Drug-induced Adverse Events

Process quality indicators for chronic kidney disease risk management: a systematic literature review.

Sat, 2017-07-08 08:22
Related Articles

Process quality indicators for chronic kidney disease risk management: a systematic literature review.

Int J Clin Pract. 2016 Oct;70(10):861-869

Authors: Smits KP, Sidorenkov G, Bilo HJ, Bouma M, Navis GJ, Denig P

Abstract
BACKGROUND AND OBJECTIVES: Quality indicators (QIs) can be used for measuring the quality of actions of healthcare providers. This systematic review gives an overview of such QIs measuring processes of care for chronic kidney disease (CKD), and identifies the QIs that have content, face, operational and/or predictive validity.
METHODS: PubMed and Embase were searched using a strategy combining the terms "quality of care," "quality indicators" and "chronic kidney disease". Papers were included if they focused on developing, testing or applying QIs for assessing the quality of care in adult patients with CKD not on renal replacement therapy.
RESULTS: Two hundred and seventy-three QIs from thirty-one papers were extracted, including QIs on adequate monitoring of kidney function and vascular risk factors, on indicated treatment, drug safety, adherence and referral to a specialist. The QIs that were considered content, face and operational valid focused on monitoring of glomerular filtration rate, albumin-creatinine ratio, lipid levels and blood pressure, the use of non-steroidal anti-inflammatory drugs, nitrofurantoin and biphosphonates in patients with CKD, and QIs on monitoring haemoglobin and treatment with angiotensin-converting-enzyme-inhibitors/angiotensin-receptor-II-blockers in patients with CKD and comorbidities. No QIs were tested for predictive validity. In addition, only two QIs focused on diet and no other QIs focused on lifestyle management.
CONCLUSIONS: Based on this review, sufficiently validated QIs can be selected for measuring the quality of CKD care. This review provides insight in QIs that need further validation, and in areas of care where QIs are still lacking.

PMID: 27640992 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Comparison of a New In-House and Three Published HLA-B*15:02 Screening Methods for Prevention of Carbamazepine-Induced Severe Drug Reactions.

Sat, 2017-07-08 08:22
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Comparison of a New In-House and Three Published HLA-B*15:02 Screening Methods for Prevention of Carbamazepine-Induced Severe Drug Reactions.

PLoS One. 2016;11(5):e0155907

Authors: Jaruthamsophon K, Sripo T, Sukasem C, Limprasert P

Abstract
Currently, there are three published HLA-B*15:02 screening methods for prevention of carbamazepine-induced severe drug reactions in Asian populations. To analyze available HLA-B*15:02 screening methods, we compared four screening methods, including a multiplex PCR method, a nested PCR method, a LAMP method and our new in-house PCR-dot blot hybridization method. These methods were reviewed regarding their sensitivity, specificity, false positivity and technical considerations. Possible false positive (FP) alleles and genotypes were checked regarding the primers and probes designs, using the IMGT/HLA database. Expected FP rates in Asian populations were predicted using the Allele Frequencies Net Database. All methods had a sensitivity of more than 99.9%, although giving FP results to certain very rare alleles and genotypes. The multiplex PCR method was the only test that gave FP results to certain genotypes of HLA-B*15:13, the allele which is prevalent in Southeast Asian populations. In conclusion, the nested PCR, LAMP and our in-house methods could be applied in various Asian populations, but the multiplex PCR, or any test with FP to HLA-B*15:13, should be applied with caution in the Southeast Asian populations.

PMID: 27196420 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

New Perspectives in Rheumatology: Avoiding Antimalarial Toxicity.

Sat, 2017-07-08 08:22
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New Perspectives in Rheumatology: Avoiding Antimalarial Toxicity.

Arthritis Rheumatol. 2016 Aug;68(8):1805-9

Authors: Rosenbaum JT, Mount GR, Youssef J, Lin P

Abstract
This report inaugurates New Perspectives in Rheumatology, a series of authoritative articles that focus on recent scientific and clinical developments and their potential to reshape rheumatology practice. Anticipated topics include the implementation of new guidelines and emerging information from clinical and translational research. Richard J. Bucala, MD, PhDEditor-in-ChiefRobert Terkeltaub, MDCo-Editor and Review Article Editor.

