Pearls and Pitfalls in the Crashing Geriatric Patient.

Emerg Med Clin North Am. 2020 Nov;38(4):919-930

Authors: Yamane DP

Abstract
The geriatric population is growing and is the largest utilizer of emergency and critical care services; the emergency clinician should be comfortable in the management of the acutely ill geriatric patient. There are important physiologic changes in geriatric patients, which alters their clinical presentation and management. Age alone should not determine the prognosis for elderly patients. Premorbid functional status, frailty, and severity of illness should be considered carefully for the geriatric population. Emergency clinicians should have honest conversations about goals of care based not only a patient's clinical presentation but also the patient's values.

PMID: 32981626 [PubMed - indexed for MEDLINE]

Adverse Effects of Antipsychotics Are Relevant in Palliative Care Too.

Dtsch Arztebl Int. 2020 06 26;117(26):462

Authors: Gahr M, Connemann BJ

PMID: 32897186 [PubMed - indexed for MEDLINE]

The authors reply.

Kidney Int. 2020 09;98(3):787-789

Authors: Vervaet BA, Nast CC, Schreurs G, Jayasumana C, Herath C, De Broe ME

PMID: 32622832 [PubMed - indexed for MEDLINE]

Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis: A Randomized, Double-Blinded, Parallel-Group Phase III Study.

BioDrugs. 2020 Feb;34(1):99-110

Authors: Kim Y, Park SK, Cho WY, Joo KW, Shin SK, Kim DJ, Kim YL, Son SH, Chung W, Lee KY, Park SK, Kim JK, Kim SW, Kang DH, Kim JK, Jeon JS, Lee KW, Lee CH, Oh DJ, An WS, Lee JS, Kang GW, Do JY, Lee JP, Jin K

Abstract
BACKGROUND: Darbepoetin-alfa is an erythropoiesis-stimulating agent (ESA) with a long elimination half-life that achieves better hemoglobin (Hb) stability than short-acting ESAs.
OBJECTIVE: We aimed to evaluate the efficacy and safety of intravenous CKD-11101 (a biosimilar of darbepoetin-alfa) compared with those of darbepoetin-alfa in hemodialysis patients.
METHODS: The study was performed in 24 centers in Korea between June 2015 and June 2017. The study subjects were randomized in a double-blind manner. The follow-up duration was 24 weeks, which consisted of 20 weeks of maintenance and 4 weeks of evaluation period. All patients underwent a stabilization period to achieve a target baseline Hb of 10-12 g/dL before randomization. Following randomization, patients received darbepoetin-alfa or CKD-11101 weekly or biweekly.
RESULTS: A total of 403 patients were randomized into two groups, and a total of 325 patients (80.6%) completed the investigation. The differences between the two groups in terms of change in the average Hb level from baseline to evaluation were not significant. The average administered dose of ESA was similar between the groups. There was no difference in the proportion of patients who maintained the target Hb during the evaluation period [60.4% vs. 66.2% in the CKD-11101 and darbepoetin-alfa groups, respectively (p = 0.3038)]. In addition, the safety analysis, consisting of adverse events and adverse drug reactions, showed comparable results between the two groups.
CONCLUSION: The changes in the level of Hb, dose of erythropoietin, and achievement rate of the target Hb during the study period were comparable between the groups. CKD-11101 has an equivalent efficacy and safety compared with darbepoetin-alfa in patients undergoing hemodialysis.

PMID: 31749113 [PubMed - indexed for MEDLINE]

Bicalutamide-associated hallucinations in a metastatic prostate cancer patient: A case report.

J Oncol Pharm Pract. 2020 Jun;26(4):1029-1031

Authors: Turkkan G, Dogan C, Tek B

Abstract
INTRODUCTION: Bicalutamide is widely used in the treatment of prostate cancer. Among its side effects, central nervous system disorders are relatively rare, and the information about bicalutamide-associated hallucinations is limited.
CASE REPORT: We report an uncommon case of a patient with metastatic prostate cancer, who had hallucinations due to the use of bicalutamide.
MANAGEMENT AND OUTCOME: The patient accepted to receive only hormonal therapy (bicalutamide and leuprolide acetate). But he developed hallucinations due to bicalutamide use. His hallucinations disappeared after discontinuation of bicalutamide. A good response was obtained with the use of luteinizing hormone-releasing hormone agonist monotherapy.
DISCUSSION: The pathophysiology of bicalutamide-induced hallucinations is unclear. We hypothesize that antiandrogens can indirectly cause hallucinations through changes in plasma testosterone and cerebral reelin expression. Additionally, luteinizing hormone-releasing hormone agonist monotherapy is a good option in metastatic prostate cancer patients who have intolerable side effects due to the use of antiandrogens.

