J Clin Pharm Ther [JOURNAL]
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200 papers
A comparison of four drug-drug interaction databases for patients undergoing haematopoietic stem cell transplantation.
Günay A, Demirpolat E, Ünal A … +1 more , Aycan MB
J Clin Pharm Ther · 2022 Oct · PMID 35777071 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Patients who have undergone haematopoietic stem cell transplantation are prone to drug-drug interactions due to polypharmacy. Drug-drug interaction databases are essential tools for identifyi...
WHAT IS KNOWN AND OBJECTIVE: Patients who have undergone haematopoietic stem cell transplantation are prone to drug-drug interactions due to polypharmacy. Drug-drug interaction databases are essential tools for identifying interactions in this patient group. However, drug-drug interaction checkers, which help manage interactions, may have disagreements about assessing the existence or severance of the interactions. The study aimed to determine differences among popular drug-drug interaction databases from several angles for patients who underwent haematopoietic stem cell transplantation. METHODS: The 21-day treatment sheets of one hundred patients who underwent haematopoietic stem cell transplantation were examined in two subscription-based (Uptodate and Micromedex) and two open-access databases (Drugs.com and Epocrates) in terms of several categories two years in a row. Statistical analysis was utilized to understand the compatibility of databases in terms of severity scores, evidence levels, given references, and word counts in interaction reports. Fleiss' and Cohen's kappa statistics were used to analyse the databases' agreement levels. RESULTS AND DISCUSSION: A total of 1393 and 1382 different drug-drug interactions were detected in subsequent versions of the databases, namely the 2021 and 2022 versions. The Fleiss kappa overall agreement among databases was slight. Uptodate and Micromedex showed fair agreement, and other database pairs showed slight agreement in severity ratings. CONCLUSION: There was a poor agreement among databases for interactions seen in bone marrow transplantation patients. Therefore, it would be safer to use more than one database in daily practice. Further work needs to be done to understand the agreement level of databases for different types of interactions.
Orthostatic blood pressure recovery in older males using alpha-blockers for lower urinary tract symptoms, an explorative study in a urology outpatient clinic.
Spies PE, Beune TNN, Heesakkers J … +2 more , van Munster BC, Claassen JAHR
J Clin Pharm Ther · 2022 Oct · PMID 35777069 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Alpha-blockers have been associated with orthostatic hypotension (OH). We aimed to assess the prevalence of OH measured with beat-to-beat blood pressure monitoring in older male outpatients w...
WHAT IS KNOWN AND OBJECTIVE: Alpha-blockers have been associated with orthostatic hypotension (OH). We aimed to assess the prevalence of OH measured with beat-to-beat blood pressure monitoring in older male outpatients who used alpha-blockers for lower urinary tract symptoms (LUTS). In addition, we investigated associations of OH with duration of alpha-blocker use, concomitant medication use and comorbidity. METHODS: Cross-sectional explorative study in a urology outpatient clinic. Older white males ≥65 years using alpha-blockers for LUTS were included. Blood pressure responses to standing up from supine were recorded using a validated beat-to-beat blood pressure device (Finapres). Prevalence rates were derived from the beat-to-beat data to include OH measured between 60-110 s (OH), impaired recovery OH at 40 s (OH[40]), initial OH (IOH) and normal orthostatic response. Subgroups were defined based on duration of alpha-blocker use, polypharmacy, and Charlson comorbidity index (CCI), to obtain relative risks. RESULTS AND DISCUSSION: Sixty-five patients were included. Median age was 75 years (range 65-92). The prevalence of OH was 7.7% (n = 5). The prevalence of OH(40) was 16.9% (n = 11) and of IOH 38.5% (n = 25). Thirty-six patients (55.4%) had a normal orthostatic response. The relative risk of OH for the subgroup using 10 medications (n = 13) was 6.0 (95%CI 1.1-32.3). For the subgroup with multimorbidity (CCI ≥3, n = 11) this was 7.4 (95%CI 1.4-39.0). Recent initiation of alpha-blocker use (<3 months) did not increase OH risk (RR 0.6 [95%CI 0.1-5.1]). WHAT IS NEW AND CONCLUSION: The overall prevalence of OH was low and comparable to age-matched population prevalence, suggesting that the relative contribution of alpha-blockers to OH was small. However, OH risk significantly increased in patients with multimorbidity or polypharmacy. For these patients, the benefits of starting alpha-blockers for LUTS should be weighed against the increased risk of OH.
The impact of vitamin D on thyroid autoimmunity and hypothalamic-pituitary-thyroid axis activity in myo-inositol-treated and myo-inositol-naïve women with autoimmune thyroiditis: A pilot study.
Krysiak R, Kowalcze K, Okopień B
J Clin Pharm Ther · 2022 Nov · PMID 35775148 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Vitamin D and myo-inositol reduce thyroid antibody titers in subjects with autoimmune thyroiditis. No previous study has investigated interactions between these agents. The aim of the current...
