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1.
Zoolog Sci ; 41(3): 257-262, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38809864

ABSTRACT

The grey-headed lapwing (Vanellus cinereus) is a wading species in East Asia. However, examples of regional population dynamics and genetic research are limited. To reconsider the natural history and current status of the grey-headed lapwing in Japan, we analyzed the genetic diversity of the Japanese grey-headed lapwing population. We collected 77 grey-headed lapwing samples from 12 locations across Japan during the breeding season and three individuals during the wintering season and extracted DNA; 496-bp sequences of the ND2, which form part of the mitochondrial DNA, were determined for genetic analysis of the population. Consequently, 10 haplotypes were detected in 80 individuals, and 67 individuals, 84% of the total, shared two haplotypes, namely Vc1 and Vc2. Furthermore, the results showed that the prevalence of Vc1 was higher mainly in northern Japan, while that of Vc2 was higher mainly in southern Japan. Genetic diversity analysis showed that the overall haplotype diversity in Japan was 0.617, which is not particularly low. The sequence of Vc1 was exactly the same as that of grey-headed lapwing in China. Our study revealed the genetic structure of the grey-headed lapwing, suggesting that as the grey-headed lapwing expanded its distribution area into southern Japan, many Vc2-positive individuals migrated southward, resulting in a higher detection rate of Vc2 in southern Japan.


Subject(s)
DNA, Mitochondrial , Genetic Variation , DNA, Mitochondrial/genetics , Animals , Japan , Haplotypes , East Asian People
2.
Article in English | MEDLINE | ID: mdl-38804569

ABSTRACT

BACKGROUND: To evaluate the efficacy of a catheter system using a 3-Fr sheath with a steerable microcatheter through right upper limb artery access for superselective intra-arterial cisplatin infusion and concomitant radiotherapy (RADPLAT) to treat right maxillary sinus squamous cell carcinoma (MS-SCC). MATERIAL AND METHODS: We retrospectively studied 46 sessions in eight patients treated between November 2020 and February 2023 using the catheter system briefly described below. A 3-Fr sheath was inserted into the distal radial, conventional radial, or brachial arteries. A coaxial catheter system with a 2.9-Fr steerable microcatheter and a 1.9-Fr microcatheter was advanced into the brachiocephalic artery. The right common carotid artery was selected by bending the tip of the steerable microcatheter. Coil embolization and intra-arterial cisplatin infusion after selecting each external carotid artery branch were achieved using this catheter system. RESULTS: Cisplatin infusion and coil embolization were successful in all sessions. Arterial occlusion at the sheath insertion sites was found in 29.4% (5/17) of the distal radial arteries and 33.3% (3/9) of the conventional radial arteries. No other major complications were observed during the procedure. CONCLUSION: Using a 3-Fr catheter system with a steerable microcatheter through right upper limb artery access is a feasible method for RADPLAT in treating right MS-SCC.

3.
Heart Rhythm ; 2024 May 24.
Article in English | MEDLINE | ID: mdl-38797307

ABSTRACT

BACKGROUND: The slow-pathway potential is difficult to annotate because it is buried within the atrial potential. Omnipolar technology Near Field (OTNF) in Ensite X can automatically annotate the peak frequency potential associated with acquired intracardiac electrograms. OBJECTIVE: This study aimed to visualize the junction between the transitional cells and the slow pathway using a peak frequency map with OTNF and evaluate whether the high-frequency site around the tricuspid annulus (TA) is an effective target for slow pathway ablation. METHODS: This prospective observational study enrolled 37 patients with typical atrioventricular nodal re-entrant tachycardia. Patients underwent slow pathway ablation using peak frequency map (n = 17) and the conventional approach based on anatomical and electrophysiological findings (n = 20). RESULTS: High-frequency sites were distributed at the TA side of 4-5 o'clock in all peak frequency map-guided patients. The distance to His bundle from successful ablation site was farther (24.0 ± 4.8 vs. 12.7 ± 4.0 mm, p < 0.0001), junctional rhythm was slower (88 ± 17 vs. 115 ± 12 bpm, p < 0.0001), time to junctional rhythm after radiofrequency application was shorter (3.4 ± 1.4 vs. 8.2 ± 4.6 sec, p < 0.0001), and elimination rate of jump up (71 vs. 30%, p = 0.02) was higher in the peak frequency map-guided group. CONCLUSION: The high-frequency site of the TA at 4-5 o'clock in the peak frequency map could be a novel target of slow pathway ablation with high safety, efficiency, and efficacy.

