Journal of Pharmaceutical Health Care and Sciences最新文献

Background: Advanced non-squamous non-small cell lung cancer has a poor prognosis, and immune checkpoint inhibitors (ICIs) plus platinum-based combination chemotherapy is the first-line treatment. Atezolizumab, an ICI, has three regimens: atezolizumab + carboplatin (CBDCA) + paclitaxel + bevacizumab [ABCP], atezolizumab + CBDCA + nab-paclitaxel (nab-PTX) [A + CnP], and atezolizumab + CBDCA + pemetrexed [A + CbP]. However, clinical trials directly comparing these regimens have not been reported, and the differences in adverse events have not been fully clarified.

Methods: We calculated the reporting odds ratio (ROR), a measure of adverse drug reaction (ADR) signals, using the FDA Adverse Event Reporting System (FAERS) to compare the major ADRs of ABCP, A + CnP, and A + CbP regimens.

Results: The ROR (95% confidence interval [CI]) for rash and hypersensitivity-related adverse events was 2.06 (1.81-2.34) for ABCP, 0.81 (0.42-1.56) for A + CnP, and 0.57 (0.37-0.87) for A + CbP; the signal was only detected for the ABCP regimen. In acute kidney injury (AKI), it was ABCP: 1.24 (0.89-1.73), A + CnP: 1.16 (0.37-3.60), and A + CbP: 1.76 (1.06-2.93), and signal was detected only for the A + CbP regimen. Contrarily, signals were detected for colitis, drug-induced liver injury, and pneumonitis for all regimens.

Conclusions: Rash and hypersensitivity-related adverse events and AKI were more frequently reported with the ABCP and A + CbP regimens, respectively. These observations may help generate hypotheses regarding regimen-specific adverse event profiles and support future studies toward individualized chemotherapy.

Background: Edoxaban is the only direct-acting oral anticoagulant (DOAC) indicated for preventing venous thromboembolism (VTE) in patients undergoing arthroplasty and can be administered for a short period (1-2 weeks). The dosage of edoxaban is set according to renal function and the presence or absence of concomitant medications with P-glycoprotein inhibitory effects. However, a small number of patients still develop VTE after lower-extremity orthopedic surgery (LE-OS), despite edoxaban administration. This single-center, exploratory cohort study retrospectively investigated patients prescribed edoxaban after LE-OS in order to explore the potential of D-dimer as a signal of VTE.

Methods: Of the 1,457 patients who received edoxaban after total hip arthroplasty or total knee arthroplasty between January 2016 and December 2020, 1,244 who cleared the exclusion criteria were divided into the non-VTE group (1,219 patients) and VTE group (25 patients). To reduce bias in VTE occurrence, patient age, sex, body weight, serum creatinine, edoxaban underdosing, previous thromboembolism, bed rest duration ≥ 48 h, and blood transfusion were matched using propensity score matching (PSM). We compared the routinely measured D-dimer values of blood samples collected on postoperative day 7 among non-VTE and VTE groups using the Mann-Whitney U test.

Results: After PSM, there were 23 patients in each of the non-VTE and VTE groups. The median (interquartile range) D-dimer value on postoperative day 7 was 6.2 (4.2-8.1) µg/mL in the non-VTE group and 9.6 (6.3-12.4) µg/mL in the VTE group (p = 0.005).

Conclusions: This retrospective exploratory study demonstrated that D-dimer values in patients receiving edoxaban after LE-OS may serve as a signal for VTE occurrence.

Background: Extravasation (EV) as an adverse effect of chemotherapy can induce tissue damage. Japanese guidelines on EV associated with cancer drug therapy were published in December 2022. However, few large-scale investigations on the frequency and patient clinical characteristics of EV have been conducted. In addition, although current guidelines newly recommend topical steroid use and consultation with dermatologists or plastic surgeons, it is necessary to clarify the actual status of EV management prior to the guideline revision in order to evaluate compliance with the current recommendations in the future. However, the real-world status has not been clarified to date. This study aimed to investigate the frequency of EV, the characteristics of patients who experienced EV, and the management of EV associated with docetaxel (DTX), a vesicant anticancer agent, using a large Japanese medical claims database.

