Abstract:
INTRODUCTION:Checkpoint inhibitor drugs including ipilimumab have been reported to induce intestinal injury. OBJECTIVE:We aimed to evaluate the risk of chronic (> 6 weeks) enterocolitis following ipilimumab administration, and the likelihood that an enteritis vs colitis or enterocolitis is seen. PATIENTS AND METHODS:We searched MEDLINE, EMBASE, CENTRAL, the World Health Organization International Clinical Trials Registry, and conference proceedings. We included: (1) randomized controlled trials comparing ipilimumab administration with placebo/standard care/other active chemotherapy regimens and (2) prospective observational studies. Separate meta-analyses were performed for randomized controlled trials and observational studies. RESULTS:Of 4760 records, we included ten unique randomized controlled trials (n = 5814 subjects) and 34 unique prospective observational studies (n = 3699 subjects). In randomized controlled trials, the pooled relative risk of ≥ grade 3 enterocolitis or ≥ grade 3 diarrhea associated with ipilimumab was 13.31 (95% confidence interval 6.01-29.48, I2 = 0%, ten trials) and 6.72 (95% confidence interval 3.30-13.65, I2 = 63%, ten trials), respectively. In observational studies, the 3-monthly risk of developing grade 3 or higher enteritis, colitis, or enterocolitis was 4% (95% confidence interval 3-7, I2 = 77.40%, 25 studies). Randomized controlled trials and observational studies did not distinguish between acute and chronic enterocolitis. Of the included observational studies, the pooled risk of incurring small bowel involvement associated with ipilimumab was 1% (95% CI 0-4, I2 = 0%, four studies) per every 3-month time period. CONCLUSIONS:Insufficient data exist to quantify or distinguish the risk of acute vs chronic enterocolitis following ipilmumab use. Because of the serious impact of chronic enterocolitis on quality of life and further cancer treatment, future trials evaluating the safety of immunotherapy should report gastrointestinal events in greater detail.
journal_name
Drug Safjournal_title
Drug safetyauthors
Witges K,Shafer LA,Zarychanski R,Abou-Setta AM,Rabbani R,Dingwall O,Bernstein CNdoi
10.1007/s40264-020-00979-4subject
Has Abstractpub_date
2020-12-01 00:00:00pages
1255-1266issue
12eissn
0114-5916issn
1179-1942pii
10.1007/s40264-020-00979-4journal_volume
43pub_type
杂志文章,评审相关文献
DRUG SAFETY文献大全abstract:BACKGROUND:Thorough QT studies are typically conducted for drugs with systemic bioavailability and include a positive control, typically moxifloxacin, with a well-described QTc effect. OBJECTIVE:This study tested two hypotheses: that (i) re-measuring the QT intervals based on electrocardiogram (ECG) pattern similarity...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-014-0142-2
更新日期:2014-03-01 00:00:00
abstract::Drug eruptions are among the most common adverse drug reactions, affecting approximately 3% of hospitalised patients. Although the rate of severe cutaneous adverse reactions to medications is low, these reactions can affect anyone who takes medication, and can result in death or disability. Two general patterns can be...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200730110-00003
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:The roll out of various public health programmes involving mass administration of medicines calls for the deployment of responsive pharmacovigilance systems to permit identification of signals of rare or even common adverse reactions. In developing countries in Africa, these systems are mostly absent and the...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200831100-00005
更新日期:2008-01-01 00:00:00
abstract::The main goal of pharmacological research in the field of topical corticosteroids (TCs) is to dissociate efficacy and adverse effects as much as possible. The optimal use of TCs, i.e. the careful evaluation of the benefit/risk ratio, depends on: (i) the chemical structure of the TC; (ii) the type of vehicle; (iii) the...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199410050-00005
更新日期:1994-05-01 00:00:00
abstract::Bisphosphonates are the primary pharmacological agents used for the management of osteoporosis and hypercalcaemia of malignant bone disease. The efficacy of these agents in these two conditions has been demonstrated in many well designed trials published over the past 2 decades. The variety of bisphosphonates currentl...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200629120-00005
更新日期:2006-01-01 00:00:00
abstract::Epilepsy is one of the most common neurological disorders. Even though existing antiepileptic drugs can render 80% of newly diagnosed patients seizure free, a significant number of patients have chronic intractable epilepsy causing disability with considerable socioeconomic implications. There is, therefore, a need fo...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199411010-00005
