Phase I study of the anti-endothelin B receptor antibody-drug conjugate DEDN6526A in patients with metastatic or unresectable cutaneous, mucosal, or uveal melanoma.

Invest New Drugs. 2019 Aug 05;:

Authors: Sandhu S, McNeil CM, LoRusso P, Patel MR, Kabbarah O, Li C, Sanabria S, Flanagan WM, Yeh RF, Brunstein F, Nazzal D, Hicks R, Lemahieu V, Meng R, Hamid O, Infante JR

Abstract
Background Endothelin B receptor (ETBR) is involved in melanoma pathogenesis and is overexpressed in metastatic melanoma. The antibody-drug conjugate DEDN6526A targets ETBR and is comprised of the humanized anti-ETBR monoclonal antibody conjugated to the anti-mitotic agent monomethyl auristatin E (MMAE). Methods This Phase I study evaluated the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DEDN6526A (0.3-2.8 mg/kg) given every 3 weeks (q3w) in patients with metastatic or unresectable cutaneous, mucosal, or uveal melanoma. Results Fifty-three patients received a median of 6 doses of DEDN6526A (range 1-49). The most common drug-related adverse events (>25% across dose levels) were fatigue, peripheral neuropathy, nausea, diarrhea, alopecia, and chills. Three patients in dose-escalation experienced a dose-limiting toxicity (infusion-related reaction, increased ALT/AST, and drug-induced liver injury). Based on cumulative safety data across all dose levels, the recommended Phase II dose (RP2D) for DEDN6526A was 2.4 mg/kg intravenous (IV) q3w. The pharmacokinetics of antibody-conjugated MMAE and total antibody were dose-proportional at doses ranging from 1.8-2.8 mg/kg. A trend toward faster clearance was observed at doses of 0.3-1.2 mg/kg. There were 6 partial responses (11%) in patients with metastatic cutaneous or mucosal melanoma, and 17 patients (32%) had prolonged stable disease ≥6 months. Responses were independent of BRAF mutation status but did correlate with ETBR expression. Conclusion DEDN6526A administered at the RP2D of 2.4 mg/kg q3w had an acceptable safety profile and showed evidence of anti-tumor activity in patients with cutaneous, mucosal, and uveal melanoma. ClinicalTrials.gov identifier: NCT01522664.

PMID: 31385109 [PubMed - as supplied by publisher]

Evaluating Chemotherapy-induced Nausea and Vomiting and Food Intake in Patients With Gynecologic Cancer.

Anticancer Res. 2019 Aug;39(8):4555-4560

Authors: Komatsu H, Oishi T, Sato S, Osaku D, Sawada M, Kudoh A, Nonaka M, Sato S, Shimada M, Itamochi H, Harada T

Abstract
BACKGROUND/AIM: Treatments for controlling delayed nausea after chemotherapy are inadequate, potentially inciting malnutrition. We sought to determine the incidence of nausea, anorexia, and food intake after chemotherapy.
PATIENTS AND METHODS: Subjects were females with gynecological cancers who underwent chemotherapy between 2008 and 2013. Nausea, anorexia, and food intake in the acute (day 1) and delayed phases (days 2 and 3) were retrospectively evaluated.
RESULTS: Subjects included 156 females. Chemotherapies were highly (HEC; n=24) and moderately emetogenic (MEC; n=132). There were no significant between-group differences for anorexia control during either the acute or the delayed phase and both groups demonstrated significantly worse control of nausea during the delayed phase. In the HEC group, food intake was significantly reduced on days 2 and 3 compared with day 1.
CONCLUSION: Rates of nausea, anorexia, and food intake significantly worsened over time, particularly in the MEC group. Current supportive therapies appear inadequate and should be improved.

PMID: 31366559 [PubMed - indexed for MEDLINE]

Adverse Effects Profile of Dicycloplatin (DCP) Offers Chemotherapeutic Advantage Over Cisplatin and Carboplatin.

