Journal Description
Pharmacoepidemiology
Pharmacoepidemiology
is an international, peer-reviewed, open access journal on high-quality epidemiological, clinical research across the fields of clinical pharmacology and epidemiology, published quarterly online by MDPI.
- Open Access— free for readers, with article processing charges (APC) paid by authors or their institutions.
- Rapid Publication: manuscripts are peer-reviewed and a first decision is provided to authors approximately 22.7 days after submission; acceptance to publication is undertaken in 6.3 days (median values for papers published in this journal in the first half of 2024).
- Recognition of Reviewers: APC discount vouchers, optional signed peer review, and reviewer names published annually in the journal.
- Pharmacoepidemiology is a companion journal of Pharmaceuticals.
Latest Articles
Evaluating Public Behavior toward Antibiotic Use in Riyadh: A Cross-Sectional Study
Pharmacoepidemiology 2024, 3(3), 297-306; https://doi.org/10.3390/pharma3030020 - 13 Sep 2024
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Background: Antibiotic resistance presents a global challenge. Community awareness of antibiotic use has not been studied extensively in Saudi Arabia. This study aimed to assess public awareness of the appropriate use and indications of antibiotics in Riyadh, Saudi Arabia. Furthermore, the responses were
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Background: Antibiotic resistance presents a global challenge. Community awareness of antibiotic use has not been studied extensively in Saudi Arabia. This study aimed to assess public awareness of the appropriate use and indications of antibiotics in Riyadh, Saudi Arabia. Furthermore, the responses were compared across gender and age groups. Methods: We conducted a cross-sectional study between September 2022 and October 2022, including adult participants from Riyadh. The questionnaires were distributed via electronic channels and included sections about participants’ sociodemographic data and behavior concerning antibiotic use. Results: This study included 453 respondents. There were 281 (62%) female and 172 (38%) male respondents. Most respondents were between 46 and 55 years (n = 111; 24.5%) and above 56 years (n = 134; 29.6%). Two hundred seventy-two (60%) were college/university graduates, and 113 (24.9%) were at the secondary school level. Most participants (n = 410; 90.5%) were not affiliated with or working in the health sector. One hundred thirty-nine (30.7%) participants used an antibiotic within the past six months, and 171 (37.7%) kept antibiotics at room temperature. Most participants (n = 380; 83.9%) completed the treatment plan as prescribed. Sixty-eight percent of respondents stopped taking antibiotics when they felt better, and 11.5% believed antibiotics can treat bacterial and viral infections. The responses were compared between patients of both genders and patients aged ≤55 years or older. The comparison indicated that females tended to store antibiotics as instructed by the manufacturer (p = 0.004) and disposed of the remaining antibiotics immediately after completing the treatment (p < 0.001). Furthermore, the indications for antibiotic use differed between the genders, with no difference between the age groups. Participants > 55 years tended to complete the treatment plan (p = 0.007) and continued taking antibiotics at the same time and dose as prescribed (p = 0.002). Conclusions: This study’s findings suggest that public health authorities should implement awareness intervention programs to educate the Riyadh community on the proper use of antibiotics, with target interventions for specific gender and age groups. This study’s findings should be interpreted in the context of the Riyadh community and the potential biases of cross-sectional studies.
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Open AccessArticle
Benzodiazepine Adverse Reaction Cases Age 50 and Older Reported to the U.S. Poison Centers: Healthcare Use and Major Medical Effects
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Bryan Y. Choi, Namkee G. Choi, C. Nathan Marti and S. David Baker
Pharmacoepidemiology 2024, 3(3), 285-296; https://doi.org/10.3390/pharma3030019 - 31 Aug 2024
Abstract
Background: Despite widespread consensus on the need to reduce benzodiazepine (BZD) use in older adults, prescription rates in the U.S. have paradoxically increased over the past few decades. Objective: We examined (1) the characteristics of the BZD adverse reaction cases in patients aged
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Background: Despite widespread consensus on the need to reduce benzodiazepine (BZD) use in older adults, prescription rates in the U.S. have paradoxically increased over the past few decades. Objective: We examined (1) the characteristics of the BZD adverse reaction cases in patients aged 50 and older that were admitted to a healthcare facility (HCF) and experienced major effects/death, and (2) the associations between the concomitant use of opioids and/or antidepressants and HCF admission and major effects/death among BZD cases. Methods: We used the 2015–2022 National Poison Data System (NPDS), which contained data from 55 America’s Poison Centers. We fitted two multivariable logistic regression models to examine the associations between the co-use of opioids and/or antidepressants and HCF admission and major effects/death. Results: Of the BZD cases that were examined (N = 1979), 14.9% or 295 cases were admitted to healthcare facilities, and 8.5% of those who were followed up (77 out of 893 cases) experienced major effects or death. The number of co-used substances, co-use of opioids and antidepressants, atypical antipsychotics, anticonvulsants, muscle relaxants, and Gabapentin were associated with greater odds of healthcare admission. Co-use of opioids and healthcare admission were associated with greater odds of major effects/death. Conclusions: Adverse reactions and healthcare admissions are likely to be prevented when healthcare providers limit and carefully monitor BZD prescribing, especially for those who are on other medications, including prescription opioids and antidepressants.
