Chemotherapy-induced peripheral neuropathy: evidence from genome-wide association studies and replication within multiple myeloma patients.

BMC Cancer. 2018 Aug 15;18(1):820

Authors: Mahmoudpour SH, Bandapalli OR, da Silva Filho MI, Campo C, Hemminki K, Goldschmidt H, Merz M, Försti A

Abstract
BACKGROUND: Based on the possible shared mechanisms of chemotherapy-induced peripheral neuropathy (CIPN) for different drugs, we aimed to aggregate results of all previously published genome-wide association studies (GWAS) on CIPN, and to replicate them within a cohort of multiple myeloma (MM) patients.
METHODS: Following a systematic literature search, data for CIPN associated single nucleotide polymorphisms (SNPs) with P-values< 10- 5 were extracted; these associations were investigated within a cohort of 983 German MM patients treated with bortezomib, thalidomide or vincristine. Cases were subjects that developed CIPN grade 2-4 while controls developed no or sub-clinical CIPN. Logistic regression with additive model was used.
RESULTS: In total, 9 GWASs were identified from the literature on CIPN caused by different drugs (4 paclitaxel, 2 bortezomib, 1 vincristine, 1 docetaxel, and 1 oxaliplatin). Data were extracted for 526 SNPs in 109 loci. One hundred fourty-eight patients in our study population were CIPN cases (102/646 bortezomib, 17/63 thalidomide and 29/274 vincristine). In total, 13 SNPs in 9 loci were replicated in our population (p-value< 0.05). The four smallest P-values relevant to the nerve function were 0.0006 for rs8014839 (close to the FBXO33 gene), 0.004 for rs4618330 (close to the INTU gene), 0.006 for rs1903216 (close to the BCL6 gene) and 0.03 for rs4687753 (close to the IL17RB gene).
CONCLUSIONS: Replicated SNPs provide clues of the molecular mechanism of CIPN and can be strong candidates for further research aiming to predict the risk of CIPN in clinical practice, particularly rs8014839, rs4618330, rs1903216, and rs4687753, which showed relevance to the function of nervous system.

PMID: 30111286 [PubMed - indexed for MEDLINE]

Impact of Expanded Access on FDA Regulatory Action and Product Labeling.

Ther Innov Regul Sci. 2017 11;51(6):787-789

Authors: Jarow JP, Moscicki R

Abstract
Background: The purpose of this study is to address concerns that expanded access may negatively impact the ultimate regulatory action and product labeling for new drugs.
Methods: We performed queries of FDA's Center for Drug Evaluation and Research (CDER) document tracking system to determine the effect of expanded access on FDA's regulatory decision making from 2010 through 2016. We also examined product labeling to determine whether safety events occurring under expanded access had an adverse effect on the approved product labeling.
Results: There were 321 regulatory decisions made by FDA, with 28% of the drugs having prior expanded access. The approval rate for drugs with expanded access (84%) was higher than those that did not (76%). None of the negative regulatory marketing decisions were based on the adverse experiences reported under expanded access. The vast majority of deaths and serious adverse events that occurred under expanded access were not interpreted by FDA to be due to the investigational drug and did not affect product labeling. There was only 1 instance, a drug-drug interaction, for which safety events occurring during expanded access alone lead to potentially adverse product labeling.
Conclusions: There was no instance in which expanded access lead to a negative regulatory decision regarding a drug application, and there was only 1 instance that safety events under expanded access had a potentially negative effect on product labeling. Concern that expanded access will have a negative impact on drug development and review is not based on the evidence and is unwarranted.

PMID: 30079277 [PubMed - indexed for MEDLINE]

How patients should be counseled on adverse drug reactions: Avoiding the nocebo effect.

Res Social Adm Pharm. 2018 Jul;14(7):705

Authors: Ren Y, Xu F

PMID: 29656936 [PubMed - indexed for MEDLINE]

Enhancing metabolic monitoring for children and adolescents using second-generation antipsychotics.