PMID: 27111663 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Adverse effects of pneumonia on physical functioning in nursing home residents: Results from the INCUR study.

Sat, 2017-07-08 08:22
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Adverse effects of pneumonia on physical functioning in nursing home residents: Results from the INCUR study.

Arch Gerontol Geriatr. 2016 Jul-Aug;65:116-21

Authors: Hoogendijk EO, Del Campo N, Rolland Y, Demougeot L, Gérard S, Vellas B, Cesari M

Abstract
BACKGROUND: Pneumonia is a very common infection in the nursing home, but little is known about its effects on levels of individual functioning. The aim of this study was to examine adverse effects of pneumonia events on physical functioning in nursing home residents.
METHODS: Data were used from the INCUR study, a 1-year prospective cohort study of older residents from 13 nursing homes in France. The sample consisted of 716 residents, who were assessed at baseline, 6 and 12 months. Pneumonia diagnosis was based on clinical conditions documented in medical records. Physical functioning was measured by Activities of Daily Living (ADL). Longitudinal associations between pneumonia and physical functioning were explored using Generalized Estimating Equations (GEE).
RESULTS: Of 716 participants, 145 (20%) had one or more pneumonia events during 12 months follow-up. Mean age of the participants was 86.0 (SD=7.4)years, and 76% of them were female. Overall, participants had relatively low levels of physical functioning at baseline (Mean ADL=2.4 out of 6, SD=1.8). The GEE analyses adjusted for age, gender, baseline physical functioning, and hospitalization during follow-up showed that pneumonia events had adverse effects on ADL functioning (B=-0.21, SE=0.08, p=0.008). Pneumonia events were mainly associated with loss of independence in transferring from bed to chair and bathing.
CONCLUSIONS: In a population of nursing home residents where levels of physical functioning were already relatively low, pneumonia events were associated with loss of physical functioning. These results highlight the importance of preventive interventions aimed at reducing pneumonia in nursing home residents.

PMID: 27017417 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Adverse Effects Associated With Newer Diabetes Therapies.

Sat, 2017-07-08 08:22
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Adverse Effects Associated With Newer Diabetes Therapies.

J Pharm Pract. 2017 Apr;30(2):238-244

Authors: Akiyode OF, Adesoye AA

Abstract
The increasing number of newer type 2 diabetes therapies has allowed providers an increased armamentarium for the optimal management of patients with diabetes. In fact, these newer agents have unique benefits in the management of type 2 diabetes. However, they are also associated with certain adverse effects. This review article aims to describe the notable adverse effects of these newer antidiabetic therapies including the glucagon-like peptide 1 receptor agonists, dipeptidyl peptidase-4 inhibitors, and the sodium-glucose cotransporter 2 inhibitors. The adverse effects reviewed herein include pancreatitis, medullary thyroid carcinoma, heart failure, gastrointestinal disturbances, renal impairment, and genitourinary infections. More clinical data are necessary to solidify the association of some of these adverse effects with the newer diabetes agents. However, it is important for health care practitioners to be well informed and prepared to properly monitor patients for these adverse effects.

PMID: 26169212 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Levodopa dose maintenance or reduction in patients with Parkinson's disease transitioning to levodopa/carbidopa/entacapone.

Fri, 2017-07-07 07:58

Levodopa dose maintenance or reduction in patients with Parkinson's disease transitioning to levodopa/carbidopa/entacapone.

