International journal of clinical pharmacology and therapeutics最新文献

{"title":"Variations in prothrombin time-international normalized ratio caused by drug-drug interaction in patients receiving warfarin: A retrospective observational study.","authors":"Chihiro Shiraishi,&nbsp;Toshinori Hirai,&nbsp;Satoshi Fujita,&nbsp;Kaoru Dohi,&nbsp;Takuya Iwamoto","doi":"10.5414/CP204306","DOIUrl":"https://doi.org/10.5414/CP204306","url":null,"abstract":"<p><strong>Objectives: </strong>Drug-drug interactions between warfarin and cytochrome P450 (CYP) 2C9 inhibitors and inducers are well known. Few studies have clarified the clinical impact of CYP2C9 inhibitors and inducers on warfarin therapy. Here, we evaluated the clinical impact of CYP2C9-mediated interactions on the pharmacodynamics of warfarin.</p><p><strong>Materials and methods: </strong>This retrospective observational study enrolled patients who received warfarin between 2008 and 2020 at Mie University Hospital. We defined prothrombin time-international normalized ratio/daily warfarin dose (PT-INR/dose) as the primary outcome and conducted a multiple linear regression analysis to clarify the factors that affected the primary outcome. Additionally, we examined the clinical features of patients who received CYP2C9 inducers.</p><p><strong>Results: </strong>Out of 1,393 patients, 17 (1.2%) received carbamazepine, rifampicin, phenobarbital, or phenytoin as CYP2C9 inducers. Multiple linear regression analysis indicated that age, body mass index (BMI), serum albumin (Alb), estimated glomerular filtration rate (eGFR), and CYP2C9 inducers were associated with PT-INR/dose. The multiple regression equation was as follows: PT-INR/dose = 1.590 + 0.004 × age - 0.020 × BMI - 0.141 × Alb - 0.001 × eGFR - 0.149 × (if concomitant use of CYP2C9 inducers) (adjusted coefficient of determination = 0.106, Akaike information criterion = 267.3, p < 0.001). In patients receiving CYP2C9 inducers, lower PT-INR/dose values were observed regardless of co-administered CYP2C9 inhibitors.</p><p><strong>Conclusion: </strong>In addition to age, BMI, Alb, and eGFR, concomitant use of CYP2C9 inducers should be considered when adjusting the warfarin dose and PT-INR.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 4","pages":"139-147"},"PeriodicalIF":0.8,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9149442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating real-world data in COVID-19 antigen and PCR testing.","authors":"Olaf Rose,&nbsp;Emina Obarcanin,&nbsp;Susanne Erzkamp","doi":"10.5414/CP204338","DOIUrl":"https://doi.org/10.5414/CP204338","url":null,"abstract":"OBJECTIVE COVID-19 testing is an important pillar in fighting the SARS-CoV-2 pandemic. Even though billions of tests have been conducted, little is known on performance of testing sites. This is a retrospective observational study with real-world data from a pharmacist-led COVID-19 testing center in Germany during the Omicron subvariant BA.4 and BA.5 wave in June 2022. MATERIALS The rapid antigen tests employed were purchased from Anbio Biotechnology (Xiamen, China). The RT-PCR was performed on Egens YS-qPCR-1 real-time system with Kewei multiple real-time PCR kits for detection of SARS-CoV-2 (Beijing Kewei Clinical Diagnostic Reagent Inc., Beijing, China). METHODS The study followed the STARD 2015 guideline. In this retrospective cohort study, the performance of testing sites was compared. RESULTS During the study period, 7,112 patients were tested by rapid antigen tests and 1,025 RT-PCR tests conducted. Included were 233 patients who were referred by other testing sites for confirmation of positive results. A positive predictive value of 99.6% was calculated for the antigen tests in the pharmacist-led testing center. Referred positive patients from non-medical sites were antigen and RT-PCR negative in 16 cases, which led to a positive predictive value of 88.8%. Difference between site performance was statistically significant (p < 0.05). CONCLUSION Results indicate that nucleic acid amplification confirmation is crucial in the context of the current testing strategy in Germany. Higher standards in antigen-testing, however, can make nucleic acid amplification in active COVID-19 infections unnecessary and testing cost efficient. This study provides the first data in the world on COVID-19 testing performance, and how it can be optimized.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 4","pages":"172-177"},"PeriodicalIF":0.8,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9149441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Persistence with first-line antihypertensive therapy in Germany: A retrospective cohort study with 2,801,469 patients.","authors":"Karel Kostev, Balaji Yakkali, Saket Chaudhari, Swati Upadhyaya, Christian Tanislav, Marcel Konrad, Mark Luedde","doi":"10.5414/CP204358","DOIUrl":"10.5414/CP204358","url":null,"abstract":"<p><strong>Background: </strong>The goal of this retrospective cohort study was to investigate 3-year persistence with antihypertensive drug therapy and the association between antihypertensive drug classes and therapy discontinuation risk in Germany.