Journal of Pharmacy & Pharmaceutical Sciences
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Persistence and switching patterns of migraine prophylactic medications in Canada: A retrospective claims analysis comparing adherence and evaluating the economic burden of illness
No full textPurpose: To describe patient characteristics, treatment patterns, and the burden of illness among adult migraine patients in Canada prescribed migraine prophylactics. Little is known about the relative persistence of treatments in the real-world setting and the impact of migraine prophylactic therapy on patients. As a result, migraine care in Canada continues to inadequately serve patients suffering from frequent headache days, reflecting a large unmet need. Methods: This retrospective study used Reformulary Group’s longitudinal prescription claims database. Private payer data were analyzed to identify 2007 migraine prophylactic naïve patients, with a prior history of acute therapy, for tracking over 24 months to determine treatment patterns and costs. Patient flow is summarized in a Sankey diagram visualizing persistence and switching across different timepoints. Results: Patient persistence to migraine prophylactic medications was low at 24.9% (n=500); Switching from index medications to another prophylactic medication was common (27%), however 50% of patients discontinued without switching. It was observed that acute treatment and opioid use were much lower when patients established and maintained therapy on migraine prophylactics. Overall, angiotensin receptor blockers and CGRP antagonists had high persistence but were underutilized therapies while the inverse was true for antidepressants and anticonvulsants. Conclusion: In a real-word setting, recognizing that many patients may discontinue preventative treatment completely after their first therapy, there is a need to employ migraine-specific prophylactics and/or tolerable medications early. Treatment guidelines aligned to costs savings and/or requiring step therapy may be inadvertently failing patients. Further, the impact of migraine on the day-to-day lives of patients and high societal costs such as its impact on productivity should be weighed in considering migraine’s burden of illness and the benefits of treatment
The 2022 Canadian Society for Pharmaceutical Sciences/Canadian Chapter of Controlled Release Society Annual Symposium was held virtually from June 1-2, 2022.
No full textNo abstract available
Applications of Exhaled Breath Condensate Analysis for Drug Monitoring and Bioequivalence Study of Inhaled Drugs
No full textThe exhaled breath condensate (EBC) presents a simple and non-invasive alternative approach for bioequivalence assessments and therapeutic drug monitoring of inhaled drugs. EBC better represents the drug at the site of action and eliminates the possibility of the contribution of a swallowed portion of the dose when systemic bioavailability is used for assessment. This review summarizes the recently reported analytical methods for the quantification of drugs in EBC. It also discusses the difficulties in the bioequivalence evaluation criteria of generic orally inhaled drug products suggested by various regulatory agencies that may be eliminated using the EBC analysis approach
Evaluating the Effects of Agomelatine on Polysomnography Parameters in Patients with Obstructive Sleep Apnea.
No full textPurpose: Obstructive sleep apnea (OSA) is a common serious sleep disorder. Melatonin-based drugs such as agomelatine may have beneficial effects on patients with sleep disorders. This study aimed to evaluate agomelatine effects on polysomnography parameters in patients with OSA. Methods: In this randomized, parallel, and single-blind study, seventy patients 18 years of age or older with obstructive sleep apnea who were referred to the sleep clinic were evaluated. The patients were randomly assigned into agomelatine and control groups. Patients in the agomelatine group received 50 mg agomelatine, one hour before sleep, for three consecutive nights prior to the polysomnography test, while the patients in the control group did not receive agomelatine. Sleep test parameters were compared between the two groups. Results: Three parameters in the agomelatine versus control group showed significant differences. They were the median and interquartile range of the total sleep time, 397 [326.5-437.4] vs. 287.5 [184-393.1; p, 0.004] minuets, sleep efficiency percentage, 75.6 [71-87.4] vs. 65.1 [50.8-80.1; p, 0.005] and the wakening percentage, 7.5 [12.01-27.6] vs. 8.8[18.3-49; p, 0.004] agomelatine vs. control group. Other polysomnography parameters revealed no significant differences between the two groups. Conclusions: Agomelatine administration in patients with OSA may improve total sleep time, sleep efficiency percentage and the percentage of patients’ awakening.