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Open AccessReview
Multi-Faceted Approach to Ventricular Tachycardia: A Review of Management Strategies
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Francis Hartge, Jamario Skeete, Alejandro Pinedo, Bethlehem Zeleke, Asad Khan, Raktham Mekritthikrai and Cicely Anne Dye
Pharmacoepidemiology 2024, 3(3), 265-284; https://doi.org/10.3390/pharma3030018 - 12 Aug 2024
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Ventricular tachycardia poses a significant therapeutic challenge. It can manifest over a spectrum from minimal palpitation symptoms to sudden cardiac death. This makes large-scale trials on the treatment of ventricular tachycardia difficult to perform. The mechanism of ventricular tachycardia must also be understood
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Ventricular tachycardia poses a significant therapeutic challenge. It can manifest over a spectrum from minimal palpitation symptoms to sudden cardiac death. This makes large-scale trials on the treatment of ventricular tachycardia difficult to perform. The mechanism of ventricular tachycardia must also be understood before embarking on treatment. Patients with or without structural heart disease will have different mechanisms for the onset and propagation of these arrhythmias. Catheter ablation is an established management option for ventricular tachycardia; however, it is not always successful and anti-arrhythmic medications are often necessary to control these life-threatening arrhythmias. Although anti-arrhythmics can suppress ventricular tachycardias they also carry side effects. In certain substrates, some of these medications can exacerbate arrhythmias or heart failure. For these reasons, a multifaceted approach to treating ventricular tachycardia is necessary. This paper is a comprehensive review of the comprehensive management strategies for ventricular tachycardia. Anti-arrhythmic medications have an important role and their use in various cardiomyopathies and channelopathies is reviewed in detail. We also review the promising effects of gene therapy and artificial intelligence on different substrates for ventricular tachycardia.
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Open AccessReview
Utilization of Real-World Data to Facilitate Clinical Trials for Patients with Lymphoma
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Dai Chihara, Brian P. Hobbs, Matthew J. Maurer and Christopher R. Flowers
Pharmacoepidemiology 2024, 3(3), 252-264; https://doi.org/10.3390/pharma3030017 - 6 Aug 2024
Abstract
The future directions in leveraging real-world evidence (RWE) and real-world data (RWD) in the field of lymphoma, as compared to traditional experimental clinical trials, are poised to significantly impact research methodologies, treatment strategies, and patient care. Current methods of clinical trials involve a
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The future directions in leveraging real-world evidence (RWE) and real-world data (RWD) in the field of lymphoma, as compared to traditional experimental clinical trials, are poised to significantly impact research methodologies, treatment strategies, and patient care. Current methods of clinical trials involve a well-controlled design and patient selection bias. Integrating RWE and RWD with experimental clinical trials offers a multifaceted approach to understanding lymphoma and enhancing patient outcomes. In this review, we discuss how RWE has helped shape lymphoma clinical trials, and we compare and evaluate evidence obtained from real-world lymphoma studies/databases with that obtained from clinical trials. We also discuss methods for utilizing surrogate endpoints to facilitate clinical trials and expedite drug development. RWE can be leveraged to bridge the gap between data obtained from clinical trial populations and the broader patient population encountered in clinical practice, by highlighting differences in outcomes and the need for effective treatment strategies across diverse patient groups.
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(This article belongs to the Special Issue Feature Papers of Pharmacoepidemiology)
Open AccessArticle
Associations between Suspected Adverse Drug Reactions of HMG-CoA Reductase Inhibitors and Polypharmacology Using a National Registry Approach
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Hasan Yousaf and Alan M. Jones
Pharmacoepidemiology 2024, 3(3), 241-251; https://doi.org/10.3390/pharma3030016 - 3 Jul 2024
Abstract
Aims: The aim of this study was to explore the suspected adverse drug reaction (ADR) data of five licensed statins in the UK: atorvastatin, fluvastatin, pravastatin, rosuvastatin, and simvastatin. A secondary aim was to determine if there are any associations between the polypharmacological
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Aims: The aim of this study was to explore the suspected adverse drug reaction (ADR) data of five licensed statins in the UK: atorvastatin, fluvastatin, pravastatin, rosuvastatin, and simvastatin. A secondary aim was to determine if there are any associations between the polypharmacological properties of the statins and their associated muscle-related side effects. Methods: The chemical database of bioactive molecules with drug-like properties, European Molecular Biology Laboratory (ChEMBL), was used to obtain data on the pharmacological interactions of statins with human proteins. The Medicines and Healthcare Products Regulatory Agency’s (MHRA) Yellow Card scheme was used to obtain reports of suspected ADRs from 2018 to 2022. The OpenPrescribing database was used to obtain the prescribing rates for statistical interpretation. Results: The study found no significant difference between the statins association with suspected ADRs across all organ classes (X2, p > 0.05). Fluvastatin was found to have a higher incidence of ADRs/100,000 Rx across multiple system organ classes. Conclusions: No significant difference was found between the suspected ADR incidence of the statins across all system organ classes.
Full article
Open AccessBrief Report
A Retrospective Analysis of the Clinical Effectiveness of Tigecycline in the Treatment of Clostridioides difficile-Associated Diarrhea
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Herman Joseph Johannesmeyer, Luiza Baloyan and Kristica Kolyouthapong
Pharmacoepidemiology 2024, 3(2), 231-240; https://doi.org/10.3390/pharma3020015 - 13 Jun 2024
Abstract
Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in the United States. Tigecycline has been proposed as a potential treatment for CDI, though limited clinical data exist to support this practice. The objective of this study was to determine if
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Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in the United States. Tigecycline has been proposed as a potential treatment for CDI, though limited clinical data exist to support this practice. The objective of this study was to determine if the provision of tigecycline provides a clinically meaningful benefit to inpatients with CDI. This study was a retrospective chart review enrolling inpatients receiving treatment for CDI. Patients were divided into cohorts depending on whether they received a standard antibiotic therapy regimen for CDI or an antibiotic treatment regimen that included tigecycline. The primary outcome was clinical recovery at the time of hospital discharge. A total of 39 and 22 patients were included in the standard antibiotic therapy and tigecycline groups, respectively. ATLAS (Age, Treatment, Leukocyte, Albumin, Serum creatinine) scores at the time of CDI diagnosis were similar between the two groups, though patients in the tigecycline groups were more likely to represent a recurrent episode of CDI. There was no difference in the rate of clinical recovery at the time of hospital discharge between the standard antibiotic therapy and tigecycline groups (38.5% vs. 36.4%, p = 0.8710). These data do not support the routine use of tigecycline for the treatment of CDI, though interpretation is limited due to baseline differences between groups and the retrospective, observational nature of this study.