Int J Ment Health Nurs. 2018 Jun;27(3):1188-1198

Authors: Coughlin M, Goldie CL, Tregunno D, Tranmer J, Kanellos-Sutton M, Khalid-Khan S

Abstract
The prevalence of children and adolescents using second-generation antipsychotics (SGAs) has increased significantly in recent years. In this population, SGAs are used to treat mood and behavioural disorders although considered 'off-label' or not approved for these indications. Metabolic monitoring is the systematic physical health assessment of antipsychotic users utilized to detect cardiovascular and endocrine side effects and prevent adverse events such as weight gain, hyperglycaemia, hyperlipidemia, and arrhythmias. This practice ensures safe and efficacious SGA use among children and adolescents. Despite widely available, evidence-based metabolic monitoring guidelines, rates of monitoring continue to be suboptimal; this exposes children to the unnecessary risk of developing poor cardiovascular health and long-term disease. In this discursive paper, existing approaches to metabolic monitoring as well as challenges to implementing monitoring guidelines in practice are explored. The strengths and weaknesses of providing metabolic monitoring across outpatient psychiatry, primary care, and collaborative community settings are discussed. We suggest that there is no one-size-fits-all solution to improving metabolic monitoring care for children and adolescents using SGA in all settings. However, we advocate for a pragmatic global approach to enhance safety of children and adolescents taking SGAs through collaboration among healthcare disciplines with a focus on integrating nurses as champions of metabolic monitoring.

PMID: 29205757 [PubMed - indexed for MEDLINE]

Medications and Adverse Voice Effects.

J Voice. 2018 Jul;32(4):515.e29-515.e39

Authors: Nemr K, Di Carlos Silva A, Rodrigues DA, Zenari MS

Abstract
OBJECTIVES: To identify the medications used by patients with dysphonia, describe the voice symptoms reported on initial speech-language pathology (SLP) examination, evaluate the possible direct and indirect effects of medications on voice production, and determine the association between direct and indirect adverse voice effects and self-reported voice symptoms, hydration and smoking habits, comorbidities, vocal assessment, and type and degree of dysphonia.
STUDY DESIGN: This is a retrospective cross-sectional study.
METHODS: Fifty-five patients were evaluated and the vocal signs and symptoms indicated in the Dysphonia Risk Protocol were considered, as well as data on hydration, smoking and medication use. We analyzed the associations between type of side effect and self-reported vocal signs/symptoms, hydration, smoking, comorbidities, type of dysphonia, and auditory-perceptual and acoustic parameters.
RESULTS: Sixty percent were women, the mean age was 51.8 years, 29 symptoms were reported on the screening, and 73 active ingredients were identified with 8.2% directly and 91.8% indirectly affecting vocal function. There were associations between the use of drugs with direct adverse voice effects, self-reported symptoms, general degree of vocal deviation, and pitch deviation.
CONCLUSIONS: The symptoms of dry throat and shortness of breath were associated with the direct vocal side effect of the medicine, as well as the general degree of vocal deviation and the greater pitch deviation. Shortness of breath when speaking was also associated with the greatest degree of vocal deviation.

PMID: 28822620 [PubMed - indexed for MEDLINE]

When to stop propranolol for infantile hemangioma.

Sci Rep. 2017 02 22;7:43292

Authors: Chang L, Gu Y, Yu Z, Ying H, Qiu Y, Ma G, Chen H, Jin Y, Lin X

Abstract
There is no definitive conclusion regarding the optimal timing for terminating propranolol treatment for infantile hemangioma (IH). A total of 149 patients who underwent detailed color Doppler ultrasound examination were included in this study. The characteristics and propranolol treatment of all patients were summarized and analyzed. Patients were divided into two groups according to the lesion regression rate. Among the 149 patients, 38 were assigned to the complete regression group, and 111 were assigned to the partial regression group. The age at which propranolol treatment started, duration of follow-up after treatment discontinuation and rate of adverse events were not significantly different between the two groups. The duration of oral propranolol treatment was shorter in the complete regression group. The age at which propranolol was terminated was younger in the complete regression group, and this group had a lower recurrence rate. Propranolol is safe and effective for the treatment of IHs that require intervention, but it should be stopped at an appropriate time, which is determined primarily by the lesion regression rate after propranolol treatment. Ultrasound is helpful in determining when to stop propranolol for IH.

PMID: 28225076 [PubMed - indexed for MEDLINE]

Time-of-Day Dictates Transcriptional Inflammatory Responses to Cytotoxic Chemotherapy.

