J Clin Pharm Ther [JOURNAL]
Sun
200 papers
Effectiveness and safety of vonoprazan-based regimen for Helicobacter pylori eradication: A meta-analysis of randomized clinical trials.
Yang C, Li S, Huang T … +5 more , Lin H, Jiang Z, He Y, Yuan J, An H
J Clin Pharm Ther · 2022 Jul · PMID 35247003 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The Helicobacter pylori (H. pylori) eradication rate of proton pump inhibitor (PPI)-based regimen remains decreasing. Vonoprazan (VPZ), a stronger and longer-lasting acid blocker, has been pr...
WHAT IS KNOWN AND OBJECTIVE: The Helicobacter pylori (H. pylori) eradication rate of proton pump inhibitor (PPI)-based regimen remains decreasing. Vonoprazan (VPZ), a stronger and longer-lasting acid blocker, has been proposed to treatment of H. pylori infection. However, previous reviews did not have a pre-established study protocol and did not conduct a comprehensive search of the database, so the results obtained were not robust. We aimed to perform a meta-analysis to assess the effectiveness and safety of VPZ-based regimens for treatment of H. pylori infection in comparison with other regimens. METHODS: We conducted a systematic literature search on PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials and ChiCTR Register. Randomized clinical trials comparing VPZ-based regimens with similar eradication regimens without VPZ in the treatment of H. pylori infection were included. Eradication rate, compliance of the patients and side effects were specified as the primary outcomes. RevMan 5.4 software was used to analyze the RCTs and provide pooled risk ratio (RR) with 95% confidence intervals (CI). Systematic searches, study selection, data extraction, risk of bias assessment and statistical analysis were performed by two independent researchers according to the predesigned criteria on the PROSPERO. RESULTS AND DISCUSSION: A total of 8 RCTs with 2012 patients qualified for evaluation. The results showed that the eradication rate of VPZ-containing regimens was significantly superior to PPI-containing regimens for both intention-to-treat (RR, 1.14; 95% CI: 1.06-1.23; p = 0.0006) and per-protocol analyses (RR, 1.12; 95% CI: 1.04-1.20; p = 0.003). Subgroup analysis based on treatment regimens, eradication experience and clarithromycin resistance, as well as sensitivity analysis further confirmed this finding. In addition, there was no significant difference in compliance (RR, 1.02; 95% CI: 0.98-0.1.05; p = 0.35) and the frequency of adverse events (RR, 0.84; 95% CI: 0.70-1.00; p = 0.05) between the regimens. WHAT IS NEW AND CONCLUSION: Compared with PPI-based regimens, the VPZ-containing regimens showed a comparable or even superior eradication rate of H. pylori in terms of overall comparison and comparison of different treatment regimens, eradication experience and clarithromycin resistance. In addition, VPZ-based regimens have better tolerability and fewer adverse events. More future studies are needed to evaluate the impact of some differences in patient characteristics. TRIAL REGISTRATION: PROSPERO CRD42021229598.
Modelling an evaluation of the efficacy and safety of gemcitabine combined with platinum in the treatment of non-small cell lung cancer.
Zhu L, Chen R, Yang Q … +3 more , Liu H, Zheng Q, Li L
J Clin Pharm Ther · 2022 Jul · PMID 35246996 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVES: Gemcitabine combined with platinum is currently the recommended first-line chemotherapy for advanced non-small cell lung cancer (NSCLC). This study aimed to quantitatively compare the effica...
WHAT IS KNOWN AND OBJECTIVES: Gemcitabine combined with platinum is currently the recommended first-line chemotherapy for advanced non-small cell lung cancer (NSCLC). This study aimed to quantitatively compare the efficacy and safety of gemcitabine-platinum combinations in the treatment of advanced NSCLC under different dosing regimens based on extensive literature data. METHODS: The PubMed and Cochrane Library databases were systematically searched for clinical trials in patients with NSCLC treated with a gemcitabine-platinum regimen. A parametric survival function was used to analyse the time course of overall survival (OS). The objective response rate (ORR) and the incidence of grade 3/4 adverse events were summarized using the random-effects model of a single-arm meta-analysis. RESULTS: The study included 63 arms from 47 publications, with a total sample size of 4344 patients for analysis. The model revealed that East Asians has a better survival benefit than non-East Asians, with a median OS of 16.4 (95% CI: 14.3-19.0) and 9.9 (95% CI: 8.1-12.4) months, respectively. Moreover, the OS of patients that underwent a 6-cycle treatment was significantly longer than those that had a 4-cycle treatment in non-East Asians, with a median OS of 10.2 (95% CI: 9.5-11.1) and 8.4 (95% CI: 7.7-9.3) months, respectively. However, the incidence of neutropenia, nausea and vomiting also increased after 6 cycles of treatment. When the dose of gemcitabine increased from 1000 mg/m to 1250 mg/m , the median OS was extended by approximately 1 month, but the incidence of grade 3/4 adverse reactions did not increase. WHAT IS NEW AND CONCLUSION: Race is an important factor affecting OS in the treatment of advanced NSCLC, which should be considered when conducting international multicentre clinical trials. Additionally, this study found that the OS increased with an increase in gemcitabine exposure, so it is necessary to construct an exposure-response model to obtain the best benefit-risk ratio for patients.
A retrospective review of the risk factors affecting the therapeutic serum concentrations of magnesium sulfate in pre-eclamptic patients.
