J Clin Pharm Ther [JOURNAL]
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200 papers
Hemophagocytic lymphohistiocytosis following gene replacement therapy in a child with type 1 spinal muscular atrophy.
Galletta F, Cucinotta U, Marseglia L … +6 more , Cacciola A, Gallizzi R, Cuzzocrea S, Messina S, Toscano A, Gitto E
J Clin Pharm Ther · 2022 Sep · PMID 35924856 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Onasemnogene abeparvovec (OA) is the first gene replacement therapy for the treatment of paediatric patients with bi-allelic mutations in the SMN1 gene. Efficacy and safety of OA have been as...
WHAT IS KNOWN AND OBJECTIVE: Onasemnogene abeparvovec (OA) is the first gene replacement therapy for the treatment of paediatric patients with bi-allelic mutations in the SMN1 gene. Efficacy and safety of OA have been assessed in several studies with promising results, despite rare side effects have been described. CASE SUMMARY: A 3-year-old child with spinal muscular atrophy was treated with OA and subsequently developed fever, widespread erythematous skin lesions and hepatosplenomegaly. Laboratory tests were suggestive for Hemophagocytic lymphohistiocytosis (HLH). WHAT IS NEW AND CONCLUSION: To our knowledge, this is the first case of HLH following gene replacement therapy with OA, described in literature.
Extracorporeal hemoadsorption with the CytoSorb device as a potential therapeutic option in severe intoxications: Review of the rationale and current clinical experiences.
Mitrovic D, Huntjens DW, de Vos EAJ … +2 more , van Tellingen M, Franssen EJF
J Clin Pharm Ther · 2022 Sep · PMID 35924306 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Many severe intoxications occur with substances with no specific antidote, which is why methods of extracorporeal elimination represent a particularly useful and even critical component in th...
WHAT IS KNOWN AND OBJECTIVE: Many severe intoxications occur with substances with no specific antidote, which is why methods of extracorporeal elimination represent a particularly useful and even critical component in their management. The purpose of this review is to summarize the accumulating evidence and clinical results from the application of CytoSorb hemoadsorption therapy in patients with severe intoxications. COMMENT: The technology represents a promising technique with an increasing number of publications in a variety of severe intoxication scenarios suggesting that early intervention might provide rapid substance removal with subsequent overall clinical improvement. WHAT IS NEW AND CONCLUSION: Given the tremendous challenges in performing prospective, randomized trials in this field, the strong safety profile of the device and the high acuity of these life-threatening situations, CytoSorb should be considered as a therapeutic option in severe intoxications, particularly when direct antidotes are not available. However, further clinical data are desirable to provide precise recommendations.
Letter to the editor concerning the case report "Successful treatment of severe quetiapine intoxication with CytoSorb hemoadsorption".
Kielstein JT, Schmidt JJ, Ghannoum M
J Clin Pharm Ther · 2022 Sep · PMID 35919960 · Publisher ↗
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Clinical features, diagnosis and management of cephalosporin-induced acute generalized exanthematous pustulosis.
Lei H, Deng H, Liu X … +2 more , Li Z, Wang C
J Clin Pharm Ther · 2022 Dec · PMID 35909299 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Acute generalized exanthematous pustulosis (AGEP) is a serious and rare adverse reaction of cephalosporins. We aimed to describe the clinical features of cephalosporin-induced AGEP and provid...
WHAT IS KNOWN AND OBJECTIVE: Acute generalized exanthematous pustulosis (AGEP) is a serious and rare adverse reaction of cephalosporins. We aimed to describe the clinical features of cephalosporin-induced AGEP and provide a reference for rational clinical use of cephalosporins. METHODS: We systematically searched Chinese and English databases for cephalosporin-induced TGEP-related case reports, retrospective studies, clinical studies, and review articles published before May 2022. RESULTS AND DISCUSSION: A total of 43 patients from 35 articles were eligible, of which 28 (65.1%) were female, with a median age of 69 years. A total of 11 cephalosporins were suspected, the most commonly involved were ceftriaxone (41.9%), cephalexin (16.3%), and cefepime (9.3%). AEGP erupted primarily within 14 days after administration, manifested as nonfollicular pustules on an erythematous base, distributed favourably to the extremities (44.2%), trunk (23.3%), face (23.3%), and could involve the oral mucosa (11.6%). During AGEP resolution, the affected area had desquamation (39.5%). The acute phase of the disease may be accompanied by fever (>38.0°C) and elevated neutrophil count (>7500/mm ). Histology of AGEP showed subcorneal pustules (56.3%), intraepidermal cavernous pustules (37.5%), with papillary dermal edema (37.5%), containing neutrophils and eosinophilic infiltration (71.9%). After drug discontinuation, the median time to resolution of AGEP symptoms was 10 days (range 2, 90). WHAT IS NEW AND CONCLUSION: Cephalosporin-induced AGEP is rare and should be properly diagnosed. This serious cutaneous adverse reaction is self-limiting and has a favourable prognosis, usually resolves with drug interruption, and may require additional interventions, such as topical steroids.
