International journal of clinical pharmacology and therapeutics最新文献

Purpose: To evaluate the rate and determinants of non-adherence to antipsychotic medications in Saudi Arabia.

Materials and methods: This was a cross-sectional study that included a questionnaire, interview, and data extraction from medical records of adult patients on antipsychotic medications. The study was conducted at outpatient clinics at the psychological care department at King Fahad Medical City, Riyadh, Saudi Arabia, between October 25 and November 26, 2020. Data collection included three parts: patients' sociodemographic characteristics; antipsychotic medications used and patients' clinical characteristics; and adherence to antipsychotic medications measured by the Medication Adherence Rating Scale (MARS).

Results: Out of 220 patients, 122 (55.5%) were considered non-adherent (MARS scores 6 or less). The MARS items contributing most to non-adherence were "the medication makes me feel tired and sluggish" and "forget to take the medication", 55 and 40.9%, respectively. Additionally, adverse drug effect significantly increased the risk of poor adherence in regression analysis (odds ratio = 1.97, p = 0.028). The model also showed that female sex, low income, cigarette smoking, substance abuse, uncontrolled disease, comorbidity, and use of Ruqyah religious therapy were associated with increased risk of poor adherence, but were however not statistically significant (p < 0.05).

Conclusion: This study showed high non-adherence rate to antipsychotic medications. Adverse drug effects and forgetting to take medications were the main patient-reported barriers to adherence. Likewise, sociodemographic, clinical, and spiritual factors affected medication adherence. Knowing these predictors helps in early identification of patients who are predisposed to medication non-adherence and allows personalized interventions that improve adherence and treatment outcomes.

Background: Various studies have reported the association of cognition and depression with diabetes. Literature suggests that metformin and sitagliptin used to control hyperglycemia in type 2 diabetes mellitus (T2DM) possess a beneficial effect on neurological symptoms associated with diabetes. However, there are scarce data in the clinical setting. Thus, this study aims to compare depression, cognitive impairment, and quality of life (QoL) of newly diagnosed T2DM patients with those of healthy individuals. Further, the impact of metformin alone or in combination with dipeptidyl peptidase-4 inhibitors on cognition, depression, and QoL of T2DM patients was also compared with newly diagnosed T2DM patients.

Materials and methods: This was a prospective observational study in 120 subjects. The subjects were equally divided into four groups: healthy controls, newly diagnosed T2DM patients, and T2DM patients taking either metformin alone or in combination with sitagliptin. We assessed cognition using Mini-Mental State Examinations (MMSE), depression using Hamilton Depression Rating Scale (HAM-D), and health status using Short-Form Health Survey-36 (SF-36).

Results: No significant change in MMSE score was observed among the groups. However, a significant increase in the HAM-D score of newly diagnosed patients (p < 0.001), T2DM patients receiving metformin alone (p < 0.05), and in combination with sitagliptin (p < 0.001) was observed as compared to healthy controls (p < 0.001). Also, a statistically significant increase in HAM-D score was observed in patients receiving sitagliptin in combination with metformin as compared to metformin alone (p < 0.01). A decrease in SF-36 scores was observed in all groups as compared to healthy controls.

Conclusion: To conclude, this preliminary study indicates that T2DM patients are most likely to suffer from depression and impaired QoL. Moreover, both the conventional and recent antidiabetic agents might lead to neurobehavioral complications and adverse impact on the QoL of these patients. Thus, we warrant the assessment of cognitive functions, depression, and QoL in patients receiving metformin and sitagliptin.

Objective: To evaluate the adverse effects and particularly the anesthetic effect of low-dose etomidate combined with oxycodone and midazolam in endoscopic injection sclerotherapy.

Materials and methods: We herein report a prospective, double-blind, randomized controlled trial. It included patients with liver cirrhosis (age, 18 - 65 years; BMI, 18 - 25 kg/m²) who were treated with endoscopic injection sclerotherapy, and the patients were randomly assigned to the propofol group or the etomidate group. The incidence of respiratory depression was the primary outcome measure. The occurrence of various adverse effects and endoscopist satisfaction score were the secondary outcome measures.

Results: In this study, we enrolled a total of 96 patients. The incidence of respiratory depression in the propofol group was 19%, while that in the etomidate group was only 4% (9/47 vs. 2/49; p = 0.026). Regarding the secondary outcome measures, the incidence of hypoxia in the propofol group was 15%, while that in the etomidate group was only 2% (7/47 vs. 1/49; p = 0.029). Injection-site pain occurred in 0% and 23% of the patients in the etomidate group and propofol group, respectively (p < 0.001). Endoscopist satisfaction scores were classified as "poor", "fair", "good", and "very good". The scores were 17% higher (46/49 vs. 36/47; p = 0.026) for the "very good" level and 15% lower (3/49 vs. 10/47; p = 0.038) for the "good" level in the etomidate group than in the propofol group.

Conclusion: Low-dose etomidate combined with oxycodone and midazolam for endoscopic injection sclerotherapy could reduce the incidence of hypoxia without increasing the incidence of complications.

Objective: To evaluate the pharmacokinetics (PK), safety, and bioequivalence of two formulations of apixaban in healthy Chinese subjects under fasting and fed conditions.

Materials and methods: A single-center, randomized, open, single-dose, two-period crossover PK study was carried out under fasting and fed conditions in 64 healthy subjects enrolled in either the fasting (36 subjects) or the fed (28 subjects) arms of the study. Subjects received a single oral dose of 2.5 mg apixaban tablets as test (T) or reference (R) formulation. The primary PK parameters determined were the area under the plasma concentration-time curve from zero to t and ∞ (AUC_0-t and AUC_0-∞) and the maximal plasma concentration (C_max). Safety was assessed mainly from the occurrence of adverse events (AEs).