Neurol India. 2017 Jul-Aug;65(4):746-751

Authors: Park J, Kim Y, Youn J, Lee PH, Sohn YH, Koh SB, Lee JY, Baik JS, Cho JW

Abstract
BACKGROUND: Levodopa bioavailability is enhanced by adding entacapone. However, the optimal dose of levodopa while transitioning to levodopa/carbidopa/entacapone (LCE) in Parkinson's disease (PD) during the wearing-off period is unclear.
AIMS: The relative therapeutic efficacy and safety of different doses of levodopa were assessed when transitioning to the LCE combination for optimizing combined levodopa therapy.
MATERIALS AND METHODS: A randomized, multicenter, double-arm, open-label study was conducted in Korea. The patients were randomly assigned to either a maintained levodopa dose (Group 1, n = 66) or a reduced levodopa dose by 15-25% (Group 2, n = 41). Treatment efficacy, safety, and tolerability were assessed during an 8-week treatment period.
RESULTS: Eighty of the 107 (74.8%) participants completed the study (Group 1, n = 50; Group 2, n = 30). The patients' global impression of a change in scores indicated significant benefits of maintaining the levodopa dose (Group 1) compared to reducing the dose (Group 2). Although changes in the unified Parkinson's disease rating scale (UPDRS) scores, Hoehn and Yahr (H and Y) stages, and duration of ON, OFF and dyskinesia were not statistically different between the groups, an increased ON time and a reduced OFF time occurred in both the groups after LCE administration. Twenty-four participants (26.7%) experienced adverse events and 15 of them did not complete the study in the safety population (Group 1, n = 57; Group 2, n = 38). Significant drug-related withdrawal caused troublesome dyskinesia and aggravation of Parkinsonism in both Group 1 and Group 2, respectively.
CONCLUSIONS: Direct transitioning to LCE, without levodopa dose reduction, is recommended in Asian patients with PD and wearing-off.

PMID: 28681744 [PubMed - in process]

Categories: Literature Watch

Amenamevir, a novel helicase-primase inhibitor, for treatment of herpes zoster: A randomized, double-blind, valaciclovir-controlled phase 3 study.

Fri, 2017-07-07 07:58
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Amenamevir, a novel helicase-primase inhibitor, for treatment of herpes zoster: A randomized, double-blind, valaciclovir-controlled phase 3 study.

J Dermatol. 2017 Jul 05;:

Authors: Kawashima M, Nemoto O, Honda M, Watanabe D, Nakayama J, Imafuku S, Kato T, Katsuramaki T, study investigators

Abstract
Amenamevir is a potent helicase-primase inhibitor and a novel class of antiviral agent other than nucleoside compounds, such as aciclovir, valaciclovir and famciclovir. This study is the first randomized, double-blind, valaciclovir-controlled phase 3 study to evaluate the efficacy and safety of amenamevir in Japanese patients with herpes zoster when treated within 72 h after onset of rash. A total of 751 patients were randomly assigned to receive either amenamevir 400 mg or 200 mg p.o. once daily or valaciclovir 1000 mg three times daily (daily dose, 3000 mg) for 7 days. The primary efficacy end-point was the proportion of cessation of new lesion formation by day 4 ("day 4 cessation proportion"). The day 4 cessation proportions for amenamevir 400 and 200 mg and valaciclovir were 81.1% (197/243), 69.6% (172/247) and 75.1% (184/245), respectively. Non-inferiority of amenamevir 400 mg to valaciclovir was confirmed by a closed testing procedure. Days to cessation of new lesion formation, complete crusting, healing, pain resolution and virus disappearance were evaluated as secondary end-points. No significant differences were observed in any of the treatment groups. Amenamevir 400 and 200 mg were well tolerated as well as valaciclovir. The proportions of patients who experienced drug-related adverse events were 10.0% (25/249), 10.7% (27/252) and 12.0% (30/249) with amenamevir 400 and 200 mg and valaciclovir, respectively. In conclusion, amenamevir 400 mg appears to be effective and well tolerated for treatment of herpes zoster in immunocompetent Japanese patients.

PMID: 28681394 [PubMed - as supplied by publisher]

Categories: Literature Watch

Efficacy and Safety Results of the Afatinib Expanded Access Program.

Fri, 2017-07-07 07:58
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Efficacy and Safety Results of the Afatinib Expanded Access Program.