The pharmacology of blinatumomab: state of the art on pharmacodynamics, pharmacokinetics, adverse drug reactions and evaluation in clinical trials.
Mocquot P, Mossazadeh Y, Lapierre L … +2 more , Pineau F, Despas F
J Clin Pharm Ther · 2022 Sep · PMID 35906791 · Full text
WHAT IS KNOWN AND OBJECTIVE: Bispecific drugs (BDs) belong to the family of immunotherapies along with checkpoint inhibitors and CAR-T cells. In the field of oncology, BDs are designed to simultaneously bind a tumour ant...
WHAT IS KNOWN AND OBJECTIVE: Bispecific drugs (BDs) belong to the family of immunotherapies along with checkpoint inhibitors and CAR-T cells. In the field of oncology, BDs are designed to simultaneously bind a tumour antigen on the one side and an antigen present on the surface of effector cells on the other. This review summarizes the information available to date on the first marketed BiTE-format bispecific antibody, blinatumomab BLINCYTO® in acute lymphoblastic leukaemia. METHODS: A literature search was conducted in the PubMed database by including studies published in English using the term blinatumomab. Furthermore, bibliographies of selected references were also evaluated for relevant articles. Clinical trial (CT) data were retrieved from clinicaltrials.gov (ongoing trials, adverse events [AEs]) and global pharmacovigilance data were retrieved from VigiBase®. RESULTS AND DISCUSSION: Blinatumomab is a fusion protein which consists of two single-chain variable fragments arranged in tandem: the first binds the CD19 surface antigen of all B cells and the second targets the CD3 antigen of T cells. Binding of blinatumomab to B and T cells induces apoptosis of B cells after secretion of granzymes and perforins by T cells. T-cell activation results in secretion of pro-inflammatory cytokines and upregulation of activation markers and adhesion molecules on the surface of T cells. The major CTs that led to an indication show increased overall survival with blinatumomab with better efficacy in patients in haematological remission with minimal residual disease ≥10 . The major AEs are cytokine release syndrome, neurotoxicity and hypogammaglobulinemia. The three most frequent system organ classes in CTs are haematological, gastrointestinal and general disorders. These results are also found in VigiBase® but neurological disorders and infections appear more frequently in real life. WHAT IS NEW AND CONCLUSION: This review summarizes the current knowledge of blinatumomab in the literature. The subject of many CTs is to improve the route of administration and expand the indications for treatment.
Intra-articular non-steroidal anti-inflammatory drugs may promote cartilage degeneration.
Toda K
J Clin Pharm Ther · 2022 Sep · PMID 35899680 · Publisher ↗
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Rosuvastatin potentiates the thyrotropin-lowering effect of metformin in men with non-autoimmune subclinical hypothyroidism and prediabetes.
Krysiak R, Kowalcze K, Okopień B
J Clin Pharm Ther · 2022 Dec · PMID 35899679 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Metformin treatment decreases thyrotropin levels in individuals with hypothyroidism and this effect seems to be mediated by the 5'-adenosine monophosphate-activated protein kinase pathway in...
WHAT IS KNOWN AND OBJECTIVE: Metformin treatment decreases thyrotropin levels in individuals with hypothyroidism and this effect seems to be mediated by the 5'-adenosine monophosphate-activated protein kinase pathway in the pituitary. The activity of this pathway is also stimulated by statins. The current study was aimed at investigating whether the impact of metformin on hypothalamic-pituitary-thyroid axis activity is affected by statin use. METHODS: The study included three matched groups of men with non-autoimmune hypothyroidism and prediabetes: patients treated for at least 6 months with high-intensity rosuvastatin therapy (20-40 mg daily) [groups A (n = 24) and C (n = 19)] and men not receiving statin therapy [group B (n = 24)]. Over the entire study period (6 months), groups A and B received metformin (2.55-3 g daily). Moreover, groups A and C continued rosuvastatin therapy. The lipid profile, glucose homeostasis markers, and plasma concentrations of thyrotropin, total and free thyroid hormones, prolactin, FSH, LH, ACTH and insulin-like growth factor-1 were determined at baseline and 6 months later. RESULTS AND DISCUSSION: Fifty-nine patients completed the study. There were differences between groups A and C and group B in baseline values of total cholesterol, LDL-cholesterol, gonadotropins and ACTH. Although observed in both groups of metformin-treated patients, the effect on thyrotropin levels was more pronounced in group A than in group B. The impact on fasting glucose and insulin sensitivity was stronger in group B than group A. In turn, only in group A metformin tended to reduce gonadotropin levels. There were no differences between follow-up and baseline values of lipids, total and free thyroid hormones, prolactin, ACTH and insulin-like growth factor-1 in both these groups. In group C, all assessed variables remained at a similar level. WHAT IS NEW AND CONCLUSION: The results of the current study suggest that rosuvastatin potentiates the inhibitory effect of metformin on thyrotrope secretory function.
