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Stroke Feb 2018Pharmacokinetic and prior studies on thienopyridine and proton pump inhibitors (PPI) coadministration provide conflicting data for cardiovascular outcomes, whereas there... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND PURPOSE
Pharmacokinetic and prior studies on thienopyridine and proton pump inhibitors (PPI) coadministration provide conflicting data for cardiovascular outcomes, whereas there is no established evidence on the association of concomitant use of PPI and thienopyridines with adverse cerebrovascular outcomes.
METHODS
We conducted a systematic review and meta-analysis of randomized controlled trials and cohort studies from inception to July 2017, reporting following outcomes among patients treated with thienopyridine and PPI versus thienopyridine alone (1) ischemic stroke, (2) combined ischemic or hemorrhagic stroke, (3) composite outcome of stroke, myocardial infarction (MI), and cardiovascular death, (4) MI, (5) all-cause mortality, and (6) major or minor bleeding events. After the unadjusted analyses of risk ratios, we performed additional analyses of studies reporting hazard ratios adjusted for potential confounders.
RESULTS
We identified 22 studies (12 randomized controlled trials and 10 cohort studies) comprising 131 714 patients. Concomitant use of PPI with thienopyridines was associated with increased risk of ischemic stroke (risk ratio, 1.74; 95% confidence interval [CI], 1.41-2.16; <0.001), composite stroke/MI/cardiovascular death (risk ratio, 1.14; 95% CI, 1.01-1.29; =0.04), and MI (risk ratio, 1.19; 95% CI, 1.00-1.40; =0.05). Likewise, in adjusted analyses concomitant use of PPI with thienopyridines was again associated with increased risk of stroke (hazard ratios adjusted, 1.30; 95% CI, 1.04-1.61; =0.02), composite stroke/MI/cardiovascular death (hazard ratios adjusted, 1.23; 95% CI, 1.03-1.47; =0.02), but not with MI (hazard ratios adjusted, 1.19; 95% CI, 0.93-1.52; =0.16).
CONCLUSIONS
Co-prescription of PPI and thienopyridines increases the risk of incident ischemic strokes and composite stroke/MI/cardiovascular death. Our findings corroborate the current guidelines for PPI deprescription and pharmacovigilance, especially in patients treated with thienopyridines.
Topics: Brain Ischemia; Drug Therapy, Combination; Humans; Platelet Aggregation Inhibitors; Proton Pump Inhibitors; Stroke; Thienopyridines
PubMed: 29339434
DOI: 10.1161/STROKEAHA.117.019166 -
The Pediatric Infectious Disease Journal Feb 2017Noroviruses are increasingly recognized as a major cause of sporadic and epidemic acute gastroenteritis (AGE). Although there have been multiple studies published on... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Noroviruses are increasingly recognized as a major cause of sporadic and epidemic acute gastroenteritis (AGE). Although there have been multiple studies published on norovirus epidemiology in Latin America, no comprehensive assessment of the role of norovirus has been conducted in the region. We aim to estimate the role of norovirus in the Latin American region through a systematic review and meta-analysis of the existing literature.
METHODS
We carried out a literature search in MEDLINE, SciELO and LILACS. We included papers that provided information on the prevalence or incidence of norovirus (including seroprevalence studies and outbreaks), with a recruitment and/or follow-up period of at least 12 months and where the diagnosis of norovirus was confirmed by reverse transcription polymerase chain reaction. The data were pooled for meta-analysis to estimate the prevalence of norovirus AGE and norovirus asymptomatic infection with 95% confidence intervals (CIs).
RESULTS
Thirty-eight studies were included in the review. Overall, the prevalence of norovirus among AGE cases was 15% (95% CI: 13-18). By location, it was 15% in the community (95% CI: 11%-21%), 14% in outpatient settings (95% CI: 10%-19%) and 16% in hospital locations (95% CI: 12%-21%). The prevalence of norovirus among asymptomatic subjects was 8% (95% CI: 4-13). Norovirus GII.4 strains were associated with 37%-100% of norovirus AGE cases, but only 7% of norovirus asymptomatic detections.
CONCLUSIONS
Noroviruses are associated with almost 1 out of every 6 hospitalizations because of acute diarrhea in children younger than 5 years of age in Latin America.