Oncol Ther. 2017;5(1):103-110

Authors: Kim ES, Halmos B, Kohut IF, Patel T, Rostorfer RD, Spira AI, Cseh A, McKay J, Wallenstein G, Mileham KF

Abstract
INTRODUCTION: Afatinib is an oral, irreversible ErbB family blocker approved for first-line treatment of metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The expanded access program (EAP) allowed early access to afatinib and provided additional data on its safety, tolerability, and efficacy.
METHODS: The afatinib EAP was an open-label, multicenter, single-arm program in the United States that treated and followed patients with locally advanced or metastatic NSCLC harboring EGFR mutations. Afatinib 40 mg was administered orally once daily until discontinuation due to disease progression, adverse events (AEs), or transition to commercially available drug.
RESULTS: Three hundred twenty-two patients received ≥1 dose of afatinib. Most patients had received prior therapies. Drug-related AEs occurred in 89.4% of patients, including 7.8% with serious AEs. The most common afatinib-related AEs (all grades) were diarrhea (77.0%) and rash (36.0%). Dose reductions occurred in 31.1% of patients. Discontinuation rates due to diarrhea (1.6%) or rash/acne (0.3%) were low. Efficacy data were collected and analyzed when available, with 17.1% and 69.9% of patients achieving objective response and disease control, respectively, in this highly pretreated population.
CONCLUSIONS: No additional or unexpected safety concerns were revealed, and afatinib demonstrated antitumor activity in a heavily pretreated NSCLC patient population in a routine clinical setting.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01649284.
FUNDING: Boehringer Ingelheim Pharmaceuticals, Inc.

PMID: 28680960 [PubMed - in process]

Categories: Literature Watch

Recommendations for the use of oral treprostinil in clinical practice: a Delphi consensus project pulmonary circulation.

Fri, 2017-07-07 07:58
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Recommendations for the use of oral treprostinil in clinical practice: a Delphi consensus project pulmonary circulation.

Pulm Circ. 2017 Mar;7(1):167-174

Authors: Rahaghi FF, Feldman JP, Allen RP, Tapson V, Safdar Z, Balasubramanian VP, Shapiro S, Mathier MA, Elwing JM, Chakinala MM, White RJ

Abstract
Oral treprostinil was recently labeled for treatment of pulmonary arterial hypertension. Similar to the period immediately after parenteral treprostinil was approved, there is a significant knowledge gap for practicing physicians who might prescribe oral treprostinil. Despite its oral route of delivery, use of the drug is challenging because of the requirement for careful titration and management of drug-related adverse effects. We aimed to create a consensus document combining available evidence with expert opinion to provide guidance for use of oral treprostinil. Following a methodology commonly used in business and social sciences (the 'Delphi Process'), two investigators from the oral treprostinil (Freedom) studies created a series of statements based on available evidence and the package insert. The set of 'best practice' statements was circulated to nine other Freedom trial investigators. Their comments were incorporated into the document as new line items for further vote and comment. The subsequent document was put to vote line by line (scale of -5 to +5) and a final statement was drafted. Consensus recommendations include initial therapy with 0.125 mg for treatment naÿ patients, three times daily dosing, aggressive use of antidiarrheal medication, and a strong preference for use of the drug in combination with other approved PAH therapies. This process was particularly valuable in providing guidance for the management of adverse events (where essentially no data is available). The Delphi process was useful to codify investigator experience and subsequently develop investigator consensus about practical issues for physicians who may wish to prescribe oral treprostinil.

PMID: 28680576 [PubMed - in process]

Categories: Literature Watch

[Optimization of the solid-phase extraction procedure for the screening of the medicinal and narcotic substances in the blood by gas chromatography with mass-spectrometric detection].

Fri, 2017-07-07 07:58
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[Optimization of the solid-phase extraction procedure for the screening of the medicinal and narcotic substances in the blood by gas chromatography with mass-spectrometric detection].

Sud Med Ekspert. 2017;60(1):29-35

Authors: Kataev SS, Dvorskaya ON, Krokhin IP

Abstract
This paper was designed to describe the application of the method for solid-phase extraction of the medicinal and narcotic substances having different physicochemical composition by gas chromatography with mass-spectrometric detection (GC-MS) for the purpose of their screening in the blood. The solid-phase extraction technique was optimized by means of the Box-Behnken modeling with the evaluation of the influence on the effectiveness of extraction of various factors including pH of the buffer solution, eluent composition, the type and the volume of the solutions used to wash the sorbent.

PMID: 28252615 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

[The distribution of amlodipine in the organism of the warm-blooded animals].

Fri, 2017-07-07 07:58
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[The distribution of amlodipine in the organism of the warm-blooded animals].