Full article
(This article belongs to the Special Issue Anti-Infectives: Pharmacoepidemiology and Clinical Pharmacology)
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Open AccessCommunication
Ocular Chloramphenicol Exposure in Early Childhood in Aotearoa/New Zealand
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Isabella M. Y. Cheung, Simon Horsburgh, Ewan Smith, Samantha Simkin and Akilesh Gokul
Pharmacoepidemiology 2024, 3(2), 223-230; https://doi.org/10.3390/pharma3020014 - 14 May 2024
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Background: The paediatric use of ophthalmic chloramphenicol in New Zealand (NZ) is relatively high; however, little more is known about its utilisation, including whether this is equitable. This study aimed to describe chloramphenicol utilisation in NZ children aged five years and under, by
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Background: The paediatric use of ophthalmic chloramphenicol in New Zealand (NZ) is relatively high; however, little more is known about its utilisation, including whether this is equitable. This study aimed to describe chloramphenicol utilisation in NZ children aged five years and under, by patient ethnicity, socioeconomic deprivation, and urban/non-urban domicile. Methods: This analysis included every publicly subsidised chloramphenicol dispensing received from birth to five years of age, for every child born in NZ in 2013. Cumulative proportion of first exposure, dispensing rate per person-year, and seasonality of dispensing were quantified. These were calculated following stratification by ethnicity, socioeconomic deprivation quintile, and urban/non-urban health district. For cumulative proportion of first exposure, odds ratios (OR) were calculated and multivariate logistic regression was performed. For dispensing rate, incidence rate ratios (IRR) were calculated and zero-inflated Poisson regression was performed. Results: Almost one-quarter of NZ children received their first dispensing within the first year of life. By five years of age, 55.2% of children had received their first dispensing. By five years of age, children of Pacific ethnicity, those in the highest deprivation quintile, and in those non-urban health districts had lower odds of receiving chloramphenicol (adjusted OR 0.90, 0.79, and 0.81, respectively, all p < 0.001). In contrast, children of Māori ethnicity had higher odds (adjusted OR 1.99, p < 0.001). Māori and Pacific ethnicity, and residence in non-urban health districts, were associated with fewer dispensings (adjusted IRR 0.88, 0.75 and 0.87, all p < 0.001). In contrast, deprivation quintile was not significantly associated with dispensing rate. Conclusion: Chloramphenicol utilisation is prevalent among NZ children, and utilisation may be lower among children of Pacific ethnicity and those in non-urban areas
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Open AccessReview
Adverse Drug Reactions in Multimorbid Older People Exposed to Polypharmacy: Epidemiology and Prevention
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Siobhán McGettigan, Denis Curtin and Denis O’Mahony
Pharmacoepidemiology 2024, 3(2), 208-222; https://doi.org/10.3390/pharma3020013 - 30 Apr 2024
Abstract
Adverse drug reactions (ADRs) are frequent and represent a significant healthcare burden. ADRs are a potentially avoidable contributor to excess unscheduled hospital admissions, higher morbidity, mortality, and healthcare costs. The objective of this review is to examine the epidemiology of ADRs in older
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Adverse drug reactions (ADRs) are frequent and represent a significant healthcare burden. ADRs are a potentially avoidable contributor to excess unscheduled hospital admissions, higher morbidity, mortality, and healthcare costs. The objective of this review is to examine the epidemiology of ADRs in older multimorbid adults and to explore strategies for ADR prevention. ADRs in this population are often linked to commonly prescribed medications, including anticoagulants, antiplatelet agents, insulin, and non-steroidal anti-inflammatory drugs, but ADRs and adverse drug events (ADEs) in fact encompass a much broader range of culprit drugs. Age-related factors such as changes in pharmacokinetics and pharmacodynamics, multimorbidity, polypharmacy, and frailty have been associated with ADR occurrences. Various strategies have been proposed to prevent ADRs in different clinical settings, such as structured routine medication review and the use of bespoke software applications to identify potentially inappropriate prescriptions and drug interactions. Although these approaches have demonstrated some improvement in the quality of prescribing, there is still a lack of consistent evidence regarding their effectiveness in preventing ADRs. The nuanced and often intricate complexities associated with older patients’ pharmacotherapy necessitate a comprehensive approach to attenuate the impact of ADRs within this growing section of most populations globally.