</p><p><strong>Materials and methods: </strong>The present retrospective cohort study was based on the IQVIA longitudinal prescription database (LRx) and included adult outpatients (≥ 18 years) with an initial prescription of antihypertensive monotherapy alone including diuretics (DIU), β-blockers (BB), calcium channel blockers (CCB), ACE inhibitors (ACEi), and angiotensin II receptor blockers (ARB) in Germany between January 2017 and December 2019 (index date). A Cox proportional hazards regression model was also used to assess the relationship between antihypertensive drug classes and non-persistence adjusted for age and sex.</p><p><strong>Results: </strong>This study included 2,801,469 patients. Patients on ARB monotherapy exhibited the highest persistence within 1 year (39.4%) and 3 years (21.7%) after the index date. Patients on DIU monotherapy showed the lowest persistence (16.5% after 1 year, 6.2% 3 years after the index date). In the overall population, initial monotherapy with DIU (HR: 1.48) was positively associated with monotherapy discontinuation, whereas ARB monotherapy was (HR = 0.74) negatively associated with monotherapy discontinuation compared to BB. However, in the age group > 80, there was a slight negative association between DIU intake and monotherapy discontinuation (HR = 0.91).</p><p><strong>Conclusion: </strong>This large cohort study reveals significant differences in 3-year persistence with antihypertensives, which were strongest for ARB and weakest for DIU. However, the differences also depended on age, with much better DIU persistence in the elderly.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2023-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10847157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative pharmacokinetics of two formulations of 2.5-mg rivaroxaban in healthy Korean subjects.","authors":"Seol Ju Moon, Yunjeong Kim, Sun-Young Kim, Ji-Young Jeon, Eunji Song, Yeji Lim, Min-Gul Kim","doi":"10.5414/CP204335","DOIUrl":"10.5414/CP204335","url":null,"abstract":"<p><strong>Objective: </strong>Rivaroxaban is a direct factor Xa inhibitor used for the prevention and treatment of thromboembolic disorders. The objective of this study was to compare the pharmacokinetic profiles of two rivaroxaban formulations after a single dose of rivaroxaban (2.5-mg tablet) in healthy Korean subjects.</p><p><strong>Materials and methods: </strong>This study was a randomized, open-label, single-dose, two-period, crossover study that included 34 healthy adult subjects under fasting conditions. The test drug (Yuhan rivaroxaban tablet) or reference drug (Xarelto tablet) was administered in each period. Serial blood samples were collected up to 36 hours post-dose. Plasma concentrations were measured by LC-MS/MS. Pharmacokinetic parameters, including maximum plasma concentration (C_max) and area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC_t), were determined by non-compartmental analysis. The 90% confidence intervals (CIs) for the ratio of the geometric means of C_max and AUC_t for the test drug/reference drug were calculated to evaluate pharmacokinetic equivalence.</p><p><strong>Results: </strong>A total of 28 subjects were included in the pharmacokinetic analysis. The geometric mean ratios (90% CI) of the test drug/reference drug for rivaroxaban were 1.0140 (0.9794 - 1.0499) for AUC_t and 0.9350 (0.8797 - 0.9939) for C_max. All adverse events (AEs) were mild, and there was no significant difference in the incidence of AEs between the formulations.</p><p><strong>Conclusion: </strong>The pharmacokinetic parameters of rivaroxaban were compared between the test and reference drug, and both formulations were bioequivalent. The newly developed rivaroxaban tablet is safe and well tolerated as the reference drug (ClinicalTrials.gov identifiers: NCT05418803).