Results: A single drop-out in the fed arm of the trial was excluded from the statistical evaluation. The 90% confidence intervals (CIs) for the geometric mean ratio (GMR) for T/R using AUC_0-t were 95.4 - 100.9% and 97.8 - 103.8%, and for AUC_0-∞ were 95.3 - 100.6% and 98.3 - 104.3% under fasting (36 subjects) and fed (27 subjects) conditions, respectively. Similarly, the 90% CIs for C_max were 94.6 - 103.1% and 88.8 - 102.0% under fasting (36 subjects) and the fed (27 subjects) conditions, respectively. Therefore, the 90% CIs for the T/R AUC and C_max ratios were within the standard range for bioequivalence (80.0 - 125.0%). There were no serious adverse events (SAEs).

Conclusion: The test and reference 2.5 mg apixaban tablets were bioequivalent and both showed good tolerability and safety.

Objectives: This study aimed to determine the effectiveness of analgesics in inhibiting cancer development in patients with diabetes based on a sample cohort supplied by the Korean National Health Insurance Service.

Materials and methods: Regular users of analgesics included those using prescription analgesics ≥ 15 days per month at least 6 times over 2 years after the diagnosis of diabetes mellitus (baseline). The effectiveness of analgesics in patients with diabetes was evaluated using metformin adherence and three models: model 1 was adjusted for age and sex; model 2 was further adjusted for body mass index (BMI), exercise, cholesterol, hypertension, and Charlson comorbidity index (CCI); and model 3 was further adjusted for analgesics.

Results: Based on stringent extraction criteria, the sample had a cancer incidence of 4.6%. The hazard ratios of models 1 and 2 were 0.830 and 0.865, respectively. The adjusted hazard ratio for all variables, including acetaminophen and nonsteroidal anti-inflammatory drugs such as aspirin and ibuprofen, was 0.871 (model 3).

Conclusion: Regular use of analgesics by patients with diabetes decreased their risk of subsequent cancer development in this large national cohort. Compared with participants who did not develop cancer, those with cancer were older and more likely to be male, did not exercise, have more comorbidities (as assessed by CCI), and did not use analgesics regularly.

Purpose: Coronavirus disease 2019 (COVID-19) has emerged as a serious threat to public health; anticancer-repositioning treatment strategy has been formulated to treat the disease. However, evidence supporting the efficacy and safety of repositioned anticancer treatment in treating COVID-19-infected non-cancer patients (CINPs) is limited. Therefore, this study analyzed published randomized controlled trials (RCTs) evaluating the impact of anticancer drugs compared to current standards of care (SOCs) on CINP treatment.

Materials and methods: The PubMed and Embase databases were searched to identify eligible RCTs. Outcome measures included mortality, the use of mechanical ventilation (MV), and serious adverse events (SAEs).

Results: 25 RCTs were reviewed in our study. Compared to SOCs, repositioned anticancer therapy for treating CINPs was associated with mortality reduction (odds ratio (OR) = 0.78, 95% confidence interval (CI) = 0.65 - 0.94, p = 0.01). Using the repositioned anticancer treatment exhibited statistically significant reduction, in both the number of CINPs using MV (OR = 0.67, 95% CI = 0.51 - 0.88, p = 0.004) and experiencing SAEs (OR = 0.79, 95% CI = 0.69 - 0.91, p = 0.0009).

Conclusion: Conclusively, repositioned anticancer treatment was shown significant differences from SOCs in treating CINPs, which appears to be more associated with mortality, MV use, and SAE development reduction in CINPs.

Background: Dysbiosis (also called dysbacteriosis) is characterized by a disruption of the microbiome, resulting in an imbalance in the microbiota, changes in their functional composition and metabolic activities, and a shift in their local distribution. Dysbiosis is most commonly reported as a condition affecting the gastrointestinal tract, for example with bacterial or fungal overgrowth in the small intestine. Known causes of dysbiosis include antibiotic use, liver disease, and alcohol misuse.

Aims: To determine those variables associated with the diagnosis of dysbiosis using a national database containing data supplied by general practitioners in Germany.

Materials and methods: Patient data for the period January 2005 to December 2018 were obtained from the Disease Analyzer database (IQVIA) based on data from 1,193 general practices in Germany. Inclusion criteria were all adult patients (≥ 18 years) with an initial diagnosis of dysbiosis documented anonymously. Data for variables such as drug treatment, other diseases etc. associated with the diagnosis were analyzed using multivariable logistic regression analyses.

Results: A total of 4,013 patients diagnosed with dysbiosis and a comparative control cohort of 4,013 patients without such a dysbiosis were included in the study. The mean age in both groups was ~ 50 years where 65.2% of subjects were women. Decongestants and other nasal preparations for topical use (OR: 1.45, 95% CI: 1.14 - 1.85), proton pump inhibitors (OR: 1.39; 95% CI: 1.21 - 1.61), and systemic antibiotics (OR: 1.28, 95% CI: 1.13 - 1.47) were significantly associated with an increased occurrence of dysbiosis, whereas non-steroidal antirheumatic drugs (OR: 0.78, 95% CI: 0.69 - 0.87), lipid-lowering drugs (OR: 0.76, 95% CI: 0.63 - 0.93), and ACE inhibitors (OR: 0.64, 95% CI: 0.53 - 0.77) were associated with a decreased occurrence of dysbiosis.

Conclusion: The study provides evidence that treatment with decongestants and other nasal preparations is strongly associated with an increased occurrence of dysbiosis. Although the pathophysiology of dysbiosis is multifactorial and confounding factors cannot be ruled out, the close correlation seen may have clinical significance.