Full article
(This article belongs to the Special Issue Feature Papers of Pharmacoepidemiology)
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Open AccessArticle
Association of Receipt of Opioid Prescription for Acute Post-Delivery Pain Management with Buprenorphine Discontinuation among Postpartum People with Opioid Use Disorder
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Taylor N. Hallet, David T. Zhu, Hannah Shadowen, Lillia Thumma, Madison M. Marcus, Amy Salisbury and Caitlin E. Martin
Pharmacoepidemiology 2024, 3(2), 198-207; https://doi.org/10.3390/pharma3020012 - 16 Apr 2024
Abstract
Buprenorphine is a safe and effective medication to treat opioid use disorder (OUD) in pregnant patients and is intended to be continued throughout pregnancy, delivery, and at least the one-year postpartum period. However, delivery often involves the need for acute pain management with
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Buprenorphine is a safe and effective medication to treat opioid use disorder (OUD) in pregnant patients and is intended to be continued throughout pregnancy, delivery, and at least the one-year postpartum period. However, delivery often involves the need for acute pain management with opioid medications, such as after a cesarean section. For patients receiving buprenorphine, the provision of prescription opioids may negatively impact OUD treatment outcomes; however, not optimally managing acute pain may also impede OUD treatment benefit. Evidence is needed to disentangle the impacts of opioid prescription provision and methods of pain management in the immediate postpartum period on OUD treatment trajectories, ultimately to inform clinical guidelines tailored to the unique needs of pregnant and postpartum people receiving buprenorphine. Accordingly, this study took an initial step towards this goal to conduct a secondary analysis of a retrospective cohort of pregnant patients taking buprenorphine for OUD at the time of delivery (n = 142) to determine whether receipt of an opioid prescription at birth hospitalization discharge was associated with the time of buprenorphine discontinuation within the 12 months following delivery. Among the sample, 26% (n = 37) were prescribed an opioid at the time of birth hospitalization discharge. The number of weeks post-delivery until buprenorphine discontinuation occurred was shorter amongst patients who were prescribed an opioid (median 11 weeks) compared to patients who were not prescribed an opioid (median 39 weeks; p < 0.001 by Mann–Whitney U test). However, a Cox regression model reported that receipt of an opioid prescription following delivery did not significantly increase the hazard ratio for buprenorphine discontinuation. In other words, OUD patients not prescribed an opioid at birth hospitalization discharge continued their buprenorphine for a longer median duration after delivery compared to their counterparts who received prescription opioids; yet, this finding did not reach statistical significance when taking into account additional clinical variables. The findings indicate how further research is warranted to inform evidence-based post-delivery pain practices for postpartum OUD treatment patients.
Full article
(This article belongs to the Special Issue Pharmacoepidemiology and Drug Safety in Pregnancy and Breastfeeding)
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Open AccessArticle
Affordability of Paediatric Oral Anti-Infective Medicines in a Selected District, Sri Lanka
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Malith Kumarasinghe and Manuj C. Weerasinghe
Pharmacoepidemiology 2024, 3(1), 183-197; https://doi.org/10.3390/pharma3010011 - 12 Mar 2024
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In this cross-sectional descriptive study conducted in the Ratnapura district, Sri Lanka, we assessed the affordability of oral pediatric anti-infective medicines (OPAIMs). Using a modified WHO/HAI medicinal price methodology, we examined the availability, median price ratios (MPRs), mean percentage difference, and affordability of
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In this cross-sectional descriptive study conducted in the Ratnapura district, Sri Lanka, we assessed the affordability of oral pediatric anti-infective medicines (OPAIMs). Using a modified WHO/HAI medicinal price methodology, we examined the availability, median price ratios (MPRs), mean percentage difference, and affordability of the standard treatment of the originator brand (OB) and lowest-priced generic (LPG) OPAIMs in 30 private and 2 state-owned pharmacies. The study revealed disparities in availability, with only 50% of private pharmacies offering all 11 medicinal drugs in their generic form. The MPRs of OPAIMs for OB and LPG varied, with three drugs exceeding the financially acceptable MPR of 2 (albendazole, amoxicillin, and erythromycin). The standard treatment with LPGs costs between 0.17 and 0.85 and between 0.06 and 0.28 days’ wages for the lowest daily salary of the private sector and unskilled public employees, respectively. We identified erythromycin and albendazole as having less than 50% availability in their generic form in private pharmacies. To address these findings, we recommend frequent pricing revisions based on exchange rates and associated costs, coupled with the establishment of a transparent scientific criterion to subsidize essential medicines deemed “unaffordable.” Failure to implement such measures amidst economic crises may adversely impact financial access to essential medications.
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Open AccessArticle
Pioneering Arterial Hypertension Phenotyping on Nationally Aggregated Electronic Health Records
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Jing Wei Neo, Qihuang Xie, Pei San Ang, Hui Xing Tan, Belinda Foo, Yen Ling Koon, Amelia Ng, Siew Har Tan, Desmond Teo, Mun Yee Tham, Aaron Yap, Nicholas Ng, Celine Wei Ping Loke, Li Fung Peck, Huilin Huang and Sreemanee Raaj Dorajoo
Pharmacoepidemiology 2024, 3(1), 169-182; https://doi.org/10.3390/pharma3010010 - 12 Mar 2024
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Background: Hypertension is frequently studied in epidemiological studies that have been conducted using retrospective observational data, either as an outcome or a variable. However, there are few validation studies investigating the accuracy of hypertension phenotyping algorithms in aggregated electronic health record (EHR) data.