Sci Rep. 2017 01 24;7:41220

Authors: Borniger JC, Walker Ii WH, Gaudier-Diaz MM, Stegman CJ, Zhang N, Hollyfield JL, Nelson RJ, DeVries AC

Abstract
Many cytotoxic chemotherapeutics elicit a proinflammatory response which is often associated with chemotherapy-induced behavioral alterations. The immune system is under circadian influence; time-of-day may alter inflammatory responses to chemotherapeutics. We tested this hypothesis by administering cyclophosphamide and doxorubicin (Cyclo/Dox), a common treatment for breast cancer, to female BALB/c mice near the beginning of the light or dark phase. Mice were injected intravenously with Cyclo/Dox or the vehicle two hours after lights on (zeitgeber time (ZT2), or two hours after lights off (ZT14). Tissue was collected 1, 3, 9, and 24 hours later. Mice injected with Cyclo/Dox at ZT2 lost more body mass than mice injected at ZT14. Cyclo/Dox injected at ZT2 increased the expression of several pro-inflammatory genes within the spleen; this was not evident among mice treated at ZT14. Transcription of enzymes within the liver responsible for converting Cyclo/Dox into their toxic metabolites increased among mice injected at ZT2; furthermore, transcription of these enzymes correlated with splenic pro-inflammatory gene expression when treatment occurred at ZT2 but not ZT14. The pattern was reversed in the brain; pro-inflammatory gene expression increased among mice injected at ZT14. These data suggest that inflammatory responses to chemotherapy depend on time-of-day and are tissue specific.

PMID: 28117419 [PubMed - indexed for MEDLINE]

Impact of Epidermal Growth Factor Receptor Mutation on Clinical Outcomes of Nintedanib Plus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer from the Korean Named Patient Program.

Oncology. 2018 Oct 26;:1-8

Authors: Hong SH, An HJ, Kim K, Lee SS, Lee YG, Yuh YJ, Park IC, Chae YS, Jang TW, Kang JH

Abstract
OBJECTIVES: Anti-angiogenic agents are reported to exert clinical activity on epidermal growth factor receptor (EGFR) mutant non-small-cell lung cancers. We evaluated the clinical outcomes of nintedanib and docetaxel in refractory NSCLC according to EGFR mutation status during the Korean nintedanib named patient program.
METHODS: Docetaxel was administered either 75 or 37.5 mg/m2 on D1, D8 q every 3 weeks for 4-6 cycles plus nintedanib 200 mg orally twice daily until disease progression or unacceptable toxicity.
RESULTS: Sixty-two patients were enrolled for study. Twenty-eight patients with activating EGFR mutations progressed after EGFR-tyrosine kinase inhibitors (TKI) therapy and 25 out of 28 patients showing progression after platinum doublet chemotherapy were enrolled. The objective response rate was 29% and median PFS and OS were 3.9 months and 11.7 months. Based on the EGFR mutation status, the objective response rate was 39.3 vs. 21.9% (EGFR mut(+) vs. EGFR mut(-), p = 0.142) and median PFS was 6.5 vs. 3.3 months (EGFR mut(+) vs. EGFR mut(-), p = 0.009). No treatment-related deaths were reported. The most frequent drug-related adverse events (AE) were neutropenia (53.2%) and diarrhea (37.1%). Treatment in 12 patients (19.3%) was permanently discontinued due to AEs without disease progression.
CONCLUSIONS: Our data indicated that nintedanib-docetaxel combination could be considered to be effective treatment in EGFR TKI-resistant EGFR mutant NSCLC.

PMID: 30368503 [PubMed - as supplied by publisher]

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 2018/10/27

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.

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 2018/10/27

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.

17 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 2018/10/26

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.

16 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 2018/10/26

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.

PREOPERATIVE TREATMENT WITH METYRAPONE IN PATIENTS WITH CUSHING'S SYNDROME DUE TO ADRENAL ADENOMA.

Endocr Connect. 2018 Sep 01;:

Authors: Puglisi S, Perotti P, Barbot M, Cosio P, Scaroni C, Stigliano A, Lardo P, Morelli V, Polledri E, Chiodini I, Reimondo G, Pia A, Terzolo M