Zhang Z, Wang J, Wang X … +1 more , Wang L
J Clin Pharm Ther · 2022 Jul · PMID 35235228 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: To identify factors that may affect the therapeutic serum magnesium levels after intravenous administration for seizure prophylaxis in pre-eclamptic patients. METHODS: One hundred and two wom...
WHAT IS KNOWN AND OBJECTIVE: To identify factors that may affect the therapeutic serum magnesium levels after intravenous administration for seizure prophylaxis in pre-eclamptic patients. METHODS: One hundred and two women with PE with severe features were identified categorized into two groups: subtherapeutic and therapeutic group. Multivariate logistic regression analysis and receiver operation characteristic curve analysis were conducted for the risk factors influencing the serum magnesium concentration. RESULTS: Among 102 eligible patients, 63 (62%) patients did not attain ideal therapeutic serum magnesium levels. Those patients had elevated albumin levels (p < 0.05), higher creatinine clearance (Ccr) (p < 0.001), and higher body mass index (BMI) (p < 0.001). Logistic regression analysis identified BMI and Ccr as independent risk factors for subtherapeutic serum magnesium concentration (p < 0.05). Receiver operating characteristic (ROC) curve analysis revealed a greater area under the curve for BMI than for Ccr in predicting subtherapeutic serum magnesium levels (0.787 vs. 0.774). WHAT IS NEW AND CONCLUSION: Maternal body weight and renal function were independent risk factors for subtherapeutic serum magnesium concentration in the early stage after administration.
Evaluating the effectiveness of drug and therapeutics committees (DTCs) in controlling irrational drug use: A retrospective analysis.
Yang J, Zheng L, Guan YY … +2 more , Li PB, Lv YT
J Clin Pharm Ther · 2022 Jul · PMID 35233796 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: This study aimed to explore methods to optimize the function of Drug and Therapeutics Committees (DTCs) in controlling irrational drug use. Clinical pharmacologists contribute their specific...
WHAT IS KNOWN AND OBJECTIVE: This study aimed to explore methods to optimize the function of Drug and Therapeutics Committees (DTCs) in controlling irrational drug use. Clinical pharmacologists contribute their specific knowledge and skills to DTCs and help guide rational therapeutics. The DTC is the highest organization of hospital pharmacy management. METHODS: From January 2016 to August 2021, the DTC promoted the optimization of clinical drug treatment schemes and reduced unreasonable drug use by improving the organizational framework, clarifying the division of functions, regularly monitoring drug use, organizing expert comments, scientific decision-making and functional intervention. During this time, we statistically analysed typical management cases, irrational drug use and drug cost to evaluate the effectiveness of the DTC's management. RESULTS AND DISCUSSION: The DTC's intervention led to a significant reduction in prescribing errors (65.98%, p < 0.05); the intervention acceptance rate increased by 16.37%; and the rate of problem resolution increased by 45.84% (p < 0.05). The level of drug treatment was improved, and the proportion of patients' drug expenses was reduced. WHAT IS NEW AND CONCLUSION: The DTC carried out a series of continuous improvement work that played a significant normative role in clinical drug use. Giving more power to the DTCs can significantly improve the level of drug treatment and reduce unreasonable drug use, which reduces unnecessary drug expenses.
Angiotensin-converting enzyme inhibitors prior to scleroderma renal crisis in systemic sclerosis: A systematic review and meta-analysis.
Xiong A, Cao Y, Xiang Q … +12 more , Song Z, Zhang Y, Zhou S, Qiang Y, Chen H, Hu Z, Cui H, Luo J, Wang Y, Yang Y, Yang M, Shuai S
J Clin Pharm Ther · 2022 Jun · PMID 35233779 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Angiotensin-converting enzyme inhibitors (ACEIs) are widely used in the treatment of scleroderma renal crisis (SRC), and their use prior to the onset of SRC in patients with systemic sclerosi...
WHAT IS KNOWN AND OBJECTIVE: Angiotensin-converting enzyme inhibitors (ACEIs) are widely used in the treatment of scleroderma renal crisis (SRC), and their use prior to the onset of SRC in patients with systemic sclerosis (SSc) has received wide attention in recent years. We undertook an evidence-based approach to identify whether the use of ACEIs prior to the onset of SRC is beneficial for patients with SSc. METHODS: We searched PubMed and Embase for any published studies produced between database inception and 22 October 2021. Articles obtained after using appropriate keywords were selected independently by two reviewers according to the established inclusion and exclusion criteria. RESULTS: Nine studies were included. Pooled results indicated that using ACEIs prior to SRC was associated with a higher incidence of SRC than no ACEIs prior to SRC (RR 2.05, 95% confidence interval 1.08-3.91, p = 0.03). Compared with patients who did not use ACEIs prior to the onset of SRC, a higher proportion of patients with SRC who used ACEIs prior to its onset had a poorer prognosis (RR 1.46, 95% confidence interval 1.20-1.78, p < 0.01). The difference in mortality between patients who used ACEIs prior to SRC onset and those who did not was not statistically significant (RR 1.12, 95% confidence interval 0.76-1.65, p = 0.57). WHAT IS NEW AND CONCLUSIONS: We recommend against using ACEIs prior to SRC in SSc patients. The use of ACEIs prior to SRC is associated with a higher incidence of SRC and poorer prognosis, especially in patients with progressive SSc or SSc-related renal vasculopathy (SSc-related hypertension and proteinuria).
Efficacy and safety of aflibercept plus chemotherapy in metastatic colorectal cancer: A systematic review and PRISMA-Compliant single-arm Meta-Analysis of noncomparative clinical studies and randomized controlled trials.