PMID: 31707924 [PubMed - indexed for MEDLINE]

Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report.

Eur Respir J. 2019 12;54(6):

Authors: Borisov S, Danila E, Maryandyshev A, Dalcolmo M, Miliauskas S, Kuksa L, Manga S, Skrahina A, Diktanas S, Codecasa LR, Aleksa A, Bruchfeld J, Koleva A, Piubello A, Udwadia ZF, Akkerman OW, Belilovski E, Bernal E, Boeree MJ, Cadiñanos Loidi J, Cai Q, Cebrian Gallardo JJ, Dara M, Davidavičienė E, Forsman LD, De Los Rios J, Denholm J, Drakšienė J, Duarte R, Elamin SE, Escobar Salinas N, Ferrarese M, Filippov A, Garcia A, García-García JM, Gaudiesiute I, Gavazova B, Gayoso R, Gomez Rosso R, Gruslys V, Gualano G, Hoefsloot W, Jonsson J, Khimova E, Kunst H, Laniado-Laborín R, Li Y, Magis-Escurra C, Manfrin V, Marchese V, Martínez Robles E, Matteelli A, Mazza-Stalder J, Moschos C, Muñoz-Torrico M, Mustafa Hamdan H, Nakčerienė B, Nicod L, Nieto Marcos M, Palmero DJ, Palmieri F, Papavasileiou A, Payen MC, Pontarelli A, Quirós S, Rendon A, Saderi L, Šmite A, Solovic I, Souleymane MB, Tadolini M, van den Boom M, Vescovo M, Viggiani P, Yedilbayev A, Zablockis R, Zhurkin D, Zignol M, Visca D, Spanevello A, Caminero JA, Alffenaar JW, Tiberi S, Centis R, D'Ambrosio L, Pontali E, Sotgiu G, Migliori GB

Abstract
The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1-2) and 57 (11.3%) as serious (grade 3-5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.

PMID: 31601711 [PubMed - indexed for MEDLINE]

Behcet's-like syndrome following pembrolizumab: An immune-related adverse event associated with programmed death receptor-1 inhibitor therapy.

J Oncol Pharm Pract. 2020 Jun;26(4):995-999

Authors: Thomas S, Bae C, Joy-Ann T, Traverse W

Abstract
INTRODUCTION: The landscape for the treatment of metastatic melanoma has been revolutionized with the introduction immune checkpoint inhibitors. Immune checkpoint inhibitors have now become the standard of care for the treatment of cancers. These immune agents including programmed death receptor-1 inhibitors, programmed death-ligand 1 inhibitors and cytotoxic T-lymphocyte antigen-4 inhibitors have shown promising results but have been associated with numerous immune-related complications. Pembrolizumab, a programmed death receptor-1 inhibitor, has been associated with a number of immune-related adverse events affecting multiple organ systems including integument, ocular, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, and musculoskeletal system.
CASE REPORT: We present a case of an 88-year-old Caucasian male with metastatic melanoma of the face with metastasis to the right fifth cranial nerve and into the right cavernous sinus. He underwent resection of the melanoma and was placed on pembrolizumab at 2 mg/kg every three weeks. Interestingly, 24 months on pembrolizumab therapy, he developed corneal erosions, oral and genital ulcerations.
MANAGEMENT AND OUTCOME: Patient completed his 24 months of pembrolizumab and was started on prednisone and colchicine with improvement in his symptoms. At his follow-up eight months, he had recurrence of an oral ulcer.
DISCUSSION: Here we present a rare case of an elderly male on pembrolizumab who suffered from corneal erosions, oral and genital ulcers, a syndrome similar to Behcet's disease. Given that pembrolizumab and other immune checkpoint inhibitors are being utilized in the treatment of cancers, physicians should be aware of the wide range immune-related adverse events including the possible Behcet's-like syndrome presentation.

PMID: 31575354 [PubMed - indexed for MEDLINE]

Drug use is associated with lower plasma magnesium levels in geriatric outpatients; possible clinical relevance.