Sud Med Ekspert. 2017;60(1):23-28

Authors: Shormanov VK, Kvachakhiya LL

Abstract
The objective of the present study was to elucidate the specific features of amlodipine distribution in the organism of the warm-blooded animals (rats) following a single intragastric administration of the poisonous substance at a dose of 686 mg/kg b/w/ (LD50). Amlodipine was isolated from the blood and various organs of the animals by means of acetone extraction and purified on the silica gel column (100/160 mcm) with the elution by an ethanol-hexane (7:3) mixture. The identification and the quantitative measurement of amlodipine were performed with the use of the TLC, GC-M, and UV-spectrophotometry. The study has shown that unmetabolized amlodipine was present in large amounts in the internal organs and blood of the poisoned animals. The principal organs of its accumulation were the stomach, kidneys, and blood.

PMID: 28252614 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

[Polypragmasy: A clinical pharmacologist's view].

Fri, 2017-07-07 07:58
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[Polypragmasy: A clinical pharmacologist's view].

Ter Arkh. 2016;88(12):94-102

Authors: Sychev DA, Otdelеnov VA, Krasnova NM, Ilyina ES

Abstract
In the modern world, there is a rapid advance in the design and clinical introduction of a huge number of drugs that are able to cure a patient or to improve his/her health status on the one hand and to cause significant harm to his/her health on the other. Polypragmasy is the desire to enhance the efficiency of treatment and to help the patient recover from all developed diseases inevitably leads to the use of a large number of medications. At the present time, polypragmasy as a result of iatrogenia is a serious public health problem, as it is clinically manifested by a reduction in the effectiveness of pharmacotherapy, by the development of severe adverse drug reactions, and by a considerable increase in healthcare expenditures. The reason for the simultaneous prescription of multiple drugs may be comorbidity (multimorbidity), the availability of drugs, as well as clinical guidelines, manuals of professional medical associations, treatment standards that contain recommendations for using combination therapy with more than 5 drugs for only one disease in some cases, the efficiency of which corresponds to a high level of evidence. Currently, the fight against polypragmasy is one of the important tasks in rendering medical care to elderly and senile patients since it is a major risk factor of adverse drug reactions in this category of people. To minimize polypragmasy in elderly patients, it is necessary to use current methods for analyzing each prescription of a drug (the index of rational drug prescribing; an anticholinergic burden scale) and those for optimizing pharmacotherapy with the use of restrictive lists (Beers criteria, STOPP/START criteria) that will be able to reduce the number of errors in the administration of drugs and to maximize the efficiency and safety of pharmacotherapy.

PMID: 28139567 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Violences et thérapeutiques 2/2.

Fri, 2017-07-07 07:58

Violences et thérapeutiques 2/2.

Rev Infirm. 2017 Jan;66(227):45-46

Authors: Roynard P, Castel C, Lebain P, Roupie É, Saint-Lorant G

PMID: 28048997 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Hospitalisation Resulting from Medicine-Related Problems in Adult Patients with Cardiovascular Diseases and Diabetes in the United Kingdom and Saudi Arabia.

Fri, 2017-07-07 07:58
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Hospitalisation Resulting from Medicine-Related Problems in Adult Patients with Cardiovascular Diseases and Diabetes in the United Kingdom and Saudi Arabia.

Int J Environ Res Public Health. 2016 May 09;13(5):

Authors: Al Hamid A, Aslanpour Z, Aljadhey H, Ghaleb M

Abstract
Cardiovascular diseases (CVDs) and diabetes (DM) are two interrelated conditions that have a heavy morbidity and mortality burden worldwide. Patients with the two conditions usually take multiple medicines and thus are more susceptible to medicine-related problems (MRPs). MRPs can occur at any stage of the treatment process and in many cases can lead to unplanned hospitalisations. The aim of the study was to determine the prevalence of hospitalisation resulting from MRPs in adult patients with CVDs and/or DM and to identify the main causes, risk factors, and medicine classes involved. A retrospective study included 300 adult patients from two hospitals, one in the United Kingdom and one in Saudi Arabia. To identify MRPs, medical records were reviewed for demographic data, clinical data, laboratory assay, and prescription records. A total of 197 (65.7%) patients had MRPs, of which less than 10% were severe. The main problems were lack of treatment effectiveness and adverse drug reactions. Moreover, polypharmacy and patient non-adherence were the main risk factors contributing to MRPs. The main medicine classes associated with MRPs were insulin and antihypertensive medicines. Further research should address the pharmaceutical care processes employed in treating CVDs and DM, and to empower patients/healthcare providers in tackling MRPs.