Ge P, Reyila A, Li XY … +5 more , Liu SY, Jiang YX, Yang YJ, Li XL, Bian Y
J Clin Pharm Ther · 2022 Jun · PMID 35229901 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Aflibercept, a recombinant protein designed to suppress the vascular endothelial growth factor (VEGF) signalling pathway, has been used in patients with metastatic colorectal cancer (mCRC). W...
WHAT IS KNOWN AND OBJECTIVE: Aflibercept, a recombinant protein designed to suppress the vascular endothelial growth factor (VEGF) signalling pathway, has been used in patients with metastatic colorectal cancer (mCRC). We conducted the first meta-analysis to systematically review the efficacy and safety of aflibercept in mCRC. METHODS: PubMed Central/Medline, Embase and cochrane library were systematically searched for randomized controlled trials and single-arm clinical trials on aflibercept plus chemotherapy for the treatment of mCRC through 9 September 2021. RESULTS: Ten studies comprising 2049 patients met the inclusion criteria. The pooled estimate rates were 16.0% for 12mPFS, 64.4% for 12mOS, 32.5% for ORR, 83.5% for DCR, while the rates of III/IV AEs rate were 80.2% respectively. The pooled estimate rates were 16.8% for III/IV diarrhoea, 22.3% for III/IV hypertension, 29.5% for III/IV neutropenia, 7.3% for III/IV proteinuria and 8.6% for III/IV oral mucositis. CONCLUSIONS: Analysis of data from randomized controlled trials(RCT) and single-arm clinical trials confirmed the good efficacy of aflibercept plus chemotherapy in mCRC, while the safety of the treatment is concerning.
Analysis of serum lipid parameters predicting lipid metabolic disorders in TSC-AML patients with treatment of mTOR inhibitors.
Wang W, Wang Z, Zhao Y … +3 more , Wang X, Li H, Zhang Y
J Clin Pharm Ther · 2022 Jul · PMID 35229896 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Patients with tuberous sclerosis complex (TSC) demonstrate disrupted lipid homeostasis before and during treatment with mammalian target of rapamycin (mTOR) inhibitor. However, few previous r...
WHAT IS KNOWN AND OBJECTIVE: Patients with tuberous sclerosis complex (TSC) demonstrate disrupted lipid homeostasis before and during treatment with mammalian target of rapamycin (mTOR) inhibitor. However, few previous reports focused on if the serum lipid status at baseline would influence lipid metabolic side-effects of mTOR inhibitors for TSC associated renal angiomyolipomas (TSC-AML). The present study was designed to evaluate the predictive function of serum lipid status at baseline for hyperlipidaemia by mTOR inhibitor treatment in TSC-AML patients. METHODS: The clinical data of TSC-AML patients who took mTOR inhibitors in Department of Urology of Peking Union Medical College Hospital (PUMCH) from 1 January 2014 to 1 January 2021, were retrospectively analysed. The record of lipid parameters at baseline and the highest levels of total cholesterol (TC) and triglyceride (TG) after treatment at least ≥3 months were collected. The correlation of serum lipid parameters at baseline with incidence of hyperlipidaemia during mTOR inhibitor treatment was analysed. Receiver operating characteristic (ROC) curve analysis was conducted to evaluate the ability of the serum lipid parameters in predicting hyperlipidaemia. RESULTS AND DISCUSSION: 19 patients experienced hyperlipidaemia and 13 patients still had normal TC and TG levels during mTOR inhibitor treatment. The levels of high-density lipoprotein cholesterol (HDL-C) (0.98 ± 0.30 mmol/L vs. 1.23 ± 0.31 mmol/L, p = 0.030), low-density lipoprotein cholesterol (LDL-C) (2.47 ± 0.69 mmol/L vs. 1.95 ± 0.53 mmol/L, p = 0.029) and apolipoprotein B (ApoB) (0.82 ± 0.21 g/L vs. 0.65 ± 0.16 g/L, p = 0.019) are higher in the patients who experienced hyperlipidaemia during mTOR inhibition therapy. TC, TG, LDL-C, ApoB and high-sensitivity C-reactive protein (hsCRP) at baseline had positive correlation with TC after treatment; ApoB at baseline had positive correlation, while HDL-C and free fat acid (FFA) at baseline had negative correlation with TG after treatment. Therefore, ApoB concentration at baseline has statistically significant correlation with both TC (p < 0.001) and TG (p = 0.012) levels after mTOR inhibitor treatment. ROC curve and AUC revealed that ApoB with a cut-off value of 0.640g/L may be the best parameter for predicting hyperlipidaemia during mTOR inhibitor treatment in TSC-AML patients. The incidence rates of hyperlipidaemia were 27.3% and 76.2% among the patients with ApoB level ≤0.640 g/L and >0.640 g/L respectively. WHAT IS NEW AND CONCLUSION: Some baseline serum lipid parameters could be used for predicting incidence of hyperlipidaemia during mTOR inhibition therapy in TSC-AML patients, and ApoB with 0.640 g/L as a cut-off value may be a potentially optimal indicator, which could help for diagnosis and treatment decision-making.
Association of orexin receptor antagonists with falls during hospitalization.
Sogawa R, Emoto A, Monji A … +7 more , Miyamoto Y, Yukawa M, Murakawa-Hirachi T, Tagomori Y, Kawasaki M, Kimura S, Shimanoe C
J Clin Pharm Ther · 2022 Jun · PMID 35229895 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The use of hypnotics, especially benzodiazepines (BZs), increases the risk of falls. Regarding the association of orexin receptor antagonists with fall risk, consistent results have not been...