Abstract
OBJECTIVE: Metyrapone has been approved for the treatment of patients with Cushing's syndrome (CS), but only few retrospective clinical studies are available. The aim of our study was the prospective assessment of metyrapone as pre-operative treatment.
DESIGN AND METHODS: Before adrenalectomy, 7 patients with ACTH-independent CS due to adrenal adenoma were prospectively treated with metyrapone for 3 months in 3 tertiary academic centers, with endocrine work-up and clinical evaluation at screening and at predefined evaluation time points (Day 14, 31, 48, 65, 82).
RESULTS: In all patients, UFC levels decreased up to normal range from baseline to Day 82 [609 (188 - 1476) vs 69 (28 - 152) nmol/24 h, p <0.02], with a reduction of serum and salivary cortisol levels, and no significant increase of plasma ACTH and serum DHEAS levels. Clinical improvement was reported on quality of life [+16.7 (+4.2; +52.00) points, p <0.04) and pressure control [systolic pressure, -25 (-52;-10) mmHg, p <0.01; diastolic pressure, -16 (-50; +2 mmHg), p <0.03)]. No significant change in weight, electrolytes, glycemic and lipid profile was reported. Although in women a significant increase of testosterone and androstenedione was reported, no worsening of clinical hyperandrogenism was observed. All drug-related adverse events (nausea, fatigue, low grade fever, edema of lower limbs and facial rash) were grade 1 or 2 and generally transient.
CONCLUSIONS: This prospective pilot study demonstrated that metyrapone is effective in normalizing biochemical and clinical parameters in patients with CS due to adrenal adenoma before surgical intervention, with minimal side effects.

PMID: 30352400 [PubMed - as supplied by publisher]

Meta-analysis of the efficacy and safety of mirabegron and solifenacin monotherapy for overactive bladder.

Neurourol Urodyn. 2018 Oct 23;:

Authors: Wang J, Zhou Z, Cui Y, Li Y, Yuan H, Gao Z, Zhu Z, Wu J

Abstract
AIM: We conducted a meta-analysis to evaluate the safety and efficacy of mirabegron (50 mg) and solifenacin (5 mg) monotherapy for overactive bladder (OAB) during a 12-week cycle.
METHODS: Randomized controlled trials (RCTs) of mirabegron and solifenacin for OAB were searched systematically by using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of retrieved studies were also perused.
RESULTS: Five RCTs which compared solifenacin with mirabegron were studied. Mirabegron achieved the same effect as solifenacin in treating OAB. The mean number of incontinence episodes per 24 h (P = 0.20), mean number of micturitions per 24 h (P = 0.11), mean number of urgency episodes per 24 h (P = 0.23), and mean volume voided per micturition (P = 0.05) suggested that mirabegron and solifenacin had no significant differences in terms of OAB treatment. With regard to drug-related treatment-emergent adverse events (DR-TEAEs) and dry mouth, mirabegron showed better tolerance than solifenacin. Post-voiding residual volume showed a distinct difference in the two groups. Hypertension and tachycardia did not show a significant difference between the two groups, but the pulse rate did.
CONCLUSION: The therapeutic effect of mirabegron is similar to that of solifenacin, and mirabegron does not increase the risk of adverse events (AEs).

PMID: 30350884 [PubMed - as supplied by publisher]

Phase I trial of afatinib and 3-weekly trastuzumab with optimal anti-diarrheal management in patients with HER2-positive metastatic cancer.

Cancer Chemother Pharmacol. 2018 Oct 22;:

Authors: Martin N, Isambert N, Gomez-Roca C, Goeldner RG, Zanetta S, Sadrolhefazi B, de Mont-Serrat H, Campone M, Delord JP

Abstract
BACKGROUND: Trastuzumab is the mainstay of therapy for patients with HER2-positive breast and gastric cancer but resistance frequently occurs. Afatinib, an irreversible oral ErbB family blocker, shows clinical activity in trastuzumab-refractory HER2-positive metastatic breast cancer.
MATERIALS AND METHODS: This phase I study used a modified 3 + 3 dose escalation design to determine the maximum tolerated dose (MTD) of oral once-daily afatinib in combination with 3-weekly intravenous trastuzumab (8 mg/kg week 1; 6 mg/kg 3-weekly thereafter) for patients with confirmed advanced or metastatic HER2-positive cancer.
RESULTS: Of the 13 patients treated, 6 received daily afatinib 20 mg and 7 received 30 mg. One patient who received afatinib 30 mg developed a tumor lysis syndrome and was not evaluable for dose-limiting toxicity (DLT). Two of the six remaining patients receiving afatinib 30 mg and 1 of the 6 patients receiving afatinib 20 mg experienced DLTs (all CTCAE ≥ grade 2 diarrhea despite optimal management) in the first treatment cycle. The most common drug-related adverse events were diarrhea (n = 13, 100%), asthenia (n = 8, 61.5%), rash (n = 7, 53.8%) and paronychia (n = 5, 38.5%). No pharmacokinetic interaction was observed. One patient (7.7%) had an objective response (20 mg afatinib cohort). Nine patients (69.2%) experienced clinical benefit.
CONCLUSIONS: Despite optimal management of diarrhea including treatment of grade I symptoms, it was not possible to treat the patients above a dose of 20 mg of afatinib daily in combination with 3-weekly trastuzumab. The MTD of afatinib in combination with the recommended 3-weekly dose of trastuzumab was 20 mg daily.