Evaluation of Clinical Outcomes of Intravenous Drug Use-Related Infective Endocarditis in Buprenorphine-Treated Patients
No full textPurpose: Intravenous drug use (IVDU) is an independent risk factor for infective endocarditis (IE). IVDU-related IE is associated with poor clinical outcomes, such as infection-related and drug abuse-related readmissions and mortality. Critical interventions to treat addiction, such as medication for opioid use disorder (MOUD) with buprenorphine, may prevent these unfavorable outcomes. This study aimed to establish the effectiveness of buprenorphine prescriptions at hospital discharge for patients admitted for IVDU-related IE. Methods: A single center, retrospective cohort study evaluated the effectiveness of discharge prescriptions of buprenorphine in adult patients (≥18 years of age) with OUD and IVDU-related IE. Outcomes of 30-day readmissions, 180-day readmissions, and mortality were compared to a cohort of patients who were not prescribed buprenorphine at hospital discharge. Results: The primary endpoint of all cause 30-day readmission was lower in patients who received buprenorphine (n=11/122, 9%) at hospital discharge for IVDU-related IE compared to those who did not (n=9/48, 19%), although not statistically significant (unadjusted OR 0.429, 95% CI 0.165-1.138, p=0.082). After accounting for intensive care admission, infusion unit admission, and psychiatry consultation, the odds of all cause 30-day readmission were statistically lower in patients prescribed buprenorphine (adjusted OR 0.337, 95% CI 0.125-0.909, p=0.029). Additionally, significantly more patients prescribed buprenorphine at discharge followed-up in an outpatient treatment program, 57% and 15% respectively (p<0.001). Incidence of readmission at 180 days and mortality was similar between the two cohorts. Conclusions: This study demonstrated that buprenorphine prescriptions at hospital discharge in patients with OUD admitted for IVDU-related IE were effective at decreasing readmission rates at 30 days and increasing outpatient treatment follow-up. Therefore, it is imperative that an emphasis on addiction-focused interventions, such as initiating buprenorphine, be considered in this patient population at hospital discharge to decrease hospital readmissions and engage patients in outpatient treatment for OUD. This study is the first to evaluate the effects of MOUD on readmission rates for patients hospitalized with IVDU-related IE and contributes to the growing body of evidence to support addiction-focused interventions for this unique patient population
Genotype-Guided Antiplatelet Therapy Versus Standard Therapy for Patients with Coronary Artery Disease: An Updated Systematic Review and Meta-Analysis
No full textObjective: Previous studies on the efficacy and safety of genotype-guided antiplatelet therapy in patients with coronary artery disease (CAD) or undergoing percutaneous coronary intervention (PCI) have been inconclusive. Aim: We conducted a meta-analysis to evaluate if the genotype-guided antiplatelet strategy is superior to the standard therapy in patients with CAD or undergoing PCI. Method: PubMed, Web of Science, Embase, and Cochrane Central Register of Controlled Trials databases were searched up to October 1st, 2021. Studies reporting efficacy and safety outcomes in the genotype-guided treatment and standard treatment groups were included. The two groups were statistically compared. Result: Eleven randomized controlled trials (RCTs) involving 11740 patients were included in this meta-analysis. Compared with the standard treatment group, the genotype-guided group had significant lower risks of all efficacy outcomes, including major adverse cardiovascular events (MACEs) (RR 0.60, 95%, CI 0.44-0.82, P=0.001), all-cause death (RR 0.70, 95% CI 0.51-0.95, P=0.02), cardiovascular death (RR 0.71, 95% CI 0.53-0.95, P=0.02), myocardial infarction (RR 0.53, 95% CI 0.42-0.67, P<0.0001), stroke (RR 0.64, 95% CI 0.41-0.98, P=0.04), stent thrombosis (RR 0.63, 95% CI 0.43-0.91, P=0.01) and targeted vessel revascularization (RR 0.79, 95% CI 0.67-0.92, P=0.003). There was no significant difference in any bleeding events between the two groups. As a result of the subgroup analyses, the genotype-guided treatment was more likely to reduce the incidence of MACEs in the subgroup where the proportion of patients with ACS was ≥ 90%, and subgroup of the Chinese population. Conclusion: Genotype-guided antiplatelet treatment could reduce the risk of MACEs without increasing the risk of bleeding events as compared with the standard treatment in patients with CAD or those undergoing PCI. In addition, Genotype-guided antiplatelet treatment might benefit Chinese population or patients with ACS
Microneedles as an Alternative Strategy for Drug Delivery
No full textThe transdermal route has been widely studied in the last decade due to its multiple advantages, where one of the most promising transdermal systems are microneedles, these allow the delivery of drugs in a painless way and with easy application, being very attractive for patients with chronic treatments. This review highlights the new research that develops this approach to transdermal therapies, including examples of materials and methods used for their manufacture and presenting an overview of the clinical trials currently available in Cochrane in a demonstrative way to understand the growing popularity of this strategy
Periostin: A Potential Biomarker and Therapeutic Target in Pulmonary Diseases
No full textPeriostin is a matricellular, nonstructural protein belonging to the fasciclin family and is encoded by the POSTN gene in humans. Periostin plays an important role in maintaining a normal tissue matrix in the lungs. Despite the vital role as a structural mediator in tissue growth and repair, periostin is involved in the pathogenic mechanism during tissue remodeling and fibrosis. Periostin is a chemoattractant mediator, promotes eosinophil recruitment and adhesion on the airways sub-epithelial membrane of asthmatic patients. POSTN gene was identified as one of the highly expressed genes induced by interleukins IL-13, IL-5 and IL-4 - the key cytokines of Th2 immune responses in the bronchial tissues of asthmatic patients. This review highlights the potential role of periostin as a validated biomarker in respiratory disease progression and its candidacy to predict the response to treatments targeting Th-2 cytokines in bronchial asthma. In addition, its potential role in COPD, IPF, lung cancer and lung infection, is also speculated.