WHAT IS KNOWN AND OBJECTIVE: The use of hypnotics, especially benzodiazepines (BZs), increases the risk of falls. Regarding the association of orexin receptor antagonists with fall risk, consistent results have not been obtained for suvorexant, and studies of lemborexant have not been reported. Therefore, this study investigated whether orexin receptor antagonists, including lemborexant, increase the risk of falls. METHODS: Data were obtained from the medical records of patients hospitalized at Saga University Hospital in Japan between July 2020 and April 2021. Patients were retrospectively divided into the fall and non-fall groups, and the groups were compared for medication usage. RESULTS AND DISCUSSION: The fall and non-fall groups included 132 and 6857 patients respectively. A significantly higher proportion of patients in the fall group used hypnotics (40.2% vs. 21.7%; p < 0.0001). Hypnotics remained significantly associated with a higher risk of falls after adjusting for confounders (adjusted odds ratio [OR] = 1.67, 95% confidence interval [CI] = 1.13-2.48, p = 0.01). In particular, the use of benzodiazepines was associated with a significantly higher risk of falls (adjusted OR = 2.08, 95% CI = 1.38-3.15, p = 0.0005). Meanwhile, suvorexant use was not linked to the risk of falls, and lemborexant use was associated with a significantly lower risk of falls (adjusted OR = 0.27, 95% CI = 0.09-0.84, p = 0.02). WHAT IS NEW AND CONCLUSION: The use of hypnotics is a risk factor for falls, but orexin receptor antagonists may represent a safe option for patients requiring hypnotics. Our results provide evidence supporting the safety of these drugs.
Correlation between CA12 and TFF3 and their prediction value of neoadjuvant chemotherapy response in breast cancer.
Shen M, Yang L, Lei T … +7 more , Zhang P, Xiao L, Cao S, Chen F, Li L, Ye F, Bu H
J Clin Pharm Ther · 2022 May · PMID 35229335 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Compared with other molecular subtypes, hormone receptor-positive breast cancer often shows worse neoadjuvant chemotherapy efficacy. This study aims to explore the relationship between the oe...
WHAT IS KNOWN AND OBJECTIVE: Compared with other molecular subtypes, hormone receptor-positive breast cancer often shows worse neoadjuvant chemotherapy efficacy. This study aims to explore the relationship between the oestrogen receptor (ER)-related genes carbonic anhydrase 12 (CA12) and trefoil factor 3 (TFF3) and their predictive value of neoadjuvant chemotherapy for breast cancer. METHODS: We investigated the relationships between CA12, TFF3 and ER status and their predictive value of anthracycline-taxane neoadjuvant chemotherapy in 115 female breast cancer patients via real-time polymerase chain reaction (RT-PCR) and 4 GEO datasets: GSE41998, GSE25065, GSE20194 and GSE20271. Then, the effects of CA12 and TFF3 on the chemotherapy drugs doxorubicin and docetaxel were verified in vitro in the breast cancer cell lines MCF-7 and BT474. RESULTS AND DISCUSSION: The GEO datasets and RT-PCR results showed that the relative expression of both CA12 and TFF3 was higher in oestrogen receptor-positive samples compared with the other samples (p < 0.05). CA12 was significantly correlated with TFF3 (p < 0.05). In MCF-7 cells, inhibition of TFF3 induced downregulation of CA12 and ESR1 (p < 0.05) at both the mRNA and the protein levels, while inhibition of CA12 also downregulated TFF3 and ESR1 (p < 0.05). In BT474 cells, inhibition of TFF3 downregulated CA12 and ESR1 (p < 0.05) at both the mRNA and the protein levels, while inhibition of CA12 led to slight upregulation of TFF3 and ESR1 (p > 0.05). Moreover, GEO datasets and RT-PCR results showed that CA12 and TFF3 were more highly expressed in nonpathological complete response (non-pCR) samples than in pCR samples (p < 0.05). Cell viability assays of MCF-7 and BT474 cells showed that inhibiting CA12 and TFF3 could enhance sensitivity to doxorubicin and docetaxel (p < 0.05). WHAT IS NEW AND CONCLUSION: CA12 and TFF3 were correlated with each other, and their high expression might explain the worse efficacy of neoadjuvant chemotherapy in oestrogen receptor-positive breast cancer patients.
Retrospective multicentre study on the effectiveness of first-line direct-acting antivirals against hepatitis C virus genotype-1.
Kaya M, Nakamura K, Sugiyama K … +13 more , Kinae A, Yamaguchi H, Ukita H, Odagiri K, Ujiie C, Kato J, Kageyama F, Nagura M, Matsushita K, Sugiue K, Ishida H, Endo S, Suzuki T
J Clin Pharm Ther · 2022 Jul · PMID 35229326 · Full text
WHAT IS KNOWN AND OBJECTIVE: In Japan, ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir are recommended as first-line treatments for patients with untreated hepatitis C virus genotype 1. Although...