Clin Nutr. 2019 12;38(6):2668-2676

Authors: van Orten-Luiten ACB, Janse A, Verspoor E, Brouwer-Brolsma EM, Witkamp RF

Abstract
BACKGROUND: Hypomagnesemia has been associated with diabetes, cardiovascular disease, and other disorders. Drug use has been suggested as one of the risk factors for low magnesium (Mg) levels. In the elderly population, prone to polypharmacy and inadequate Mg intake, hypomagnesemia might be relevant. Therefore, we aimed to investigate associations between drug use and plasma Mg.
METHODS: Cross-sectional data of 343 Dutch geriatric outpatients were analysed by Cox and linear regression, while adjusting for covariates. Drug groups were coded according to the Anatomical Therapeutic Chemical classification system; use was compared to non-use. Hypomagnesemia was defined as plasma Mg < 0.75 mmol/l and <0.70 mmol/l.
RESULTS: Prevalence of hypomagnesemia was 22.2% (Mg < 0.75 mmol/l) or 12.2% (Mg < 0.70 mmol/l); 67.6% of the patients used ≥5 medications (polypharmacy). The number of different drugs used was inversely linearly associated with Mg level (beta -0.01; p < 0.01). Fully adjusted Cox regression showed significant associations of polypharmacy with hypomagnesemia (Mg < 0.75 mmol/l) (prevalence ratio (PR) 1.81; 95%CI 1.08-3.14), proton pump inhibitors (PR 1.80; 95%CI 1.20-2.72), and metformin (PR 2.34; 95%CI 1.56-3.50). Moreover, stratified analyses pointed towards associations with calcium supplements (PR 2.26; 95%CI 1.20-4.26), insulins (PR 3.88; 95%CI 2.19-6.86), vitamin K antagonists (PR 2.01; 95%CI 1.05-3.85), statins (PR 2.44; 95%CI 1.31-4.56), and bisphosphonates (PR 2.97; 95%CI 1.65-5.36) in patients <80 years; selective beta blockers (PR 2.01; 95%CI 1.19-3.40) if BMI <27.0 kg/m2; and adrenergic inhalants in male users (PR 3.62; 95%CI 1.73-7.56). Linear regression supported these associations.
CONCLUSION: As polypharmacy and several medications are associated with hypomagnesemia, Mg merits more attention, particularly in diabetes, cardiovascular disease, and in side-effects of proton pump inhibitors and calcium supplements.

PMID: 30581015 [PubMed - indexed for MEDLINE]

National Italian Delphi panel consensus: which measures are indicated to minimize pegylated-asparaginase associated toxicity during treatment of adult acute lymphoblastic leukemia?

BMC Cancer. 2020 Oct 02;20(1):956

Authors: Lussana F, Minetto P, Ferrara F, Chiaretti S, Specchia G, Bassan R

Abstract
BACKGROUND: L-asparaginase (L-ASP) is a key component of acute lymphoblastic leukemia (ALL) treatment, but its use in clinical practice raises challenges to clinicians due to a relatively high incidence of drug-related adverse events, mainly in adult patients. In the past years the use of ASP in adult population has been mainly limited due to a poor knowledge of its safety profile and to an approximate management of ASP-related toxicity. Recently the development of pediatric-inspired treatment protocols for adult ALL has led to a wider use of ASP and since 2010 in Italy three national treatment protocols including Pegylated asparaginase (Peg-ASP) have been sequentially developed for adolescents, young adults and adults with Philadelphia-negative (Ph-) ALL.
METHODS: With the aim to better understand the approach adopted in Italian centers for the management and prevention of Peg-ASP toxicity in adult ALL and to provide practical, consensus-based recommendations, a board of 6 Italian clinicians, with known expertise in adult ALL, designed 41 consensus statements on current challenges on the management of Peg-ASP associated toxicity. A group of 19 clinical experts in the field then rated these statements using the 5-point Likert-type scale (1 = strongly disagree; 5 = strongly agree).
RESULTS: The main Peg-ASP related issues identified by the board included: 1) clinician's attitudes; 2) toxicity profile; 3) hypersensitivity reactions; 4) hepatic toxicity; 5) hepatic and/or metabolic toxicity; 6) hemorrhagic/thrombotic toxicity; 7) pancreatitis; 8) metabolic toxicity management and prevention; 9) activity levels monitoring. Overall, participants agreed on most statements, except those addressing the potential contraindications to the treatment with Peg-ASP, such as patients with a diagnosis of chronic liver disease or the subsequent administrations of the drug in patients who had previously developed chemical pancreatitis or severe metabolic toxicity. Participants agreed that adult patients with ALL should receive Peg-Asp because this drug is essential to improve treatment results.
CONCLUSIONS: The panel agreed that a critical evaluation of specific risk factors for each patient is crucial in order to reduce the risk of adverse events and specific advices in the management of Peg-ASP toxicities are reported.