WHAT IS KNOWN AND OBJECTIVE: Vitamin D and myo-inositol reduce thyroid antibody titers in subjects with autoimmune thyroiditis. No previous study has investigated interactions between these agents. The aim of the current study was to determine whether the impact of exogenous vitamin D on thyroid autoimmunity and thyroid function in women with Hashimoto's thyroiditis depends on myo-inositol supplementation. METHODS: The study population consisted of three thyroid antibody- and insulin sensitivity-matched groups of women with autoimmune thyroiditis and high-normal or slightly elevated TSH levels. Forty-one women (21 in group A and 20 in group C) had been treated for at least 6 months with myo-inositol (group A), while 21 women (group B) had not received myo-inositol preparations. Over the entire study period (6 months), groups A and C continued treatment with myo-inositol (2 g daily), while groups A and B received exogenous vitamin D (4000 IU daily). Plasma titers of thyroid peroxidase and thyroglobulin antibodies, as well as plasma concentrations of glucose, insulin, TSH, free thyroid hormones, prolactin, and 25-hydroxyvitamin D (25-OH-D) were assessed at entry and 6 months later. Moreover, baseline and follow-up values of the structure parameters of thyroid homeostasis were calculated RESULTS AND DISCUSSION: In groups A and B, vitamin D improved insulin sensitivity and increased 25-OH-D levels. Although follow-up antibody titers in both these groups were lower than baseline ones, the impact of vitamin D on thyroid peroxidase and thyroglobulin antibodies was stronger in group A than in group B. Only in group A, vitamin D decreased TSH levels and increased SPINA-GT. There were no differences between baseline and follow-up free values of glucose, thyroid hormones, prolactin, Jostel's index, and SPINA-GD. The impact of vitamin D treatment on antibody titers correlated with treatment-induced changes in 25-OH-D levels and the degree of improvement in insulin sensitivity. In group C, glucose homeostasis markers, antibody titers and hormone levels remained at a similar level throughout the study period. WHAT IS NEW AND CONCLUSION: The obtained results suggest that the impact of vitamin D on thyroid autoimmunity and hypothalamic-pituitary-thyroid axis activity in subjects with autoimmune thyroiditis is more pronounced if they receive myo-inositol.
Pharmacokinetic variability of vancomycin in patients with nosocomial meningitis.
Okamoto G, Furuya E, Ito D … +3 more , Sawai M, Terada K, Kobayashi E
J Clin Pharm Ther · 2022 Nov · PMID 35775147 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: High doses of vancomycin are required early in the treatment of nosocomial meningitis. However, the dosage is often reduced later during treatment, irrespective of renal function. This study...
WHAT IS KNOWN AND OBJECTIVE: High doses of vancomycin are required early in the treatment of nosocomial meningitis. However, the dosage is often reduced later during treatment, irrespective of renal function. This study was designed to investigate the pharmacokinetic variability of vancomycin and the associated factors throughout the treatment course for patients with nosocomial bacterial meningitis. METHODS: This study included 17 patients who received vancomycin for nosocomial bacterial meningitis at the Tokyo Women's Medical University Yachiyo Medical Center from April 2013 to May 2020. All patients had their serum vancomycin concentrations and cerebrospinal fluid (CSF) parameters measured within 7 days of initiating treatment (early period) and after 8 days (later period) of treatment. RESULTS AND DISCUSSION: The relative error between the predicted serum vancomycin concentration and the measured value was significantly higher in the later period than in the early period. In 13 patients who did not have their dosing interval shortened, the vancomycin dosage/serum vancomycin concentration/estimated glomerular filtration rate (D/C/eGFR) ratio significantly decreased in the later period. Moreover, the rate of change in the D/C/eGFR ratio significantly correlated with that in the CSF protein and C-reactive protein levels. WHAT IS NEW AND CONCLUSION: This study suggests that the clinical condition and inflammatory response of a patient with meningitis influence the pharmacokinetics of vancomycin. Therefore, the vancomycin dosage for the treatment of nosocomial bacterial meningitis must be adjusted according to changes in the clinical condition and renal function of the patient, necessitating careful therapeutic drug monitoring.
Differences in levothyroxine action on thyroid autoimmunity and hypothalamic-pituitary-thyroid axis activity between metformin- and myo-inositol-treated women with autoimmune subclinical hypothyroidism.
Krysiak R, Kowalcze K, Okopień B
J Clin Pharm Ther · 2022 Oct · PMID 35768336 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Insulin resistance impairs the impact of levothyroxine on thyroid autoimmunity and hypothalamic-pituitary-thyroid axis activity. Both metformin and myo-inositol were found to improve insulin...
WHAT IS KNOWN AND OBJECTIVE: Insulin resistance impairs the impact of levothyroxine on thyroid autoimmunity and hypothalamic-pituitary-thyroid axis activity. Both metformin and myo-inositol were found to improve insulin sensitivity and to reduce thyrotropin levels in individuals with hypothyroidism. The aim of the present study was to compare the effect of levothyroxine on thyroid autoimmunity and hypothalamic-pituitary-thyroid axis activity between women receiving metformin and myo-inositol. METHODS: The study included two groups of women with autoimmune hypothyroidism, treated for at least 6 months with either metformin (group A; n = 25) or myo-inositol (group B; n = 25). Both groups were matched for age, insulin sensitivity, hormone levels and antibody titers. For the following 6 months, all women received levothyroxine. Plasma levels of glucose, insulin, thyrotropin, free thyroid hormones, prolactin, 25-hydroxyvitamin D and high-sensitivity C-reactive protein (hsCRP), as well as titers of thyroid peroxidase and thyroglobulin antibodies were assessed at the beginning and at the end of the study. RESULTS AND DISCUSSION: At baseline there were not differences between the study groups. Although levothyroxine reduced thyrotropin levels, increased free thyroid hormone levels and decreased antibody titers in both study groups, these effects were more pronounced in group A than group B. Only in group A, levothyroxine increased 25-hydroxyvitamin D, decreased hsCRP and improved insulin sensitivity. The impact of levothyroxine on thyrotropin and free thyroid hormones correlated with treatment-induced changes in insulin sensitivity, antibody titers, 25-hydroxyvitamin D and hsCRP. WHAT IS NEW AND CONCLUSION: The present study suggests that the impact of levothyroxine on thyroid autoimmunity and hypothalamic-pituitary-thyroid axis activity is stronger in women receiving metformin than in women treated with myo-inositol.