Polymorphisms in solute carrier genes (SLC19A1, SLCO1B1, and SLCO1B3) predicts survival and toxicity in North Indian lung cancer patients undergoing platinum-based doublet chemotherapy.
Sharma P, Singh N, Sharma S
J Clin Pharm Ther · 2022 Dec · PMID 35896189 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Solute Carrier (SLC) transporters are known mediators of drug disposition that facilitate the influx of substrates and various chemotherapeutic agents into cells. Polymorphisms in the SLC19A1...
WHAT IS KNOWN AND OBJECTIVE: Solute Carrier (SLC) transporters are known mediators of drug disposition that facilitate the influx of substrates and various chemotherapeutic agents into cells. Polymorphisms in the SLC19A1, SLCO1B1, and SLCO1B3 gene influence the prognosis in the cancer patients, but little is known about their role in lung cancer in Asians. So, the current study aims to investigate the polymorphisms in SLC19A1, SLCO1B1, and SLCO1B3 genes in Northern Indian lung cancer patients. METHODS: Patients with lung cancer who had a confirmed histology and cytology diagnosis were enrolled in the study. SLC polymorphisms were assessed by Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) for variations in SLC19A1 (G A), SLCO1B1 (A G, T C), and SLCO1B3 (A G). RESULTS AND DISCUSSION: Our results showed that mutant genotype for SLC19A1 G A polymorphism had higher median survival time (MST) compared to wild genotype. ADCC patients with mutant genotype showed better survival compared to wild genotype for SLC19A1 G A. SCLC patients G A polymorphism showed increased survival in patients with mutant genotype (p = 0.04). In SLCO1B3, A G patients carrying heterozygous alleles and administered with platinum and docetaxel showed inferior survival (p = 0.006). In T C variant, patients with carrier genotype had reduced chances of developing anaemia (p = 0.04). Patients with SLC19A1 and SLCO1B3 variants showed lower incidence of thrombocytopenia and nephrotoxicity. WHAT IS NEW AND CONCLUSION: Our findings imply that Solute Carrier gene polymorphisms modulate the overall survival in lung cancer patients undergoing platin-based doublet chemotherapy, also these polymorphisms have a modifying impact on the associated adverse events/toxicity.
Evaluation of potentially inappropriate medications in older patients admitted to the cardiac intensive care unit according to the 2019 Beers criteria, STOPP criteria version 2 and Chinese criteria.
Bai Y, Wang J, Li G … +2 more , Zhou Z, Zhang C
J Clin Pharm Ther · 2022 Dec · PMID 35894086 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVES: Potential inappropriate medications (PIMs) can increase the risk of medication-induced harm. However, there are no studies regarding PIMs in older and critically ill patients with cardiovasc...
WHAT IS KNOWN AND OBJECTIVES: Potential inappropriate medications (PIMs) can increase the risk of medication-induced harm. However, there are no studies regarding PIMs in older and critically ill patients with cardiovascular diseases in China. Therefore, studies evaluating PIMs in these patients can help in the implementation of more effective interventions to reduce the risk of drug use. Our objective was to analyse the prevalence of PIMs in elderly patients admitted to the cardiac intensive care unit (CICU) comparing the 2019 Beers criteria (Beers criteria), Screening Tool of Older People's Potentially Inappropriate Prescriptions (STOPP) criteria version 2 (STOPP criteria) and criteria of potentially inappropriate medications for older adults in China (Chinese criteria); and analyse the factors influencing the PIMs. METHODS: This cross-sectional and retrospective study was performed with elderly patients (≥65 years) admitted to the CICU of the Beijing Tongren Hospital in China from January 2019 to June 2020. The PIMs were identified based on the Chinese, STOPP and Beers criteria at admission and discharge. The three criteria were compared using the Kappa statistic. Multiple regression analysis was used to investigate the influencing factors associated with PIMs. RESULTS AND DISCUSSION: A total of 369 patients who met the inclusion/exclusion criteria were included in this study. According to the three criteria used to evaluate the PIMs, the prevalence was 78.3% and 72.6% at admission and discharge, respectively. The prevalence rate of PIMs determined by the Chinese criteria was 62.1% at admission versus 56.6% at discharge (p = 0.134); the Beers criteria was 53.9% at admission versus 46.9% at discharge (p = 0.056); by the STOPP criteria was 20.6% at admission versus 13.8% at discharge (p = 0.015). Moreover, 28.9% (STOPP criteria), 56.8% (Beers criteria) and 73.4% (Chinese criteria) of patients taking PIMs on admission still had the same problem at discharge. The most common PIMs screened by the Beers, STOPP and Chinese criteria were diuretics, benzodiazepines and clopidogrel, respectively. Besides, the three criteria showed poor agreement. Finally, the stronger predictor of PIMs was the increased number of medications (p < 0.05). WHAT IS NEW AND CONCLUSION: The prevalence of PIMs in elderly patients admitted to the CICU was high. The Chinese, STOPP and Beers criteria are effective screening tools to detect PIMs, but the consistency between them was poor. The increased number of medications was a significant predictor of PIMs.
