Journal of Pharmacy & Pharmaceutical Sciences
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Effects of Vitamin D Serum Level on Morbidity and Mortality in Patients with COVID-19: A Systematic Review and Meta-Analysis
No full textPurpose: It has been shown that low Vitamin D serum concentration is associated with increased pneumonia and viral respiratory infections. Vitamin D is readily available, inexpensive, and easy to administer to subjects infected with COVID-19. If effective in reducing the severity of COVID-19, it could be an important and feasible therapeutic intervention. Methods: We performed a systematic review and meta-analysis of the literature to determine the effects of Vitamin D serum concentration on mortality and morbidity in COVID-19 patients. The primary objectives were to determine if Vitamin D serum concentration decrease mortality, ICU admissions, ventilator support, and length of hospital stay in COVID-19 patients. Results: A total of 3572 publications were identified. Ultimately, 20 studies are included. A total of 12,806 patients aged between 42 to 81 years old were analyzed. The pooled estimated RR for mortality, ICU admission, ventilator support and length of hospital stay were 1.49 (95% CI: 1.34, 1.65), 0.87 (95% CI: 0.67, 1.14), 1.29 (95% CI: 0.79, 1.84), and 0.84 (95% CI -0.45, 2.13). Conclusion: There is no statistical difference in mortality, ICU admission rate, ventilator support requirement, and length of hospital stay in COVID-19 patients with low and high Vitamin D serum concentration.
Short Acting Beta Agonist Use Associated with Increased Mortality and Morbidity in Asthma Patients: A Systematic Review and Meta-Analysis
No full textPurpose: Short acting b2 agonists are recommended to be used ≤ 2 canisters per year. It is suggested that overuse of b2 agonists will lead to increased morbidity and mortality. This study aimed to determine if overuse of b2 agonists result in increased morbidity and mortality. Methods: We performed a systematic review and meta-analysis of the literature to determine if overuse of b2 agonists cause increase mortality, ICU admissions, hospitalization, and exacerbation. Results: A total of 11,888 publications were identified and 4260 duplications were removed, resulting in 7268 abstracts that were screened and 7254 irrelevant studies that were excluded. Ultimately, 14 studies were included. The overall pooled estimated odds ratio (OR) for mortality was 0.83 (95% CI: 0.66, 1.05), 0.99 for ICU admission (95% CI: 0.80, 1.21), 1.22 for hospitalization (95% CI: 0.96, 1.31), and 0.99 for exacerbation (95% CI: 0.85, 1.15). Conclusion: There is no statistical difference in mortality, ICU admission rate, hospitalization, or exacerbation with using b2 agonists
Torsade de Pointes/QT Prolongation Associated with Antifungal Triazoles: A Pharmacovigilance Study Based on the U.S. FDA Adverse Event Reporting System（FAERS）: A study of antifungal triazoles related to torsade de pointes/QT prolongation
No full textPurpose: Torsade de pointes (TdP)/QT prolongation is a fatal adverse event (AE) when using antifungal triazoles. We aimed to compare the AE signals of TdP/QT prolongation and onset time among different drugs of this kind comprehensively. Methods: This retrospective research was to analyze the U.S. FDA Adverse Event Reporting System (FAERS) database containing 71 quarters of reports through online retrieval. We calculated the strength of signals of TdP/QT prolongation related to 4 drugs of triazoles by using the following indicators: reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayesian geometric mean (EBGM). The onset time to the AE of TdP/QT prolongation among different antifungal triazoles were compared by using nonparametric tests. Management and visualization of the data were performed by employing MySQL Workbench and R software. The data information including clinical features, AE onset time, and outcomes were extracted for analysis as well. Results: After filtering the FAERS database, 448 reports were identified that were associated with TdP/QT prolongation when 4 triazoles played the primary suspected role. The AE signals of TdP/QT prolongation for any involved antifungal triazoles were detected by using the 4 detection indicators, and the signals of fluconazole are the strongest. This AE mostly occurred within 0-14 days after triazoles therapy. Conclusions: The AE signals of TdP/QT prolongation associated with antifungal triazoles were very intense. Attention must be paid to the TdP/QT prolongation of various triazoles, particularly at the early stages of antifungal triazoles treatment
Erratum to \u27Piecing Together Human Adult Comparative Pharmacokinetic Trials and Rodent Studies: What Happens to Drug Clearance in Obesity?\u27