Analgesia and stress attenuation of ultrasound-guided modified pectoral nerve block type-II with different volumes of 0.3% ropivacaine in patients undergoing modified radical mastectomy for breast cancer: A prospective parallel randomized double-blind controlled clinical trial.
Lin X, Cai Y, Chen X … +5 more , Lin J, He Y, Xie L, Jiang X, Chen Y
J Clin Pharm Ther · 2022 Oct · PMID 35765728 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: A previous randomized clinical trial concluded that an optimal concentration of 0.3% ropivacaine could provide satisfactory analgesia for breast cancer patients undergoing modified radical ma...
WHAT IS KNOWN AND OBJECTIVE: A previous randomized clinical trial concluded that an optimal concentration of 0.3% ropivacaine could provide satisfactory analgesia for breast cancer patients undergoing modified radical mastectomy. We wondered if a smaller volume (30 ml vs. 40 ml) of 0.3% ropivacaine could still provide adequate analgesia in an ultrasound-guided PECS II block in modified radical mastectomy. METHODS: We performed a prospective parallel randomized double-blind controlled clinical trial. Eligible patients were assigned to either the P or P group (30 or 40 ml of 0.3% ropivacaine, respectively). The skin area of hypoesthesia, anaesthetic plane determined with ultrasound, pain visual analogue scale (VAS), anaesthetic dosages, and complications were recorded. Serum levels of interleukin-1β and interleukin-6 were measured postoperatively. RESULTS AND DISCUSSION: A total of 40 patients completed the trials, with 20 patients in each group. Although the skin area of hypoesthesia and the anaesthetic planes were significantly larger in the P group compared with the P group (p < 0.05), the VAS, analgesic and opioid doses, serum cytokine levels, anaesthetic toxicity, and complications had no significant differences between the two groups. WHAT IS NEW AND CONCLUSION: Compared with 40 ml, 30 ml of 0.3% ropivacaine could provide adequate analgesia and reduce surgical stress in patients undergoing modified radical mastectomy for breast cancer.
The impact of midazolam used in cataract surgery sedation on frontal QRS-T angle.
Gokalp G, Ozbeyaz NB
J Clin Pharm Ther · 2022 Oct · PMID 35764598 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Midazolam is one of the most commonly used drugs in procedures requiring sedoanalgesia. It affects the myocardium's ventricular depolarization and repolarization. Previous studies examining t...
WHAT IS KNOWN AND OBJECTIVE: Midazolam is one of the most commonly used drugs in procedures requiring sedoanalgesia. It affects the myocardium's ventricular depolarization and repolarization. Previous studies examining the arrhythmogenic effects of midazolam yielded conclusive results. These studies are based on QT and Tp -e distances. The frontal QRS-T angle (f-[QRS-T]a) is a new electro cardiac parameter that shows the heterogeneity of ventricular electrical activity. This study aims to examine the effect of midazolam on f-(QRS- T)a and other depolarization-repolarization parameters in patients who have had cataract surgery. METHODS: The study included 177 patients administered midazolam as a sedoanalgesia during cataract surgery. The sedative effect was evaluated 2-3 minutes after a 0.05 mg/kg dose of midazolam was given. Sedation was assessed again by giving 0.5 mg every 2-3 minutes until the desired level of sedation was achieved. 12-lead electrocardiogram (ECG) recordings of all patients were taken just before and immediately after surgery. ECGs were used to calculate the QT interval, QTc interval, Tp -e interval, Tp -e/QT, Tp -e/ QTc ratios and f-(QRS-T)a. RESULTS AND DISCUSSION: After cataract surgery, f-(QRS-T)a was unchanged compared to presurgery (29.14 ± 4.52 vs. 29.18 ± 5.39, p = 0.852). In addition, no significant change in QT(351.32 ± 21.98 vs. 351.94 ± 22.44, p = 0.091), QTc (384.05 ± 24.52 vs. 385.19 ± 26.12, p = 0.819), Tp -e interval (93.12 ± 9.60 vs. 94.44 ± 8.82, p = 0.179) and Tp -e/QT (0.27 ± 0.02 vs. 0.28 ± 0.03, p = 0.664), Tp -e/ QTc ratios (0.28 ± 0.02 vs. 0.29 ± 0.03, p = 0.655) was observed after surgery when compared to presurgery values. Significant ventricular and supraventricular arrhythmias were not observed in any patient during the operation. WHAT IS NEW AND CONCLUSION: Midazolam did not affect f -(QRS-T) with classical repolarization parameters in patients who underwent cataract surgery, according to this study. Midazolam has been found to be safe for the heart in sedoanalgesia. These results show that sedation with midazolam can be performed without electrocardiogram monitoring.