PMID: 33008391 [PubMed - as supplied by publisher]

Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study.

Pediatr Res. 2020 Oct 02;:

Authors: Zhang Y, Wei P, Chen B, Li X, Luo X, Chen X, Xiang M, Li L, Zhao S, Xiao X, Yang X, Chen J, Fu Y, Xiao S, Liu H, Cheng L, Yao H

Abstract
BACKGROUND: Intranasal corticosteroids are the most efficacious anti-inflammatory medications for allergic rhinitis (AR). However, the efficacy and safety of intranasal corticosteroids in children have not yet been subject to specific research in China. The aim of this study was to investigate the efficacy and safety of fluticasone furoate nasal spray (FFNS) in a Chinese pediatric population.
METHODS: In this phase 4 randomized, double-blind, placebo-controlled, multicenter study, pediatric AR patients aged 2-12 years were randomized 1:1:1, receiving either FFNS 55 or 110 µg or placebo. Electronic diary cards were completed to record symptoms, rescue medication use, and treatment compliance. Anterior rhinoscopy and overall response to therapy were evaluated and recorded.
RESULTS: Patients treated with FFNS at either dose experienced a significantly greater reduction in daily reflective total nasal symptom score compared with placebo. This was maintained in a younger subset of patients (2-6 years). Drug-related adverse events occurred in <20% of patients in all groups. FFNS was well tolerated at both doses.
CONCLUSIONS: This study demonstrates favorable efficacy and safety profiles for FFNS 55 or 110 µg in Chinese pediatric populations (2-12 years), supporting its use in clinical treatment for AR children, including younger children aged 2-6 years.
IMPACT: The aim of this study was to investigate the efficacy and safety of intranasal fluticasone furoate in Chinese pediatric allergic rhinitis.This research not only addresses the deficiency in efficacy and safety data for intranasal corticosteroids in very young patients (aged 2-6 years) worldwide but also demonstrates that fluticasone furoate nasal spray shows a favorable benefit/risk profile at different dose levels.Our data will be of interest to the broad readership of Pediatric Research and will positively contribute to the dialog regarding the treatment of allergic rhinitis in children aged 2-6 years.

PMID: 33007780 [PubMed - as supplied by publisher]

Carbamazepine Versus levetiracetam in epilepsy due to neurocysticercosis.

Acta Neurol Scand. 2020 Oct 02;:

Authors: Santhosh AP, Goyal MK, Modi M, Kharbanda PS, Ahuja CK, Tandyala N, Prabhat N, Singh R, Mehta S, Mahesh KV

Abstract
BACKGROUND: The choice of antiepileptic drug (AED) in newly diagnosed neurocysticercosis (NCC) patients with epilepsy continues to be arbitrary. We compared efficacy and side effect profile of Levetiracetam (LEV) and carbamazepine (CBZ) for the treatment of seizures in newly diagnosed patients with NCC.
PATIENTS AND METHODS: This was an open labelled randomized comparative monotherapy study including newly diagnosed drug naïve patients of NCC (n=99) presenting with seizures who were randomized in 1:1 ratio using computed generated numbers. All patients were followed up for at least six months after start of treatment. The primary outcome measure was seizure control over six months following start of AEDs.
RESULTS: 15 (15.2%) patients [CBZ- 4(8.2%); LEV- 11(22%)] developed recurrence of seizures. A trend (P=0.09) was found towards better control of seizures in CBZ compared to LEV. 2 (4%) patients in LEV group and 17 (34.6%) patients in CBZ group developed drug related minor side effects (p<0.0001). 3 patients in CBZ group needed discontinuation of therapy due to skin rash. 11 patients who relapsed while on LEV did not have any recurrence of seizures after switching over to CBZ. Out of 3 patients who relapsed while receiving CBZ and were changed to LEV, two developed seizures during follow up.
CONCLUSION: CBZ and LEV could be used as alternatives in newly diagnosed patients of NCC at the behest of minor side effects in the CBZ group.