No full textAssociation Between Vitamin D Levels and Inflammatory Markers in COVID-19 Patients: A Meta-Analysis of Observational Studies
No full textPurpose: Vitamin D has immunomodulatory properties that can be useful in COVID-19 patients. We performed a meta-analysis of observational studies to analyze the association of vitamin D levels with the inflammatory markers in COVID-19 patients. Methods: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews, and ClinicalTrial.gov for any relevant studies with comparison data reporting vitamin D levels and inflammatory markers in COVID-19 patients. A literature search was conducted from December 1, 2019, to January 14, 2022. Vitamin D deficiency was defined by each individual study and ranged from <9.9 ng/mL to <30 ng/mL. The inflammatory markers of interest were interleukin-6 (IL-6), C-reactive protein (CRP), ferritin, procalcitonin, erythrocyte sedimentation rate (ESR), lactate dehydrogenase (LDH), fibrinogen and D-dimer. Weighted mean difference (WMD) and 95% confidence intervals (CIs) were pooled using random or fixed-effects models. Two independent investigators assessed study eligibility and synthesized the evidence. Results: Thirty-two observational studies were included comprising of 7,771 patients ranging from 40-81 years of age with 57.1% being male. Meta-analysis showed that patients that were vitamin D sufficient (levels >30ng/mL) had statistically significant lower levels of IL-6, CRP, ferritin, LDH, fibrinogen, and D-dimer compared to vitamin D deficient group. With the highest mean difference found in ferritin (95.62; 95% CI, 33.14-158.10); P=0.003; I2=99%). No significant reductions were found in ESR (P=0.97). All inflammatory markers analyzed were higher than the normal healthy reference ranges in both groups. Conclusions: Our results suggest that low vitamin D levels are associated with increased inflammatory marker levels. Vitamin D deficiency may potentially serve as an early identifier for COVID-19 patients at high risk of developing severe inflammatory conditions as well as thrombotic complications. Randomized controlled trials should be conducted to establish a causal relationship
Recent Advances in Oral Mucoadhesive Drug Delivery
No full textThe oral cavity is one of the most important routes for local and systemic drug delivery, as it has a large surface, high permeability, and rich blood supply. Oral mucosal drug delivery has some advantages, such as enhancing bioavailability, preventing first-pass metabolism, reducing dose frequency, and non-invasiveness. In recent years, notable oral mucoadhesive patents were introduced to the pharmaceutical field, which indicates promising potentials for therapeutic purposes. Oral mucosal drug delivery can play a key role to deliver the biological drugs, such as antimicrobial peptides. This article gives an overview of oral mucoadhesive drug delivery systems and provides basic principles for the researchers to overcome the problems associated with the formulation design
in Vitro Effect of Methamphetamine on Proliferation, Differentiation and Apoptosis of Adipose Tissue Stem Cells: In vitro Effect of Methamphetamine
No full textPurpose: Among abused substances, methamphetamine is a psychostimulant drug widely used recreationally with public health importance. This study investigated the effect of methamphetamine on proliferation, differentiation, and apoptosis of human adipose tissue stem cells (AdSCs). Methods: AdSCs were isolated from human abdominal adipose tissue and were characterized for mesenchymal properties and growth kinetics. MTT assay was undertaken to assess methamphetamine toxicity on proliferation and differentiation properties and apoptosis of hAdSCs. Results: Isolated cells were shown to have mesenchymal properties and a population doubling time (PDT) of 40.1 h. Following methamphetamine treatment, expressions of KI-67 and TPX2 as proliferation genes and Col1A1 and PPARg as differentiation genes decreased. Methamphetamine administration increased the expression of Bax and decreased Bcl-2 genes responsible for apoptosis. Conclusions: Our data suggested when AdSCs were exposed to methamphetamine, it decreased proliferation and differentiation properties of stem cells together with an increase in apoptosis. These findings can be added to the literature, especially when methamphetamine is used recreationally for weight loss purposes
Tenapanor: A new treatment option for hyperphosphatemia in end stage kidney disease
