Bioequivalence and Pharmacokinetic Profiles of Generic and Branded Obeticholic Acid in Healthy Chinese Subjects Under Fasting and Fed Conditions.

Drug Des Devel Ther. 2021;15:185-193

Authors: Wang MN, Yu HT, Li YQ, Zeng Y, Yang S, Yang GP, Pei Q, Huang J

Abstract
Objectives: This study was conducted to evaluate the bioequivalence (BE) of a generic form of obeticholic acid (OCA) and OcalivaTM under fasting and fed conditions and to determine the effects of food on the pharmacokinetic (PK) profiles of OCA in healthy Chinese subjects.
Methods: A randomized, single-dose, three-sequence, three-period, partial replicated crossover study was conducted with a 21-day washout interval between periods under fasting (n=48) and fed (n=48) conditions. Blood samples for OCA and its metabolites Glyco-OCA and Tauro-OCA were collected up to 168 hours after administration in each period. PK parameters were calculated using the non-compartmental method. Geometric mean ratios for PK parameters of the test to reference drug under fasting and fed conditions and their 90% confidence intervals were estimated. Safety evaluations were carried out all through the study.
Results: A total of 91 subjects completed the study with 45 in a fasted state and 46 receiving a high-fat diet. There were no serious or unexpected drug-related adverse events occurring during the study. There was no significant difference in the main PK parameters of the two preparations, irrespective of the fasting or fed conditions. Under fasting and fed conditions, the SWR of lnCmax, lnAUC0-t and lnAUC0-∞ were 0.445, 0.370, 0.448, 0.340, 0.168, and 0.180, respectively. Thus, the average BE or the reference-scaled average BE was used to verify that the two preparations were bioequivalent under fasting and fed conditions. Compared with the fasting state, the AUC0-t of the test drug, the AUC0-t, and AUC0-∞ of the reference drug were higher in the fed state.
Conclusion: The test drug and the reference drug were BE and well tolerated in Chinese healthy subjects under both fasting and fed conditions. Food-intake may cause a significant difference in the main PK parameters of the two preparations.

PMID: 33469270 [PubMed - in process]

Partnering with Clinical Pharmacologists to Improve Medication Use in Children.

J Pediatr. 2020 12;227:5-8

Authors: Miyagi SJ, Lam E, Tang Girdwood S

PMID: 33228913 [PubMed - indexed for MEDLINE]

Cancer immunotherapy-related adverse events: causes and challenges.

Support Care Cancer. 2020 Dec;28(12):6111-6117

Authors: Blidner AG, Choi J, Cooksley T, Dougan M, Glezerman I, Ginex P, Girotra M, Gupta D, Johnson D, Shannon VR, Suarez-Almazor M, Rapoport BL, Anderson R

Abstract
Despite the success and ongoing promise of monoclonal antibody-targeted immune checkpoint inhibitor immunotherapy of advanced malignancies, in particular, antibodies directed against CTLA-4 and PD-1/PD-L1, the development of immune-related adverse events (irAEs) remains a constraint of this type of therapy. Although rarely fatal, the occurrence of irAEs may necessitate discontinuation of immunotherapy, as well as administration of corticosteroids or other immunosuppressive therapies that may not only compromise efficacy but also predispose for development of opportunistic infection. Clearly, retention of efficacy of immune checkpoint-targeted therapies with concurrent attenuation of immune-mediated toxicity represents a formidable challenge. In this context, the current brief review examines mechanistic relationships between these events, as well as recent insights into immunopathogenesis, and strategies which may contribute to resolving this issue. These sections are preceded by brief overviews of the discovery and functions of CTLA-4 and PD-1, as well as the chronology of the development of immunotherapeutic monoclonal antibodies which target these immune checkpoint inhibitors.

PMID: 32857220 [PubMed - indexed for MEDLINE]

Multinational Association of Supportive Care in Cancer (MASCC) 2020 clinical practice recommendations for the management of immune checkpoint inhibitor endocrinopathies and the role of advanced practice providers in the management of immune-mediated toxicities.

