Pub Date : 2024-10-05eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S481448
Olulade Ayodele, Howard J Cabral, David D McManus, Susan S Jick
Background: A substantial proportion of adults receive statins for treatment of hypercholesterolemia and cardiovascular risk, and statins have been found to improve outcomes in this patient population. However, studies have not consistently demonstrated the potential benefits of statins in preventing venous thromboembolism (VTE). Therefore, we conducted this study to investigate this association.
Methods: We conducted a cohort analysis in a study sample comprised of 40-79-year-old patients with hyperlipidemia who received at least one fibrate or statin prescription between January 1995 and December 2018 in the United Kingdom Clinical Practice Research Datalink (CPRD) GOLD. We evaluated the association between statin use and incident unprovoked VTE, compared to fibrate use, an active comparator, using Kaplan-Meier (KM) analysis, Poisson regression (with and without propensity score matching), and inverse probability of treatment weights (IPTW) marginal structural models (MSM).
Results: In this cohort of 166,292 patients with hyperlipidemia, 0.81% (N=1,353) developed incident unprovoked VTE. In analyses using the KM method, patients who received statins had a slightly lower risk of VTE compared to those who received fibrates (Log rank test: p=0.0524). The adjusted incident rate ratio (95% CI) for VTE, calculated using Poisson regression, controlling for serum cholesterol and other baseline covariates, in patients prescribed statins compared to fibrates was 0.77 (0.45-1.33) in the full cohort, 0.74 (0.38-1.45) in the propensity score matched analysis, and 0.51 (95% conservative CI: 0.34-0.76) in the IPTW MSM analysis.
Conclusion: While the magnitude of effect varied across the different analytic methods, there is consistent evidence for a protective effect of statin use on the occurrence of unprovoked VTE.
{"title":"Risk of Venous Thromboembolism in Statin Users Compared to Fibrate Users in the United Kingdom Clinical Practice Research Datalink (UK CPRD) GOLD.","authors":"Olulade Ayodele, Howard J Cabral, David D McManus, Susan S Jick","doi":"10.2147/CLEP.S481448","DOIUrl":"10.2147/CLEP.S481448","url":null,"abstract":"<p><strong>Background: </strong>A substantial proportion of adults receive statins for treatment of hypercholesterolemia and cardiovascular risk, and statins have been found to improve outcomes in this patient population. However, studies have not consistently demonstrated the potential benefits of statins in preventing venous thromboembolism (VTE). Therefore, we conducted this study to investigate this association.</p><p><strong>Methods: </strong>We conducted a cohort analysis in a study sample comprised of 40-79-year-old patients with hyperlipidemia who received at least one fibrate or statin prescription between January 1995 and December 2018 in the United Kingdom Clinical Practice Research Datalink (CPRD) GOLD. We evaluated the association between statin use and incident unprovoked VTE, compared to fibrate use, an active comparator, using Kaplan-Meier (KM) analysis, Poisson regression (with and without propensity score matching), and inverse probability of treatment weights (IPTW) marginal structural models (MSM).</p><p><strong>Results: </strong>In this cohort of 166,292 patients with hyperlipidemia, 0.81% (N=1,353) developed incident unprovoked VTE. In analyses using the KM method, patients who received statins had a slightly lower risk of VTE compared to those who received fibrates (Log rank test: p=0.0524). The adjusted incident rate ratio (95% CI) for VTE, calculated using Poisson regression, controlling for serum cholesterol and other baseline covariates, in patients prescribed statins compared to fibrates was 0.77 (0.45-1.33) in the full cohort, 0.74 (0.38-1.45) in the propensity score matched analysis, and 0.51 (95% conservative CI: 0.34-0.76) in the IPTW MSM analysis.</p><p><strong>Conclusion: </strong>While the magnitude of effect varied across the different analytic methods, there is consistent evidence for a protective effect of statin use on the occurrence of unprovoked VTE.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"683-697"},"PeriodicalIF":3.4,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463176/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388538","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-04eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S477778
Sarah Cook, David Osborn, Arti Maini, Ravi Parekh, Shamini Gnani, Thomas Beaney, Ana Luisa Neves, Sonia Saxena, Jennifer K Quint
Purpose: Electronic health records (EHR) are valuable resources for health research; however, their use is challenging. A validated alcohol use disorder (AUD) codelist for UK primary care is needed to improve population-based research in this patient group. We aimed to develop an AUD codelist for use in the Clinical Practice Research Datalink (CPRD) Aurum database, a UK EHR primary-care database.