WHAT IS KNOWN AND OBJECTIVE: In Japan, ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir are recommended as first-line treatments for patients with untreated hepatitis C virus genotype 1. Although they have demonstrated a high efficacy in clinical trials, there are no direct comparative studies. Clarification of their effectiveness and safety in real-world clinical practice is required. Therefore, we conducted a retrospective multicentre study on the effectiveness of these direct-acting antivirals in real-world clinical practice. METHODS: We retrospectively evaluated the clinical data of untreated patients with persistent HCV genotype 1 infection who started first-line treatment with ledipasvir/sofosbuvir, elbasvir/grazoprevir or glecaprevir/pibrentasvir between September 2015 and January 2019 at 11 medical institutions in Japan. The primary efficacy endpoint was a sustained virologic response after 12 weeks of treatment. The secondary endpoints included sustained virologic response after 24 weeks of treatment and end of treatment response. The safety endpoint was treatment completion rate. RESULTS AND DISCUSSION: During the study, 420 patients (median age, 70 years; 181 males) received ledipasvir/sofosbuvir, 48 (median age 72, years; 29 males) received elbasvir/grazoprevir and 63 (median age 66, years; 35 males) received glecaprevir/pibrentasvir. For ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir, the sustained virologic response after 12 weeks of treatment was 98.6%, 97.9% and 100%; the sustained virologic response after 24 weeks of treatment was 99.0%, 97.7% and 100%; the end of treatment response was 99.8%, 97.9% and 98.4%; and the treatment completion rate was 98.3%, 91.7% and 100% respectively. WHAT IS NEW AND CONCLUSION: In real-world clinical practice, hepatitis C virus treatment with ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir was effective with safety.
Implementation assessment of a patient personalized clinical pharmacy programme (5P project) into orthogeriatric care pathway.
Martin J, Barral M, Janoly Dumenil A … +9 more , Carre E, Poletto N, Goutelle S, Rioufol C, Novais T, Pivot C, Hoegy D, Mouchoux C, 5P study group
J Clin Pharm Ther · 2022 Jul · PMID 35218218 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The orthogeriatric path (hip-fractured elderly patients) is composed of several transition points (emergency surgery, orthopaedic, geriatric and rehabilitation units). The intervention of cli...
WHAT IS KNOWN AND OBJECTIVE: The orthogeriatric path (hip-fractured elderly patients) is composed of several transition points (emergency surgery, orthopaedic, geriatric and rehabilitation units). The intervention of clinical pharmacists can ensure the continuity of patients' drug management during their hospital stay. The aim of the study was to assess the implementation of clinical pharmacy activities in an orthogeriatric pathway, regarding its impact on medication error prevention, the healthcare professionals' and patients' satisfaction, and the estimated associated pharmaceutical workload. METHODS: Participants were aged 75 or older and managed for proximal femoral fracture. Their admission prescription was reviewed. If they were evaluated at high risk of adverse event (AE), medication reconciliation (MedRec) and pharmaceutical interviews (admission, discharge, and targeted on oral anticoagulant) were added at different steps of their care pathway. The achievement and duration of each clinical pharmacy activity were recorded. The number of pharmaceutical interventions (PI) made during prescription review, and unintentional discrepancies (UID) identified during MedRec were collected. A satisfaction questionnaire was sent to patients and healthcare professionals. RESULTS AND DISCUSSION: Among 455 included patients, 284 patients were considered at high risk of AE. Clinical pharmacy activity achievement rates varied between 12% and 98%. A total of 622 PI and 333 UID were identified. The overall patients' and healthcare professionals' satisfaction was rated from 63% to 100%. The total workload was estimated at 376 h: on average 16 min per prescription review, 43 min per admission MedRec, 26 min per discharge MedRec and 17 to 25 minutes per interview. CONCLUSION: The implementation of the programme showed a high potential of drug management securing. To sustain it, additional pharmaceutical human resources and high-performance computing tools are needed.
Identification of drug-related problems followed by clinical pharmacist interventions in an outpatient pharmacotherapy clinic.
Shahrami B, Sefidani Forough A, Najmeddin F … +5 more , Hadidi E, Toomaj S, Javadi MR, Gholami K, Sadeghi K
J Clin Pharm Ther · 2022 Jul · PMID 35218217 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Pharmacotherapy is an essential strategy for the treatment of many medical conditions especially chronic disease and often involves multiple medications being used simultaneously. Increasing...
WHAT IS KNOWN AND OBJECTIVE: Pharmacotherapy is an essential strategy for the treatment of many medical conditions especially chronic disease and often involves multiple medications being used simultaneously. Increasing the use of medications may pose some challenges to safe and effective drug therapy and if not identified and prevented by the pharmacists eventually can lead to drug-related problems (DRPs). The present study aimed to examine the incidence of DRPs in Iranian patients and to evaluate patients' adherence to the clinical pharmacist interventions as well as the physicians' acceptance of these recommendations. METHODS: This study was conducted in a university-affiliated outpatient pharmacotherapy clinic over a 22-month period. Patients aged 18 years and older with at least one chronic disease receiving at least four medications were included in the study. The patients were interviewed by a clinical pharmacist for comprehensive medication review. DRPs were identified using the DOCUMENT classification system. Recommendations were provided by the clinical pharmacist including interventions involving patient and/or physician to resolve DRPs. The patients were followed up after 2 weeks to evaluate their compliance and physician acceptance of clinical pharmacist recommendations. RESULTS AND DISCUSSION: Two hundred patients were included in this study. Overall, 875 DRPs were identified with an average of 4.37 per patient. The most prevalent DRPs were related to patient education or information (22.8%), undertreated indications (17.4%) and patient compliance (17.2%). The most common drugs associated with DRPs were alimentary and metabolism (22.2% of DRPs) followed by the cardiovascular system (19.2%) and nervous system (9.6%) medications. The DRP incidence correlated with gender only and was higher in females (p = 0.019). The clinical pharmacist provided 912 interventions with an average of 4.56 and 1.04 interventions per patient and per DRPs respectively. Patient education (41.3%), medication initiation or discontinuation (24.5%), and non-pharmacological interventions (12.9%) were the most common clinical pharmacist interventions. Out of 912 interventions, 665 were followed up, out of which 427 were patient dependent and 228 involved physicians. The patient's compliance with clinical pharmacist recommendations was 81.2%. The physician acceptance rate of the recommendations was 44.1%. WHAT IS NEW AND CONCLUSION: The study shows that especially designed services such as pharmacotherapy clinics running by clinical pharmacists are necessary to detect and resolve DRPs in an effective way. The high compliance rate of the patients indicates patients' confidence in the clinical pharmacist services provided in the pharmacotherapy clinic. The low acceptance rate of the physicians highlights the need to improve interprofessional collaboration between clinical pharmacists and physicians in an outpatient setting.