PMID: 33006755 [PubMed - as supplied by publisher]

In Reply.

Dtsch Arztebl Int. 2020 06 26;117(26):462

Authors: Pralong A

PMID: 32897187 [PubMed - indexed for MEDLINE]

Is This a 737 Max Moment for Brolucizumab?

Am J Ophthalmol. 2020 08;216:A7-A8

Authors: Rosenfeld PJ, Browning DJ

PMID: 32505363 [PubMed - indexed for MEDLINE]

Systematic review and meta-analysis: efficacy and safety of early biologic treatment in adult and paediatric patients with Crohn's disease.

Aliment Pharmacol Ther. 2020 05;51(9):831-842

Authors: Ungaro RC, Aggarwal S, Topaloglu O, Lee WJ, Clark R, Colombel JF

Abstract
BACKGROUND: There is an increasing body of evidence showing that earlier use of biologics improves clinical outcomes in Crohn's disease (CD).
AIM: To perform a systematic review and meta-analysis to assess the impact of early biologic use in the treatment of CD.
METHODS: PubMed and Embase databases were searched for English language papers and conference abstracts published through April 30, 2019. Studies were selected for inclusion if patients initiated biologics within 2 years of a CD diagnosis or if earlier biologics use (top-down) was compared with a conventional step-up strategy. Random-effects meta-analyses were conducted to compare clinical remission (CR), relapse and endoscopic healing rates between early biologic treatment (<2 years of disease duration or top-down treatment strategy) and late/conventional treatment (biologic use after >2 years of disease duration or conventional step-up treatment strategy).
RESULTS: A total of 3069 records were identified, of which 47 references met the selection criteria for systematic review. A total of 18 471 patients were studied, with a median follow-up of 64 weeks (range 10-416). Meta-analysis found that early use of biologics was associated with higher rates of clinical remission (OR 2.10 [95% CI: 1.69-2.60], n = 2763, P < .00001), lower relapse rates (OR 0.31 [95% CI: 0.14-0.68], n = 596, P = .003) and higher mucosal healing rates (OR 2.37 [95% CI: 1.78-3.16], n = 994, P < .00001) compared with late/conventional management.
CONCLUSIONS: Early biologic treatment is associated with improved clinical outcomes in both adult and paediatric CD patients, not only in prospective clinical trials but also in real-world settings.

PMID: 32202328 [PubMed - indexed for MEDLINE]

Hydroxychloroquine Retinopathy in the Era of Advanced Imaging Modalities.

Int Ophthalmol Clin. 2020;60(1):73-83

Authors: Dahrouj M, Young L

PMID: 31855897 [PubMed - indexed for MEDLINE]

Proton pump inhibitors: placing putative adverse effects in proper perspective.

Curr Opin Gastroenterol. 2019 11;35(6):509-516

Authors: Schubert ML

Abstract
PURPOSE OF REVIEW: This review summarizes the past year's literature, both clinical and basic science, regarding potential adverse effects of proton pump inhibitors (PPIs).
RECENT FINDINGS: PPIs are amongst the most widely prescribed and over-prescribed medications worldwide. Although generally considered well tolerated, epidemiologic studies that mine large databases have reported a panoply of putative adverse effects associated with PPIs. It should be emphasized that the quality of the evidence underlying most of these associations is very low and the studies, by design, cannot ascribe cause and effect. These associations continue to be sensationalized in the media and misinterpreted by providers and patients. The unintended consequences are that patients who require PPIs, such as those taking dual antiplatelet agents, are not being prescribed or taking these necessary medications. In addition, physicians are spending an inordinate amount of additional time placing these findings into proper perspective for their patients and reassuring them upon initiating PPI treatment as well as at every follow-up visit.
SUMMARY: Most of the recent publicized putative serious adverse effects attributed to PPIs rely on observational data and have not been confirmed in prospective randomized trials. Nevertheless, PPIs should be prescribed for valid indications and when prescribed long-term, they should be used at the lowest effective dose and the need for their use periodically reassessed.

PMID: 31433315 [PubMed - indexed for MEDLINE]

Bridging blinded and unblinded analysis for ongoing safety monitoring and evaluation.