更新日期:1994-07-01 00:00:00
abstract::Cutaneous adverse drug reactions are a frequent occurrence and have been reported in more than 2% of hospitalised patients. Among the most commonly involved drugs are sulphonamides, penicillins, anticonvulsants and non-steroidal anti-inflammatory drugs. Two groups of mechanisms are involved in the pathogenesis of drug...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199005010-00005
更新日期:1990-01-01 00:00:00
abstract::Although travellers' diarrhoea can sometimes be associated with postinfectious complications, the condition is typically self-limiting. The infectious-diarrhoea guidelines subcommittees of the Infectious Disease Society of America and the American College of Gastroenterology recommend empirical antibacterial therapy f...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200629030-00004
更新日期:2006-01-01 00:00:00
abstract::While classifications into generations according to antimicrobial activity has helped clinicians incorporate the increasing number of cephalosporins into their pharmacological repertoire, adverse effects among the different agents fail to follow similar categories. In general, cephalosporins are fairly well tolerated ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199309020-00005
更新日期:1993-08-01 00:00:00
abstract:BACKGROUND:The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11319000-000000000-00000
更新日期:2010-02-01 00:00:00
abstract::NSAIDs are widely used to treat pain and inflammation in osteoarthritis. Their use in this indication is generally intermittent and fluctuates with the intensity of the disease. Nonetheless, success of the therapy is frequently limited by injury to the gastrointestinal mucosa and complications such as bleeding, ulcera...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200427030-00003
更新日期:2004-01-01 00:00:00
abstract:INTRODUCTION:Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9Is) were associated with a risk of neurocognitive adverse drug reactions (ADRs). OBJECTIVE:We aimed to investigate the occurrence of neuropsychiatric ADRs related to PCSK9Is. METHODS:We analyzed Individual Case Safety Reports (ICSRs) sent thr...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-020-01021-3
更新日期:2020-12-22 00:00:00
abstract:BACKGROUND:Newly approved drugs, in comparison with older drugs, are more often prescribed to patients who have not responded satisfactorily to established related drugs or as first-line therapy to patients with a high baseline risk for adverse outcomes (i.e. channelling). However, these patients are less likely to ben...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200831020-00004
更新日期:2008-01-01 00:00:00
abstract::Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated. ...
journal_title:Drug safety
pub_type: 杂志文章,已发布勘误
doi:10.1007/s40264-018-0672-0
更新日期:2018-08-01 00:00:00
abstract::Clinical and pathophysiological differences between Japanese and Caucasian patients are observed in many aspects of heart disease. Indeed, data derived from studies in one population cannot be automatically extrapolated to the other. The therapeutic goal of heart failure has recently been aimed at improving mortality ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200427001-00004
更新日期:2004-01-01 00:00:00
abstract:INTRODUCTION:Pharmacovigilance includes analysis of large databases of information on drugs and events using algorithms that detect disproportional frequencies of associations. In order to test such algorithms, attempts have been made to provide canonical reference lists of so-called 'positive controls' and 'negative c...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0392-2
更新日期:2016-05-01 00:00:00
abstract:BACKGROUND:For many regularly used drugs, evidence for safe use in pregnancy has not been established. Despite this, international studies have identified high levels of drug prescribing among pregnant women. OBJECTIVE:To investigate the patterns of prescribing of drugs to women who gave birth in Tayside, Scotland, in...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11532330-000000000-00000
更新日期:2010-07-01 00:00:00
abstract:INTRODUCTION:Non-steroidal anti-inflammatory drugs are associated with a dose and duration-dependent coronary risk. There is little information concerning analgesic-dose ibuprofen, among the most widely used drugs worldwide. OBJECTIVE:Our objective was to measure the risks of acute coronary syndrome (ACS) after dispen...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-018-0686-7
更新日期:2018-11-01 00:00:00
abstract::The New Zealand Intensive Medicines Monitoring Programme (IMMP) undertakes prospective observational cohort studies on selected new drugs in the early postmarketing period using prescription-event monitoring (PEM) methodology with the purpose of identifying signals of previously unrecognised ADRs and establishing risk...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200225060-00007