Effect of body weight on bleeding events of aspirin in ischemic stroke or transient ischemic attack patients.
Wang X, Zhu Q, Wu Y … +6 more , Li H, Deng X, Cheng J, Zhang Z, Ma Y, Shi T
J Clin Pharm Ther · 2022 Oct · PMID 35748660 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVES: Bleeding is the most common adverse reaction to aspirin and can lead to drug discontinuation or even be life-threatening in the secondary prevention of stroke or transient ischemic attack. T...
WHAT IS KNOWN AND OBJECTIVES: Bleeding is the most common adverse reaction to aspirin and can lead to drug discontinuation or even be life-threatening in the secondary prevention of stroke or transient ischemic attack. The aim of this study was to evaluate risk factors for bleeding adverse reaction of aspirin in ischemic stroke or transient ischemic attack. METHODS: This retrospective analysis included patients treated with aspirin (100 mg) as a secondary prevention for ischemic stroke or transient ischemic attack. The bleeding events that occurred during the first year were collected, including gastrointestinal, skin, nasal cavity, gum, and urinary tract bleeding events. Then, univariate and multivariate logistic regression analyses were used to identify independent factors associated with bleeding events of aspirin. RESULTS AND DISCUSSION: A total of 578 patients were enrolled in this study, and 58 patients developed bleeding during the first year of secondary prevention. Body weight and combination with selective serotonin reuptake inhibitors were found to be significant risk factors for overall bleeding (p = 0.025 and 0.012). Body weight below 60 kg was a risk factor for overall bleeding and gastrointestinal bleeding events. WHAT IS NEW AND CONCLUSION: Patients weighing less than 60 kg were at increased risk of bleeding with 100 mg aspirin for secondary prevention of cerebral infarction transient ischemic attack.
Dose of deferasirox correlates with its effects, which differ between low-risk myelodysplastic syndrome and aplastic anaemia.
Zhang R, Han B
J Clin Pharm Ther · 2022 Oct · PMID 35748618 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Patients with low-risk myelodysplastic syndrome (MDS) and aplastic anaemia (AA) often need transfusions, which may accelerate iron overload. The aim of this study was to evaluate the efficacy...
WHAT IS KNOWN AND OBJECTIVE: Patients with low-risk myelodysplastic syndrome (MDS) and aplastic anaemia (AA) often need transfusions, which may accelerate iron overload. The aim of this study was to evaluate the efficacy, safety and dose-effect relationships of deferasirox (DFX) in patients with low-risk MDS and AA who were refractory to regular treatment in a real-world setting. METHODS: Patient data were recorded, and dose-effect relationships of DFX were calculated after the first 6 months. Total annual exposure to DFX was calculated after 12 months and expressed as the accumulated exposure time at a dosage of 20 mg/kg/day. RESULTS AND DISCUSSION: Sixty-one patients with low-risk MDS and 51 with AA were enrolled. The minimum dosage of DFX needed for a significant serum ferritin (SF) decrease was 20 mg/kg/day at 6 months, and the minimum accumulation of DFX had to reach 9 months at 20 mg/kg/day by 12 months for patients with low-risk MDS. For patients with AA, the minimum dosage was 10 mg/kg/day at 6 months, and the minimum accumulation had to reach 3 months at 20 mg/kg/day by 12 months. With the same exposure, significant improvements in haematological parameters were also observed in AA. Lower liver enzymes compared with baseline were observed. Gastrointestinal disorders and elevated serum creatinine were the most common side effects. Higher exposure to DFX correlated with longer overall survival (OS). WHAT IS NEW AND CONCLUSION: A significant decrease in SF and an improvement in haematologic parameters, organ function and even OS can be achieved if the accumulated DFX dose reaches a certain level. Patients with low-risk MDS need a higher dose than those with AA.
China starts to pay for pharmaceutical services.
Wushouer H, Shi L, Guan X … +1 more , Cui Y
J Clin Pharm Ther · 2022 Jul · PMID 35735168 · Publisher ↗
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Validation of the Turkish version of the DOSE-Nonadherence measure among patients with cardiometabolic conditions.
Yagmur M, Ay P, Sancar M … +2 more , Voils CI, Okuyan B
J Clin Pharm Ther · 2022 Oct · PMID 35735120 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: There are no validated self-report measures to assess extent of and reasons for medication nonadherence in the Turkish language. The aim of this study is to evaluate validity and reliability...