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Background: Hypertension is frequently studied in epidemiological studies that have been conducted using retrospective observational data, either as an outcome or a variable. However, there are few validation studies investigating the accuracy of hypertension phenotyping algorithms in aggregated electronic health record (EHR) data. Methods: Utilizing a centralized repository of inpatient EHR data from Singapore for the period of 2019–2020, a new algorithm that incorporates both diagnostic codes and medication details (Diag+Med) was devised. This algorithm was intended to supplement and improve the diagnostic code-only model (Diag-Only) for the classification of hypertension. We computed various metrics (sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)) to assess the algorithm’s effectiveness in identifying hypertension on 2813 chart-reviewed records. This pool was composed of two patient cohorts: a random sampling of all inpatient admissions (Random Cohort) and a targeted group with atrial fibrillation diagnoses (AF Cohort). Results: The Diag+Med algorithm was more sensitive at detecting hypertension patients in both cohorts compared to the Diag-Only algorithm (83.8 and 87.6% vs. 68.2 and 66.5% in the Random and AF Cohorts, respectively). These improvements in sensitivity came at minimal costs in terms of PPV reductions (88.2 and 90.3% vs. 91.4 and 94.2%, respectively). Conclusion: The combined use of diagnosis codes and specific antihypertension medication exposure patterns facilitates a more accurate capture of patients with hypertension in a database of aggregated EHRs from diverse healthcare institutions in Singapore. The results presented here allow for the bias correction of risk estimates derived from observational studies involving hypertension.
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Open AccessReview
Beyond Statins: Novel Lipid-Lowering Agents for Reducing Risk of Atherosclerotic Cardiovascular Disease
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Teimur Kayani, Bachar Ahmad, Rachel S. Chang, Frank Qian, Melis Sahinoz, Muhammad Waqar Rehan, Antonio Giaimo, Erica S. Spatz and Jiun-Ruey Hu
Pharmacoepidemiology 2024, 3(1), 117-168; https://doi.org/10.3390/pharma3010009 - 5 Mar 2024
Cited by 2
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Although statins have served as the cornerstone for pharmacological lowering of lipid levels in atherosclerotic cardiovascular disease (ASCVD) risk reduction, many patients are unable to achieve target doses of statin medication due to side effects or target levels of cholesterol reduction on statin
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Although statins have served as the cornerstone for pharmacological lowering of lipid levels in atherosclerotic cardiovascular disease (ASCVD) risk reduction, many patients are unable to achieve target doses of statin medication due to side effects or target levels of cholesterol reduction on statin monotherapy. The landscape of lipid-lowering strategies has expanded in recent years, with the emergence of therapies that make use of small interfering RNA (siRNA) and antisense oligonucleotides, in addition to traditional small-molecule agents. Non-statin therapies that have shown promising results in randomized controlled trials include adenosine triphosphate-citrate lyase inhibitors, proprotein convertase subtilisin/kexin 9 (PCSK9)-inhibiting antibodies and siRNA, omega-3 polyunsaturated fatty acids, and lipoprotein(a) gene-inhibiting siRNA and ASOs, in addition to older therapies such as ezetimibe. In contrast, cholesteryl ester transfer protein (CETP) inhibitors have shown less promising results in randomized trials. The purpose of this narrative review is to summarize the evidence for these medications, with a focus on phase III randomized trials.
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Open AccessArticle
Treatment Patterns, Effectiveness, and Safety of Originator Insulin Glargine versus Insulin Glargine-yfgn within the Veterans Health Administration
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Samantha Walczuk, Francesca E. Cunningham, Xinhua Zhao, Diane Dong, Peter A. Glassman, Donald R. Miller, Deborah Khachikian, Anthony Au, Cedric Salone, Kelly Bryan, Qoua Her and Sherrie L. Aspinall
Pharmacoepidemiology 2024, 3(1), 103-116; https://doi.org/10.3390/pharma3010008 - 1 Mar 2024
Abstract
We described insulin glargine (originator) and insulin glargine-yfgn (biosimilar) treatment patterns, assessed effectiveness and safety outcomes, and identified reasons for switching back to the originator product from the biosimilar. This retrospective study included 328,463 Veterans 18 years of age and older who received
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We described insulin glargine (originator) and insulin glargine-yfgn (biosimilar) treatment patterns, assessed effectiveness and safety outcomes, and identified reasons for switching back to the originator product from the biosimilar. This retrospective study included 328,463 Veterans 18 years of age and older who received one or more outpatient prescriptions for insulin glargine and/or insulin glargine-yfgn between 1 June 2021 and 31 December 2022. Patients were assigned to subgroups based on the initial prescription during the study period, prevalent versus incident use for originator insulin glargine, and prior versus no prior use of the originator before the biosimilar (i.e., prevalent originator non-switcher (n = 189,734), originator switch to biosimilar (n = 81,010), incident originator non-switcher (n = 49,401), and incident biosimilar (n = 8318)). There were no differences in the outcome of mean HbA1c (7.9% for all subgroups). There were also no differences in the unadjusted rates of hospitalization and/or emergency room visits for hyper- and hypoglycemia between the prevalent originator non-switcher and originator switched to biosimilar subgroups (p = 0.09 and 0.38, respectively) or the incident originator non-switcher and incident biosimilar subgroups (p = 0.054 and 0.61, respectively). Finally, none of the HbA1c or hyperglycemia outcomes adjusted for baseline characteristics were statistically different. Adjusted analyses for rates of hospitalization and/or emergency room visits for hypoglycemia could not be performed due to the low number of events. Overall, patients who received insulin glargine-yfgn had similar effectiveness and safety outcomes as patients who received the originator.