Support Care Cancer. 2020 Dec;28(12):6175-6181

Authors: Cooksley T, Girotra M, Ginex P, Gordon RA, Anderson R, Blidner A, Choi J, Dougan M, Glezerman I, Gupta D, Johnson D, Shannon VR, Suarez-Almazor M, Rapoport BL

Abstract
Immune checkpoint inhibitors (ICIs) have emerged as the newest pillar of cancer treatment, transforming outcomes in melanoma and showing benefit in a range of malignancies. Immune-mediated toxicities, stemming from increased activity within the T cell lineage, range from asymptomatic or mild complications to those that are fulminant and potentially fatal. Immune-mediated endocrinopathies include hypophysitis, thyroiditis, and insulin-dependent diabetes mellitus. These presentations, which may be vague and non-specific, can be life-threatening if not diagnosed and treated appropriately. This review considers the work-up and management of immune-mediated endocrinopathies and also considers the role of advanced practice practitioners in the management of immune-mediated toxicities. These state-of-the-art MASCC recommendations represent a comprehensive overview of the management and clinical work-up in those in whom the diagnosis should be considered.

PMID: 32856213 [PubMed - indexed for MEDLINE]

Multinational Association of Supportive Care in Cancer (MASCC) 2020 clinical practice recommendations for the management of immune-mediated cardiovascular, rheumatic, and renal toxicities from checkpoint inhibitors.

Support Care Cancer. 2020 Dec;28(12):6159-6173

Authors: Suarez-Almazor ME, Pundole X, Abdel-Wahab N, Johnson DB, Gupta D, Glezerman I, Cooksley T, Anderson R, Blidner A, Choi J, Dougan M, Ginex P, Girotra M, Shannon VR, Rapoport BL

Abstract
Immune checkpoint inhibitors (ICIs) have emerged as the newest pillar of cancer treatment. Immune-mediated toxicities, stemming from increased activity within the T cell lineage, range from asymptomatic or mild complications to those that are fulminant and potentially fatal. Although they are of variable occurrence, cardiovascular, rheumatic, and renal immune-mediated toxicities are among the most serious of these adverse events. We present MASCC recommendations with respect to the workup and management of cardiovascular, rheumatic, and renal immune-mediated toxicities with a focus on presentations that require treatment with immunomodulating agents.

PMID: 32856212 [PubMed - indexed for MEDLINE]

Multinational Association of Supportive Care in Cancer (MASCC) 2020 clinical practice recommendations for the management of severe gastrointestinal and hepatic toxicities from checkpoint inhibitors.

Support Care Cancer. 2020 Dec;28(12):6129-6143

Authors: Dougan M, Blidner AG, Choi J, Cooksley T, Glezerman I, Ginex P, Girotra M, Gupta D, Johnson D, Shannon VR, Suarez-Almazor M, Anderson R, Rapoport BL

Abstract
Immune-related adverse events (IrAEs) affecting the gastrointestinal (GI) tract and liver are among the most frequent and most severe inflammatory toxicities from contemporary immunotherapy. Inflammation of the colon and or small intestines (entero)colitis is the single most common GI IrAE and is an important cause of delay of discontinuation of immunotherapy. The severity of these GI IrAEs can range from manageable with symptomatic treatment alone to life-threatening complications, including perforation and liver failure. The frequency and severity of GI IrAEs is dependent on the specific immunotherapy given, with cytotoxic T lymphocyte antigen (CTLA)-4 blockade more likely to induce severe GI IrAEs than blockade of either programmed cell death protein 1 (PD-1) or PD-1 ligand (PD-L1), and combination therapy showing the highest rate of GI IrAEs, particularly in the liver. To date, we have minimal prospective data on the appropriate diagnosis and management of GI IrAEs, and recommendations are based largely on retrospective data and expert opinion. Although clinical diagnoses of GI IrAEs are common, biopsy is the gold standard for diagnosis of both immunotherapy-induced enterocolitis and hepatitis and can play an important role in excluding competing, though less common, diagnoses and ensuring optimal management. GI IrAEs typically respond to high-dose corticosteroids, though a significant fraction of patients requires secondary immune suppression. For colitis, both TNF-α blockade with infliximab and integrin inhibition with vedolizumab have proved highly effective in corticosteroid-refractory cases. Detailed guidelines have been published for the management of low-grade GI IrAEs. In the setting of more severe toxicities, involvement of a GI specialist is generally recommended. The purpose of this review is to survey the available literature and provide management recommendations focused on the GI specialist.