Contemp Clin Trials. 2019 08;83:81-87

Authors: Lin LA, Zhan Y, Li H, Yuan SS, Ball G, Wang W

Abstract
In order to better characterize the safety profile of investigational new drugs (INDs) during clinical development, more interest and attention have been paid to ongoing safety monitoring and evaluation. The 2015 US FDA IND safety reporting draft guidance compels sponsors to periodically evaluate unblinded safety data. However, maintaining the trial blind is necessary to avoid jeopardizing the validity of study findings. In this article, we propose an innovative new approach which includes analyzing both blinded and unblinded data. The proposed two-stage framework incorporates periodic analyses of blinded safety data to detect and flag adverse events that may have potential risk elevation related to experimental treatment, as well as planned unblinded analyses to quantify associations between the drug and adverse events, and to determine thresholds for referring adverse events for medical review and safety reporting.

PMID: 31260790 [PubMed - indexed for MEDLINE]

The inclination to shun healthy behaviours that generate only transient benefits: the role of future clarity.

Health Promot Int. 2020 Feb 01;35(1):e32-e42

Authors: Moss SA, Skinner TC, Irons M, Alexi N

Abstract
Research has not definitively ascertained the circumstances that motivate people to live a healthier lifestyle. To redress this shortfall, we report two overlapping studies that examined whether people are more inclined to value health benefits that seem enduring and fundamental rather than transient or superficial-even after controlling effort and cost. In these studies, 242 participants indicated the degree to which they implement 17 health behaviours-as well as the extent to which they perceive the benefits of these behaviours as enduring and fundamental. Furthermore, participants completed a measure that gauges future clarity. Finally, they chose which of two drugs-drugs that differ only on the longevity of effects-they prefer. Participants were more inclined to implement health behaviours that seemed to generate enduring and fundamental benefits. This effect was more pronounced in people who perceive their future as vivid and certain. Furthermore, participants tended to choose the drug that was touted as generating more enduring benefits, even after controlling cost and effort. As these results imply, to encourage healthy behaviour, health practitioners should help people clarify their future goals and then advocate behaviours that generate lasting benefits.

PMID: 30590556 [PubMed - indexed for MEDLINE]

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Does screening for adverse effects improve health outcomes in epilepsy? A randomized trial.

Neurology. 2020 07 21;95(3):e239-e246

Authors: Franco V, Canevini MP, De Sarro G, Fattore C, Fedele G, Galimberti CA, Gatti G, La Neve A, Rosati E, Specchio LM, Striano S, Tinuper P, Perucca E, SOPHIE Study Group

Abstract
OBJECTIVE: To determine whether systematic screening for adverse effects of antiepileptic drugs (AEDs) reduces toxicity burden and improves health-related quality of life in patients with epilepsy.
METHODS: Consecutive patients with uncontrolled seizures aged ≥16 years and a high Adverse Event Profile (AEP) score were randomized to 2 groups and followed up for 18 months at 11 referral centers. AEP scores were made available to treating physicians at all visits in the intervention group, but not in the control group. Co-primary endpoints were changes in AEP scores and Quality of Life Inventory for Epilepsy-31 (QOLIE-31) scores.
RESULTS: Of 809 enrolled patients able to complete the AEP questionnaire, 222 had AEP scores ≥45 and were randomized to the intervention (n = 111) or control group (n = 111). A total of 206 patients completed the 18-month follow-up. Compared with baseline, AEP scores decreased on average by 7.2% at 6 months, 12.1% at 12 months, and 13.8% at 18 months in the intervention group (p < 0.0001), and by 7.7% at 6 months, 9.2% at 12 months, and 12.0% at 18 months in controls (p < 0.0001). QOLIE-31 scores also improved from baseline to final visit, with a mean 20.7% increase in the intervention group and a mean 24.9% increase in the control group (p < 0.0001). However, there were no statistically significant differences in outcomes between groups for the 2 co-primary variables.
CONCLUSIONS: Contrary to findings from a previous study, systematic screening for adverse effects of AEDs using AEP scores did not lead to a reduced burden of toxicity over usual physician treatment.
ITALIAN MEDICINES AGENCY AIFA IDENTIFIER: FARM52K2WM_003.
CLINICALTRIALSGOV IDENTIFIER: NCT03939507 (registered retrospectively in 2019; the study was conducted during the 2006-2009 period and registration of clinical trials was not a widely established practice when this study was initiated).
CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that the additional collection of formal questionnaires regarding adverse effects of AEDs does not reduce toxicity burden over usual physician treatment.

PMID: 32601123 [PubMed - indexed for MEDLINE]