Anticancer Res. 2019 Aug;39(8):4455-4462

Authors: Yu JJ, Hogan T, Morley C, Crigger C, Jiao S, Williams DJ, Salkini MW, Yang X, Liang X, Yan B, Cecil C, Winn AC, Zheng J, Guo YI, Jiang BH, Washington IM

Abstract
BACKGROUND/AIM: Platinum-based chemotherapy often fails due to its severe adverse effects. The aim of this study was to examine the adverse effects profile and efficacy of dicycloplatin and compare them to those of cisplatin and carboplatin.
MATERIALS AND METHODS: Cystoscopy surveillance of the first American cancer patient treated with dicycloplatin was performed quarterly. In vitro and in vivo studies were conducted using immunoblotting and flow cytometry to assess immune status of spleen and bone marrow of mice treated with dicycloplatin, cisplatin and carboplatin.
RESULTS: The American patient did not suffer clinically significant myelosuppression; dicycloplatin has sustained remission in this patient to date. Experimental studies showed that dicycloplatin is less toxic to bone marrow and spleen of mice than cisplatin and carboplatin.
CONCLUSION: Dicycloplatin is a promising drug in cancer chemotherapy with less aggressive side-effects than those typically associated with cisplatin and carboplatin. This is an important therapeutic advantage in cancer chemotherapy. Clinical investigation of dicycloplatin as an alternative to cisplatin or carboplatin is warranted.

PMID: 31366544 [PubMed - indexed for MEDLINE]

Known and novel ocular toxicities of biologics, targeted agents, and traditional chemotherapeutics.

Graefes Arch Clin Exp Ophthalmol. 2019 Aug;257(8):1771-1781

Authors: Kunkler AL, Binkley EM, Mantopoulos D, Hendershot AJ, Ohr MP, Kendra KL, Davidorf FH, Cebulla CM

Abstract
PURPOSE: Increases in cancer with an aging population and the rapid development of new chemotherapeutics underscore the need for ophthalmologists to identify and manage potential ocular toxicities. This retrospective case series reports the ocular side effects of traditional and novel chemotherapeutic agents from a large center.
METHODS: The medical records of 3537 adult patients 18 years and older who presented to an academic ophthalmology department on high-risk medications identified by ICD-9 search between January 2010 and February 2015 were reviewed. A cancer diagnosis, as well as a temporal association with chemotherapeutic use and ocular side effect, was deemed necessary for inclusion in the study. The main measures were ocular side effects in cancer patients taking chemotherapy, ocular imaging abnormalities, and the outcome of each side effect.
RESULTS: Of the 161 oncology patients referred to the ophthalmology clinic for chemotherapeutic screening or ocular side effect, 31 (19.3%) were identified as having an ocular adverse reaction due to a novel or traditional chemotherapeutic medication. A novel flattening of the corneal curvature with hyperopic shift and corneal microcysts was identified in a patient taking the antibody-drug conjugate mirvetuximab soravtansine and was reversible with topical steroids. A bilateral medium-vessel choroidal vasculopathy with serous retinal detachment was seen with ipilimumab. The most frequent medication with ocular toxicity was interferon-α(2b) (IFN-α(2b)) (6/31, 19.4%); headache was typical in these patients (83.3%). Ibrutinib ocular toxicity was second most common (5/31, 16.1%), usually causing red or dry eye, while one patient developed branch retinal artery occlusion. Retinal abnormalities documented on OCT imaging occurred with IFN-α(2b), ipilimumab, binimetinib, and docetaxel, while rod-cone ERG abnormality was seen with cisplatin. Inflammatory conditions included anterior scleritis with zoledronic acid, focal eyelid inflammation with veliparib, bilateral chemosis with R-CHOP, iritis, and blepharospasm with IFN-α(2b). AION occurred with pemetrexed, and transient vision loss with hyperemic disc OS was seen with FOLFOX. Two patients (2/31, 6.5%) developed permanent vision loss. Six patients were lost to follow-up, and the clinical course was unknown (6/31, 19.4%).
CONCLUSIONS AND RELEVANCE: Cases of permanent visual loss were observed; yet, in the majority of side effects, they improved with topical therapy and/or holding the medication. Further research is needed to elucidate the incidence and the pathophysiology of these side effects and maximize patient quality of life.