4.
Eur Heart J Case Rep ; 8(1): ytad598, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38239309

ABSTRACT

Background: The radiofrequency catheter ablation of peri-mitral atrial flutter is occasionally difficult, mostly due to epicardial or intramural conduction on the mitral isthmus (MI). However, cryoballoon ablation (CBA) of peri-mitral atrial flutter refractory to radiofrequency ablation has not been reported. Case summary: We report a case of a 66-year-old male patient who experienced a recurrence of atypical atrial flutter and underwent the sixth catheter ablation. The activation and entrainment maps showed that this atypical atrial flutter (AFL) was peri-mitral AFL via pathways other than endocardial conduction in the MI. Previous radiofrequency catheter ablation attempts on the MI line, including endocardial, coronary sinus, and epicardial ablations, failed to achieve a bidirectional block of the MI. In this case, we selected CBA for the MI area and successfully achieved a bidirectional block of the MI. Discussion: Although using CBA in the MI is off-label, it could be safely implemented using CARTOUNIVU™. We attributed the success of the bidirectional block of the MI in this case to the crimping of the northern hemisphere of the CBA to the mitral isthmus area, which resulted in the formation of a broad, uniform, and deep ablation lesion site.

5.
Pacing Clin Electrophysiol ; 47(4): 561-563, 2024 04.
Article in English | MEDLINE | ID: mdl-37377387

ABSTRACT

T-wave oversensing in pacemakers is rare because the set sensitivity is generally fixed. However, several models of pacemaker employ automatic sensitivity adjustment. Here, we present two cases of atrioventricular block treated by implantation of the pacemaker with automatic sensitivity adjustment. After implanting the pacemaker with automatic sensitivity adjustment, ventricular pacing suppression due to T-wave oversensing occurred. In both cases, T-wave oversensing disappeared after adjusting the setting sensitivity from 0.9 to 2.0 mV.


Subject(s)
Atrioventricular Block , Pacemaker, Artificial , Humans , Atrioventricular Block/diagnosis , Atrioventricular Block/therapy , Atrioventricular Block/etiology , Cardiac Pacing, Artificial/adverse effects , Pacemaker, Artificial/adverse effects , Heart Ventricles
6.
J Interv Card Electrophysiol ; 67(3): 471-477, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37394659

ABSTRACT

BACKGROUND: The effect of His bundle pacing (HBP) on the incidence of new-onset atrial fibrillation (AF) after pacemaker implantation (PMI) for atrioventricular conduction disturbance (AVCD) remains unknown. We compared the incidence of new-onset atrial high-rate episode (AHRE) in conventional right ventricular (RV) septum pacing (RVSP) and His bundle pacing (HBP) after PMI for AVCD. METHODS: One hundred and four consecutive patients who underwent dual chamber PMI for AVCD in our hospital were screened. Thirty-five patients with mitral or aortic valve disease, history of open-heart surgery, prior AF, subclinical AF, cumulative ventricular pacing percentage < 90%, and RV lead revision were excluded, and 69 patients were effectively enrolled in this study. The primary endpoint was new-onset AHRE within the follow-up period. New-onset AHRE was defined as an atrial high-rate episode that occurred 3 months after PMI and lasted for > 6 min at an atrial heart rate > 190 bpm. RV leads were placed in the His bundle region and RV septum region in 22 and 47 patients, respectively. The mean follow-up period was 539 ± 218 days. The follow-up period was 2 years after PMI or until the new-onset AHRE occurred. RESULTS: The incidence of new-onset AHRE was lower in the HBP group than in the RVSP group (11% vs. 43%, p = 0.01). Multivariate analysis in the Cox regression hazard model showed that HBP had a significantly lower risk of new-onset AHRE compared with RVSP (HR = 0.21; 95% confidence interval 0.04-0.78, p = 0.02). CONCLUSION: The incidence of new-onset AHRE was significantly less in HBP compared to RVSP during the 2-year follow-up period after pacemaker implantation in AVCD patients with RV pacing dependence.