WHAT IS KNOWN AND OBJECTIVE: There are no validated self-report measures to assess extent of and reasons for medication nonadherence in the Turkish language. The aim of this study is to evaluate validity and reliability of the Domains of Subjective Extent of Nonadherence Scale, which assesses extent of and reasons for nonadherence in Turkish patients with hypertension, diabetes mellitus and/or dyslipidaemia in community pharmacy settings. METHODS: The Turkish version of the DOSE-Nonadherence scale was developed through translation and cultural adaption. Psychometric properties of the scale were evaluated in a cross-sectional study among 203 patients who visited six community pharmacies located in Istanbul, Turkey between November 2020 and March 2021. For the extent of nonadherence domain, reliability was estimated through Cronbach's alpha, and convergent validity was evaluated with Spearman's rank correlation with the validated Turkish version of the Medication Adherence Report Scale (MARS). Reasons for nonadherence were characterized among participants reporting nonadherence to the extent of nonadherence items. The measure was administered at baseline and 2 weeks later to 30 patients to estimate stability of extent scores using the Wilcoxon test and intraclass correlation coefficient. p < 0.05 was set as the level of statistical significance. RESULTS: Among the 203 participants (65 male), the median (25th-75th percentiles) age was 59.0 years [51.0-67.0]. Cronbach's alpha for the extent of nonadherence scale was 0.86. A moderate negative correlation (r = -0.58; p < 0.001) was found between the extent of nonadherence scores and MARS, supporting convergent validity. The most common reasons for medication nonadherence were forgetfulness (22.5%) and mismatch between the patients' daily routine and medication taking (17.5%). The intraclass correlation coefficient was 0.97 for extent of nonadherence scores at baseline and 2 weeks (p < 0.001). WHAT IS NEW AND CONCLUSION: The DOSE-Nonadherence Scale could be used to identify nonadherent patients and their reasons for nonadherence in Turkish patients with chronic cardiometabolic conditions. This scale can be used to evaluate clinical pharmacist-led services to reduce medication nonadherence. Nonadherence could be recorded longitudinally in electronic health records to provide a more accurate picture of medication use. Pharmacists or other providers could administer interventions tailored to patients' reasons for nonadherence.
Global trends of dalbavancin: A bibliometric analysis.
Monteagudo-Martínez N, Solís García Del Pozo J, Ikuta I … +2 more , Galindo MF, Jordán J
J Clin Pharm Ther · 2022 Sep · PMID 35735062 · Full text
WHAT IS KNOWN AND OBJECTIVE?: Dalbavancin is used against gram-positive pathogens such as Staphylococcus aureus in acute bacterial skin and skin-structure infections. METHODS: Our main goal was to identify the key articl...
WHAT IS KNOWN AND OBJECTIVE?: Dalbavancin is used against gram-positive pathogens such as Staphylococcus aureus in acute bacterial skin and skin-structure infections. METHODS: Our main goal was to identify the key articles sustaining the current knowledge of this drug's therapeutic possibilities through a bibliometric analysis of the available literature. RESULTS AND DISCUSSION: On 15 March 2021, we searched the Web of Science electronically for documents that contain within its title the term "dalbavancin." We found a total of 675 documents that average 20.23 citations/publication with a density of 682.60 citations per/year, yielding an h-index of 58. After ranking them by the number of times cited, we extracted the top 100 most-cited records (T100). Number of citations/publication ranged from 13 to 231, publication years were 2002-2019, with the top-cited article published in 2014. All T100 publications were written in English. JMI Laboratories was the institution with the most articles in the T100 (22 documents), and the United States was the top country (75 documents). Five authors participated in at least five of the T100, led by Jones RN with 20 articles. Positions #1, #2, #5, and #9 were clinical trials for acute bacterial skin and skin structure infections (ABSSSI), the on-label indication for dalbavancin. Only one article in the top 10 (T10) was an off-label indication that was published in 2005 with 186 citations, and occupied the third position among the T100. Using the VOSviewer© programme, we observed that the most used keywords were: dalbavancin, lipoglycopeptide, gram-positive, osteomyelitis, vancomycin, and MRSA. WHAT IS NEW AND CONCLUSIONS?: Our study identifies the most significant research on dalbavancin, including the highest impact publications, and highlights the recent trend of dalbavancin in new therapies. The T10 articles include the most important dalbavancin clinical trials, along with other studies and reviews that support the growing role of this antibiotic in clinical use. Emphasis has been on the favourable pharmacokinetic profile that allows administration once-weekly, with minimal risk of severe adverse events.
Drugs-associated with red man syndrome: An integrative approach using disproportionality analysis and Pharmip.
M Shaju A, Panicker N, Chandni V … +3 more , Lakshmi Prasanna VM, Nair G, Subeesh V
J Clin Pharm Ther · 2022 Oct · PMID 35730973 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Red man syndrome (RMS) is a non-IgE-mediated anaphylactoid adverse event frequently witnessed after a rapid infusion of vancomycin. This study aims to unravel drugs and associated off-label t...
WHAT IS KNOWN AND OBJECTIVE: Red man syndrome (RMS) is a non-IgE-mediated anaphylactoid adverse event frequently witnessed after a rapid infusion of vancomycin. This study aims to unravel drugs and associated off-label targets that induce RMS by exploiting FDA Adverse Event Reporting System (FAERS) and Pharmacovigilance/Pharmacogenomics Insilico Pipeline (PHARMIP). METHODS: The case/non-case retrospective observational study was conducted in the FAERS database. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) data mining algorithms were used to evaluate the strength of the signal. The off-label targets of the drugs with potential signals were obtained using online servers by applying a similarity ensemble approach and a reverse pharmacophore database, which was further validated by molecular docking studies. RESULTS AND DISCUSSION: Oritavancin exhibited a strong positive signal (PRR:1185.20 and ROR:1256), which suggests a higher risk for causing RMS. The literature search revealed the involvement of the MRGPRX2 gene in the development of RMS. PHARMIP study unearthed Carbonic anhydrase II (CA2) as the common off-label target among the drugs causing RMS. The results obtained from molecular docking studies reinforced the findings as mentioned earlier, wherein the highest docking score was disinterred for oritavancin (-9.4 for MRGPRX2 and - 8.7 for CA2). WHAT IS NEW AND CONCLUSION: Many antibiotics and other classes of medications have been discovered in the quest for drugs that may induce RMS, although a causal relationship could not be established. The implication of MRGPX2 and CA2 in the initial stages of pathogenesis necessitates the development of inhibitors that could be used as potential therapeutic agents against RMS.