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(This article belongs to the Special Issue Feature Papers of Pharmacoepidemiology)
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Open AccessArticle
Opioid Prescribing for Noncancer Patients—Issues of Drug Therapy Safety: Results from a German Study Based on Routine Data
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Veronika Lappe, Daniel Grandt, Ursula Marschall and Ingrid Schubert
Pharmacoepidemiology 2024, 3(1), 94-102; https://doi.org/10.3390/pharma3010007 - 22 Feb 2024
Abstract
Opioids are highly effective drugs but need close monitoring to avoid harm to patients. The aim of this study was to analyze how guideline recommendations are met for (i) the avoidance of the concomitant use of anxiolytics, hypnotics, or sedatives; (ii) the prescribing
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Opioids are highly effective drugs but need close monitoring to avoid harm to patients. The aim of this study was to analyze how guideline recommendations are met for (i) the avoidance of the concomitant use of anxiolytics, hypnotics, or sedatives; (ii) the prescribing of laxatives in long-term opioid treatment; (iii) the co-prescribing of drugs to control the emetic effect of opioids; (iv) pretreatment with non-opioids; and (v) screening for depression when initiating opioids. The results are based on a routine data analysis of a large German health insurance fund. Different study populations of noncancer patients (18+ years old) treated with opioids were analyzed: 10.4% of the opioid recipients in 2021 received at least one concomitant prescription with anxiolytics, hypnotics, or sedatives; 69.3% of those with long-term opioid treatment received at least one laxative prescription. Of those with first-time opioid prescriptions, 4.8% received an antiemetic drug; 47.3% of those with a newly initiated opioid therapy received a non-opioid prescription within three months before the start of the opioid therapy; and 22.0% of patients with incident opioid prescription had at least one documentation of a depression diagnosis within three months of the first prescription. There is an urgent need to improve opioid prescribing to avoid risky combinations and adverse effects.
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(This article belongs to the Special Issue Pharmacoepidemiology and Addiction)
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Open AccessReview
Crises in Antimicrobial Stewardship: Misuse of Clarithromycin for Helicobacter pylori Therapy
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David Y. Graham
Pharmacoepidemiology 2024, 3(1), 82-93; https://doi.org/10.3390/pharma3010006 - 20 Feb 2024
Abstract
Helicobacter pylori is a class I carcinogen that infects more than 100 million individuals in the United States. Antimicrobial therapy for H. pylori has typically been prescribed empirically rather than based on susceptibility testing. Until recently, therapeutic recommendations have generally ignored the principles
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Helicobacter pylori is a class I carcinogen that infects more than 100 million individuals in the United States. Antimicrobial therapy for H. pylori has typically been prescribed empirically rather than based on susceptibility testing. Until recently, therapeutic recommendations have generally ignored the principles of antibiotic stewardship. A combination of a proton pump inhibitor (PPI), amoxicillin, and clarithromycin (triple therapy) remains popular despite increasing clarithromycin resistance and poor cure rates. Concomitant therapy (a PPI, amoxicillin, clarithromycin, and metronidazole) is recommended and widely used despite all patients receiving at least one unneeded antibiotic. In 2020, the Food and Drug Administration approved vonoprazan, amoxicillin, and clarithromycin triple therapy, which administers unneeded clarithromycin to >90% of patients (i.e., ~6 tons of unneeded clarithromycin/million treatments). In the late 1980s, the infectious disease community functionally transferred responsibility for the management of H. pylori to gastroenterology, which has managed the infection as another common gastrointestinal disease such as constipation. In 2022, both traditional and noninvasive molecular-based susceptibility testing for H. pylori became available in the United States. In order to reduce and prevent antibiotic misuse, the infectious disease community should reclaim responsibility for the management of this important infectious disease.
Full article
(This article belongs to the Special Issue Feature Papers of Pharmacoepidemiology)
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Open AccessReview
Remdesivir and the Liver: A Concise Narrative Review of Remdesivir-Associated Hepatotoxicity in Patients Hospitalized Due to COVID-19
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Alireza FakhriRavari and Mazyar Malakouti
Pharmacoepidemiology 2024, 3(1), 69-81; https://doi.org/10.3390/pharma3010005 - 13 Feb 2024
Abstract
Severe acute respiratory syndrome coronavirus 2 has infected millions of people, but about 20% of infected individuals do not develop symptoms. COVID-19 is an inflammatory disease that affects a portion of individuals infected with the virus and it is associated with liver injury
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Severe acute respiratory syndrome coronavirus 2 has infected millions of people, but about 20% of infected individuals do not develop symptoms. COVID-19 is an inflammatory disease that affects a portion of individuals infected with the virus and it is associated with liver injury and other complications, leading to hospitalization, critical illness, and death. Remdesivir is an antiviral agent used for the treatment of hospitalized patients with COVID-19 to improve the time to recovery, reduce the duration of mechanical ventilation, decrease the need for supplemental oxygen, and decrease the risk of mortality. Remdesivir-associated hepatotoxicity has been observed as increased transaminases more than five times the upper limit of normal in hospitalized patients with COVID-19, but causality has not been proven. It is generally difficult to distinguish between remdesivir-associated hepatotoxicity and COVID-19-induced hepatotoxicity. The purpose of this review is to evaluate the evidence for remdesivir-associated hepatotoxicity. Current evidence suggests that elevated liver enzymes in hospitalized COVID-19 patients are more likely to be due to the infection than remdesivir, and a 5-day course of remdesivir seems to be safe in regard to hepatotoxicity.