PMID: 30350178 [PubMed - as supplied by publisher]

Anti-Cancer and Protective Effects of Royal Jelly for Therapy-Induced Toxicities in Malignancies.

Int J Mol Sci. 2018 Oct 21;19(10):

Authors: Miyata Y, Sakai H

Abstract
Royal jelly (RJ) is a glandular secretion produced by worker honeybees and is a special food for the queen honeybee. It results in a significant prolongation of the lifespan of the queen honeybee compared with the worker honeybees through anti-inflammatory, anti-oxidant and anti-microbial activities. Consequently, RJ is used as cosmetic and dietary supplement throughout the world. In addition, in vitro studies and animal experiments have demonstrated that RJ inhibits cell proliferation and stimulates apoptosis in various types of malignant cells and affects the production of various chemokines, anti-oxidants and growth factors and the expression of cancer-related molecules in patients with malignancies, especially in patients treated with anti-cancer agents. Therefore, RJ is thought to exert anti-cancer effects on tumor growth and exhibit protective functions against drug-induced toxicities. RJ has also been demonstrated to be useful for suppression of adverse events, the maintenance of the quality of life during treatment and the improvement of prognosis in animal models and patients with malignancies. To understand the mechanisms of the beneficial effects of RJ, knowledge of the changes induced at the molecular level by RJ with respect to cell survival, inflammation, oxidative stress and other cancer-related factors is essential. In addition, the effects of combination therapies of RJ and other anti-cancer agents or natural compounds are important to determine the future direction of RJ-based treatment strategies. Therefore, in this review, we have covered the following five issues: (1) the anti-cancer effects of RJ and its main component, 10-hydroxy-2-decenoic acid; (2) the protective effects of RJ against anti-cancer agent-induced toxicities; (3) the molecular mechanisms of such beneficial effects of RJ; (4) the safety and toxicity of RJ; and (5) the future directions of RJ-based treatment strategies, with a discussion on the limitations of the study of the biological activities of RJ.

PMID: 30347885 [PubMed - in process]

Pazopanib, Cabozantinib, and Vandetanib in the Treatment of Progressive Medullary Thyroid Cancer with a Special Focus on the Adverse Effects on Hypertension.

Int J Mol Sci. 2018 Oct 20;19(10):

Authors: Milling RV, Grimm D, Krüger M, Grosse J, Kopp S, Bauer J, Infanger M, Wehland M

Abstract
Medullary thyroid cancer (MTC) is a rare malignancy with a poor prognosis. First line therapy is surgery, which is the only curative method of the disease. However, in non-operable cases or with tumor progression and metastases, a systemic treatment is necessary. This form of cancer is often insensitive to conventional chemotherapy, but the use of tyrosine kinase inhibitors (TKIs), such as pazopanib, cabozantinib, and vandetanib, has shown promising results with an increase in progression-free survival and prolonged lifetime. Therefore, we focused on the pharmacological characteristics of TKIs, their mechanism of action, their application as a secondary treatment option for MTC, their efficacy as a cancer drug treatment, and reviewed the ongoing clinical trials. TKIs also act systemically causing various adverse events (AEs). One common AE of this treatment is hypertension, known to be associated with cardiovascular disease and can therefore potentially worsen the well-being of the treated patients. The available treatment strategies of drug-induced hypertension were discussed. The mechanism behind the development of hypertension is still unclear. Therefore, the treatment of this AE remains symptomatic. Thus, future studies are necessary to investigate the link between tumor growth inhibition and hypertension. In addition, optimized, individual treatment strategies should be implemented.

PMID: 30347815 [PubMed - in process]

Coping with chemotherapy for breast cancer: Asking women what works.