PMID: 32856210 [PubMed - indexed for MEDLINE]

The potential role of big data in the detection of adverse drug reactions.

Expert Rev Clin Pharmacol. 2020 Mar;13(3):201-204

Authors: Sultana J, Trifirò G

PMID: 32176553 [PubMed - indexed for MEDLINE]

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Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial.

Epilepsy Res. 2020 Dec 04;170:106526

Authors: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C

Abstract
This long-term open-label extension (OLE) trial was conducted to evaluate the long-term safety and tolerability of brivaracetam (BRV) at individualized doses in patients with epilepsy and focal (partial-onset) or generalized onset seizures, or Unverricht-Lundborg disease (ULD). A secondary objective was to evaluate efficacy of BRV in the subgroups of patients with focal or generalized onset seizures. Patients with epilepsy were eligible to enroll in this OLE (N01125; NCT00175916) and were analyzed if they had completed a previous double-blind BRV trial (N01114 [NCT00175929], N01252 [NCT00490035], N01254 [NCT00504881], N01187 [NCT00357669], and N01236 [NCT00368251]), and were expected to obtain a reasonable benefit from long-term BRV treatment. Patients entered the OLE at the BRV dose recommended at the end of the previous trial, with dose adjustments of BRV and concomitant antiseizure medications permitted. Safety variables included treatment-emergent adverse events (TEAEs). Efficacy variables in patients with focal seizures were percent reduction in focal seizure frequency, 50 % responder rates, and 6- and 12-month seizure-freedom. Eight hundred and fifty-three patients (729 [85.5 %] with focal seizures, 30 [3.5 %] with generalized onset seizures, and 94 [11.0 %] with ULD) were enrolled and included in the Safety Set. Overall, 619 (72.6 %) patients discontinued the trial, mainly due to lack of efficacy (354 [41.5 %]), adverse events (100 [11.7 %]), and patient choice (98 [11.5 %]). During the OLE, 588 (68.9 %) patients received BRV for ≥12 months, 403 (47.2 %) for ≥36 months, and 223 (26.1 %) for ≥96 months. The most common modal dose of BRV was 150 mg/day (415 [48.7 %] patients). In the ULD subgroup, the most common modal BRV dose was 100 mg/day (44/94 [46.8 %] patients), and 37/94 (39.4 %) patients had ≥96 months of BRV exposure. Overall, 720/853 (84.4 %) patients reported TEAEs, 451 (52.9 %) had a drug-related TEAE, and 95 (11.1 %) discontinued BRV due to a TEAE. In the ULD subgroup, 87/94 (92.6 %) patients reported TEAEs, 60 (63.8 %) had a drug-related TEAE, and 16 (17.0 %) discontinued due to a TEAE. In patients with focal seizures, the median reduction in focal seizure frequency from Baseline was 43.1 % (n = 728), the 50 % responder rate was 43.6 % (n = 729), and 6- and 12-month seizure freedom rates were 22.2 % and 15.8 %, respectively (n = 595). Overall, BRV was well-tolerated as long-term adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease, with improvements in focal seizure frequency maintained over time.

PMID: 33461041 [PubMed - as supplied by publisher]

Generalized Lichen Planus-like Eruption Related to Trimebutine.