PMID: 31098752 [PubMed - indexed for MEDLINE]

Reappraisal of probiotics' safety in human.

Food Chem Toxicol. 2019 Jul;129:22-29

Authors: Sotoudegan F, Daniali M, Hassani S, Nikfar S, Abdollahi M

Abstract
Contrary to the safe usage of probiotics for years, their threat is still worthy of attention. Several risks have been explained or mentioned in the case reports, clinical trials and experimental studies. Due to a large number of probiotic products worldwide, the certainty of the safety of such products is a matter of concern. Current review appraises all the available information about a range of adverse effects by probiotics in different populations of consumers and almost all qualified investigations and reports, relevant to the adverse effects of probiotics. Furthermore, the effects of basic or original sources of probiotics were studied. The principally noticed adverse effects of probiotics are systemic infections, gastrointestinal side effects, skin complications, inflammation of endocardium, gene transfer from probiotics to the normal microbial flora, metabolic harmful impacts of probiotics, and immune system stimulation. The most at-risk groups consist of infants, elderly people, patients in hospitalized condition, and those with immunodeficiency due to a genetic or acquired disease. The existing evidence suggests careful evaluation of the risk-benefit ratio of probiotics prior to prescription or recommendation to use.

PMID: 31009735 [PubMed - indexed for MEDLINE]

Information-Derived Mechanistic Hypotheses for Structural Cardiotoxicity.

Chem Res Toxicol. 2018 11 19;31(11):1119-1127

Authors: Svensson F, Zoufir A, Mahmoud S, Afzal AM, Smit I, Giblin KA, Clements PJ, Mettetal JT, Pointon A, Harvey JS, Greene N, Williams RV, Bender A

Abstract
Adverse events resulting from drug therapy can be a cause of drug withdrawal, reduced and or restricted clinical use, as well as a major economic burden for society. To increase the safety of new drugs, there is a need to better understand the mechanisms causing the adverse events. One way to derive new mechanistic hypotheses is by linking data on drug adverse events with the drugs' biological targets. In this study, we have used data mining techniques and mutual information statistical approaches to find associations between reported adverse events collected from the FDA Adverse Event Reporting System and assay outcomes from ToxCast, with the aim to generate mechanistic hypotheses related to structural cardiotoxicity (morphological damage to cardiomyocytes and/or loss of viability). Our workflow identified 22 adverse event-assay outcome associations. From these associations, 10 implicated targets could be substantiated with evidence from previous studies reported in the literature. For two of the identified targets, we also describe a more detailed mechanism, forming putative adverse outcome pathways associated with structural cardiotoxicity. Our study also highlights the difficulties deriving these type of associations from the very limited amount of data available.

PMID: 30350600 [PubMed - indexed for MEDLINE]

CYP3A Activation and Glutathione Depletion Aggravate Emodin-Induced Liver Injury.

Chem Res Toxicol. 2018 10 15;31(10):1052-1060

Authors: Jiang LL, Jiang Y, Zhao DS, Fan YX, Yu Q, Li P, Li HJ

Abstract
1,3,8-Trihydroxy-6-methylanthraquinone (emodin), a widely existing natural product in herbal medicines, has been reported to be hepatotoxic, but the exact underlying mechanism is still not fully understood. The objective of the present study was to evaluate the role of CYP3A and glutathione (GSH) in emodin-induced liver injury. Primary human hepatocytes were exposed to emodin with and without addition of CYP3A inducer/inhibitor and GSH synthesis inhibitor. It was found that emodin-mediated cytotoxicity increased when CYP3A was activated and GSH was depleted. Hepatotoxicity induced by emodin in rats by activation/inhibition of CYP3A and depletion of GSH was further investigated. Administration of emodin in combination with l-buthionine sulfoximine (BSO) or dexamethasone (DEX) resulted in aggravated liver injury, whereas pretreatment with ketoconazole (KTZ) suppressed the side effects caused by emodin. In addition, plasma exposure of emodin and its glucuronide metabolite were measured by ultraperformance liquid chromatography triple quadrupole mass spectrometry. Emodin and its glucuronide were lower in BSO-, DEX-, and KTZ- co-treated rats compared with those administered with emodin alone. In conclusion, these mentioned results suggested that CYP3A induction and GSH depletion might be involved in hepatotoxicity induced by emodin. This study may help to understand the risk factors and the mechanism of hepatotoxicity of emodin in humans.