Interaction between the HIF-1α gene rs1957757 polymorphism and CpG island methylation in the promoter region is associated with the risk of anti-tuberculosis drug-induced liver injury in humans: A case-control study.
Chong Y, Zhu H, Ren Q … +2 more , Ma X, Feng F
J Clin Pharm Ther · 2022 Jul · PMID 35218216 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: HIF-1α gene polymorphisms, including rs11549465, rs11549467, rs1957757 and rs10873142, cause liver cell damage or pulmonary disease. The aim of this study was to analyse the association betwe...
WHAT IS KNOWN AND OBJECTIVE: HIF-1α gene polymorphisms, including rs11549465, rs11549467, rs1957757 and rs10873142, cause liver cell damage or pulmonary disease. The aim of this study was to analyse the association between the polymorphisms of the loci of the HIF-1α gene and its CpG island methylation in the promoter region with the risk of anti-tuberculosis drug-induced liver injury (ADLI). METHODS: 286 patients with tuberculosis (TB) and ADLI (case group) and 286 patients with TB but without liver injury (control group) were matched one-to-one, among the 1728 TB patients recruited from July 2019 to July 2020. Genotyping of the four loci of the HIF-1α gene was confirmed using PCR-RFLP technology. Methylation of the HIF-1α gene was measured using the MSP method. The comparison of risk factors, HIF-1α genotype and methylation status between the case group and the control group was all achieved through univariate and multivariate conditional logistic regression. RESULTS AND DISCUSSION: Univariate analysis showed that the frequency of rs1957757 mutation genotype and CpG island methylation was significantly higher in the case group than in the control group (P<0.001, all). In contrast, there was no statistical difference in the frequency of mutated genotypes at the other three loci between the two groups (p = 0.21, p = 0.12 and p = 0.55, respectively). Further, multivariate analysis showed that CpG islands were methylated, the mutation genotype of the rs1957757 locus was independently associated with the high risk of ADLI, and the adjusted OR (95%CI) reached 1.92 (1.32-2.63) and 2.01 (1.32-2.83), respectively. Furthermore, taking the rs1957757 locus wild genotype and CpG islands without methylation as the reference group, the mutation genotype and CpG island methylation increased the risk of ADLI, and the probability of ADLI could reach 4.73 times that of the reference group. WHAT IS NEW AND CONCLUSION: This is the first demonstration of the association of HIF-1α gene polymorphism and CpG island methylation with ADLI risk stratification. The interaction between CpG islands methylated in the promoter region of the HIF-1α gene and its rs1957757 locus mutant genotype was associated with a higher risk of ADLI.
Efficacy and safety analysis of bevacizumab combined with capecitabine in the maintenance treatment of RAS-mutant metastatic colorectal cancer.
Huang W, Zhang H, Tian Y … +3 more , Cha Y, Xiong H, Yuan X
J Clin Pharm Ther · 2022 Apr · PMID 35218209 · Full text
WHAT IS KNOWN AND OBJECTIVES: The optimal strategy for maintenance therapy in patients with metastatic colorectal cancer (mCRC) remains controversial. Considering that, beyond progression, co-therapy with bevacizumab and...
WHAT IS KNOWN AND OBJECTIVES: The optimal strategy for maintenance therapy in patients with metastatic colorectal cancer (mCRC) remains controversial. Considering that, beyond progression, co-therapy with bevacizumab and cytotoxic chemotherapy showed less toxicity and a significant disease control rate. We aimed to investigate the differences in efficacy and safety between bevacizumab combined with capecitabine maintenance therapy and capecitabine monotherapy for RAS-mutant mCRC （as defined by mutations in KRAS and NRAS exons 2-4）controlled by bevacizumab plus FOLFIRI chemotherapy for at least 12 weeks. METHODS: We retrospectively analysed patients with RAS-mutant mCRC admitted to the Department of Oncology, Huizhou Municipal Central Hospital from December, 2015 to December, 2020. All patients were first treated with bevacizumab combined with FOLFIRI for at least 12 weeks of induction therapy. 154 patients whose disease was brought under control then continued maintenance therapy. 78 patients were in the observation group (bevacizumab plus capecitabine) and 76 patients were in the control group (capecitabine alone). The efficacy and adverse effects of maintenance treatment were compared between the two groups. The clinicopathological characteristics such as sex, age, performance status (PS) score, primary tumour site, degree of pathological differentiation, baseline carcinoembryonic antigen (CEA) level, microsatellite instability (MSI) status, number of metastatic tumour sites and efficacy of induction treatment were compared in terms of prognosis. RESULTS AND DISCUSSION: The median progression-free survival (mPFS)of patients was 9.0 months (95% CI 8.0-10.0) in the observation group and 7.2 months (95% CI 6.0-8.4) in the control group, with a statistically significant difference (p < 0.05). The baseline CEA level was an independent prognostic factor. Both groups tolerated the toxic side effects. WHAT IS NEW AND CONCLUSION: Bevacizumab combined with capecitabine was well tolerated and contributed to a longer PFS time than capecitabine alone, and it is worthy of popularization in clinical practice.