PMID: 27171100 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Natalizumab treatment of multiple sclerosis: new insights.

Thu, 2017-07-06 07:37
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Natalizumab treatment of multiple sclerosis: new insights.

Immunotherapy. 2017 Jan;9(2):157-171

Authors: Delbue S, Comar M, Ferrante P

Abstract
Natalizumab is a monoclonal antibody directed against the α4 chain of the very late activating antigen 4 and α4β7 integrins, present on the leukocytes surface, used as monotherapy for the treatment of relapsing-remitting multiple sclerosis. It substantially reduces relapse rate and the accumulation of disability, but its use is associated with a very adverse event, that is the development of progressive multifocal leukoencephalopathy, a fatal demyelinating disease of the CNS, due to the lytic replication of the human polyomavirus JC. The main focus of the review is to describe the newest insights on natalizumab, its current use in the clinical practice, the natalizumab-treated patients' management and the risk stratification related to the progressive multifocal leukoencephalopathy development.

PMID: 28004598 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Pathological characterization of nivolumab-related liver injury in a patient with glioblastoma.

Thu, 2017-07-06 07:37
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Pathological characterization of nivolumab-related liver injury in a patient with glioblastoma.

Immunotherapy. 2016 12;8(12):1363-1369

Authors: Simonelli M, Di Tommaso L, Baretti M, Santoro A

Abstract
Immune checkpoint inhibitors such as anti-CTLA-4 and anti-PD-1/PD-L1 monoclonal antibodies have dramatically changed the paradigm of cancer therapy over the past few years. The use of these agents is associated with a unique pattern of autoimmune-like/inflammatory side effects termed immune-related adverse events (irAEs), that may cause collateral damage to normal tissues. Although severe irAEs remain rare, they can become life-threatening if not anticipated and managed appropriately. Improving our knowledge of the mechanisms underlying the development of these toxicities is crucial to optimize clinical efficacy and safety of these new immunotherapeutics. Herein we describe for the first time the pathological features of a severe liver-injury associated with the administration of the anti-PD-1 agent nivolumab in a patient with glioblastoma.

PMID: 28000537 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Immune checkpoint inhibitors renal side effects and management.

Thu, 2017-07-06 07:37
Related Articles

Immune checkpoint inhibitors renal side effects and management.

Immunotherapy. 2016 Dec;8(12):1417-1425

Authors: Rassy EE, Kourie HR, Rizkallah J, Karak FE, Hanna C, Chelala DN, Ghosn M

Abstract
The choice of immunotherapy in the treatment of cancer has improved the prognosis of many patients affected by various malignancies. The high expectations foreseen with immunotherapy have led to fast approvals despite the incomplete understanding of the toxicity profiles in the different organs, including the kidneys. The high prevalence of chronic kidney disease in cancer patients complicates the issue further and requires a better knowledge of the renal safety profile to ensure an optimal safe treatment. This review summarizes the present knowledge of renal adverse events secondary to immune checkpoint inhibitors and discusses their pathophysiology, clinical presentation and adequate management. We also advocate the need for a multidisciplinary approach in patients with immune-related toxic adverse events.

PMID: 28000536 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Dermatologic adverse events of checkpoint inhibitors: what an oncologist should know.

Thu, 2017-07-06 07:37
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Dermatologic adverse events of checkpoint inhibitors: what an oncologist should know.

Immunotherapy. 2016 Dec;8(12):1437-1446

Authors: Habre M, Habre SB, Kourie HR

Abstract
Immune checkpoint inhibitors (ICI) represent a new revolutionary weapon in the armamentarium of anti-cancer therapies. The side effects of these new agents represent a new challenge for oncologists; they are usually unpredictable and sometimes life threatening, if not managed rapidly and adequately. The most frequent side effects are the dermatologic, but they are usually low grade side effects and consequently easily manageable. Rash, pruritus and vitiligo are the most frequent dermatologic side effects. We aimed in this review to describe first all the dermatologic side effects of ICI according to the subtype of ICI and combination therapies in the clinical trials, then to report all the rare case reports dermatologic side effects, and finally to present the management algorithm of these side effects.