PMID: 30203651 [PubMed - indexed for MEDLINE]

Effect of a Scenario-tailored Opioid Messaging Program on Parents' Risk Perceptions and Opioid Decision-making.

Clin J Pain. 2018 Jun;34(6):497-504

Authors: Voepel-Lewis T, Zikmund-Fisher BJ, Boyd CJ, Veliz PT, McCabe SE, Weber MJ, Tait AR

Abstract
OBJECTIVES: Poor parental understanding of prescription opioid risks is associated with potentially dangerous decisions that can contribute to adverse drug events (ADE) in children and adolescents. This study examined whether an interactive Scenario-tailored Opioid Messaging Program (STOMP) would (1) enhance opioid risk perceptions and (2) improve the safety of parents' decision-making.
MATERIALS AND METHODS: In total, 546 parents were randomized to receive the STOMP versus control information and 516 completed the program. A baseline survey assessed parents' opioid risk knowledge, perceptions, and preferences for pain relief versus risk avoidance (Pain Relief Preference). Parents then made hypothetical decisions to give or withhold a prescribed opioid for high-risk (excessive sedation) and low-risk (no ADE) scenarios. The STOMP provided immediate feedback with specific risk and guidance information; the control condition provided general information. We reassessed knowledge, perceptions, and decision-making up to 3 days thereafter.
RESULTS: Following the intervention, the STOMP group became more risk avoidant (Pain Relief Preference, mean difference -1.27 [95% confidence interval, -0.8 to -1.75]; P<0.001) and gained higher perceptions of the critical risk, excessive sedation (+0.56 [0.27 to 0.85]; P<0.001). STOMP parents were less likely than controls to give a prescribed opioid in the high-risk situation (odds ratio, -0.14 [-0.24 to -0.05]; P=0.006) but similarly likely to give an opioid for the no ADE situation (P=0.192).
DISCUSSION: The STOMP intervention enhanced risk perceptions, shifted preferences toward opioid risk avoidance, and led to better decisions regarding when to give or withhold an opioid for pain management. Scenario-tailored feedback may be an effective method to improve pain management while minimizing opioid risks.

PMID: 29135696 [PubMed - indexed for MEDLINE]

The Experience of Fatigue in Breast Cancer Patients 1-12 Month Post-Chemotherapy: A Qualitative Study.

Behav Med. 2019 Jan-Mar;45(1):7-18

Authors: Levkovich I, Cohen M, Karkabi K

Abstract
The study explored the experience of fatigue, its effects and ways of coping with fatigue and the role of family and social support among breast cancer patients. In-depth, semi-structured interviews were conducted with 13 breast cancer patients stages I-III, aged 34-67, who were up to one year after the termination of chemotherapy. Two main themes emerged: "Being imprisoned in the body of an 80-year-old," focuses the fatigue experienced by younger and older women, during and post treatment, including the different patterns of fatigue and the various means of coping with fatigue; The "Family's bear-hug" exemplifies the role of the environment in coping with the experience of fatigue and the complexities entailed in receiving support from family and friends. The study provides a comprehensive picture of fatigue in its various contexts during and post-treatment and its impact on family relations and quality of life among younger and older breast cancer patients.

PMID: 29095129 [PubMed - indexed for MEDLINE]

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")

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12 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 2019/08/06

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.

Technique, protocols and adverse reactions for contrast-enhanced spectral mammography (CESM): a systematic review.