Pharmacokinetic and pharmacodynamic simulation for the quantitative risk assessment of linezolid-associated thrombocytopenia.
Onita T, Ishihara N, Ikebuchi A … +6 more , Yano T, Nishimura N, Tamaki H, Ikawa K, Morikawa N, Naora K
J Clin Pharm Ther · 2022 Dec · PMID 35893441 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Linezolid (LZD) may cause thrombocytopenia, which can result in discontinuation of treatment. In this study, the blood LZD trough concentration was estimated based on population pharmacokinet...
WHAT IS KNOWN AND OBJECTIVE: Linezolid (LZD) may cause thrombocytopenia, which can result in discontinuation of treatment. In this study, the blood LZD trough concentration was estimated based on population pharmacokinetic (PK) parameters derived from two previously published models in the Japanese population to determine the rate of achieving the target trough value when the risk of thrombocytopenia is low and to clarify its relationship with the onset of thrombocytopenia. METHODS: This study included adult patients hospitalized at Shimane University Hospital, who received LZD treatment for at least 4 days from January 2010 to December 2017. Patients whose platelet count fell below 70% before LZD administration were categorized as the thrombocytopenic group. Patient PK parameters were calculated based on the population PK models described by Matsumoto et al. and Sasaki et al., and these parameters were designated A and B, respectively. Based on these parameters, the rate of achieving an LZD trough concentration of less than 8 μg/ml, which is the safety target achievement rate, was calculated using a random simulation for each patient. We further analysed the association between the incidence of thrombocytopenia and patient factors, including safety target achievement rate, through univariate, multivariate, and receiver operating characteristic (ROC) analyses. RESULTS AND DISCUSSION: Patients (n = 77) aged 72 ± 11 years and weighing 56.7 ± 10.9 kg, with a creatinine clearance (CL ) of 60.5 ± 47.2 ml/min and a cirrhosis prevalence of 9.1%, were analysed. All patients received LZD at a dose of 600 mg twice daily for a total of 10.9 ± 8.9 days. Univariate analyses revealed significant differences (p < 0.05) in the duration of LZD therapy, serum creatinine, creatinine clearance, LZD clearance, and the safety target achievement rate for parameters A and B between the thrombocytopenic and non-thrombocytopenic groups. A multivariate analysis of these factors stratified with the cutoff values obtained by ROC analysis revealed that the duration of LZD therapy and the safety target achievement rates for parameters A and B were significant factors (odds ratios for duration of LZD therapy: 7.436 [95% confidence interval (CI): 1.918-28.831] and 4.712 [95% CI: 1.567-14.163]; odds ratio for safety target achievement rate: 0.060 [95% CI: 0.016-0.232] and 0.167 [95% CI: 0.056-0.498] for parameters A and B, respectively). When the safety target achievement rates for patients treated with LZD were compared between the thrombocytopenic and non-thrombocytopenic groups, the safety target achievement rate was higher in the non-thrombocytopenic group in both the patients treated with LZD for less than 10 days and those for 10 days or more. Therefore, the safety target achievement rate estimated by the PK/PD simulation may represent to be an important index for risk assessment of LZD-induced thrombocytopenia. WHAT IS NEW AND CONCLUSION: The risk of LZD-induced thrombocytopenia, which increased with the duration of LZD therapy, may be predicted using the safety target achievement rate obtained by the blood concentration simulation.
Association between body mass index and bleeding events associated with the use of aspirin in ischemic stroke or transient ischemic attack patients.
Kostev K, Tanislav C
J Clin Pharm Ther · 2022 Sep · PMID 35871530 · Publisher ↗
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No two classes of biosimilars: Urgent advice to the US Congress and the FDA.
Niazi SK
J Clin Pharm Ther · 2022 Sep · PMID 35869625 · Full text
WHAT IS KNOWN AND OBJECTIVE: The United States is the only country with legislation to approve two classes of biosimilars. One has "no clinically meaningful difference" from the reference product, and when it is tested f...