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(This article belongs to the Special Issue Anti-Infectives: Pharmacoepidemiology and Clinical Pharmacology)
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“My Addiction Doesn’t Define Me”—Experiences of Stigma among Mothers with Opioid Use Disorder
by
Christine Bakos-Block, Andrea Yatsco, A. Sarah Cohen, Francine Vega and Tiffany Champagne-Langabeer
Pharmacoepidemiology 2024, 3(1), 57-68; https://doi.org/10.3390/pharma3010004 - 29 Jan 2024
Abstract
Opioid use in women has increased by 300% since 1999, and opioid use disorder among pregnant women has quadrupled. The stigma of substance use disorder is a significant barrier to treatment, especially among women. The purpose of this study was to explore the
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Opioid use in women has increased by 300% since 1999, and opioid use disorder among pregnant women has quadrupled. The stigma of substance use disorder is a significant barrier to treatment, especially among women. The purpose of this study was to explore the experiences and perceptions of stigma among mothers and the underlying themes. (1) Background: To understand the stigmatization of women with substance use disorders, we interviewed mothers in recovery from opioid use disorder. (2) Methods: Qualitative methods and descriptive analysis was used to extrapolate themes related to the experienced stigma. (3) Results: A total of 20 mothers in recovery from opioid use disorder were interviewed and three main themes emerged from the data: internal stigma, external stigma, and healing from stigma. (4) Conclusion: The examination of stigma is important in reducing its effect on all individuals with substance use disorders, and it is important to understand gender inequities.
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(This article belongs to the Special Issue Pharmacoepidemiology and Addiction)
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Characteristics and Outcomes of Patients on Tofacitinib for Alopecia Areata or Rheumatoid Arthritis: A Retrospective Cohort Study
by
Sarah Choe, Abhinav Birda, Jesse Salas, Olive Anagu and Natasha Mesinkovska
Pharmacoepidemiology 2024, 3(1), 51-56; https://doi.org/10.3390/pharma3010003 - 29 Jan 2024
Abstract
Tofacitinib is a Janus kinase inhibitor (JAKi) that is used off-label for the treatment of alopecia areata (AA). Its boxed warning includes an increased risk of serious adverse events (SAEs) based on the results of a safety trial in rheumatoid arthritis (RA) patients
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Tofacitinib is a Janus kinase inhibitor (JAKi) that is used off-label for the treatment of alopecia areata (AA). Its boxed warning includes an increased risk of serious adverse events (SAEs) based on the results of a safety trial in rheumatoid arthritis (RA) patients taking the medication. The purpose of this study was to investigate the differences in patients’ characteristics and SAEs profiles between RA and AA populations taking tofacitinib. The cohorts were constructed using the TrinetX database to identify the patients who were prescribed tofacitinib for RA or AA between October 2012 and October 2023. A total of 22,873 patients were included in this analysis, with 21,080 individuals in the RA cohort and 1793 individuals in the AA cohort. After matching for age, sex, and race, each cohort had a sample size of 1482. Data on the patients’ sex, age, race, comorbidities, concomitant medications, and associated SAEs were collected. The cohorts were compared by calculating the odds ratios and tested for significance associations using Fisher’s Exact Tests. Both the RA and AA cohorts were predominantly female (RA 79%, AA 70%), with mean ages of 61 ± 14 years and 38 ± 19 years (p-value < 0.0001), respectively. Both the groups showed similar racial distributions. The RA cohort had increased rates of hypertension, obesity, type 2 diabetes mellitus, and nicotine dependence compared to those of the AA cohort (p-value < 0.0001). With the exception of cyclosporine and azathioprine, the percentage of concomitant medication use was higher in all the categories in the RA cohort than those in the AA cohort (p-value < 0.0001). Higher rates of adverse events were seen in the RA cohort across all the categories, except myocardial infarction, stroke, and lymphomas/hematopoietic malignancies. Our findings show that the SAEs on the boxed warning of tofacitinib should be strongly considered when being used off-label for the treatment of AA. Clinicians must carefully assess the individual patient factors when determining the appropriateness of tofacitinib use.
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(This article belongs to the Special Issue Drug Safety and Effectiveness in the Real World)
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Rescue Therapy for Supratherapeutic Concentrations of Calcineurin Inhibitors Using Potent Cytochrome P450 Inducers
by
Seth Duwor, Katharina Enthofer, Christoph Ganter, Prabin Poudel, Anna Svarin and Gerd A. Kullak-Ublick
Pharmacoepidemiology 2024, 3(1), 33-50; https://doi.org/10.3390/pharma3010002 - 29 Jan 2024
Abstract
Introduction: Calcineurin inhibitors (CNIs), ciclosporin and tacrolimus, are utilized primarily in organ transplantation and the treatment of autoimmune diseases. Since patients depend on these drugs over long periods, they face a potential risk of intoxication. This risk increases substantially when patients are overdosed
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Introduction: Calcineurin inhibitors (CNIs), ciclosporin and tacrolimus, are utilized primarily in organ transplantation and the treatment of autoimmune diseases. Since patients depend on these drugs over long periods, they face a potential risk of intoxication. This risk increases substantially when patients are overdosed or inadvertently exposed to cytochrome P450 (CYP) 3A4 inhibitors. Objectives: To analyze the utility of CYP inducers as a plausible treatment modality for acute CNI intoxication using real-world data from the WHO global pharmacovigilance database (VigiBase™) and supporting evidence from published data. Methodology: We explored all individual case safety reports (ICSRs) regarding CNI intoxications registered in VigiBase™. The queries “overdose” or “drug intoxication” were applied against the active ingredients “ciclosporin” and “tacrolimus”. Regarding the utility of CYP inducers, an extensive literature analysis was undertaken. We also report an index clinical case of a 60-year-old liver transplant patient that developed severe tacrolimus intoxication with multiple organ dysfunction at a peak concentration of 33.1 μg/L after a single dose of intravenous fluconazole. Results: Out of 143,710 documented ICSRs reported in VigiBase™ since 1992, 0.26% and 0.02% were registered as CNI overdoses and intoxications, respectively. The main etiological factor for CNI intoxication was the interaction with CYP 3A4 inhibitors (40.0% vs. case reports: 50.0%). The most commonly reported manifestation was acute kidney injury (36.7% vs. case reports: 46.3%). A total of 16.7% of intoxications led to fatal outcomes after drug withdrawal or dose reduction; however, in 43.0% of cases the exact actions undertaken were not reported. In peer-reviewed reports, 34 distinct clinical cases were treated with CYP inducers. Diverse pharmacoenhancement strategies with phenobarbital (5), phenytoin (23) and rifampicin (6) were described with a mean time of achieving the therapeutic target after 2.7 (±0.7), 3.1 (±0.5) and 4.6 (±1.0) days, respectively. In the index case, a therapeutic concentration of 4.9 [4–6 μg/L] was achieved after a 3-day regimen of rifampicin. Conclusion: In addition to general supportive treatment, the administration of phenobarbital, phenytoin, or rifampicin to reverse acute CNI intoxication is a viable treatment modality. The relatively long half-life of phenobarbital coupled with its exclusive renal elimination are potential pitfalls to reckon with. In spite of the favorable pharmacokinetic advantages of rifampicin, phenytoin offers a competitive pharmacodynamic advantage that is indisputable in patients with overt neurotoxicity.