Insights Imaging. 2019 Aug 02;10(1):76

Authors: Zanardo M, Cozzi A, Trimboli RM, Labaj O, Monti CB, Schiaffino S, Carbonaro LA, Sardanelli F

Abstract
We reviewed technical parameters, acquisition protocols and adverse reactions (ARs) for contrast-enhanced spectral mammography (CESM). A systematic search in databases, including MEDLINE/EMBASE, was performed to extract publication year, country of origin, study design; patients; mammography unit/vendor, radiation dose, low-/high-energy tube voltage; contrast molecule, concentration and dose; injection modality, ARs and acquisition delay; order of views; examination time. Of 120 retrieved articles, 84 were included from 22 countries (September 2003-January 2019), totalling 14012 patients. Design was prospective in 44/84 studies (52%); in 70/84 articles (83%), a General Electric unit with factory-set kVp was used. Per-view average glandular dose, reported in 12/84 studies (14%), ranged 0.43-2.65 mGy. Contrast type/concentration was reported in 79/84 studies (94%), with Iohexol 350 mgI/mL mostly used (25/79, 32%), dose and flow rate in 72/84 (86%), with 1.5 mL/kg dose at 3 mL/s in 62/72 studies (86%). Injection was described in 69/84 articles (82%), automated in 59/69 (85%), manual in 10/69 (15%) and flush in 35/84 (42%), with 10-30 mL dose in 19/35 (54%). An examination time < 10 min was reported in 65/84 studies (77%), 120 s acquisition delay in 65/84 (77%) and order of views in 42/84 (50%) studies, beginning with the craniocaudal view of the non-suspected breast in 7/42 (17%). Thirty ARs were reported by 14/84 (17%) studies (26 mild, 3 moderate, 1 severe non-fatal) with a pooled rate of 0.82% (fixed-effect model). Only half of CESM studies were prospective; factory-set kVp, contrast 1.5 mL/kg at 3 mL/s and 120 s acquisition delay were mostly used; only 1 severe AR was reported. CESM protocol standardisation is advisable.

PMID: 31376021 [PubMed]

Efficacy and safety of 0.05% cyclosporine ophthalmic emulsion in treatment of Chinese patients with moderate to severe dry eye disease: A 12-week, multicenter, randomized, double-masked, placebo-controlled phase III clinical study.

Medicine (Baltimore). 2019 Aug;98(31):e16710

Authors: Chen D, Zhang S, Bian A, Hong J, Deng Y, Zhang M, Chen W, Shao Y, Zhao J

Abstract
BACKGROUND: Dry eye disease (DED) is a chronic ocular surface disease that affects hundreds of millions of people worldwide. Although 0.05% cyclosporine ophthalmic emulsion (CsA OE) has long been prescribed in the U.S. for the treatment of DED, it is not commercially available in China. Our study aims to compare the efficacy and safety profile of 0.05% CsA OE versus vehicle in Chinese patients with moderate to severe DED.
METHODS: This was a multicenter, randomized, double-masked, 2-parallel-arm, 3-month phase III study. Patients with moderate to severe DED were randomized to receive twice-daily 0.05% CsA OE or its vehicle, along with unpreserved hypromellose eye drops 3 times per day. Patients were followed up at day 7, 28, 56, and 84, as well as 2 weeks after the medications were discontinued for safety assessment.
RESULTS: A total of 240 patients were randomized. The overall effective rate (OER) and efficacy index were significantly better in the CsA OE than vehicle group at all follow up times (all P < .05), and the OER of CsA OE and vehicle group at month 3 was 70.6% and 27.8%, respectively (P < .001) (primary endpoint). The patients in CsA OE group displayed a significant improvement in dry eye symptoms from day 28 and ocular surface test results from day 7 (all P < .05). The ocular surface disease index scores of 0.05% CsA OE treated patients were significantly better than those treated with vehicle control at day 56 and 84 (P = .0061 and <.001, respectively). Drug related adverse events (AEs) were recorded in 6(5%) and 3(2.5%) patients in the CsA OE and vehicle groups respectively (P = .4061) with ocular pain as the most frequently reported AEs, and it was mostly mild to moderate. There were no detrimental effects on visual acuity, intraocular pressure, or vital signs.
CONCLUSIONS: Twice-daily instillation of 0.05% CsA OE was effective and well tolerated for the treatment of moderate to severe DED in Chinese population during the 3 months of the study.