Eur J Case Rep Intern Med. 2020;7(12):002103

Authors: Koumaki D, Koumaki V, Katoulis A, Boumpoucheropoulos S, Evangelou G, Stefanidou M, Krasagakis K

Abstract
Trimebutine is a spasmolytic agent with antimuscarinic effects that is used for the treatment of irritable bowel syndrome (IBS) and lower gastrointestinal tract motility disorders. Lichenoid drug eruptions (LDE) to trimebutine maleate have not been previously reported. Here we present the case of a 50-year-old male patient who developed an extensive lichenoid eruption on his upper and lower extremities and trunk 4 weeks after starting treatment with trimebutine maleate 300 mg once daily for IBS. Two months after discontinuation of the drug and administration of topical treatment with emollients and corticosteroids, the LDE cleared completely with no recurrence. The diagnosis of LDE due to trimebutine was made, based upon the clinical features resembling lichen planus, the histological findings of interface dermatitis, the evidence of a temporal relationship between drug intake and the development of skin lesions, and resolution upon discontinuation of the drug. To the best of the authors' knowledge, LDE following trimebutine maleate intake has not been previously reported. Management of trimebutine-induced LDE includes withdrawal of the causative agent and treatment with potent topical corticosteroids.
LEARNING POINTS: Cutaneous adverse events due to trimebutine maleate, an antispasmodic agent frequently used for the treatment of irritable bowel syndrome (IBS), have rarely been reported.Lichenoid drug eruption (LDE), also called drug-induced lichen planus, is an uncommon cutaneous adverse effect of several drugs.Here we report the first case of trimebutine maleate-induced LDE.

PMID: 33457371 [PubMed]

Vancomycin-induced linear IgA bullous dermatosis.

Proc (Bayl Univ Med Cent). 2020 Aug 26;34(1):83-84

Authors: Wiggins CJ, Chon SY

Abstract
Adverse medication side effects are not uncommon in the inpatient setting, where polypharmacy is the norm. Linear IgA bullous dermatosis (LABD) can be a cutaneous side effect of commonly used inpatient medications, such as vancomycin. Symptoms of LABD can be severe, and proper recognition of this drug-induced disease is important to ensuring proper treatment, including the removal of the inciting agent. This report describes a case of vancomycin-associated LABD in a 66-year-old man and the proper management of drug-induced LABD.

PMID: 33456152 [PubMed]

Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia.

Schizophr Res. 2021 Jan 12;228:198-205

Authors: Correll CU, Vanover KE, Davis RE, Chen R, Satlin A, Mates S

Abstract
BACKGROUND: Lumateperone is a mechanistically novel agent FDA-approved for the treatment of schizophrenia. Efficacy and favorable tolerability of lumateperone were demonstrated in 2 short-term placebo-controlled studies in patients with schizophrenia. This open-label study investigated the short-term safety/tolerability of lumateperone in outpatients with stable schizophrenia switched from previous antipsychotic treatment.
METHODS: Adult outpatients with stable schizophrenia were switched from previous antipsychotics to lumateperone 42 mg once daily for six weeks, then patients were switched back to previous or another approved antipsychotic for 2 weeks. The primary objective assessed adverse events (AE), vital signs, laboratory tests, and extrapyramidal symptoms (EPS). Schizophrenia symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS).
RESULTS: Among 301 patients switched to lumateperone (study completion=71.2%), treatment-emergent AEs (TEAEs) occurred in 137 patients (45.5%), with 92 (30.6%) experiencing a drug-related TEAE. The most common drug-related TEAEs were somnolence (6.6%), headache (5.3%), and dry mouth (5.3%). Most TEAEs were mild or moderate in severity. EPS-related TEAEs were rare (1.0%). There were significant decreases from previous antipsychotics baseline in total cholesterol (P<.01), low-density lipoprotein cholesterol (P<.05), body weight (P<.01), and prolactin (P<.01); most of these parameters worsened within 2 weeks of resuming other antipsychotic treatment. PANSS Total scores remained stable relative to previous antipsychotics baseline during lumateperone treatment.
CONCLUSIONS: In outpatients with stable schizophrenia, lumateperone was well tolerated with low risk of cardiometabolic and EPS adverse effects and stably maintained or improved schizophrenia symptoms. These data further support the safety, tolerability, and effectiveness of lumateperone in patients with schizophrenia.

PMID: 33453691 [PubMed - as supplied by publisher]

Characteristics of interstitial lung disease in patients from post-marketing data on metastatic breast cancer patients who received abemaciclib in Japan.