Maintained P2Y inhibitor monotherapy after shorter-duration of dual antiplatelet therapy in patients undergoing coronary drug-eluting stents implantation: An updated meta-analysis of randomized trials.
Fan ZG, Tian NL, He SH … +1 more , Ma GS
J Clin Pharm Ther · 2022 Jul · PMID 35218029 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: It is well known that high in-stent thrombotic risk due to the superimposition of a platelet-rich thrombus was considered as the main origin of major adverse cardiac events after stent implan...
WHAT IS KNOWN AND OBJECTIVE: It is well known that high in-stent thrombotic risk due to the superimposition of a platelet-rich thrombus was considered as the main origin of major adverse cardiac events after stent implantation. The clinical management of antiplatelet therapy strategy after percutaneous coronary intervention (PCI) remains controversial. This study is sought to explore the efficacy and safety of a maintained P2Y inhibitor monotherapy after shorter-duration of dual antiplatelet therapy (DAPT) in these patients. METHODS: Medline, Google Scholar, Web of Science, and the Cochrane Controlled Trials Registry were searched online for retrieving eligible citations. A composite of all-cause death, myocardial infarction (MI) and stroke was defined as major adverse cardio- and cerebro-vascular events (MACCE), which is analysed as the primary efficacy endpoint. The risk of bleeding events was chosen as safety endpoint. RESULTS: Five randomized clinical trials (RCT) with 32,143 patients were finally analysed. A maintained P2Y inhibitor monotherapy after shorter-duration of DAPT cloud not only reduce the incidence of MACCE [odds ratios (OR): 0.89, 95% confidence intervals (CI): 0.79-0.99, p = 0.037], but also the bleeding risk (OR 0.61, 95% CI: 0.44-0.85, p = 0.003). No higher incidence of any ischaemic events, including MI, stroke or definite stent thrombosis (ST) was observed with respect to this new antiplatelet therapy option. CONCLUSIONS: A maintained P2Y inhibitor monotherapy after shorter-duration of DAPT was suggested as a more preferable antiplatelet therapy option in patients undergoing coronary drug-eluting stents (DES) placement. Larger and more powerful randomized trials with precise sub-analyses are still necessary for further confirming these relevant benefits.
Effectiveness and safety of erenumab and galcanezumab in the prevention of chronic and episodic migraine: A retrospective cohort study.
Viudez-Martínez A, Pascual-Carrasco A, Beltrán-Blasco I … +2 more , Hernandez-Lorido R, F Ruiz de Apodaca R
J Clin Pharm Ther · 2022 Jun · PMID 35212025 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE?: Erenumab and galcanezumab have shown great results for migraine prevention. However, strict inclusion criteria, absence of concomitant medication and selective outcome report of clinical tri...
WHAT IS KNOWN AND OBJECTIVE?: Erenumab and galcanezumab have shown great results for migraine prevention. However, strict inclusion criteria, absence of concomitant medication and selective outcome report of clinical trials may sometimes be barely representative of the real-world daily practice. Therefore, this study was designed to evaluate effectiveness and safety of these two monoclonal antibodies targeting calcitonin gene-related peptide in real-world patients. METHODS: This observational, retrospective study evaluated the effectiveness and safety of erenumab 140 mg and galcanezumab 120 mg in 142 real-world patients who had previously not responded to three well-established pharmacological alternatives for migraine prevention. To do so, a combination of objective parameters (monthly headache days and acute migraine-specific medication days) and subjective measurements (Migraine Disability Assessment questionnaire, Headache Impact Test and Visual Analogue Scale), validated for clinical research in migraine, were assessed during clinical interview. RESULTS AND DISCUSSION: Findings here reported show that erenumab and galcanezumab reduced monthly headache days, acute migraine specific medication days per month, Headache Impact Test score, Migraine Disability Assessment Test score and Visual Analogue Scale score after 3 and 6 doses (p < 0.01). Additionally, more than 25% of the patients enrolled in the study experienced a reduction by a half in monthly headache days, and more than 50% of the patients also reported a reduction by a half in the number of migraine specific medication days. Both treatments exhibited a great safety profile, rarely leading to discontinuation because of poor tolerance. WHAT IS NEW AND CONCLUSIONS?: Altogether, these results support previous real-life studies regarding effectiveness and safety and provide an interesting insight in how these preventive therapies are also effective in patients diagnosed with difficult to treat migraine who have previously failed, at least, three different drug classes stablished by current neurology guidelines for migraine prevention. Moreover, these data may suggest that erenumab and galcanezumab are able to not only diminish frequency, but also migraine intensity, and that it should be also considered as an effectiveness measure in line with other authors suggestion.
Efficacy and safety of intravenous iron with different frequencies for renal anaemia: A systematic review and meta-analysis.
Chen T, Deng Y, Gong R
J Clin Pharm Ther · 2022 Jun · PMID 35167721 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: To evaluate the efficacy and safety of intravenous iron supplementation in patients with renal anaemia. METHODS: We searched the PubMed, Embase, Cochrane Library, and Web of Science from thei...