PMID: 31374063 [PubMed - in process]

A rare cutaneous phototoxic rash after vandetanib therapy in a patient with thyroid cancer: A case report.

Medicine (Baltimore). 2019 Aug;98(31):e16392

Authors: Yin Y, Qiu XY, Zhang YH, Zhang B

Abstract
RATIONALE: Vandetanib is effective for treating symptomatic or progressive medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease, but its toxicity such as photosensitivity reactions should be considered. It is a rare adverse effect of this drug but might cause severe morbidity and even mortality.
PATIENT CONCERNS: A 26-year man with MTC developed phototoxic rashes on the sun-exposed areas of his shin after 15 days from the initiation of vandetanib treatment. Grade II skin toxicity was evaluated based on the Common Terminology Criteria for Adverse Events standard.
DIAGNOSES: Drug-induced phototoxic rash.
INTERVENTIONS: The vandetanib dose was reduced by 30%, and the application of topical steroids and sunscreen was adopted.
OUTCOMES: After dose reduction of vandetanib, the symptoms of vandetanib-induced phototoxic rash resolved, although residual pigmentation was observed.
LESSONS: Close attention should be paid to the adverse effect of vandetanib, phototoxic rash, and patients should be advised on the prevention and treatment measures.

PMID: 31374006 [PubMed - in process]

On restricted optimal treatment regime estimation for competing risks data.

Biostatistics. 2019 Aug 02;:

Authors: Zhou J, Zhang J, Lu W, Li X

Abstract
It is well accepted that individualized treatment regimes may improve the clinical outcomes of interest. However, positive treatment effects are often accompanied by certain side effects. Therefore, when choosing the optimal treatment regime for a patient, we need to consider both efficacy and safety issues. In this article, we propose to model time to a primary event of interest and time to severe side effects of treatment by a competing risks model and define a restricted optimal treatment regime based on cumulative incidence functions. The estimation approach is derived using a penalized value search method and investigated through extensive simulations. The proposed method is applied to an HIV dataset obtained from Health Sciences South Carolina, where we minimize the risk of treatment or virologic failures while controlling the risk of serious drug-induced side effects.

PMID: 31373360 [PubMed - as supplied by publisher]

Safety and Efficacy of Repeated Thrombolysis with Alteplase in Early Recurrent Ischemic Stroke: A Systematic Review.

J Stroke Cerebrovasc Dis. 2019 Jul 29;:104290

Authors: Sarmiento RJC, Diestro JDB, Espiritu AI, San Jose MCZ

Abstract
BACKGROUND AND AIM: The current American Heart Association guidelines for the management of acute ischemic stroke advise against the use of intravenous (IV) alteplase in patients with recurrent stroke occurring within 90 days of their index event. Following these guidelines strictly, patients having early recurrent ischemic stroke would be unable to avail of this reperfusion strategy that has been proven to confer superior clinical outcomes. While some registry-based studies have demonstrated the safety of IV alteplase in this subgroup of patients, data on the repeated use of the drug are lacking. Thus, we aim to determine the safety and efficacy of repeated thrombolysis in patients with early recurrent ischemic strokes.
METHODS: The following electronic databases were searched for relevant studies: the Cochrane Central Register for Controlled Trials by The Cochrane Library, MEDLINE by PubMed, Health Research and Development Information Network, Scopus, and ClinicalTrials.gov. Data on symptomatic intracranial hemorrhage, 90-day clinical outcomes, systemic hemorrhage and allergic reactionswere synthesized.
RESULTS: Ten articles with 33 patients in total were included in our review. One patient developed symptomatic intracranial hemorrhage after the second reperfusion attempt and subsequently died from pneumonia. Another died from spontaneous rupture of previously unidentified infrarenal aortic aneurysm. Six of the 13 patients with available follow-up data had good clinical outcomes (Modified Rankin Score 0-2). There were no allergic reactions and other drug-related adverse events noted.
CONCLUSIONS: Repeated IV alteplase can be safe and efficacious in patients who have early recurrent ischemic stroke. Larger studies, trials, or registry-based data are needed to ascertain the encouraging findings of our review.