Keywords
Periostin, Asthma, Pneumonia, COPD, Idiopathic pulmonary fibrosis, Biomarker
Biosimilars: A Comparative Study of Regulatory, Safety and Pharmacovigilance Monograph in the Developed and Developing Economies
No full textEpitomizing one of the rapidly maturing segments of pharmaceutical industry, biologics gestalt has severely implicated treatment algorithms of many life-threatening diseases especially in oncology, immunology, diabetes, and irresistible infections through integration of biologics in the clinical practice guidelines. As of 2021, the impact is expected to gain resilience as more patents on new biological drugs (such as Erbitux, Avastin, Orencis) are going off. Growing acceptance, trusting on stringent risk-benefits assessment, cost-effectiveness, and potential for return on investment, drive the global market of biosimilars is expected to remain steadfast in the following years; hence knowing about regulatory requirements for approval, opportunities, and barriers to biosimilars uptake in the biggest markets of USA, European Union, Canada, and Asia-Pacific (India and Pakistan) is warranted for development of effective biosimilars marketing strategies. This article reviews the biosimilars development from the beginning (historic) to the end (development & marketing approval perspectives) and then tries to present a clear picture on areas that are still uncertain concerning the biosimilars landscape especially the biologics effect on immunogenicity, the provocative issue of interchangeability, and extrapolation of indications
A Review of Electronic Cigarettes and Liquid Nicotine Poisoning Exposure Cases in the United States: The health impact of the short-term exposure.
No full textPurpose: In 2007, electronic cigarettes (e-cigarette) were introduced as a smoking cessation device. Since then, its sale and marketing has been expanded annually. Concomitantly, there is an increase in the electronic cigarette (e-cigarette) and liquid nicotine exposure cases reported to the United States (US) poison control centers. The purpose of this review is to assess the exposure cases reported to US poison control centers to characterize the adverse health effects of e-cigarette and liquid nicotine use. Methods: The PubMed database was searched for e-cigarette and e-liquid exposure reports since 2010. The qualitative analysis was conducted to depict the characteristics related to the incident cases and health outcomes of e-cigarette and e-liquid exposure to support public awareness. Results: Since 2010, there was an increase in e-cigarette exposure incidents with ingestion, inhalation, ocular and dermal identified as the commonly reported routes of exposure in both children and adults. The clinical symptoms were well characterized based upon the specific route of exposure. The exposure incidents were categorized into age, sex, type of exposure, symptoms, management site and medical outcome. The children less than 5 years of age were unintentionally exposed followed by both unintentional and intentional exposure in adults. The reported medical outcomes have a range from minor effects exhibiting symptoms that were not bothersome to major effects with life-threatening symptoms, and death. The short-term or acute exposure was mostly associated with mishandling or misuse of the e-cigarette device or e-liquid. The case reports of young adult males who are linked to intensive use of e-cigarettes show lung injury. Conclusion: E-liquid and e-cigarette use continue to pose a serious health risk for both adults and children. There is accumulating data of incidents associated with short-term e-cigarette use or intensive use of e-cigarettes. However, monitoring of the long-term health effect of e-cigarettes is needed in order to raise public awareness among young adults