Subject(s)
Atrial Fibrillation , Pacemaker, Artificial , Ventricular Septum , Humans , Bundle of His , Atrial Fibrillation/epidemiology , Atrial Fibrillation/therapy , Atrial Fibrillation/etiology , Cardiac Pacing, Artificial/adverse effects , Pacemaker, Artificial/adverse effects , Electrocardiography , Treatment Outcome
7.
J Cardiovasc Electrophysiol ; 35(2): 366-369, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38044489

ABSTRACT

INTRODUCTION: In patients with prior atrial septal defect (ASD) closure and atrial tachyarrhythmias, transseptal puncture can be challenging. METHODS AND RESULTS: This case report discusses a 65-year-old man who had previously undergone pulmonary vein isolation (PVI) and cavo-tricuspid isthmus ablation for atrial fibrillation before ASD closure, respectively. He developed atrial tachycardia (AT) and underwent catheter ablation. AT was diagnosed as peri-mitral flutter and the mitral isthmus (MI) linear ablation via a trans-aortic approach successfully terminated it. CONCLUSION: This case demonstrates the feasibility and safety of transaortic MI linear ablation in patients with ASD closure devices or anatomical challenges when transseptal puncture is difficult.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Heart Septal Defects, Atrial , Tachycardia, Supraventricular , Male , Humans , Aged , Heart Septal Defects, Atrial/diagnostic imaging , Heart Septal Defects, Atrial/surgery , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Tachycardia, Supraventricular/diagnosis , Tachycardia, Supraventricular/etiology , Tachycardia, Supraventricular/surgery , Heart Atria , Tachycardia/surgery , Catheter Ablation/adverse effects
8.
Circ J ; 88(1): 146-156, 2023 Dec 25.
Article in English | MEDLINE | ID: mdl-37967949

ABSTRACT

BACKGROUND: Left heart abnormalities are risk factors for heart failure. However, echocardiography is not always available. Electrocardiograms (ECGs), which are now available from wearable devices, have the potential to detect these abnormalities. Nevertheless, whether a model can detect left heart abnormalities from single Lead I ECG data remains unclear.Methods and Results: We developed Lead I ECG models to detect low ejection fraction (EF), wall motion abnormality, left ventricular hypertrophy (LVH), left ventricular dilatation, and left atrial dilatation. We used a dataset comprising 229,439 paired sets of ECG and echocardiography data from 8 facilities, and validated the model using external verification with data from 2 facilities. The area under the receiver operating characteristic curves of our model was 0.913 for low EF, 0.832 for wall motion abnormality, 0.797 for LVH, 0.838 for left ventricular dilatation, and 0.802 for left atrial dilatation. In interpretation tests with 12 cardiologists, the accuracy of the model was 78.3% for low EF and 68.3% for LVH. Compared with cardiologists who read the 12-lead ECGs, the model's performance was superior for LVH and similar for low EF. CONCLUSIONS: From a multicenter study dataset, we developed models to predict left heart abnormalities using Lead I on the ECG. The Lead I ECG models show superior or equivalent performance to cardiologists using 12-lead ECGs.


Subject(s)
Deep Learning , Heart Defects, Congenital , Wearable Electronic Devices , Humans , Electrocardiography , Echocardiography , Hypertrophy, Left Ventricular/diagnosis
9.
J Arrhythm ; 39(5): 830-833, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37799785

ABSTRACT

A 72-year-old man was treated for recurrent atrial tachycardia (AT) and underwent ablation. The AT was diagnosed as bi-AT based on the activation map and the postpacing interval. Another AT appeared and was diagnosed as bi-AT by the same method. Surprisingly, the circuits of both ATs were perfectly matched and rotated in opposite directions. The left atrial anteroseptal wall was ablated during the AT. The AT was immediately stopped and was no longer induced.

10.
Sci Rep ; 13(1): 17361, 2023 10 13.
Article in English | MEDLINE | ID: mdl-37833438

ABSTRACT

We developed a 3D convolutional neural network (CNN)-based automatic kidney segmentation method for patients with chronic kidney disease (CKD) using MRI Dixon-based T1-weighted in-phase (IP)/opposed-phase (OP)/water-only (WO) images. The dataset comprised 100 participants with renal dysfunction (RD; eGFR < 45 mL/min/1.73 m2) and 70 without (non-RD; eGFR ≥ 45 mL/min/1.73 m2). The model was applied to the right, left, and both kidneys; it was first evaluated on the non-RD group data and subsequently on the combined data of the RD and non-RD groups. For bilateral kidney segmentation of the non-RD group, the best performance was obtained when using IP image, with a Dice score of 0.902 ± 0.034, average surface distance of 1.46 ± 0.75 mm, and a difference of - 27 ± 21 mL between ground-truth and automatically computed volume. Slightly worse results were obtained for the combined data of the RD and non-RD groups and for unilateral kidney segmentation, particularly when segmenting the right kidney from the OP images. Our 3D CNN-assisted automatic segmentation tools can be utilized in future studies on total kidney volume measurements and various image analyses of a large number of patients with CKD.