PHAREO study: Perceived and observed accessibility to therapeutic drugs used for treating patients with inherited bleeding disorders.
Chamouard V, Fraticelli L, Freyssenge J … +4 more , Claustre C, Négrier C, El Khoury C, PHAREO investigators
J Clin Pharm Ther · 2022 Oct · PMID 35726381 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The dispensing of clotting factor concentrates in hospital pharmacies imposes accessibility constraints on patients and their caregivers, thereby increasing the disease burden. Very few studi...
WHAT IS KNOWN AND OBJECTIVE: The dispensing of clotting factor concentrates in hospital pharmacies imposes accessibility constraints on patients and their caregivers, thereby increasing the disease burden. Very few studies have addressed these issues so far in terms of individual perceptions and actual difficulties. The PHAREO study aims to report patient's perception of treatment accessibility and evaluate spatial accessibility. METHODS: The PHAREO study is an observational survey based on a questionnaire specifically designed for the study purpose in collaboration with patients' representatives in the second demographic and economic French region. RESULTS AND DISCUSSION: We collected 293 responses (participation rate of 64.1%) which show that 89.8% of respondents were either very or rather satisfied with regard to access to treatment. However, respondents reported difficulties in accessing the hospital pharmacy. The data also showed that 79.2% of respondents tended to over-estimate travel time which was reported above their acceptable threshold for 39.2% of them. The main determinants of dissatisfaction were parental burden (OR 2.5 [1.3; 4.8], p = 0.008) and waiting time at the hospital pharmacy (OR 1.5 [1.1;2.0], p = 0.016, per 10 min increase). WHAT IS NEW AND CONCLUSION: The PHAREO study provides subjective and objective data regarding satisfaction levels of persons with haemophilia and other coagulation deficiencies, with a high representativeness rate for patients on prophylaxis (87.5%). Both respondents and hospital pharmacists pled for an evolution of the current dispensing circuit to improve access to treatment and reduce the burden for patients. Currently, the community pharmacists are apart from the dispensing circuit. The authors propose improvements in the pathway of care for patients and their caregivers by including the community pharmacists alongside the hospital pharmacists in a centralized coordination scheme.
Cardiovascular toxicities associated with immune checkpoint inhibitors: An updated comprehensive disproportionality analysis of the FDA adverse event reporting system.
Wang F, Wu X
J Clin Pharm Ther · 2022 Oct · PMID 35726369 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Immune checkpoint inhibitors (ICIs) have significantly improved clinical outcomes for a wide range of cancers but can also lead to cardiovascular toxicities. This study was to scientifically...
WHAT IS KNOWN AND OBJECTIVE: Immune checkpoint inhibitors (ICIs) have significantly improved clinical outcomes for a wide range of cancers but can also lead to cardiovascular toxicities. This study was to scientifically and systematically explore the association between cardiovascular toxicities and immune checkpoint inhibitors (ICIs) and also to characterize the main features of ICI-related cardiovascular toxicities. METHODS: From January 2012 to December 2020, data in the Food and Drug Administration Adverse Event Reporting System (FAERS) database were retrieved for disproportionality analysis. The definition of adverse events (AEs) relied on the Medical Dictionary for Regulatory Activities (MedDRA). We used the reporting odds ratio (ROR) with 95% confidence intervals (CIs) to evaluate the association between ICIs and cardiovascular AEs. Clinical characteristics of patients with ICI-associated cardiovascular toxicities were collected, and the time to onset following different ICI regimens was further investigated. RESULTS AND DISCUSSION: We identified a total of 13,713 ICI-associated cardiovascular toxicities which appeared to influence more men (56.90%) than women (36.79%), with a median age of 67 (interquartile range [IQR] 58-74) years. ICI-associated cardiovascular AEs were most frequently reported in lung, pleura, thymus and heart cancer patients (34.49%). Compared with the full database, ICI therapies were detected with pharmacovigilance of myocardial disorders (ROR: 2.64; 95% CI: 2.55-2.75) and pericardial disorders (ROR: 4.51; 95% CI: 4.30-4.74). Concerning myocardial and pericardial disorders, a significant increased ROR was found for all anti-PD-1 and anti-PD-L1 monotherapies, with the exception of anti-CTLA-4 monotherapies. Regarding cardiac arrhythmias, only tremelimumab among ICI monotherapies was associated with an increased ROR (1.92, 1.09-4.72; 4 cases). Compared with ICI monotherapy, ICI combination therapy detected an increase in cardiovascular toxicity spectrum, but did not prolong the onset time. WHAT IS NEW AND CONCLUSION: We observed that the spectrum and risk of ICI-associated cardiovascular AEs differed between therapeutic regimens. The poor clinical outcome and early onset of these events should attract clinical attention.