Methods: Patients with cancer who received DTX monotherapy between 2008 and 2020 were evaluated. The patients were identified from the hospital-based medical claims database of Medical Data Vision Co., Ltd. The baseline characteristics of the study patients, the characteristics of patients who experienced EV, steroid prescriptions, and consultations with dermatologists or plastic surgeons were descriptively investigated.

Results: Among the 46,698 patients evaluated, 0.075% (35) patients developed DTX-related EV. In patients who experienced EV, 8.6% (3/35) had a history of EV. This proportion was higher than that of the overall study population. Only 34.3% (12/35) of the patients were prescribed injectable or topical steroids for EV, and 11.4% (4/35) received a consultation from the dermatology or plastic surgery department.

Conclusions: DTX monotherapy-related EV occurs in 0.075% of cancer patients. The proportion of patients with a history of EV was higher among those who experienced EV than among the overall study population. Only a small proportion of patients who develop EV are prescribed topical steroids or receive consultation from the dermatology or plastic surgery department. The incidence and management of EV may change following the publication of the 2023 edition of the Japanese EV guidelines, and thus, further investigation is warranted.

Background: Anemia is a frequent complication of heart failure (HF) that exacerbates cardiac dysfunction and worsens prognosis. However, its exact burden and treatment patterns in Sudan HF remain unknown. Thus, this study aimed to describe the prevalence, characteristics, and management of anemia among Sudanese HF patients.

Methods: We conducted a retrospective cross-sectional study of adult HF patients admitted to Wad Medani Heart Center, Sudan, over three years. Baseline hemoglobin (Hb) was defined as the first measurement within 24-48 h of index admission. Only patients with evaluable baseline Hb were included in the analytic cohort.

Results: Of 557 HF patients, 266 (47.8% of full cohort; 51% of analytic cohort) were anemic (mean Hb 10.68 ± 1.51 g/dL). The mean age was 60.4 ± 18 SD, 136 (51%) were females, 114 (43%) aged more than 65 years, and 77 (28%) had prior HF admissions. Hypertension 136 (51%), diabetes 91 (34%) and chronic kidney disease 75 (28%) were other comorbidities. Anemia was most prevalent in the HF with mid-range ejection fraction (HFmrEF) cohort 134 (50.4%), followed by HF with reduced ejection fraction (HFrEF) 71 (26.7%) and HF with a preserved ejection fraction (HFpEF) 61 (22.9%). Among anemic HF patients, only 77 (29%) received anemia management. Of those, 28(36.4%) received blood transfusions, and 34 (44.2%) received iron supplementation.

Conclusions: Nealy half of HF patients were anemic, particularly older and those with HFmrEF, and treatment was suboptimal. Incorporating routine anemia screening and standardized management into HF care protocols is essential to enhance clinical outcomes.

Background: This study aimed to investigate whether medication adherence was changed by the prescription of a single-pill combination (SPC) of antihypertensive drugs and whether it was associated with the incidence of major adverse cardiovascular events (MACE) at the 5-year follow-up.

Methods: The medical records of 707 patients whose medication adherence could be assessed at least one year before and after the date SPC was first prescribed were retrospectively reviewed. The patients' baseline characteristics included sex, age, medical and medication history within the past year (MACE, antidiabetic drugs, and antihyperlipidemic drugs), and polypharmacy (six or more drugs taken orally). Medication adherence was evaluated as the proportion of days covered, and the patients were divided into poor adherence (n = 28) and good adherence (n = 679) groups. Fisher's exact test and the Mann-Whitney U test were used to examine the differences in variables between the groups. Kaplan-Meier survival analysis was performed to assess time-to-event data, with group differences evaluated using the log-rank test and Cox proportional hazards models adjusted for baseline variables.

Results: No significant differences were observed in the patients' baseline characteristics between the good and poor adherence groups. During the first year after the initiation of prescribing the SPC of antihypertensive drugs, the percentage of patients who developed MACE was higher in the poor adherence group than in the good adherence group (21.4% and 11.8%, respectively), but the difference was not statistically significant (p = 0.137). No significant difference in the cumulative incidence of MACE during the 5-year observation period was observed between the poor and good adherence groups (p = 0.199). In the Cox proportional hazards analysis, 75 years of age or older, the occurrence of MACE within the past year, and polypharmacy were associated with increased risk of 5-year MACE compared to the references (adjusted hazard ratios 1.42 [95% Confidence Intervals: 1.10-1.83], p = 0.007; 0.72 [0.55-0.93], p = 0.011; and 1.36 [1.01-1.83], p = 0.044, respectively).