WHAT IS KNOWN AND OBJECTIVE: The United States is the only country with legislation to approve two classes of biosimilars. One has "no clinically meaningful difference" from the reference product, and when it is tested for switching and alternating, it can receive an interchangeable status. The objective of this review is to establish whether it is possible from the switching and alternating studies to evaluate additional safety or efficacy. METHODS: Analysed published data to ascertain if the testing with switching and alternating provide additional proof of safety or efficacy. Political and scientific rationale of creating a new class of biosimilars and how this affects the confidence in biosimilars. RESULTS AND DISCUSSION: There is no safety or efficacy concern when switching or alternating biosimilars with the reference product. Unfortunately, the rationale for interchangeability is more political than scientific, and it has brought more confusion and mistrust in using biosimilars in the United States. WHAT IS NEW AND CONCLUSION: The US Congress is requested to remove the interchangeability clause from the Biological Price and Competition Act to enable faster acceptance of biosimilars and remove the threat of lack of confidence in the safety of biosimilars.
Benefit of medication reviews by renal pharmacists in the setting of a computerized physician order entry system with clinical decision support.
Seiberth S, Mannell H, Birkenmaier C … +4 more , Neuerburg C, Smolka V, Andraschko M, Strobach D
J Clin Pharm Ther · 2022 Oct · PMID 35868964 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: A 'renal pharmacist consultant service' (RPCS) reviewing patients' charts with renal impairment (RI) for drug-related problems (DRP) can foster patient safety. However, the benefit of this se...
WHAT IS KNOWN AND OBJECTIVE: A 'renal pharmacist consultant service' (RPCS) reviewing patients' charts with renal impairment (RI) for drug-related problems (DRP) can foster patient safety. However, the benefit of this service in the new setting of a computerized physician order entry (CPOE)-system with a clinical decision support (CDS)-system is unknown. The aim of our study was to evaluate the general need for an RPCS on wards with a CPOE-CDS-system already in use and its effectiveness on prescription changes to ensure in-hospital patient safety. METHODS: Over a period of 3 months (02-04/2021), elective orthopaedic and trauma patients with eGFR /CrCl <60 ml/min at a German University Hospital received a medication review by a renal pharmacist for all medication entered into the CPOE-system (Meona®) by the treating physicians. Written consultations explaining identified DRP and recommending interventions to solve them, for example, dose or drug adaptation, were shared with the physicians directly in the drug chart tab of Meona®. In complex cases, DRP were additionally discussed via phone. The prescription changes were evaluated retrospectively. RESULTS AND DISCUSSION: During 53 working days, 712 (30.5%) of 2331 screened patients were included with an eGFR /CrCl <60 ml/min and a pharmacist-led medication review was performed for all medication presented in the CPOE-system (Meona®). In 79 of 712 (11.1%) patients, one or more DRP were detected (median 1 DRP (1-3) per patient) and written recommendations concerning 106 of 1090 (9.7%) drugs were shared via Meona®. In total, 104 DRP were identified, mostly caused by 'dosage too high' (n = 55, 52.9%), 'dosage regime wrong' (n = 13, 12.5%), and 'contraindication' (n = 9, 8.7%). Acceptance rate of recommendations was 74.0% (n = 77/104). In nine cases (8.7%), despite of specific recommendations, no adjustment of drugs was made because of lack of alternatives. In 11 (10.6%) cases, prescription remained unchanged for unknown reasons and in seven (6.7%) cases, the result was unknown due to discharge. WHAT IS NEW AND CONCLUSION: In the setting of prescribing in a CPOE-CDS-system, that provides physicians with advice for drug or dose adaption, the pharmacist-led medication reviews still identified DRP in orthopaedic and trauma patients with RI. A RPCS forwarding recommendations to solve DRP via the electronic medical record increased appropriate prescribing by physicians and, thus, may further improve patient safety.
Camrelizumab plus chemotherapy in advanced non-squamous non-small cell lung cancer: Treatment response, survival pattern, and safety.
Cao H, Wei W, Lu Y
J Clin Pharm Ther · 2022 Nov · PMID 35851702 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Camrelizumab, a humanized monoclonal programmed cell death protein-1 antibody independently developed by China, is introduced as a treatment selection for non-small cell lung cancer (NSCLC)....