PMID: 28000535 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Evaluation of efficacy and safety of different pembrolizumab dose/schedules in treatment of non-small-cell lung cancer and melanoma: a systematic review.

Thu, 2017-07-06 07:37
Related Articles

Evaluation of efficacy and safety of different pembrolizumab dose/schedules in treatment of non-small-cell lung cancer and melanoma: a systematic review.

Immunotherapy. 2016 Dec;8(12):1383-1391

Authors: Abdel-Rahman O

Abstract
AIM: Pembrolizumab is a fully humanized anti-PD-1 agent currently approved for the treatment of advanced melanoma and pretreated non-small-cell lung cancer (NSCLC).
OBJECTIVE: To assess the efficacy and safety of different dose schedules of pembrolizumab in the treatment of patients with advanced NSCLC and melanoma. Search method: MEDLINE database has been searched. Reference lists of original studies and review articles were checked for other related articles.
SELECTION CRITERIA: Prospective clinical trials reporting the outcomes of more than one dose schedule of pembrolizumab in the treatment of advanced NSCLC and melanoma.
DATA COLLECTION & ANALYSIS: The review author extracted information on the outcomes of the study for this review, and presented the results.
MAIN RESULTS: Four trials with 3425 patients were included in this systematic review. Pooled analysis for the odds ratio of objective response rate comparing 2 versus 10 mg/kg every 3 weeks in advanced melanoma was 1.03 (95% CI: 0.71-1.49; p = 0.89), while for advanced NSCLC, it was 0.97 (95% CI: 0.66-1.43; p = 0.87). Moreover, odds ratio for selected side effects between the two doses was as follows: rash: 0.83 (95 CI: 0.58-1.18; p = 0.29); vitiligo: 1.27 (95% CI: 0.62-2.61; p = 0.52); diarrhea: 0.94 (95% CI: 0.63-1.42; p = 0.79); hypothyroidism: 0.97 (95% CI: 0.63-1.50; p = 0.90); hepatitis/elevated transaminases: 1.86 (95% CI: 0.91-3.79; p = 0.09); nephritis: 0.88 (95% CI: 0.32-2.44; p = 0.80); pneumonitis: 1.17 (95% CI: 0.62-2.23; p = 0.63).

PMID: 27892744 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Pain Treatment of Underserved Older African Americans.

Thu, 2017-07-06 07:37
Related Articles

Pain Treatment of Underserved Older African Americans.

J Am Geriatr Soc. 2016 Oct;64(10):2116-2121

Authors: Yazdanshenas H, Bazargan M, Smith J, Martins D, Motahari H, Orum G

Abstract
Older African Americans who experience pain are especially at high risk of underassessment and undertreatment. This study examined patterns and correlates of pain medication use: severity of pain, medical conditions, and access to care. African Americans aged 65 and older were recruited from 16 churches located in south Los Angeles (N = 400). Structured face-to-face interviews and visual inspection of each participant's medications were conducted. More than 39% of participants were aged 75 and older, and 65% were female. Forty-seven percent used at least one type of pain medication. The frequency of pain medication use according to pharmaceutical class was nonopioid, 33%; opioid, 12%; adjuvant, 9%; and other drug, 8%. Seventy-seven percent of nonopioids were nonsteroidal anti-inflammatory drugs (NSAIDs), which 25% of participants with hypertension, 28% with stroke, 26% with kidney disease, and 28% with gastrointestinal problems used. Ninety-eight percent of participants who used NSAIDs, 98% experienced potentially inappropriate medication (PIM) use, 69% experienced drug duplication, and 65% experienced drug-drug interactions. This study suggests severe mismanagement of pain in underserved older African Americans, particularly those with comorbidity, multiple providers, and limited access to health care. The use of pain medication was associated with drug-drug interactions, drug duplication, and PIM use. The data show that many participants with severe pain are not taking pain medication or experience PIM use. One in four participants was taking NSAIDs, which can cause serious side effects in older African Americans with multiple chronic conditions.

PMID: 27590566 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

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