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(This article belongs to the Special Issue Feature Papers of Pharmacoepidemiology)
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Direct Oral Anticoagulants’ Consumption and Expenditure in the COVID-19 Pandemic in Russia and Clinical Practice Guidelines for Their Use
by
Elena A. Baybulatova, Mikhail S. Chenkurov, Elina A. Korovyakova, Sergey K. Zyryanov and Liliya Eugenevna Ziganshina
Pharmacoepidemiology 2024, 3(1), 1-32; https://doi.org/10.3390/pharma3010001 - 29 Dec 2023
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Background: The coronavirus pandemic has led to the creation of clinical guidelines by a large number of professional medical communities. However, the quality and methodology of development of Russian clinical guidelines has been little studied. The continued relevance of studying the use of
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Background: The coronavirus pandemic has led to the creation of clinical guidelines by a large number of professional medical communities. However, the quality and methodology of development of Russian clinical guidelines has been little studied. The continued relevance of studying the use of DOACs (Direct oral anticoagulants) in patients with COVID-19 was the basis for conducting this study. Aim: The objective of this study was to assess DOAC consumption and expenditure in the Russian Federation during the COVID-19 pandemic and to analyze whether it was supported by the domestic evidence base for the use of DOACs in COVID-19 patients through identifying all publicly available Russian-produced CPGs (Clinical practice guidelines) for the treatment of COVID-19 and assessing their quality as the source of recommendations for the use of oral anticoagulants for the prevention of thrombotic complications in COVID-19 patients. We searched Russian databases for CPGs, published between 2020 and 2023. We identified seven relevant documents that met our inclusion criteria. Three authors analyzed Russian clinical guidelines using an AGREE II questionnaire. We calculated DOAC DDD (defined daily dose) consumption according to Russian clinical guidelines and DDD consumption in patients with COVID-19 for the period 2020–2022. Results: Seven clinical CPGs were analyzed with the AGREE II tool. It was revealed that experts gave the highest scores for the sections on scope and purpose (from 62.98% to 100%), and clarity of presentation (from 96.30% to 100%). The lowest scores were given for the sections on stakeholder involvement (33.33% to 64.81%), rigour of development (from 0% to 49.31%), applicability (from 23.61% to 50%), and editorial independence (from 0% to 50%). When comparing the total score, it was found that two clinical guidelines received the highest scores—ROPNIZ (Livzan), and ROPNIZ (Drapkina). The minimum score was registered with the NIIOZMM (Khripun) clinical guideline. No guideline received a total score of more than 70%. According to clinical recommendations, the consumption of apixaban and rivaroxaban is 15 DDD (30-day course of therapy), or 22.5 DDD (45-day course of therapy). Consumption of apixaban in the Russian Federation in 2020 and 2021 corresponds to the indicators presented in clinical recommendations (in 2020—26.59 DDD per patient with COVID-19; in 2021—15.75 DDD per patient with COVID-19), and in 2022—10.67 DDD, which is below the recommended values. In 2020, consumption of rivaroxaban in the Russian Federation was 26.59 which corresponds to data from clinical recommendations; in 2021, consumption decreased to 7.87 DDD; in 2022 it decreased to 5.48 DDD, which is 2.74 times less than recommended. Conclusions: Analysis of seven clinical recommendations revealed that such sections of clinical recommendations as scope, purpose, and clarity of presentation had the highest degree of assessment in accordance with AGREE II. The lowest scores were given for the sections on stakeholder involvement, rigour of development, applicability, and editorial independence. When comparing the total score, it was found that two clinical guidelines received the highest scores—the Russian Society for the Prevention of Non-communicable Diseases (Livzan), and the Russian Society for the Prevention of Non-communicable Diseases (Drapkina). The minimum score was registered with the Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department clinical guideline. No guideline received a total score of more than 70%. During the pandemic, the highest DDD consumption of DOACs was in 2020, which exceeded the DOACs’ recommended DDD by Russian clinical guidelines. DOAC consumption had decreased by 2022. There was a decrease in the consumption of rivaroxaban, with an increase in apixaban’s share in the structure of DOAC consumption during the coronavirus pandemic. Obtained data indicate that in 2021 the apixaban consumption in the Russian Federation corresponded to the recommended DDD in the national guidelines, which indicates the most correct use of apixaban according to Russian GPGs.
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