Subject(s)
Neural Networks, Computer , Renal Insufficiency, Chronic , Humans , Magnetic Resonance Imaging/methods , Image Processing, Computer-Assisted/methods , Kidney/diagnostic imaging , Renal Insufficiency, Chronic/diagnostic imaging
11.
Article in English | MEDLINE | ID: mdl-37858001

ABSTRACT

BACKGROUND: Although previous studies have shown the isolated areas after pulmonary vein isolation (PVI) using cryoballoons (CB) (CB-PVI), no studies have investigated the association between the isolated area and recurrence of atrial fibrillation (AF) and atrial tachycardia (AT). This single-center observational study investigated the association between the ablated area and recurrence rate after durable CB-PVI for paroxysmal AF. METHODS: This study included 76 patients with paroxysmal AF who underwent CB-PVI and established durable PVI with a second procedure, regardless of AF/AT recurrence, 6 months after the first procedure. To compare the ablated zones, we quantified the left- and right-sided PV antral isolation areas and non-ablated posterior wall (PW) area. We examined non-ablated areas of the PW and AF/AT recurrence in the chronic phase. RESULTS: In total, 16 of the 76 patients had AF/AT recurrence. The mean follow-up duration was 34 months. The non-ablated PW area (14.0 ± 4.6 cm2 vs. 11.5 ± 3.7 cm2; p = 0.0213) and the ratio of the non-ablated PW area to the whole PW area (NAPW) (52.9 ± 9.1% vs. 44.8 ± 9.8%; p = 0.003) were significantly higher in the AF/AT recurrence group than in the AF/AT non-recurrence group. NAPW > 50% was an independent predictor of AF/AT recurrence. CONCLUSION: The NAPW after durable CB-PVI is associated with AF/AT recurrence. PW isolation or additional applications on the PV antrum with cryoballoon may be considered in addition to PVI in paroxysmal AF, especially in patients with dilated left atria.

12.
J Arrhythm ; 39(4): 658-660, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37560285

ABSTRACT

The LUMIPOINT™ software allows visualization of arrhythmia circuits through the MB. In cases where the full extent of the arrhythmia circuit cannot be identified and epicardial conduction is suspected, it is better to perform the analysis while adjusting the confidence slider in LUMIPOINT™.

13.
J Cardiovasc Electrophysiol ; 34(8): 1622-1629, 2023 08.
Article in English | MEDLINE | ID: mdl-37393602

ABSTRACT

INTRODUCTION: Posterior wall isolation (PWI) combined with pulmonary vein isolation (PVI) has proven effective for persistent atrial fibrillation (AF). However, when performing PWI, creating transmural lesions with subendocardial ablation is sometimes difficult. Endocardial unipolar voltage amplitude had a higher sensitivity than bipolar voltage mapping for identifying intramural viable myocardium in the atria. In this study, we aimed to retrospectively investigate the correlation between the residual potential in the posterior wall (PW) following PWI for persistent AF and atrial arrhythmia recurrence using endocardial unipolar voltage. METHODS: This was a single-center observational study. Patients who underwent PVI and PWI for persistent AF in the first procedure between March 2018 and December 2021 at the Tokyo Metropolitan Hiroo Hospital were included in this study. The patients were divided into two groups based on the presence of residual unipolar PW potentials after PWI with a cutoff of 1.08 mV and the recurrence of atrial arrhythmias was compared. RESULTS: In total, 109 patients were included in the analysis. Forty-three patients had residual unipolar potentials after PWI and 66 patients had no residual unipolar potentials. The atrial arrhythmia recurrence rate was significantly higher in the group with residual unipolar potential (41.8% vs. 17.9%, p = 0.003). The residual unipolar potential was an independent predictor of recurrence (odds ratio: 4.53; confidence interval: 1.67-12.3, p = 0.003). CONCLUSION: Residual unipolar potential after PWI for persistent AF is associated with recurrent atrial arrhythmias.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Retrospective Studies , Treatment Outcome , Catheter Ablation/adverse effects , Catheter Ablation/methods , Recurrence , Heart Atria/surgery , Pulmonary Veins/surgery
14.
J Interv Card Electrophysiol ; 66(9): 2063-2070, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37043092