The population pharmacokinetics and dose optimization of polymyxin B in critically ill patients with or without extracorporeal membrane oxygenation.
Ye Q, Wang Q, Chen W … +6 more , Zhang R, Chen Z, Li P, Zhang X, Zhan Q, Wang C
J Clin Pharm Ther · 2022 Oct · PMID 35716048 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: The presence of extracorporeal membrane oxygenation (ECMO) is suggested to further exacerbate the pharmacokinetics (PK) alterations that occur during critical illness. The objectives of this...
WHAT IS KNOWN AND OBJECTIVE: The presence of extracorporeal membrane oxygenation (ECMO) is suggested to further exacerbate the pharmacokinetics (PK) alterations that occur during critical illness. The objectives of this study were to determine the population PK model of polymyxin B in critically ill patients with or without ECMO support investigated the influence of ECMO on PK variability and to identify an optimal dosing strategy. METHODS: Forty-four critically ill patients were enrolled, including eight patients with ECMO support. Eight serial serum samples were collected from each patient at steady state. The population PK was determined using NONMEM and Monte Carlo simulation was performed to evaluate the exposures of different dosing regimens. RESULTS: The PK analyses included 342 steady-state concentrations and a two-compartment model was optimal for polymyxin B PK data modelling. In the final model, creatinine clearance (CL ) was the significant covariate on CL (typical value 1.27 L/h; between-subject variability 15.1%) and ECMO did not show a significant impact on the polymyxin B PK. Additionally, we found that the PK parameter estimates of patients with and without ECMO support were mostly similar. Based on Monte Carlo simulations, the dose escalation of polymyxin B in patients with increased CL improved the probability of achieving required exposure. For patients with CL ≤ 120 ml/min, a dosage regimen of 100 mg every 12 h may represent the optimal regimen at an MIC of 1 mg/L. WHAT IS NEW AND CONCLUSION: The impact of ECMO on the polymyxin B PK is likely to be minimal. Our study showed a potential relationship between CL and polymyxin B CL, and the dose of polymyxin B should be adjusted in patients with increased CL .
Optimization of initial dose regimen of tacrolimus in paediatric lung transplant recipients based on Monte Carlo simulation.
Wang DD, Mei YQ, Yang L … +5 more , Ding KW, Xue JJ, Wang X, He SM, Wei QL
J Clin Pharm Ther · 2022 Oct · PMID 35716040 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVES: The initial tacrolimus dose regimen in paediatric lung transplant recipients is unknown. The present study optimized the initial tacrolimus dose regimen for paediatric lung transplant recipi...
WHAT IS KNOWN AND OBJECTIVES: The initial tacrolimus dose regimen in paediatric lung transplant recipients is unknown. The present study optimized the initial tacrolimus dose regimen for paediatric lung transplant recipients. METHODS: This study was based on a published population pharmacokinetic model of tacrolimus in lung transplant recipients and used Monte Carlo simulations to recommend an initial dose regimen of tacrolimus in paediatric lung transplant recipients. RESULTS: Without voriconazole, the tacrolimus doses recommended for paediatric lung transplant recipients who were not CYP3A5*1 carriers were 0.02, 0.03, and 0.04 mg/kg/day, split into two doses, for weights of 10-16, 16-30, and 30-40 kg, respectively. For paediatric lung transplant recipients who were CYP3A5*1 carriers, the tacrolimus doses of 0.03, 0.04, 0.05, and 0.06 mg/kg/day, split into two doses, were recommended for weights of 10-16, 16-25, 25-30, and 30-40 kg, respectively. With voriconazole, the tacrolimus dose recommended for paediatric lung transplant recipients who were not CYP3A5*1 carriers was 0.02 mg/kg/day, split into two doses, for weights of 10-40 kg. For paediatric lung transplant recipients who were CYP3A5*1 carriers, tacrolimus doses of 0.02 and 0.03 mg/kg/day, split and two doses, were recommended for weights of 10-24 and 24-40 kg, respectively. WHAT IS NEW AND CONCLUSIONS: This study developed tacrolimus dose regimens for the first time for paediatric lung transplant recipients using Monte Carlo simulation and optimized initial dosage in paediatric lung transplant recipients.
Efficacy and safety of Tanreqing injection combined with antibiotics against Streptococcus pneumoniae pneumonia: A systematic review and meta-analysis.
Li X, Wei S, Ma X … +4 more , Li H, Jing M, Liu H, Zhao Y
J Clin Pharm Ther · 2022 Aug · PMID 35712904 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: Tanreqing injection (TRQ) is a traditional Chinese medicine injection. The goal of this study was to assess the clinical efficacy and safety of TRQ injection in combination with azithromycin...