</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2023-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10853145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Extremely high unbound flucloxacillin concentrations in a patient with acute septic renal failure during continuous venovenous hemofiltration: Therapeutic drug monitoring to optimize treatment.","authors":"Evine M Appelman, Elisabeth A Wammes van-der-Heijden, Sjoerd D Meenks, Paddy K C Janssen, Jos L M L le Noble","doi":"10.5414/CP204313","DOIUrl":"10.5414/CP204313","url":null,"abstract":"<p><p>A 75-year-old female orthopedic patient with spondylodiscitis was admitted to the intensive care unit, where she developed severe acute renal injury (AKI) due to a <i>Staphylococcus aureus</i> bloodstream infection. Continuous venovenous hemofiltration (CVVH) was initiated as renal replacement therapy. According to physician experience and based on (inter)national guidelines and the severity of the infection, treatment with intravenous (IV) flucloxacillin at an initial continuous dose of 9 g/24h was started. The dose was increased to 12 g/24h because endocarditis could not be excluded. Therapeutic drug monitoring (TDM) was used to monitor flucloxacillin levels which are related to antibiotic efficacy and toxicity. Total and unbound flucloxacillin concentrations were measured following 24 hours of continuous infusion at three time points before regional citrate anticoagulation (RCA)-CVVH was initiated, at three time points in plasma, pre-filter, and post-filter, and in ultrafiltrate samples during RCA-CVVH treatment and 1 day following cessation of CVVH treatment. Extremely high total (up to 299.8 mg/L) and unbound (up to 155.1 mg/L) flucloxacillin concentrations were found in the plasma. This led to a dose decrease to 6 g/24h and subsequently to 3 g/24h. Antimicrobial target attainment against <i>S. aureus</i> was achieved by dosing IV flucloxacillin based on TDM. Based on these findings, we conclude that current dosing guidelines for flucloxacillin during renal replacement therapy need revision. We suggest a starting dose of 4 g/24h, which should be adjusted based on the TDM of the unbound flucloxacillin concentration.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2023-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10853143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of reduced edoxaban administration on bleeding risk and D-dimer levels in patients wearing elastic stockings after total hip arthroplasty: A retrospective cohort study.","authors":"Akihiro Uchiike, Dai Tsurusaki, Norikazu Kikuchi, Toru Imai, Susumu Otsuka, Kyoko Motoyoshi, Motoki Arakawa, Shinji Hidaka","doi":"10.5414/CP204359","DOIUrl":"10.5414/CP204359","url":null,"abstract":"<p><strong>Objective: </strong>Edoxaban is sometimes given at reduced doses when used concomitantly with physical prophylaxis to prevent symptomatic venous thromboembolism (VTE) after total hip arthroplasty (THA). This study aimed to evaluate the safety of reduced doses of edoxaban administered independent of the dose-reduction criteria and their effects on D-dimer levels after THA in Japanese patients.</p><p><strong>Materials and methods: </strong>This study enrolled 22 patients who received edoxaban 30 mg/day and 45 patients who received edoxaban 15 mg/day with dose adjustment as a standard-dose group, and 110 patients who received edoxaban 15 mg/day without dose adjustment as a low-dose group. The incidence of bleeding events was then compared between groups with patients wearing elastic stockings. Multivariate regression analysis was also performed to examine the effect of edoxaban administration on D-dimer levels after THA.</p><p><strong>Results: </strong>The incidence of bleeding events after THA did not differ significantly between groups. In the multivariate model, dose reduction of edoxaban did not correlate with D-dimer levels on postoperative days 7 and 14, but higher D-dimer levels at postoperative days 7 and 14 correlated significantly with longer duration of surgery (odds ratio (OR) 1.66, 95% confidence interval (CI) 1.20 - 2.29, p = 0.002; OR 1.63, 95% CI 1.17 - 2.29, p = 0.004, respectively).</p><p><strong>Conclusion: </strong>These results suggest that information on the duration of surgery may be useful in the pharmaceutical management in edoxaban drug prophylaxis combined with physical prophylaxis after THA in Japanese patients.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2023-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10853144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A pharmacokinetic analysis of amisulpride in adult Chinese patients with schizophrenia: Impact of creatinine clearance.","authors":"Wei Liu, Jingqi Zhou, Minjuan Cao, Fangming Zhang, Xiaoming Sun","doi":"10.5414/CP204334","DOIUrl":"10.5414/CP204334","url":null,"abstract":"<p><strong>Objective: </strong>To develop a stable population pharmacokinetic (PPK) model of amisulpride and to investigate the effects of covariates on the pharmacokinetic parameters in adult Chinese patients with schizophrenia.</p><p><strong>Materials and methods: </strong>This retrospective study was carried out using 168 serum samples from 88 patients collected during routine clinical monitoring. Covariates recorded included demographic parameters (gender, age, weight), clinical parameters (serum creatinine, creatinine clearance), and intake of co-medications. The amisulpride PPK model was established using a nonlinear mixed effects modeling (NONMEM) approach. Goodness-of-fit (GOF) plots, bootstrap validation (1,000 runs), and normalized prediction distribution error (NPDE) were used in the evaluation of the final model.