ABSTRACT

BACKGROUND: The relationship between coronary blood flow during atrial fibrillation (AF) and improvement of cardiac function after catheter ablation (CA) for persistent AF (PeAF) is not prominent; this study was conducted to evaluate this relationship. METHODS: This was a retrospective case-control study. Eighty-five patients with PeAF (resting heart rate < 100 bpm) and heart failure with reduced ejection fraction (left ventricular ejection fraction (LVEF) < 40%) who had undergone coronary angiography within 1 week before CA were included. All patients could maintain a sinus rhythm for > 6 months after CA. The primary outcome was improvement of cardiac function with an LVEF cutoff value of > 50% during sinus rhythm 6 months after CA. RESULTS: In the LVEF improvement group (N = 57), patients were younger, with a higher baseline diastolic blood pressure and lower baseline brain natriuretic peptide level than the no LVEF improvement group (N = 28). Heart rate at baseline and 6 months after CA and AF duration did not differ between the two groups. Thrombolysis in myocardial infarction frame count parameters was significantly higher in the LVEF improvement (P < 0.001) than in the no LVEF improvement group. Multivariate logistic regression analysis revealed mean thrombolysis in myocardial infarction frame count as an independent factor for LVEF improvement (odds ratio, 1.72 (95% confidence interval 1.17-2.54); P = 0.006). CONCLUSION: Coronary blood flow in patients with PeAF is strongly associated with improved left ventricular systolic function after the restoration of sinus rhythm by CA for PeAF and heart failure with reduced ejection fraction.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Heart Failure , Myocardial Infarction , Ventricular Dysfunction, Left , Humans , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/surgery , Atrial Fibrillation/complications , Stroke Volume/physiology , Case-Control Studies , Retrospective Studies , Ventricular Function, Left , Treatment Outcome , Myocardial Infarction/complications
15.
Eur Heart J Case Rep ; 7(1): ytac481, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36694876

ABSTRACT

Background: The pulmonary vein (PV) variant is present in 23-38% of patients who undergo atrial fibrillation ablation, and the common inferior PV (CIPV) variant is a rare PV variant that has been reported in 0.9-1.5% of patients. The arrhythmogenicity of the common trunk of the CIPV is unknown. Case summary: A 77-year-old woman underwent catheter ablation for paroxysmal atrial fibrillation (AF). Preoperative computed tomography revealed a common trunk from which the bilateral inferior PVs and a left superior PV originated. The voltage map of the left atrium (LA) showed three PVs stemming from a common trunk. There was a low-voltage area bounded by the common trunk entrance. An isolation line was created to connect the right superior PV and the common trunk. Twelve months later, AF recurred. The voltage map in second session showed residual irregular potentials at the boundary between the common trunk and the LA, and posterior wall isolation was performed. Postoperatively, the patient maintained sinus rhythm with no antiarrhythmic drugs during the 12-month follow-up period. Discussion: The CIPV is likely to predict the AF recurrence, even if preoperative voltage mapping shows a low voltage area. Substrate modification should be performed on abnormal potentials at the entrance of the common trunk, even though no potential is detected in the PVs or their antrum.

16.
J Cardiovasc Electrophysiol ; 33(11): 2407-2410, 2022 11.
Article in English | MEDLINE | ID: mdl-36183403

ABSTRACT

Although it is common for bi-atrial tachycardia (AT) circuits to include the Bachmann bundle, there are few reports of its role in left AT circuits. A 77-year-old man was admitted for recurrent AT with a cycle length of 425 ms. The endocardial and epicardial activation map revealed an AT circuit located in the left atrial anterior wall and transverse pericardial sinus, showing a centrifugal pattern stemming from the left atrial appendage. After radiofrequency ablation, AT was no longer induced. This case suggests that the Bachmann bundle may be part of the left AT circuit.