PMID: 31371140 [PubMed - as supplied by publisher]

Acceptance of interprofessional learning between medical and pharmacy students in a prescribing skills training workshop: pre-post intervention study.

BMC Med Educ. 2019 Apr 05;19(1):101

Authors: Chua SS, Lai PSM, Sim SM, Tan CH, Foong CC

Abstract
BACKGROUND: The success of interprofessional collaboration in healthcare services requires a paradigm shift in the training of future health profession practitioners. This study aimed to develop and validate an instrument to measure Student Acceptance of Interprofessional Learning (SAIL) in Malaysia, and to assess this attribute among medical and pharmacy students using a prescribing skills training workshop.
METHODS: The study consisted of two phases. In Phase 1, a 10-item instrument (SAIL-10) was developed and tested on a cohort of medical and pharmacy students who attended the workshop. In Phase 2, different cohorts of medical and pharmacy students completed SAIL-10 before and after participating in the workshop.
RESULTS: Factor analysis showed that SAIL-10 has two domains: "facilitators of interprofessional learning" and "acceptance to learning in groups". The overall SAIL-10 and the two domains have adequate internal consistency and stable reliability. The total score and scores for the two domains were significantly higher after students attended the prescribing skills workshop.
CONCLUSIONS: This study produced a valid and reliable instrument, SAIL-10 which was used to demonstrate that the prescribing skills workshop, where medical and pharmacy students were placed in an authentic context, was a promising activity to promote interprofessional learning among future healthcare professionals.

PMID: 30953493 [PubMed - indexed for MEDLINE]

Ellagic acid ameliorates cisplatin induced hepatotoxicity in colon carcinogenesis.

Environ Toxicol. 2019 Jul;34(7):804-813

Authors: Goyal Y, Koul A, Ranawat P

Abstract
The clinical application of cisplatin (CP), one of the most extensively used antineoplastic drug, is restricted by its numerous side effects. CP's antitumor potential resides in the free generation of reactive oxygen species leading to oxidative stress. This stress is a source of the side effects associated with its use. Ellagic acid (EA), a polyphenol is known to possess multiple health benefits owing to its antioxidant properties. EA is largely metabolized by the colon microbiota of different mammals and therefore was a polyphenol of choice in the present study. The present study was thus carried out to explore the protective potential of EA on CP induced hepatotoxicity in colon tumor bearing mice. The administration of EA (10 mg/kg bwt po daily for 6 weeks) significantly ameliorated the toxicity caused by CP (5 mg/kg bwt ip once a week for 4 weeks). Activities of liver marker enzymes and lactate dehydrogenase were brought back to normal. EA cotreatment also led to a marked reduction in the extent of peroxidative damage to liver tissue as was evident from the improvement in the histopathological changes observed and FT-IR analysis. The present study, therefore, suggests that the administration of EA reduces the CP-induced hepatotoxicity, thereby emerging out as a potential candidate for chemopreventive action.

PMID: 30953405 [PubMed - indexed for MEDLINE]

A Randomized Trial of Rapamycin to Increase Longevity and Healthspan in Companion Animals: Navigating the Boundary Between Protections for Animal Research and Human Subjects Research.

Am J Bioeth. 2018 Oct;18(10):58-59

Authors: Taylor HA, Morales C, Johnson LM, Wilfond BS

PMID: 30339066 [PubMed - indexed for MEDLINE]

Ethical Considerations for Unblinding a Participant's Assignment to Interpret a Resolved Adverse Event.

Am J Bioeth. 2018 Oct;18(10):66-67

Authors: Wilfond BS, Morales C, Johnson LM, Taylor HA

PMID: 30339065 [PubMed - indexed for MEDLINE]