WHAT IS KNOWN AND OBJECTIVE: Camrelizumab, a humanized monoclonal programmed cell death protein-1 antibody independently developed by China, is introduced as a treatment selection for non-small cell lung cancer (NSCLC). This study aimed to evaluate the efficacy and safety of camrelizumab plus chemotherapy in treating advanced non-squamous NSCLC patients. METHODS: This study retrospectively analysed 31 driver-gene-negative advanced non-squamous NSCLC patients who received a 21-day therapy cycle for four cycles of camrelizumab (intravenous injection, 200 mg/cycle) plus carboplatin and pemetrexed (CP) chemotherapy, followed by maintenance therapy using camrelizumab or pemetrexed or camrelizumab plus pemetrexed. Another 40 patients who underwent CP chemotherapy were retrieved as control group. RESULTS AND DISCUSSION: The objective response rate (ORR) was elevated in camrelizumab plus CP group compared to CP group (58.1% vs. 32.5%, p = 0.031), while disease control rate (DCR) was of no difference between those two groups (83.9% vs. 72.5%, p = 0.255). Camrelizumab plus CP achieved a prolonged PFS compared with CP alone (median: 11.0 (95% CI: 9.1-12.9) months versus 7.2 (95% CI: 5.1-9.3) months, p = 0.026), also realized an increasing OS trend (without statistical significance; 19.3 (95% CI: 15.4-23.2) months versus 15.1 (95% CI: 13.9-16.3) months, p = 0.093). Further multivariate Cox's regression analysis exhibited that camrelizumab plus CP (vs. CP) independently related to prolonged PFS (p < 0.001) and OS (p = 0.027). Moreover, the most common adverse events related to camrelizumab plus CP were fatigue (45.2%), peripheral neuropathy (35.5%), nausea and vomiting (35.5%); furthermore, most adverse events were controllable. WHAT IS NEW AND CONCLUSION: Camrelizumab plus chemotherapy exhibits good efficacy and manageable adverse events in treating advanced non-squamous NSCLC patients.
Allopurinol-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: Signal detection and preventability from Vietnam National pharmacovigilance database.
Huong PT, Ha TN, Nhu TTQ … +5 more , Nga NTH, Anh NH, Hoa VD, Binh NQ, Anh NH
J Clin Pharm Ther · 2022 Dec · PMID 35848069 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Allopurinol, the first-line medication for hyperuricemia is well-known for its association with severe cutaneous adverse reactions, especially Stevens-Johnson syndrome (SJS) and toxic epiderm...
WHAT IS KNOWN AND OBJECTIVE: Allopurinol, the first-line medication for hyperuricemia is well-known for its association with severe cutaneous adverse reactions, especially Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). In the current study, we analysed the Vietnamese spontaneous reporting database to identify signals and preventability of allopurinol-induced SJS/TEN in Vietnam from 2010 to 2019. METHODS: Signal generation was assessed using the case/non-case method. Reporting odds ratios (RORs) and 95% confidence intervals (95% CI) were calculated. RESULTS: Among 72,822 spontaneous ADR reports submitted to the Vietnam National Drug Information and Adverse Drug Reaction Monitoring Centre, 392 reports were on SJS/TEN, of which, 65 cases (16.6%) were related to allopurinol. The signals of allopurinol-induced SJS/TEN in Vietnam started in 2014 (ROR of 3.531, 95% CI: 1.830-6.810) and annually increased until 2019 (ROR of 11.923, 95% CI: 8.508-16.710). The preventability assessment showed that no allopurinol-induced SJS/TEN case was definitely unpreventable. 61.6% of the SJS/TEN cases were avoidable because they were associated with inappropriate prescribing such as unapproved indications, too high initial dose and even rechallenging in patients with a history of allopurinol allergy. WHAT IS NEW AND CONCLUSION: The signals of allopurinol-induced SJS/TEN in Vietnam started in 2014 and annually increased until 2019. Our first report specifically focusing on the ADR preventability of allopurinol showed that correction of medical errors relating to prescription could prevent more than 60% of SJS/TEN cases in Vietnamese allopurinol users. This is a feasible and practical solution, provided that there would be a systematic change in both healthcare systems and public awareness.
Medication management in Minority, Asian and Black ethnic older people in the United Kingdom: A mixed-studies systematic review.
Secchi A, Booth A, Maidment I … +2 more , Sud D, Zaman H
J Clin Pharm Ther · 2022 Sep · PMID 35844186 · Publisher ↗
WHAT IS NEW AND OBJECTIVES: Older people from ethnic minorities experience the intersectionality of age and ethnicity in relation to complex medication management and polypharmacy. Minority ethnic groups in the United Ki...
WHAT IS NEW AND OBJECTIVES: Older people from ethnic minorities experience the intersectionality of age and ethnicity in relation to complex medication management and polypharmacy. Minority ethnic groups in the United Kingdom are at risk of poor medication management because factors such as cultural beliefs, language barriers, lack of knowledge of how the healthcare system works may affect their ability to safely manage their medications. The aim of this systematic review was to review the literature focussing on medication management in the older population amongst ethnic minority communities in United Kingdom. METHODS: The review was conducted and reported according to methods in the Cochrane Handbook and in the PRISMA 2020 statement using databases such as EMBASE, ASSIA, MEDLINE, PsychINFO and others. Studies conducted in the United Kingdom on individuals over 60 years of age and from a minority ethnic background were included. A thematic analysis was used to synthesize the results. RESULTS AND DISCUSSION: Nine studies (eight from initial searches, one from a search update in 2021) met the inclusion criteria. Three main themes were identified: misbeliefs around medications, poor health literacy, communication and education as possible intervention to improve medication management. Misbeliefs around long-term illnesses exert a negative impact on medication management. Poor health literacy around medications influences patients' adherence to treatments. Poor communication is perceived as barrier to successful medication management. Despite extensive searching, the team identified a limited number of studies and a lack of intersectional studies focussing on minority ethnic groups and the older population. WHAT IS NEW AND CONCLUSION: Our findings suggest tailored education as a possible intervention to improve medication management amongst these minority groups. Future research should look at recruiting participants from specific ethnic groups and from rural as well as urban areas to explore how medication management operates in different areas of the United Kingdom.