Breast Cancer. 2021 Jan 16;:

Authors: Chen Y, Noma S, Taguchi Y, Takahashi M, Tsurutani J, Mori S, Sakaguchi S, Asou H, Tomii K

Abstract
BACKGROUND: This study evaluated characteristics of patients treated with abemaciclib and diagnosed with interstitial lung disease (ILD), using 12-month post-marketing data from the real-world setting in Japan.
METHODS: Spontaneous reports of adverse events in patients receiving abemaciclib were collected regularly from healthcare providers (HCPs) from November 30, 2018, to November 29, 2019. Detailed follow-up was requested on suspected ILD cases via questionnaires and/or interviews. Radiological images (when available) were reviewed by an ILD adjudication committee of specialists. The age distribution of patients prescribed abemaciclib in Japan was estimated based on insurance claims data.
RESULTS: Of 4700 patients estimated to be exposed to abemaciclib, 82 cases of ILD were reported (46 serious, 13 fatal). Most (91%) had ≥ 1 symptom at diagnosis, commonly dyspnea/shortness of breath (59%), cough (44%), and/or fever (37%). The majority (68%) received steroid therapy (24 [56%] recovered/recovering; 5 [12%] not recovered; 13 [30%] deaths, 1 [2.3%] unknown). No specific imaging patterns or sites of predilection were identified, but a diffuse alveolar damage (DAD) pattern was observed at outcome in 3 of 4 evaluated fatal cases (16 in total evaluated). Features of fatal cases included advanced age, pre-existing interstitial change, and advanced Eastern Cooperative Oncology Group Performance Status.
CONCLUSION: Advanced age and a DAD pattern were identified as potential risk factors for cases with poorer outcomes, as previously reported for drug-induced ILD. HCPs should consider the benefit-risk profile when prescribing abemaciclib, informing patients of risks and regularly monitoring treated patients to ensure early detection and treatment of ILD.

PMID: 33453015 [PubMed - as supplied by publisher]

Efficacy and safety of apatinib for patients with advanced extremity desmoid fibromatosis: a retrospective study.

J Cancer Res Clin Oncol. 2021 Jan 15;:

Authors: Zheng C, Fang J, Wang Y, Zhou Y, Tu C, Min L

Abstract
PURPOSE: Desmoid fibromatosis (DF) is a locally aggressive connective-tissue tumor arising in deep soft tissues. Although multiple therapeutic modalities have been demonstrated effective for DF, there is no standard systemic treatment for progressive and recurrent DF. As a part of systemic treatment, tyrosine kinase inhibitors have shown promising activity against DF with tolerable toxicity profiles. Thus, the aim of this study was to investigate the efficacy and safety of apatinib, a novel multi-target angiogenesis inhibitor, in patients with DF.
METHODS: We retrospectively analyzed the medical records of patients with advanced extremity DF regularly treated with apatinib between October 2017 and January 2020 in our center. Apatinib was initially administered with a dose of 250 mg daily and the dose was adjusted according to the toxicity. Tumor response was assessed by the Response Evaluation Criteria in Solid Tumors 1.1 criteria. The primary endpoint was progression-free survival (PFS); objective response rates and drug-related adverse events were also evaluated.
RESULTS: A total of 22 (6 male, 16 female) patients with advanced extremity DF were included. The mean medication time was 17 months. None of the patients reached a complete response, but ten (45.5%) patients achieved partial response, and 11 patients (50%) achieved stable disease. One (4.5%) patient developed progressive disease, and the 1-year PFS rate was 95.2%. The disease control rate was 95.4% (21/22) and the objective response rate was 45.5% (10/22). Meanwhile, 18 (81.8%) patients with a tumor shrinkage were accompanied by a decreased signal intensity of lesions in T2-weighted magnetic resonance imaging. The most frequent adverse events included hand-foot syndrome (n = 7, 31.8%), fatigue (n = 6, 27.2%), local pain (n = 4, 18.1%), diarrhea (n = 4, 18.1%).
CONCLUSION: Apatinib is an effective and well-tolerated option for patients with advanced extremity DF. Indeed, further prospective, randomized studies with larger cases are required to fully explore the clinical utility of apatinib in DF.