Methods: The CPRD code browser was searched using keywords related to alcohol use using a previously developed search strategy. The resulting codes were categorised as AUD if they were: a) diagnostic of AUD, b) indicated alcohol withdrawal, or c) indicated chronic alcohol-related harm (physical or mental). Codes related to alcohol use but not used to define AUD were also classified into relevant categories (alcohol status, acute harm, and alcohol screening). All codes were categorised independently by at least two reviewers (one person reviewed all codes and five reviewers (all practising GPs) each reviewed a subset of codes (100-200 codes each). Disagreements in categorisation were discussed by at least three coders and a consensus was reached. The reliability of categorisation was assessed using kappa statistics.
Results: In total, 556 potential codes related to alcohol use were identified. The Kappa for reliability between coders was moderate for both AUD (0.72) and across all categories (0.62), with substantial variability between coders (AUD: 0.33-0.97; all categories 0.36-0.74). In the final codelist, 138 codes were included as indicating AUD: 38 codes identified which indicated diagnosis of AUD, 14 indicating withdrawal plus 85 codes indicating chronic alcohol-related harm (41 physical health and 44 mental health).
Conclusion: Many codes are used in primary care to record alcohol use and associated harms, and there is substantial variability in how clinicians categorise them. While future work formally validating the codelist against gold standard clinical reviews and qualitative work with General Practitioners is needed for a deeper understanding of coding processes, we have documented here the process used for the development of an AUD codelist within primary care which can be used as a reference for future research.
{"title":"Recording of Alcohol Use Disorder in Electronic Health Records: Developing a Recommended Codelist for Research.","authors":"Sarah Cook, David Osborn, Arti Maini, Ravi Parekh, Shamini Gnani, Thomas Beaney, Ana Luisa Neves, Sonia Saxena, Jennifer K Quint","doi":"10.2147/CLEP.S477778","DOIUrl":"https://doi.org/10.2147/CLEP.S477778","url":null,"abstract":"<p><strong>Purpose: </strong>Electronic health records (EHR) are valuable resources for health research; however, their use is challenging. A validated alcohol use disorder (AUD) codelist for UK primary care is needed to improve population-based research in this patient group. We aimed to develop an AUD codelist for use in the Clinical Practice Research Datalink (CPRD) Aurum database, a UK EHR primary-care database.</p><p><strong>Methods: </strong>The CPRD code browser was searched using keywords related to alcohol use using a previously developed search strategy. The resulting codes were categorised as AUD if they were: a) diagnostic of AUD, b) indicated alcohol withdrawal, or c) indicated chronic alcohol-related harm (physical or mental). Codes related to alcohol use but not used to define AUD were also classified into relevant categories (alcohol status, acute harm, and alcohol screening). All codes were categorised independently by at least two reviewers (one person reviewed all codes and five reviewers (all practising GPs) each reviewed a subset of codes (100-200 codes each). Disagreements in categorisation were discussed by at least three coders and a consensus was reached. The reliability of categorisation was assessed using kappa statistics.</p><p><strong>Results: </strong>In total, 556 potential codes related to alcohol use were identified. The Kappa for reliability between coders was moderate for both AUD (0.72) and across all categories (0.62), with substantial variability between coders (AUD: 0.33-0.97; all categories 0.36-0.74). In the final codelist, 138 codes were included as indicating AUD: 38 codes identified which indicated diagnosis of AUD, 14 indicating withdrawal plus 85 codes indicating chronic alcohol-related harm (41 physical health and 44 mental health).</p><p><strong>Conclusion: </strong>Many codes are used in primary care to record alcohol use and associated harms, and there is substantial variability in how clinicians categorise them. While future work formally validating the codelist against gold standard clinical reviews and qualitative work with General Practitioners is needed for a deeper understanding of coding processes, we have documented here the process used for the development of an AUD codelist within primary care which can be used as a reference for future research.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"673-681"},"PeriodicalIF":3.4,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11460355/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-02eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S467874
Frantisek Zitricky, Anni Koskinen, Kristina Sundquist, Jan Sundquist, Vaclav Liska, Asta Försti, Akseli Hemminki, Kari Hemminki
Introduction: Thyroid cancer (TC) is diagnosed in several histological types which differ in their clinical characteristics and survival. We aim to describe how they influence TC survival in Sweden.
