0.00001), Interstitial Cystitis Problem and Symptom Index scores (WMD -6.34; 95% CI -9.57 to -3.10; p = 0.0001; and WMD -7.17; 95% CI -9.90 to -4.45; p < 0.00001, respectively), daytime frequency (WMD -7.45; 95% CI -9.68 to -5.22; p < 0.00001), nocturia (WMD -3.01; 95% CI -3.56 to -2.45; p < 0.00001), voids per 24 hours (WMD -9.32; 95% CI -10.90 to -7.74; p < 0.00001) and urgency (WMD -1.08; 95% CI -1.79 to -0.37; p = 0.003) as well as significant improvement in average voided volume (WMD 95.16 ml; 95% CI 63.64 to 126.69; p < 0.0001). The pooled treatment success rate was 84% (95% CI 76% to 91%). SNM-related adverse events were minimal. Current evidence indicates that SNM might be effective and safe for treating refractory BPS/IC.

PMID: 28887515 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +15 new citations

Tue, 2019-06-04 09:22

15 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2019/06/04

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Categories: Literature Watch

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +15 new citations

Tue, 2019-06-04 06:00

15 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2019/06/04

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Categories: Literature Watch

Efficacy and safety of rituximab for relapsing-remitting multiple sclerosis: A systematic review and meta-analysis.

Mon, 2019-06-03 11:52
Related Articles

Efficacy and safety of rituximab for relapsing-remitting multiple sclerosis: A systematic review and meta-analysis.

Autoimmun Rev. 2019 May;18(5):542-548

Authors: Hu Y, Nie H, Yu HH, Qin C, Wu LJ, Tang ZP, Tian DS

Abstract
OBJECTIVE: To evaluate the efficacy and safety of rituximab for relapsing-remitting multiple sclerosis.
RESULTS: Fifteen studies that collectively included 946 patients were selected for the meta-analysis. Rituximab therapy was associated with the mean annualized relapse rates decreasing by 0.80 (95% confidence interval, 0.45-1.15) and the mean Expanded Disability Status Scale score decreasing by 0.46 (95% confidence interval, 0.05-0.87). The likelihood of patients experiencing a relapse after starting rituximab therapy was only 15% (95% confidence interval, 7%-26%). Although mild-to-moderate adverse events occurred in 29.6% of the patients, there were no severe adverse events.
CONCLUSIONS AND RELEVANCE: This systematic review and meta-analysis shows that rituximab is associated with reduced annualized relapse rates and disability levels in patients with relapsing-remitting multiple sclerosis. It is also well tolerated and is not associated with serious adverse events.

PMID: 30844555 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Pages