PMID: 33452581 [PubMed - as supplied by publisher]

Solifenacin-induced acute urticaria and angioedema: a rare adverse effect.

Postgrad Med J. 2021 Jan 15;:

Authors: Younas U, Shafiq O, Mansoor SN, Khalil MT

Abstract
Antimuscarinics are first-line medication for management of overactive bladder with solifenacin being commonly prescribed. Angioedema is the swelling of mucosa and submucosal tissue. There are no published case reports of drug-induced angioedema involving solifenacin. We report a case of a 41-year-old man with spinal cord injury who presented with oedema of face, lips, tongue and associated pruritic urticaria after taking 5 mg of solifenacin. All other possible causes including food allergy, insect bite, hereditary angioedema, use of NSAIDs, ACE inhibitors and antibiotics were ruled out. The temporal association between solifenacin and angioedema and complete resolution of symptoms after discontinuing the drug suggest that solifenacin was the most probable cause of angioedema in our patient.

PMID: 33452148 [PubMed - as supplied by publisher]

A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine: a preliminary report.

Eur J Hosp Pharm. 2021 Jan 15;:

Authors: Falcão F, Viegas E, Carmo I, Soares J, Falcao M, Solano M, Cavaco P, Mendes D, Rijo J, Povoa P, Pais Martins A, Carmo E, Mansinho K, Fonseca C, Campos L, Carvalho A, Mirco A, Farinha H, Aldir I, Correia J

Abstract
OBJECTIVES: Since the outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the pressure to minimise its impact on public health has led to the implementation of different therapeutic strategies, the efficacy of which for the treatment of coronavirus disease 2019 (COVID-19) was unknown at the time. Remdesivir (REM) was granted its first conditional marketing authorisation in the EU in June 2020. The European Medicines Agency (EMA) and local health authorities all across the EU have since strongly recommended the implementation of pharmacovigilance activities aimed at further evaluating the safety of this new drug. The objective of this study was to evaluate adverse drug reactions (ADRs) attributed to either REM or hydroxychloroquine (HCQ) in patients hospitalised for COVID-19 in Centro Hospitalar de Lisboa Ocidental, a Portuguese hospital centre based in Lisbon. We present the preliminary results reporting plausible adverse effects of either HCQ or REM.
METHODS: An observational cohort study was carried out between 16 March and 15 August 2020. Participants were divided into two cohorts: those prescribed an HCQ regimen, and those prescribed REM. Suspected ADRs were identified using an active monitoring model and reported to the Portuguese Pharmacovigilance System through its online notification tool. The ADR cumulative incidence was compared between the two cohorts.
RESULTS: The study included 149 patients, of whom 101 were treated with HCQ and the remaining 48 with REM. The baseline characteristics were similar between the two cohorts. A total of 102 ADRs were identified during the study period, with a greater incidence in the HCQ cohort compared with the REM cohort (47.5% vs 12.5%; p<0.001). Causality was assessed in 81 ADRs, all of which were considered possible.
CONCLUSIONS: Real-world data are crucial to further establish the safety profile for REM. HCQ is no longer recommended for the treatment of COVID-19.

PMID: 33452110 [PubMed - as supplied by publisher]

[The Role of Pharmacovigilance in the COVID-19 Pandemic].

Acta Med Port. 2021 Jan 15;:

Authors: Ferreira-da-Silva R, Ribeiro-Vaz I, Morato M, Silva AM, Junqueira Polónia J

PMID: 33448925 [PubMed - as supplied by publisher]

Medication Safety in Older Adults: Learning From 2020 as We Launch into 2021.

J Gerontol Nurs. 2021 Jan 01;47(1):7-11

Authors: Brandt NJ, Lee M

Abstract
In health care, the year 2020 is marked by the ongoing coronavirus (COVID-19) pandemic, with much research published to clarify infection risk, treatment approaches, and proposed interventions to reduce spread and combat complications. Although much work focused on COVID-19, medication safety remains a priority, and studies on adverse drug reactions, high-risk medications, and approaches to mitigate risk associated with chronic medication use, such as inappropriate dosing in hospital settings, were published. A continued commitment to patient-centered care, such as the approach put forth by the Age-Friendly Health Systems initiative and telehealth initiatives, ensures that even as health care practice strives to meet the challenge of an unprecedented global pandemic, safe medication use informed by patient needs continues to guide best practices through lessons learned. [Journal of Gerontological Nursing, 47(1), 7-11.].