Topics: Caliciviridae Infections; Child; Child, Preschool; Diarrhea; Disease Outbreaks; Gastroenteritis; Humans; Infant; Infant, Newborn; Latin America; Norovirus; Seroepidemiologic Studies
PubMed: 27755462
DOI: 10.1097/INF.0000000000001369 -
Therapeutic Innovation & Regulatory... Sep 2022In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing... (Review)
Review
BACKGROUND
In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries' PV systems' performance.
METHODS
EMBASE, MEDLINE, CINAHL Plus and Web of Science were searched for peer-reviewed studies published in English between 2012 and 2021. Reference lists of included studies were screened. Included studies were quality assessed using Hawker et al.'s nine-item checklist; data were extracted using the WHO PV indicators checklist. Scores were assigned to each group of indicators and used to compare countries' PV performance.
RESULTS
Twenty-one unique studies from 51 countries were included. Of a total possible quality score of 36, most studies were rated medium (n = 7 studies) or high (n = 14 studies). Studies obtained an average score of 17.2 out of a possible 63 of the WHO PV indicators. PV system performance in all 51 countries was low (14.86/63; range: 0-26). Higher average scores were obtained in the 'Core' (9.27/27) compared to 'Complementary' (5.59/36) indicators. Overall performance for 'Process' and 'Outcome' indicators was lower than that of 'Structural'.
CONCLUSION
This first systematic review of studies evaluating PV performance in developing countries provides an in-depth understanding of factors affecting PV system performance.
Topics: Data Collection; Developing Countries; Pharmacovigilance; World Health Organization
PubMed: 35657484
DOI: 10.1007/s43441-022-00415-y -
Research in Veterinary Science Jan 2024This article aims to perform a comparative systematic review of regulations in veterinary medicine between the years 2016 to 2023. It explores the complex web of... (Review)
Review
This article aims to perform a comparative systematic review of regulations in veterinary medicine between the years 2016 to 2023. It explores the complex web of veterinary medicine regulations in various agencies and the nations, including USA (United States of America), EU (European Union), UK (United Kingdom), Japan, Australia, and India. Current article provides the comparative study on the veterinary regulations of different countries, including acts, directives, and drug approval processes. Such as, the specific legislation is needed to address zoonotic diseases. The strategic and regulated stockpiling of the veterinary drugs especially in chronic veterinary disease outbreak. It is essential to develop the dedicated Veterinary Pharmacopoeia for the regulated standardization of the raw materials as well as the formulations. Veterinary medical device is a field which is highly unregulated. There is a need to have regulations for the same. It is important to have dedicated veterinary pharmacovigilance centers which help in improving quality of medications to the livestock farms. After comparing the regulations of different countries. We observed that there is the absence of the zoonotic diseases and pharma stockpiling in every country. There is also an absence of the dedicated veterinary pharmacopoeia in every country. USA and Australia have the veterinary medical device regulation which is not there in other countries. Around the globe only Australia has the dedicated pharmacovigilance center. Including these recommendations into regulatory framework enhances the quality and safety of veterinary medicine. The current article adds a valuable resource for policymakers, veterinarians, and stakeholders in the field of animal health care.
Topics: Animals; Humans; Animal Husbandry; European Union; Japan; United States; Veterinarians; Zoonoses
PubMed: 38016218
DOI: 10.1016/j.rvsc.2023.105101 -
PloS One 2016Spontaneous or voluntary reporting of suspected adverse drug reactions (ADRs) is one of the vital roles of all health professionals. In India, under-reporting of ADRs by... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Spontaneous or voluntary reporting of suspected adverse drug reactions (ADRs) is one of the vital roles of all health professionals. In India, under-reporting of ADRs by health professionals is recognized as one of the leading causes of poor ADR signal detection. Therefore, reviewing the literature can provide a better understanding of the status of knowledge, attitude and practice (KAP) of Pharmacovigilance (PV) activities by health professionals.
METHODS
A systematic review was performed through Pubmed, Scopus, Embase and Google Scholar scientific databases. Studies pertaining to KAP of PV and ADR reporting by Indian health professionals between January 2011 and July 2015 were included in a meta-analysis.