No full textPurpose: This narrative review explores the currently published studies that have evaluated tenapanor for the treatment of hyperphosphatemia in end-stage kidney disease (ESKD) patients on hemodialysis. This medication’s new phosphate lowering mechanism of action reduces intestinal phosphate absorption predominantly through reduction of passive paracellular phosphate flux by inhibition of the sodium/hydrogen exporter isoform 3 (NHE3). Tenapanor additionally prevents active transcellular phosphate absorption compensation by decreasing the expression of sodium phosphorus 2b transport protein (NaPi2b). Methods: A comprehensive search of the literature was conducted using PubMed and ClinicalTrials.gov search engines. The search term “tenapanor hyperphosphatemia” was used for study retrieval. Results were limited to studies published in the English language and excluded review articles. Human, animal, and in vitro studies were included. No date range was specified. Results: A total of 11 primary studies were identified and included in this review, the largest human study of which enrolled 236 patients. Each study is presented in table format along with measured end points. Conclusions: Tenapanor is the first drug in its class that lowers hyperphosphatemia in ESKD patients through a novel mechanism of action involving paracellular inactive transport. Although more studies are needed, early results indicate that tenapanor may have a place in managing hyperphosphatemia in ESKD patients both as monotherapy and as an adjunct to existing phosphate binder therapy
Post-Marketing Safety of Vemurafenib: A Real-World Pharmacovigilance Study of the FDA Adverse Event Reporting System
No full textPurpose: Vemurafenib received approval for treatment of BRAF V600 variation metastatic melanoma in August 2011. This study analyzed Vemurafenib-related adverse events (AEs) to detect and characterize relevant safety signals using the real-word-data through the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Disproportionality analyses, including the reporting odds ratio (ROR), the healthcare products regulatory agency (MHRA), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) algorithms, were applied to quantify the signals of vemurafenib-related AEs. Results: Out of 8,042,244 reports gathered from the FAERS, 9554 reports of vemurafenib as the ‘primary suspected (PS)’ AEs were recognized. Vemurafenib-induced AEs occurrence targeted 23 system organ class (SOC). A total of 138 significant disproportionality PTs was simultaneously reserved according to the four algorithms. Unexpected significant AEs such as sarcoidosis and kidney fibrosis might also occur. The median onset time of vemurafenib-related AEs was 26 days (interquartile range [IQR] 8-97 days), and most of the cases occurred within the first one and two months after vemurafenib initiation. Conclusion: Our study detected potential new AEs signals and might provide powerful support for clinical monitoring and risk identification of vemurafenib
Health Canada Usage of Real World Evidence (RWE) in Regulatory Decision Making compared with FDA/EMA usage based on publicly available information: Real-World Evidence used by Health Canada in Regulatory Decision Making
No full textPurpose: Between January 2020 and December 2021, Health Canada provided a Summary Basis of Decision (SBD) for each of 110 products approved, including 29 oncology products and 21 non-oncology orphan drugs. This review sought to gain insight into how Real Word Evidence (RWE) impacts regulatory decision making. Methods: SBDs for oncology drugs and non-oncology orphan drugs were reviewed for evidence of use of the RWE or historical data to support regulatory decisions. This information was compared with both FDA and EMA reviews. Results: For the 29 Health Canada-approved oncology products, 11 were approved with Notice of Compliance with Conditions (NOCc) status. Two NOCc approvals received extensive RWE reviews, while two other approvals briefly mentioned the use of RWE/historical data. Of the 12 NOC approvals, one received RWE reviews. FDA also approved all 29 drugs, 14 of which received extensive comments on RWE and/or historical data and 8 of which mentioned RWE or historical data. EMA approved 25 of the 29 products and provided extensive comments on 10. Four products received a mention of RWE review. The percentages of submissions with RWE/historical reviews conducted by Health Canada, FDA and EMA were 24.1, 75.9 and 56.0 respectively. Of the 21 non-oncology orphan drugs, Health Canada provided priority review status to 11, with extensive RWE comments in 5 and the mention of RWE in 2 of the regular approvals. Two approvals that used third-party data were not included in the comparison. FDA approved 19, and provided extensive RWE assessment on 5 and mentioned use of historical data in 8. EMA approved 17 and provided extensive RWE and historical comments in 7 and mentioned historical data in 4. The percentages of submissions with RWE/historical reviews by Health Canada, FDA and EMA were 36.8, 68.4 and 64.7 respectively. Conclusions: Use of Real World Data is common among FDA/EMA reviews and Health Canada used RWE in recent NOCc and orphan drug approvals