WHAT IS KNOWN AND OBJECTIVE: To evaluate the efficacy and safety of intravenous iron supplementation in patients with renal anaemia. METHODS: We searched the PubMed, Embase, Cochrane Library, and Web of Science from their inception until 17 September 2021, for randomized controlled trials (RCTs) to evaluate the efficacy and safety of intravenous iron at different frequencies. The observed efficacy indicators included transfer saturation (TSAT), serum ferritin (SF) and haemoglobin (HGB). Outcomes of interest included allergies, infections, all-cause mortality and cardiovascular events. RESULTS AND DISCUSSION: Of the 751 eligible studies, 7 RCTs met the inclusion criteria. The RCTs showed that there were no significant differences between the low-frequency high-dose group (1-2 doses, >200 mg/dose) and the high-frequency low-dose group (4-5 doses, ≤200 mg/dose) in the increase in TSAT (WMD = 1.90; 95% CI = -2.04 to 5.84; I = 0%), SF (WMD = 15.70; 95% CI = -32.20 to 70.61; I = 0%) and HGB (WMD = -0.00; 95% CI = -0.43 to 0.42; I = 0%). There was also no significant difference in the occurrence of outcome events, including allergies (RR = 1.84; 95% CI = 0.95 to 3.57; I = 45%), infections (RR = 0.61; 95% CI = 0.20-1.86; I = 0%), cardiovascular events (RR = 0.88; 95% CI = 0.67-1.15; I = 48%) and all-cause mortality (RR = 0.74; 95% CI = 0.40-1.35; I = 0%). WHAT IS NEW AND CONCLUSION: Frequencies of intravenous iron supplementation with similar doses share similar safety and efficacy in patients with renal anaemia. However, a single dose or two doses of intravenous iron are more cost-effective and patient friendly. These findings may provide evidence for the clinical application of intravenous iron supplementation for patients with renal anaemia.
Persistent remission of acromegaly in a patient with GH-secreting pituitary adenoma: Effect of treatment with pasireotide long-acting release and consequence of treatment withdrawal.
Yu N, Wang L, Yang H … +3 more , Pan H, Duan L, Zhu H
J Clin Pharm Ther · 2022 Jun · PMID 35167717 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Somatostatin analogues (SSAs) have been used for the treatment of acromegaly for several decades. However, a unified conclusion on the duration of SSAs therapy or the possibility of medicatio...
WHAT IS KNOWN AND OBJECTIVE: Somatostatin analogues (SSAs) have been used for the treatment of acromegaly for several decades. However, a unified conclusion on the duration of SSAs therapy or the possibility of medication withdrawal is still missing. We aimed to report a case of acromegaly cured by pasireotide long-acting release (PAS-LAR) and provide some information on the withdrawal of SSAs after stable regression in acromegalic patients. CASE SUMMARY: A 55-year-old male patient, who was diagnosed with acromegaly and refused surgery and received PAS-LAR as initial treatment, had maintained stability for ten years under the regular treatment with PAS-LAR. The pituitary microadenoma was also decreased during the treatment. After the PAS-LAR discontinuation for 21 months, no evidence of biochemical or clinical recurrence was found in this patient. WHAT IS NEW AND CONCLUSION: The use of PAS-LAR in a subset of naive-treatment patients is promising to induce long-term regression. A subgroup of patients with mild and well-controlled acromegaly might hope for perpetual remission after the withdrawal of medication.
An evidence-based approach to antibiotic prophylaxis for oral, craniomaxillofacial plastic/head and neck surgical procedures.
Pitak-Arnnop P
J Clin Pharm Ther · 2022 Jun · PMID 35132644 · Publisher ↗
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Omicron variant as nature's solution to the COVID-19 pandemic.
Li Wan Po A
J Clin Pharm Ther · 2022 Jan · PMID 35128705 · Full text
WHAT IS KNOWN AND OBJECTIVE: Omicron is a variant of the COVID-19 virus that is causing considerable concern worldwide, with an increasing number of countries re-imposing national lockdowns. Our objective is to comment o...
WHAT IS KNOWN AND OBJECTIVE: Omicron is a variant of the COVID-19 virus that is causing considerable concern worldwide, with an increasing number of countries re-imposing national lockdowns. Our objective is to comment on its impact and to suggest that, threatening as it is, Omicron may well contribute to a resolution of the current pandemic. COMMENT: On 31 December 2019, the World Health Organization (WHO) reported on a cluster of cases of pneumonia in Wuhan, China. Soon after, Chinese investigators who made the discovery identified the causative virus as a new coronavirus, now known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). An effective vaccine was licenced for emergency use within a year of its first sequencing. SARS-CoV-2, in common with many respiratory viruses, mutates rapidly, and the challenge for vaccine developers is to obtain vaccines that are effective against the new variants. The licenced first-generation vaccines were fortunately all highly effective against the variant known as Delta. The variant of greatest current concern is the Omicron variant, a highly infectious agent, which seems to show a significant vaccine escape with existing vaccines. Infection protects against further infection. If Omicron turns out to cause less severe disease, it may well be a contributor to ending the pandemic. WHAT IS NEW AND CONCLUSION: It is unlikely that the available vaccines will bring rapid control of the current pandemic, given their patchy availability worldwide and the residual pool of unvaccinated people. New vaccines take time to develop and to deploy even in the age of mRNA vaccines. If Omicron turns out to be relatively mild, it may well be that when we look back at the history of the current pandemic, the variant would be seen as a contributor to its solution. The hand of nature may well show more largesse than the developed nations in immunizing the world.
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