Empagliflozin has favourable effect on frontal plane QRS-T angle in diabetic patients with cardiovascular disease.
Eyuboglu M, Celik A
J Clin Pharm Ther · 2022 Nov · PMID 35839522 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Empagliflozin treatment is significantly associated with lower risk of cardiovascular events in patients with diabetes mellitus (DM) independent of its antihyperglycemic effect. However, litt...
WHAT IS KNOWN AND OBJECTIVE: Empagliflozin treatment is significantly associated with lower risk of cardiovascular events in patients with diabetes mellitus (DM) independent of its antihyperglycemic effect. However, little is known regarding the impact of empagliflozin on electrocardiography (ECG) parameters. This study aimed to investigate whether empagliflozin has favourable effect on frontal plane QRS-T (fQRST) angle, which is an ECG sign of ventricular repolarization heterogeneity, in patients with type 2 DM. METHODS: We prospectively enrolled 111 patients with known diagnosis of type 2 DM who newly prescribed empagliflozin on top of their standard anti-diabetic therapy. Patients were divided into two groups according to presence or absence of cardiovascular disease (CVD) at baseline and followed-up for 6 months. The impact of empagliflozin treatment on fQRST angle was investigated and patient groups were compared regarding the pre- and post-treatment fQRST angle. RESULTS AND DISCUSSION: Among 111 patients, 32 (28.8%) had CVD and 79 (71.2%) had no CVD. Empagliflozin treatment lead a significant decrease in the mean fQRST angle throughout the study period and mean fQRST angle was significantly lower at 3- and 6-month follow-up visits compared to baseline values (62° ± 17.4° vs. 57.2° ± 14.8° vs. 50.5° ± 13.6°, p < 0.001 for all dual comparisons). However, despite similar antihyperglycemic effect with empagliflozin treatment in patients with and without CVD, the significant decrease in the mean fQRST angle was observed only in patients with CVD and no significant decrease was observed in the mean fQRST angle in patients without CVD. WHAT IS NEW AND CONCLUSION: Empagliflozin leads a significant narrowing in the fQRST angle in type 2 DM patients with known CVD.
LASSO-derived nomogram predicting new-onset diabetes mellitus in patients with kidney disease receiving immunosuppressive drugs.
Shao L, Luo C, Yuan C … +8 more , Ye X, Zeng Y, Ren Y, Ye B, Li Y, Jin J, He Q, Shen X
J Clin Pharm Ther · 2022 Oct · PMID 35791031 · Full text
WHAT IS KNOWN AND OBJECTIVE: Patients with kidney disease receiving immunosuppressive drugs (ISDs) (tacrolimus, cyclosporine and glucocorticoids) have a high risk of developing new-onset diabetes mellitus (NODM). We aime...
WHAT IS KNOWN AND OBJECTIVE: Patients with kidney disease receiving immunosuppressive drugs (ISDs) (tacrolimus, cyclosporine and glucocorticoids) have a high risk of developing new-onset diabetes mellitus (NODM). We aimed to establish a precise and convenient model for predicting NODM in patients receiving immunosuppressive drugs. METHODS: This retrospective study recruited 1883 patients receiving ISDs between January 2010 and October 2018. The occurrence of NODM was the primary endpoint. The patients were randomly divided into training (n = 1318) and validation cohorts (n = 565) at a 7:3 ratio. A nomogram was established based on a least absolute shrinkage and selection operator (LASSO)-derived logistic regression model. The nomogram's discrimination and calibration abilities were evaluated in both cohorts using the Hosmer-Lemeshow test and calibration curves. Decision curve analysis (DCA) was used to evaluate the net benefit of the predictive efficacy. RESULTS AND DISCUSSION: Amongst the 1883 patients with kidney disease receiving immunosuppressive drugs, 375 (28.5%) and 169 (29.9%) developed NODM in the training (n = 1318) and validation cohorts (n = 565), respectively. Nine clinic predictors were included in this LASSO-derived nomogram, which is easy to be operated clinically. The discriminative ability, determined by the area under the receiver operating characteristic curve (AUC), was 0.816 (95% confidence interval [CI] 0.790-0.841) and 0.831 (95%CI 0.796-0.867) in the training and validation cohorts, respectively. Calibration was confirmed with the Hosmer-Lemeshow test in the training and validation cohorts (p = 0.238, p = 0.751, respectively). WHAT IS NEW AND CONCLUSION: Nearly one-third of patients with kidney disease receiving immunosuppressive drugs developed NODM. The nomogram established in this study may aid in predicting the occurrence of NODM in patients with kidney disease receiving immunosuppressive drugs.