RESULTS
A total of 28 studies were included in the systematic review and 18 of them were selected for meta-analysis. Overall, 55.6% (95% CI 44.4-66.9; p<0.001) of the population studied were not aware of the existence of the Pharmacovigilance Programme in India (PvPI), and 31.9% (95% CI 16.3-47.4; p<0.001) thought that "all drugs available in the market are safe". Furthermore, 28.7% (95% CI 16.4-40.9; p<0.001) of them were not interested in reporting ADRs and 74.5%, (95% CI 67.9-81.9; p<0.001) never reported any ADR to PV centers.
CONCLUSION
There was an enormous gap of KAP towards PV and ADR reporting, particularly PV practice in India. There is therefore an urgent need for educational awareness, simplification of the ADR reporting process, and implementation of imperative measures to practice PV among healthcare professionals. In order to understand the PV status, PvPI should procedurally assess the KAP of health professionals PV activities in India.
Topics: Drug Therapy; Health Knowledge, Attitudes, Practice; Health Personnel; Humans; India
PubMed: 27010447
DOI: 10.1371/journal.pone.0152221 -
PloS One 2020The objective of this review is to evaluate the existing evidence about the knowledge, attitude, and perceptions (KAP) of healthcare students towards pharmacovigilance...
OBJECTIVE
The objective of this review is to evaluate the existing evidence about the knowledge, attitude, and perceptions (KAP) of healthcare students towards pharmacovigilance and adverse drug reactions reporting (ADRs).
METHODS
A systematic literature search was conducted using MEDLINE, CINAHL, EMBASE, ERIC, and Cochrane Database of Systematic Reviews via OVID. This review restricted the search to studies published in English from inception until December 2019.
PRIMARY AND SECONDARY OUTCOME MEASURES
The primary outcome was healthcare students' knowledge, attitude, and perceptions of pharmacovigilance.
RESULTS
Of the 664 articles identified, twenty-nine studies were included in the review. Overall, healthcare students vary in their knowledge and attitude towards pharmacovigilance and ADRs reporting. There was inconsistency in measuring KAP between the studies and the main drawback in the literature is lacking validated KAP measures.
CONCLUSIONS
In summation, optimal KAP assessment can be achieved through developing a standard validated measure. Our future healthcare providers should have basics pharmacovigilance knowledge in order to rationally reporting ADRs and preventing serious health problems.
Topics: Adverse Drug Reaction Reporting Systems; Health Knowledge, Attitudes, Practice; Health Personnel; Humans; Pharmacovigilance; Students, Health Occupations
PubMed: 32433649
DOI: 10.1371/journal.pone.0233393 -
Climacteric : the Journal of the... Dec 2023Studies have shown racial/ethnic differences in the prevalence of vasomotor symptoms (VMS), sleep disturbance and VMS treatment in menopause. To assess the... (Review)
Review
Studies have shown racial/ethnic differences in the prevalence of vasomotor symptoms (VMS), sleep disturbance and VMS treatment in menopause. To assess the reproducibility of these differences, we systematically reviewed observational studies, published in 2000-2021, reporting the prevalence/incidence of VMS, sleep disturbance or treatment use in menopausal women stratified by race/ethnicity. We screened 3799 records from PubMed and Embase and included 27 papers (19 studies). No incidence data were found. Prevalence data varied widely, but some common patterns emerged. In all five studies comparing VMS between Black women and White, Hispanic and/or East Asian women, the prevalence was highest in Black women and lowest in East Asian women. The prevalence of sleep disturbance overall was compared among Black, White and East Asian women in two study populations, and was highest in White women in both papers. Sleep disturbance was more common than VMS in East Asian women. In all four studies comparing hormone therapy use between White women and Black and/or East Asian women, treatment use was more common in White women. These results highlight the need for individualized counseling and treatment, outreach to under-served minorities, and standardized definitions and outcome measures for VMS and sleep disturbance for future studies.