</p><p><strong>Results: </strong>A one-compartment model with first-order absorption and elimination was developed. The population estimates for apparent clearance (CL/F) and apparent volume of distribution (V/F) were 32.6 L/h and 391 L, respectively. Estimated creatinine clearance (eCLcr) was a significant covariate for CL/F. The established model was: CL/F = 32.6 × (eCLcr/114.3)0.485 (L/h). The stability of the model was confirmed using GOF plots, bootstrap, and NPDE.</p><p><strong>Conclusion: </strong>Creatinine clearance is a major covariate which is positively correlated with CL/F. Therefore, additional dose adjustments of amisulpride may be required on the basis of eCLcr. An ethnic difference may exist in the pharmacokinetics of amisulpride, but further research is needed in order to confirm this possibility. The PPK model of amisulpride for adult Chinese schizophrenic patients established here using NONMEM, is potentially an important tool for individualizing drug dosage and therapeutic drug monitoring.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2023-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10852693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hypovitaminosis D in infants: Evidence that increased intake of vitamin D reduces the incidence of allergic and respiratory disorders.","authors":"Katerina Dajic,&nbsp;Bojko Bjelakovic,&nbsp;Andrijana Kostic,&nbsp;Ana Vujic,&nbsp;Slobodan Jankovic,&nbsp;Jasmina Milovanovic,&nbsp;Sandra Matovic,&nbsp;Predrag Sazdanovic,&nbsp;Andjelka Stojkovic","doi":"10.5414/CP204093","DOIUrl":"https://doi.org/10.5414/CP204093","url":null,"abstract":"<p><strong>Aim: </strong>The study assessed the relationship between vitamin D status in infants and the presence of allergic and/or respiratory disorders.</p><p><strong>Materials and methods: </strong>The study cohort comprised 81 hospitalized infants presenting at the Pediatric Clinic, University Clinical Center Kragujevac, Serbia, between January 2011 and June 2016.</p><p><strong>Results: </strong>The age of the infants ranged from 29 days to 12 months. All infants received prophylactic doses of vitamin D3 of 400 IU/daily until the end of the first year of life regardless of whether they are fed with adapted infant formula (n = 20) or breast milk (n = 37) or concurrently both (n = 24), up to the 5^th month of life. The mean level of plasma 25(OH)D was 29.65 ng/mL. Hypovitaminosis D (mean serum level of 25(OH)D < 30 ng/mL) was found in n = 38 infants of which 6 presented with severe vitamin D deficiency (level below 10 ng/mL), 13 presented with vitamin D deficiency (level between 10 and 20 ng/mL) and 19 had vitamin D insufficiency (levels between 20 and 30 ng/mL). The median vitamin D serum level in infants with allergic disease (n = 16) was 32.35 ng/mL and in infants with respiratory disease (n = 65) 28.99 ng/mL.</p><p><strong>Conclusion: </strong>Daily vitamin D3 supplementation with 400 IU in infants until the end of the first year of life is too low to provide optimal defense against respiratory and/or allergic conditions.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 3","pages":"96-101"},"PeriodicalIF":0.8,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9191450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence and risk factors of non-adherence to antipsychotic medications in Saudi Arabia.","authors":"Bshra A Alsfouk,&nbsp;Jouri A Alsamnan,&nbsp;Mariam M Alamri,&nbsp;Nouf Z Alshammari,&nbsp;Raghad A Madkhali,&nbsp;Ali Garatli,&nbsp;Muhammad Salman Bashir,&nbsp;Aisha A Alsfouk","doi":"10.5414/CP204300","DOIUrl":"https://doi.org/10.5414/CP204300","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the rate and determinants of non-adherence to antipsychotic medications in Saudi Arabia.</p><p><strong>Materials and methods: </strong>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).</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 3","pages":"111-121"},"PeriodicalIF":0.8,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9191056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Metformin alone and in combination with sitagliptin induces depression and impairs quality of life in type 2 diabetes mellitus patients: An observational study.","authors":"Mohammed Athar,&nbsp;Aakriti Garg,&nbsp;Mohd Ashif Khan,&nbsp;Rizwana Parveen,&nbsp;Sunil Kohli,&nbsp;Divya Vohora,&nbsp;Nidhi","doi":"10.5414/CP204288","DOIUrl":"https://doi.org/10.5414/CP204288","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Materials and methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 3","pages":"102-110"},"PeriodicalIF":0.8,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9489399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}