The efficacy and safety of combined administration of intravenous and intra-articular tranexamic acid in total knee arthroplasty: An update meta-analysis.
Ling T, Zhang L, Huang L
J Clin Pharm Ther · 2022 Sep · PMID 35790455 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: This study was performed to compare the efficacy and safety of combined administration of intravenous (IV) and intra-articular (IA) tranexamic acid (TXA) with IV or IA TXA alone in total knee...
WHAT IS KNOWN AND OBJECTIVE: This study was performed to compare the efficacy and safety of combined administration of intravenous (IV) and intra-articular (IA) tranexamic acid (TXA) with IV or IA TXA alone in total knee arthroplasty (TKA). METHODS: PubMed, Embase, Cochrane Library and Web of Science were searched for randomized controlled trials (RCTs) in July 2021. Total blood loss, transfusion rate, postoperative haemoglobin drop, drain output, deep venous thrombosis (DVT) and pulmonary embolism (PE) were pooled. Data were analyzed using Stata 14.0 software. The study protocol was registered with PROSPERO, number CRD42020186654. RESULTS: Ten RCTs involving 1306 patients were included. Combined TXA group provided lower total blood loss (SMD -0.47; 95% CI -0.64 to -0.30; p < 0.001), postoperative haemoglobin drop (SMD -0.47; 95% CI -0.60 to -0.33; p < 0.001) and drain output (SMD -0.50; 95% CI -0.71 to -0.29; p = 0.009) compared with IV or IA TXA alone group. No significant difference was found in terms of transfusion rate (OR 0.53; 95% CI 0.23 to 1.23; p = 0.137) and DVT (OR 0.55; 95% CI 0.18 to 1.68; p = 0.293). PE data was provided by all 10 studies, but PE only occurred in one patient in IV TXA alone group. WHAT IS NEW AND CONCLUSION: Combined administration of IV and IA TXA was relatively more effective in reducing total blood loss, transfusion rate, postoperative haemoglobin drop, and drain output after TKA. TXA may not increase the risk of DVT/PE, but it also needs to be monitored in clinical application.
Adverse drug reaction reporting quality among different health professionals and the contribution of clinical pharmacists: A pilot study.
Yan J, Xiong X, Shen J … +1 more , Huang T
J Clin Pharm Ther · 2022 Nov · PMID 35781820 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Adverse drug reaction (ADR) reporting is generally of poor quality, which may delay post-marketing regulatory actions. Here, we evaluated the quality of ADR reporting at our institution and e...
WHAT IS KNOWN AND OBJECTIVE: Adverse drug reaction (ADR) reporting is generally of poor quality, which may delay post-marketing regulatory actions. Here, we evaluated the quality of ADR reporting at our institution and examined the roles of clinical pharmacists in this process. METHODS: We retrospectively reviewed ADR reports at our hospital between 2017 and 2019 to assess the number, source, drugs, and routes of administration. The quality assessment of ADR case reports form issued by the China Adverse Drug Reaction Monitoring Centre was used to assess the quality of ADR reports. Quality scores of ADR reports from pharmacists and nonpharmacists were assessed before and after review by clinical pharmacists. RESULTS AND DISCUSSION: Reports of adverse drug reaction reporting by healthcare professionals increased annually, with 59, 77 and 82 reports submitted in 2017, 2018 and 2019, respectively. The numbers of new or serious ADR reports by healthcare professionals in 2017, 2018, and 2019 were 5 (8.47%), 77 (11.69%) and 82 (10.98%), respectively. New or serious ADR reports accounted for approximately 10% (23/218) of all reported cases, and more than 70% (158/218) of the reports were from pharmacists. Systemic administration accounted for more than 80% (233/265) of adverse reactions, whereas ADRs due to topical drug use were rarely reported. The drugs that reportedly triggered ADRs were mainly antibacterial and patented Chinese medicines and accounted for more than half of all reported cases. The scores of ADR reports from pharmacists and nonpharmacists before modification by clinical pharmacists were 86.69 ± 8.12 and 68.36 ± 5.94, respectively, and the scores of ADR reports from pharmacists and nonpharmacists after modification by clinical pharmacists were 91.14 ± 6.64 and 90.02 ± 5.63, respectively. WHAT IS NEW AND CONCLUSION: In a real-world setting, pharmacists are commonly responsible for most ADR reports. The quality of ADR reports from pharmacists and nonpharmacists before review did not reach the standard of excellence. An audit of clinical pharmacists may improve the overall quality of ADR reports. However, under-reporting of adverse reactions still occurs.
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