Conclusions: The present findings demonstrated that age 75 or older age, history of MACE, and polypharmacy were significant risk factors for MACE after the prescription of antihypertensive SPC.

Background: Sodium-glucose cotransporter-2 inhibitors (SGLT2is) occupy a pivotal role in the management of Type 2 diabetes due to their unique glucose-lowering mechanism and multiple clinical benefits. Physicians, as decision-makers in treatment, and pharmacists, as disseminators of drug knowledge, play crucial roles in ensuring the effectiveness and safety of treatments involving SGLT2is. However, the extent of primary healthcare workers' understanding of SGLT2i characteristics prior to usage remains unclear.

Aim: This study aims to evaluate the level of knowledge pertaining to the use of SGLT2is among primary care physicians and hospital pharmacists.

Methods: A field survey on the cognition of SGLT2is was conducted among internal medicine, surgical, general practice, and pharmacy departments within healthcare institutions and community health service centers in Kaihua County, Zhejiang Province, China. An online questionnaire, including demographic information and knowledge about SGLT2is, was designed and administered.

Results: The survey included 105 physicians and 31 pharmacists, with 59.56% being male and 66.18% holding intermediate or senior professional titles. Scores were predominantly in the range of 9-11 out of a maximum of 16 points, encompassing 102 participants (75.00%), while 9 individuals (11.76%) scored 13 points or higher, and 13 participants (9.56%) scored 8 points or lower. Notably, 33.09% correctly identified that SGLT2is are not applicable for Type 1 diabetes patients, 15.44% correctly noted the need to discontinue SGLT2is before major surgery, 23.53% correctly answered that SGLT2is are not approved in China for treating Type 2 diabetes in children and adolescents, and 47.06% correctly recognized that SGLT2is can be combined with metformin to enhance glucose-lowering effects. Additionally, the average score of physicians in surgical departments was significantly lower than other departments (H = 19.733, P < 0.001), and female participants had significantly higher average scores than males (Z = -3.528, P < 0.001).

Conclusion: Primary care physicians and pharmacists in Kaihua County exhibit a robust understanding of the mechanisms of SGLT2is. However, there are notable deficiencies in the management of perioperative care in surgery, in discerning indications across internal and general medicine, in identifying contraindications in special populations, and in the pharmacists' roles in prescription review. These findings suggest a need for targeted educational initiatives to enhance understanding and safe use of SGLT2 inhibitors at the primary-care level.

Background: A team-based approach is essential to provide cancer patients with high-quality treatment. To ensure the best possible care while reducing the workload of physicians, Ehime University Hospital has introduced three protocol-based pharmacotherapy management (PBPM) strategies in the field of chemotherapy. First, we introduced PBPM to avoid reactivation of hepatitis B virus (HBV) in patients receiving immunosuppressive therapy or chemotherapy. In this PBPM strategy, pharmacists added laboratory test orders for patients who require regular HBV-DNA quantification (HBV-PBPM). Second, we devised PBPM for measurement of the urine protein/creatinine ratio (UPC) in patients receiving anti-vascular endothelial growth factor therapy. Finally, we introduced PBPM for measurement of serum magnesium in patients receiving anti-epidermal growth factor receptor antibody therapy (Mg-PBPM). In this study, we evaluated the usefulness of these three PBPM strategies in outpatients receiving chemotherapy.

Methods: The study included patients treated in the outpatient chemotherapy unit between July 2021 and February 2023. Rates of compliance with laboratory tests in the 6 months before and after introduction of PBPM were compared.

Results: Compliance with HBV-DNA quantification improved significantly from 66.3% before PBPM to 86.7% after implementation of PBPM (p = 0.002). The median duration of noncompliance was significantly shorter after initiation of PBPM (p = 0.021). Compliance with measurement of UPC was already greater than 95% before PBPM and showed no change after implementation (98.7% pre-PBPM vs 99.3% post-PBPM). Compliance with measurement of serum magnesium improved from 95.8% pre-PBPM to 99.2% after starting PBPM, but the improvement was not statistically significant.

Conclusions: Introduction of PBPM improves compliance with the laboratory tests required in cancer patients during chemotherapy and enables safer delivery of treatment.