Subject(s)
Atrial Appendage , Catheter Ablation , Tachycardia, Supraventricular , Male , Humans , Aged , Epicardial Mapping , Tachycardia, Supraventricular/diagnosis , Tachycardia, Supraventricular/surgery , Heart Atria/surgery , Tachycardia
18.
Int Dairy J ; 133: 105436, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35702275

ABSTRACT

Bovine whey IgG enriched fraction contains IgG antibodies against bacterial and viral pathogens, including antibodies against the spike protein [amino acids (aa) 1-1274] of SARS-CoV-2 Wuhan strain (2019-nCoV WHU01). To date, 13 SARS-CoV-2 variants have been identified, including gamma, delta, kappa, and omicron, which contain 10, eight, seven, and over 30 mutations in the spike protein, respectively. We investigated whether bovine whey IgG enriched fraction contains antibodies against spike proteins of these variants, specifically recombinant partial length spike proteins (aa 177-512, aa 509-685, aa 177-324, aa 250-410 and aa 387-516) of these variants. Direct enzyme-linked immunosorbent assays revealed bovine whey IgG enriched fraction contained antibodies against all recombinant spike proteins of these variants with highest reactivity against aa 177-512 region of omicron spike protein. These results indicate bovine whey IgG enriched fraction contains antibodies against spike proteins of several SARS-CoV-2 variants, including omicron.

19.
Antibiotics (Basel) ; 11(5)2022 May 18.
Article in English | MEDLINE | ID: mdl-35625326

ABSTRACT

The purpose of this study was to evaluate the defined daily doses (DDD)/1000 prescriptions/month (DPM) as a new indicator that can be used in pharmacies, and to describe antimicrobial use patterns in pharmacies nationwide in Japan. Dispensing volumes, number of prescriptions received, and facility information were obtained from 2638 pharmacies that participated in a survey. DPM was calculated based on the dispensing volume and number of prescriptions, which are routinely collected data that are simple to use. Use of third-generation cephalosporins, quinolones, and macrolides in pharmacies that received prescriptions primarily from hospitals or clinics decreased from January 2019 to January 2021. In particular, the antimicrobial use was higher in otorhinolaryngology departments than in other departments, despite a decrease in the antimicrobial use. In the linear multiple regression analysis, otorhinolaryngology department was independently associated with the third-generation cephalosporin, quinolone, and macrolide prescription in all periods. This study reveals for the first-time trends in antimicrobial use through a new indicator using the volume of drugs dispensed in pharmacies throughout Japan. Antimicrobial use differed by the medical department, suggesting the need to target interventions according to the department type.

20.
Curr Drug Saf ; 17(4): 350-356, 2022.
Article in English | MEDLINE | ID: mdl-35209830

ABSTRACT

BACKGROUND: The Japan Pharmaceutical Association has conducted drug event monitoring to detect drug events related to pemafibrate. As there are a few studies on the safety of pemafibrate in clinical settings, a pilot study evaluating the association between drug use and detected events was performed in Japan. AIMS: In this study, the association between detected events and the use of pemafibrate, utilizing pharmacy records maintained by community pharmacists, was investigated. We identified the newuser cohort using a test and active comparison drug and collected the baseline information. An active comparison group comprising new users was used to assess the events. METHODS: A retrospective cohort study using questionnaires regarding baseline and event data was conducted by community pharmacists belonging to the Japan Pharmaceutical Association. The incidence of event and estimated hazard ratio were calculated using the Cox proportional hazards model that was adjusted for confounding factors, such as age and sex. RESULTS: A total of 1294 patients using pemafibrate and 508 patients using fenofibrate were identified as new drug users. The most reported events involving suspected adverse reactions and add-on drugs were increased blood pressure and lipid-lowering effects with pemafibrate use, and nasopharyngitis, pruritus, dizziness, and lipid-lowering effects with fenofibrate use. No significant differences were found in commonly occurring events, except that an add-on anti-hypertensive drug has been used by pemafibrate users compared to fenofibrate users. CONCLUSION: This study conducted by pharmacists can facilitate the safety assessment of newly marketed drugs, as few drug use investigations with a comparator are carried out by the Japanese authority for pharmaceutical companies. However, further research is required.


Subject(s)
Fenofibrate , Benzoxazoles , Butyrates/adverse effects , Fenofibrate/adverse effects , Humans , Japan/epidemiology , Pharmaceutical Preparations , Pharmacists , Pilot Projects , Retrospective Studies
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