PMID: 33377979 [PubMed - indexed for MEDLINE]

The association between age and adverse events due to biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: A retrospective cohort study.

Medicine (Baltimore). 2020 Dec 24;99(52):e23861

Authors: Ikari Y, Yajima N, Miwa Y

Abstract
ABSTRACT: We examined whether the age of patients with rheumatoid arthritis was associated with adverse events (AEs) caused by biologic disease-modifying antirheumatic drugs (bDMARDs).Patients with rheumatoid arthritis using bDMARDs from Showa University Hospital, Showa University Northern Yokohama Hospital, and Showa University Koto Toyosu Hospital from January 2005 to December 2017 were eligible for this retrospective cohort study. The maximum observation period was determined to be 1 year. Outcomes in patients older and younger than 75 years were compared. The primary outcome was the rate of drug discontinuation because of AEs caused by bDMARDs. Univariate and multivariate analyses were performed using Pearson's chi-squared test and logistic regression analysis, respectively.A total of 416 patients were enrolled; median (interquartile range [IQR]): 60.0 (44.3 - 71.0) years and 84.6% women; patients ≥ 75 years were 67/416 (16.1%). The rates of drug discontinuation because of AEs caused by bDMARDs were 10.5% (7/67) in patients 75 years and older and 10.9% (38/349) in those younger than 75 years (relative risk 0.95, 95% confidential interval 0.45-2.24). In logistic regression analysis adjusted for covariates, the rate of drug discontinuation showed no significant difference between the patients ≥ 75 years and the those < 75 years (adjusted odds ratio 0.70, 95% confidential interval 0.29-1.75, P = .45).The rate of drug discontinuation because of AEs caused by bDMARDs was not significantly different between patients 75 years and older and patients younger than 75 years.

PMID: 33350780 [PubMed - indexed for MEDLINE]

Incidence of acute spinal cord injury and associated complications of methylprednisolone therapy: a national population-based study in South Korea.

Spinal Cord. 2020 Feb;58(2):232-237

Authors: Choi SH, Sung CH, Heo DR, Jeong SY, Kang CN

Abstract
STUDY DESIGN: Retrospective population-based cohort study OBJECTIVES: To evaluate the incidence of acute spinal cord injury (SCI) in South Korea, and the prescription rates and complications related to high dose methylprednisolone therapy.
SETTING: Health Insurance Review and Assessment Service (HIRA) data METHODS: National database of the Korean HIRA between 2007 and 2017 was reviewed. To identify patients with acute SCI and the use of high dose methylprednisolone, International Classification of Disease revision codes, medical behavior codes and examination codes were used. Patients were grouped according to whether or not they received methylprednisolone therapy (MP group vs non-MP group).
RESULTS: The average age-adjusted incidence of acute SCI per 1,000,000 persons was 26.4 and the peak incidence was in the 50s overall. The methylprednisolone prescription rate was highest in 2012 (76%) and continued to decrease thereafter, being lowest in 2017 (41%). The MP group showed higher complication rates in terms of pneumonia (OR 1.8, 95% CI, 1.62-2.0), GI bleeding (OR 1.2, 95% CI, 1.05-1.38), and UTI (OR 1.68, 95% CI, 1.53-1.84). The average length of hospitalization was longer in patients who received methylprednisolone (26.5 days vs. 24.4 days, p < 0.05).
CONCLUSIONS: The average age-adjusted incidence of acute SCI for 11 years was 26.4 per 1,000,000 persons and highest in 50s. Strategies should be established, and national health resources should be allocated to prevent acute SCI from occurring in older people. The prescription rate of high dose methylprednisolone for acute SCI is decreasing in South Korea but it is still high.

PMID: 31527724 [PubMed - indexed for MEDLINE]