WHAT IS KNOWN AND OBJECTIVE: Tanreqing injection (TRQ) is a traditional Chinese medicine injection. The goal of this study was to assess the clinical efficacy and safety of TRQ injection in combination with azithromycin or ceftriaxone, as well as azithromycin or ceftriaxone alone, in treating Streptococcus pneumoniae pneumonia (SPP). METHODS: The randomized controlled trial (RCT) of TRQ injection combined with antibiotics versus antibiotics alone in the treatment of SPP was retrieved from Chinese and English databases (the control group was treated with antibiotics alone, while the experimental group received TRQ injection combined with antibiotics). The retrieval period was from the database's inception through February 2022. The data was extracted using the Cochrane Collaboration Network Quality Evaluation Standards, the methodological quality of the included literature was assessed, and the outcome indicators were calculated using RevMan5.4.1 software. RESULTS AND DISCUSSION: A total of 25 RCTs were collected, including 2057 patients. TRQ injection combined with antibiotics significantly improved clinical efficacy and reduced defervescence time, lung rale disappearance time, cough disappearance time, disappearance time of chest pain, and average hospitalization time when compared to control group, according to meta-analysis results (p < 0.05). WHAT IS NEW AND CONCLUSION: In the treatment of SPP, TRQ injection combination with antibiotics can significantly improve the total effect rate when compared to standard western medicine. Due to the low quality of the randomized controlled trials included in this investigation, more high-quality, multi-center, large-sample, prospective, randomized, double-blind clinical studies are needed to confirm the aforementioned conclusions.
Improving patient outcomes by promoting antimicrobial stewardship for patients with positive blood cultures: Investigation of patients with gram negative bacterium.
Tai T, Yamaguchi K, Watanabe M … +6 more , Tanaka H, Okazaki T, Watanabe N, Yokota K, Kadowaki N, Kosaka S
J Clin Pharm Ther · 2022 Oct · PMID 35708200 · Publisher ↗
WHAT IS KNOWN AND OBJECTIVE: In this study, changes in patient outcomes were analysed to evaluate the effects of prospective audit and feedback (PAF), which was promoted under a new system of antimicrobial stewardship (A...
WHAT IS KNOWN AND OBJECTIVE: In this study, changes in patient outcomes were analysed to evaluate the effects of prospective audit and feedback (PAF), which was promoted under a new system of antimicrobial stewardship (AS), in patients with gram-negative rod (GNR)-positive blood cultures. METHODS: This study included patients with positive blood cultures treated at Kagawa University Hospital between 2019 and 2020. The effects of PAF, as promoted in 2020 and performed within a few days of treatment initiation, were examined in terms of patient prognosis and estimated cost of extra hospital stay associated with GNR infection. RESULTS AND DISCUSSION: As AS activities under the new system, proposals were made for targeted therapy based on susceptibility results and for the duration of antimicrobial therapy, escalation and dose increases, and imaging evaluation. Between 2019 and 2020, there was no difference in the rate of de-escalation in the form of switching to a narrower-spectrum intravenous antimicrobial, the rate of image inspection, but the rate of switching to oral therapy after receiving culture results increased from 19.7% to 31.3%, the rate of sensitivity-based treatment increased from 76.4% to 92.2%. Regarding patient outcomes, the 90-day mortality rate and the duration of hospital stay were similar between the groups. The rate of recurrent bloodstream infections decreased from 8.7% to 0.9%. WHAT IS NEW AND CONCLUSION: Most of the changes in the indicators related to patient outcomes analysed in this study suggest that the increased use of PAF in AS activities improved patient outcomes.
Critical care tele-pharmacy services during COVID-19 pandemic: A qualitative exploration of healthcare practitioners' perceptions.
Isleem N, Shoshaa S, AbuGhalyoun A … +4 more , Khatib M, Naseralallah LM, Ibn-Mas'ud Danjuma M, Saad M
J Clin Pharm Ther · 2022 Oct · PMID 35699243 · Full text
WHAT IS KNOWN AND OBJECTIVE: The scope of clinical pharmacy services has changed during COVID-19 pandemic with the view to mitigating both exposure and spread of the virus. The performance of novel pandemic-driven servic...
WHAT IS KNOWN AND OBJECTIVE: The scope of clinical pharmacy services has changed during COVID-19 pandemic with the view to mitigating both exposure and spread of the virus. The performance of novel pandemic-driven services such as tele-pharmacy has remained unexplored, until now. The aim of this study is to investigate the perceptions of healthcare providers of the impact of tele-pharmacy services provided in critical care units during COVID-19. METHODS: A qualitative study of semi-structured interviews conducted with healthcare practitioners who worked in COVID-19 intensive care units and remotely interacted with clinical pharmacists at the Weill Cornell-affiliated Hamad Medical Corporation, Doha, Qatar. Random sampling technique was employed to recruit participants, with the resultant interview guide piloted before commencement of data collection process. RESULTS AND DISCUSSION: From a total 129 and 200 physicians and nurses, respectively, 20 interviews were conducted with physicians (n = 15), and nurses (n = 5). From these interactions, a number of major themes emerged including: satisfactory understanding across clinical environment and personnel (physician and nurses) about remote clinical pharmacists' roles; additional robust feedback on the perception of the remote clinical pharmacy service; an understanding by 'frontline' health personnel on the discernible differences between remote and in-person coverage of clinical pharmacists; a reflection by both physicians and nurses on the novel challenges involved in the implementation of such pandemic-driven service; and solutions to overcome these challenges. WHAT IS NEW AND CONCLUSION: In this novel qualitative study of pandemic-driven tele-pharmacy service, we found a positive perception amongst healthcare practitioners towards this service; with residual challenges that will need further evaluation by large sampled sized surveys or mixed methods research.
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