更新日期:2002-01-01 00:00:00
abstract:INTRODUCTION:Controversy exists about an association between angiotensin-converting-enzyme inhibitors (ACEIs), angiotensin-receptor blockers (ARBs), and thiazides (TZs) and the risk of malignant melanoma (MM), and non-melanoma skin cancer-basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). OBJECTIVE:The aim ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0487-9
更新日期:2017-03-01 00:00:00
abstract::Betahistine is a structural analogue of histamine that is prescribed for the treatment of vestibular disorders such as Ménière's disease and the symptomatic treatment of vertigo. It is estimated from sales information that >130 million patients have been exposed to the drug since its registration in 1968. In this revi...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200629110-00004
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:Pioglitazone is an antidiabetic drug that belongs to the thiazolidinedione (TZD) class of insulin-sensitizing agents. Adverse events to pioglitazone of potential severity are listed in the 'special warnings and special precautions for use' section of the pioglitazone summary of product characteristics (SPC),...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200932030-00005
更新日期:2009-01-01 00:00:00
abstract:INTRODUCTION:The Bradford Hill criteria are a widely used, useful tool for the assessment of biomedical causation. We have examined their application to pharmacovigilance using the example of cisapride-induced QTc interval prolongation/arrhythmia. METHODS:A literature search was conducted using MEDLINE, EMBASE, Reacti...
journal_title:Drug safety
pub_type: 杂志文章,meta分析
doi:10.2165/00002018-200730040-00006
更新日期:2007-01-01 00:00:00
abstract:OBJECTIVE:During proton pump inhibitor (PPI) use, in clinical trials, headache is one of the most frequently reported adverse events (frequency 1.3 to 8.8%), while results of one observational study indicate that headache is the fifth most frequently reported adverse event (incidence densities 2.5 to 4.6 per 1000 patie...
journal_title:Drug safety
pub_type: 临床试验,杂志文章
doi:10.2165/00002018-200225040-00005
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND:It has been shown that the abrupt cessation of treatment with beta-adrenoceptor antagonists (beta-blockers) increases the risk of myocardial infarction in patients with hypertension. As beta-blockers differ in their pharmacokinetic and pharmacodynamic properties, this risk of discontinuation might also diffe...
journal_title:Drug safety
pub_type: 临床试验,杂志文章
doi:10.2165/00002018-200730060-00008
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Depressive disorders and use of antidepressants are associated with adverse effects on sexual function. In pharmacoepidemiological studies, sexual disorders are reported by more than 50 % of patients taking serotonin reuptake inhibitors (SRIs). OBJECTIVE:The aim of this study was to determine the reporting ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-013-0069-z
更新日期:2013-07-01 00:00:00
abstract:INTRODUCTION:There are few studies assessing how data on adverse drug events from consumers on social media compare with other sources. AIM:The aim of this study was to assess the consistency of adverse event data of statin medications from social media as compared with other sources. METHODS:We collected data on the...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-020-00998-1
更新日期:2021-02-01 00:00:00
abstract::Histone deacetylases (HDACs) are expressed at increased levels in cells of various malignancies, and the use of HDAC inhibitors has improved outcomes in patients with haematological malignancies (T-cell lymphomas and multiple myeloma). However, they are not as effective in solid tumours. Five agents are currently appr...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-018-0773-9
更新日期:2019-02-01 00:00:00
abstract::Drug safety is not a matter for healthcare professionals alone. Patients are also involved, at three different levels: (i) in the behaviours patients adopt to reduce the adverse effects of the drugs; (ii) in regard to what some doctors say to their patients about drug risks; and (iii) in what the pharmaceutical indust...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/11538320-000000000-00000
更新日期:2010-08-01 00:00:00
abstract::The prognosis is generally poor for patients who experience a cardiac arrest. The most common causes of sudden cardiac arrest are massive pulmonary embolism (PE) and acute myocardial infarction (MI). While thrombolysis is a first-line treatment option in massive PE and acute MI, cardiopulmonary resuscitation (CPR) has...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200326060-00001
更新日期:2003-01-01 00:00:00