Eur J Oncol Nurs. 2018 Aug;35:85-91

Authors: Gibbons A, Groarke A

Abstract
PURPOSE: To explore the coping strategies women use to cope with the side effects and distress of chemotherapy for breast cancer.
METHODS: Twenty women with breast cancer who received chemotherapy took part in qualitative, semi-structured face-to-face interviews about their coping strategies. Ten women had received their diagnosis via a national breast cancer screening programme, and ten women had been diagnosed through referral to a symptomatic breast cancer services clinic. Data was analysed using thematic analysis based on an interpretative phenomenological approach.
RESULTS: A combination of coping strategies were utilised to deal with the side effects of chemotherapy, with three main themes emerging. Behavioural coping strategies such as anticipatory coping and maintenance of activities were used to regain a sense of control. Emotional coping strategies such as seeking support and reappraisal were utilised to cope with treatment-related distress. Women also engaged in coping appraisal, whereby women evaluated how effective their responses were in reducing their distress, often leading to a change in the coping strategies used. Women who were diagnosed through the screening programme were less likely to seek treatment information or access cancer support services.
CONCLUSIONS: Anticipating side effects and engaging in coping strategies to minimise their impact highlights the importance of providing accurate information about the side effects of treatment, and the potential for these strategies as components of effective interventions to reduce distress. Oncology nurses are ideally placed to drive provision of pre-chemotherapy care programmes that include specific preparatory information to increase adaptive coping, and reduce distress.

PMID: 30057089 [PubMed - indexed for MEDLINE]

Understanding Patient Adherence and Concerns with STatins and MedicatION Discussions With Physicians (ACTION): A survey on the patient perspective of dialogue with healthcare providers regarding statin therapy.

Clin Cardiol. 2018 Jun;41(6):710-720

Authors: Brinton EA

Abstract
BACKGROUND: Statins are first-line for cholesterol lowering and prevention of atherosclerotic cardiovascular disease (ASCVD), but their use is complicated by side effects and potential for drug-drug interactions. Provider-patient communication is the basis of the recommended shared decision-making, but relatively little is known about this in the context of statin use.
METHODS: We surveyed 5014 US adults prescribed a statin for hypercholesterolemia to learn their perspectives on communication with their provider.
RESULTS: Ninety-four percent reported currently taking a statin while 6% had stopped. Past users vs current users were more likely to be female, age < 65 years, and to have fewer cardiovascular disease-related comorbidities (hypertension, type 2 diabetes mellitus, and coronary heart disease, respectively). Although 93% of current statin users were taking ≥1 other prescription medications (median of 4), 76% were "not at all"/"not very concerned" about potential drug-drug interactions with their statin, and fewer than one-quarter recalled mention of these from their provider. Ninety-five percent of subjects said it was "extremely"/"somewhat" important that their healthcare provider take "an individualized approach to selecting the right statin," but 73% and 76%, respectively, said their statin choice was made with little or no input from them. Only 25% were told that "some statins might be more likely than others to interact with other medications," and only 18% (and only 20% of past users) were told that "their particular statin might interact with other medications."
CONCLUSION: Provider-patient communication regarding statin therapy appears inadequate, by patient recall, and efforts to improve it are warranted.

PMID: 29749101 [PubMed - indexed for MEDLINE]

[Adverse Drug Reactions in Sichuan Children During 2012-2014.]

Sichuan Da Xue Xue Bao Yi Xue Ban. 2016 Nov;47(6):904-907

Authors: Liu C, Peng D, Lan S, Zhang Q

Abstract
OBJECTIVES: To determine the characteristics of adverse drug reactions (ADRs) in children.
METHODS: Reported ADRs in the patients aged from 0-18 years were extracted from the 2012-2014 Sichuan ADR surveillance system.The time trend,category of ADRs [system organ class (SOC)],outcomes,and demographic characteristics of the patients were analyzed.
RESULTS: The reported paediatric ADRs increased over time;most occurred in males (7 709,56.40%) and preschool children (5 928,43.37%).The majorities involved intravenous drips (8 492,62.13%) and skin and appendages (7 510,55.10%).About 267 (1.95%) cases were deemed as serious ADRs,most (120,44.94%) involving whole body consequences.The majority (13 515,98.87%) of patients recovered.But deaths (5,0.04%) were also reported.
CONCLUSIONS: Pediatric ADRs are associated with young age (less than 5 years old) and intravenous drips.Serious ADRs should be identified for early interventions.

PMID: 28598122 [PubMed - indexed for MEDLINE]