Topics: Female; Humans; Hot Flashes; Reproducibility of Results; Menopause; Ethnicity; Sleep; Vasomotor System
PubMed: 37751852
DOI: 10.1080/13697137.2023.2256658 -
Nutrients Jul 2023Chemotherapy represents the main pharmacological cancer treatment. Recently, positive effects emerged with the combination of anticancer therapy and nutraceutical... (Review)
Review
Chemotherapy represents the main pharmacological cancer treatment. Recently, positive effects emerged with the combination of anticancer therapy and nutraceutical products. The aim of this systematic review is to collect and synthesize the available scientific evidence regarding the potential effects of nutraceuticals on cancer cells. A systematic literature search of randomized clinical trials of nutraceutical products in patients with cancer published up to 15 December 2022 was conducted using three data sources: Embase, PubMed, and Web of Science. The effect of high-dose isoflavone supplements on prostate cancer resulted in stabilization or reduction of PSA concentrations in 50% of isoflavone group patients six months after treatment. High doses of vitamin D supplementation plus chemotherapy in patients with advanced or metastatic colorectal cancer showed a median PFS of 13.0 months (95% CI, 10.1-14.7 months) for 49 patients. The effect of vitamin D supplementation on markers of inflammatory level and antioxidant capacity in women with breast cancer showed a significant increase in serum vitamin D concentration (28 ± 2.6 to 39 ± 3.5; = 0.004) after 8 weeks of treatment. In conclusion, nutraceutical supplements represent a potentially growing sector and can be utilized in medical treatment or nutrition to provide integrated medical care.
Topics: Male; Humans; Female; Randomized Controlled Trials as Topic; Vitamins; Dietary Supplements; Vitamin D; Antioxidants; Neoplasms
PubMed: 37513667
DOI: 10.3390/nu15143249 -
European Journal of Clinical... Sep 2022Adverse Drug Reactions (ADR) add a significant clinical and economic burden to the healthcare system of a country. We present an overview of the different approaches of... (Review)
Review
OBJECTIVE
Adverse Drug Reactions (ADR) add a significant clinical and economic burden to the healthcare system of a country. We present an overview of the different approaches of ADR reporting systems worldwide and their evolution over time.
METHODS
A systematic review of the literature was made based on PubMed and the Cochrane database of systematic reviews. The articles searched for included original articles, WHO and FDA reports and institute of medicine reports. Reporting ADRs is the cornerstone of detecting uncommon ADRs once the drugs are on the market. In many countries, ADR reporting is regulated by national regulatory bodies and various methods are employed to report ADRs. Direct reporting by healthcare professionals has been adopted by many developed and developing countries. With emerging new technologies in the field of medicine, there is a great potential to develop better ADR reporting systems in the countries where they have poor reporting.
CONCLUSION
Development and acquisition of newer technologies to promote ADR monitoring and reporting is a necessity for an effective pharmacovigilance system in a country.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Software; Systematic Reviews as Topic
PubMed: 35788724
DOI: 10.1007/s00228-022-03358-3 -
Drug Design, Development and Therapy 2016To assess those published cases of yellow fever (YF) vaccine-associated viscerotropic disease that meet the Brighton Collaboration criteria and to assess the safety of... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
To assess those published cases of yellow fever (YF) vaccine-associated viscerotropic disease that meet the Brighton Collaboration criteria and to assess the safety of YF vaccine with respect to viscerotropic disease.
LITERATURE SEARCH
Ten electronic databases were searched with no restriction of date or language and reference lists of retrieved articles.
METHODS
All abstracts and titles were independently read by two reviewers and data independently entered by two reviewers.
RESULTS
All serious adverse events that met the Brighton Classification criteria were associated with first YF vaccinations. Sixty-two published cases (35 died) met the Brighton Collaboration viscerotropic criteria, with 32 from the US, six from Brazil, five from Peru, three from Spain, two from the People's Republic of China, one each from Argentina, Australia, Belgium, Ecuador, France, Germany, Ireland, New Zealand, Portugal, and the UK, and four with no country stated. Two cases met both the viscerotropic and YF vaccine-associated neurologic disease criteria. Seventy cases proposed by authors as viscerotropic disease did not meet any Brighton Collaboration viscerotropic level of diagnostic certainty or any YF vaccine-associated viscerotropic disease causality criteria (37 died).
CONCLUSION
Viscerotropic disease is rare in the published literature and in pharmacovigilance databases. All published cases were from developing countries. Because the symptoms are usually very severe and life threatening, it is unlikely that cases would not come to medical attention (but might not be published). Because viscerotropic disease has a highly predictable pathologic course, it is likely that viscerotropic disease post-YF vaccine occurs in low-income countries with the same incidence as in developing countries. YF vaccine is a very safe vaccine that likely confers lifelong immunity.
Topics: Developing Countries; Humans; Multiple Organ Failure; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vaccination; Yellow Fever Vaccine
PubMed: 27784992
DOI: 10.2147/DDDT.S99600