Methods: Cancer data were obtained from the Swedish cancer registry between years 1999 and 2018, and these were used to analyze relative survival.
Results: Relative survival for all TC improved when analyzed in 10-year periods, and female survival improved more than male survival. Female survival advantage appeared to be present also for specific histological types, although case numbers were low for rare types. Female 5-year relative survival for TC was 100% for follicular, 95.1% for oncocytic, 93.4% for papillary, 89.7% for medullary, and 6.1% for anaplastic cancer. Among the clinical TNM classes, only T4 and M1 stages were associated with decreased survival compared to T1-3 and M0. Anaplastic cancer presented most often at high T and M1 stages, in contrast to other TC. Curiously, the diagnostic age for anaplastic M1 patients was lower than that for M0 patients. Both anaplastic and medullary cancers did not show age-dependent increases in the probability of metastases, in contrast to the main histological types. This could indicate the presence of several types of anaplastic and medullary cancers.
Conclusion: The poor survival for anaplastic TC is an extreme contrast to the excellent survival of differentiated TC. As less than 20% of anaplastic cancer patients survived one year, urgent diagnosis and initiation of treatment are important. Facilitated treatment pathways have been instituted in Denmark resulting in improved survival. Anaplastic cancer should be a target of a major research focus.
{"title":"Survival in Thyroid Cancer in Sweden From 1999 To 2018.","authors":"Frantisek Zitricky, Anni Koskinen, Kristina Sundquist, Jan Sundquist, Vaclav Liska, Asta Försti, Akseli Hemminki, Kari Hemminki","doi":"10.2147/CLEP.S467874","DOIUrl":"10.2147/CLEP.S467874","url":null,"abstract":"<p><strong>Introduction: </strong>Thyroid cancer (TC) is diagnosed in several histological types which differ in their clinical characteristics and survival. We aim to describe how they influence TC survival in Sweden.</p><p><strong>Methods: </strong>Cancer data were obtained from the Swedish cancer registry between years 1999 and 2018, and these were used to analyze relative survival.</p><p><strong>Results: </strong>Relative survival for all TC improved when analyzed in 10-year periods, and female survival improved more than male survival. Female survival advantage appeared to be present also for specific histological types, although case numbers were low for rare types. Female 5-year relative survival for TC was 100% for follicular, 95.1% for oncocytic, 93.4% for papillary, 89.7% for medullary, and 6.1% for anaplastic cancer. Among the clinical TNM classes, only T4 and M1 stages were associated with decreased survival compared to T1-3 and M0. Anaplastic cancer presented most often at high T and M1 stages, in contrast to other TC. Curiously, the diagnostic age for anaplastic M1 patients was lower than that for M0 patients. Both anaplastic and medullary cancers did not show age-dependent increases in the probability of metastases, in contrast to the main histological types. This could indicate the presence of several types of anaplastic and medullary cancers.</p><p><strong>Conclusion: </strong>The poor survival for anaplastic TC is an extreme contrast to the excellent survival of differentiated TC. As less than 20% of anaplastic cancer patients survived one year, urgent diagnosis and initiation of treatment are important. Facilitated treatment pathways have been instituted in Denmark resulting in improved survival. Anaplastic cancer should be a target of a major research focus.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"659-671"},"PeriodicalIF":3.4,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11456301/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-27eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S494770
Georgie M Massen, Jennifer K Quint
{"title":"Using Routinely Collected Electronic Healthcare Record Data to Investigate Fibrotic Multimorbidity in England [Response to Letter].","authors":"Georgie M Massen, Jennifer K Quint","doi":"10.2147/CLEP.S494770","DOIUrl":"10.2147/CLEP.S494770","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"657-658"},"PeriodicalIF":3.4,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444052/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-25eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S469958
Frederik P B Kristensen, Sia K Nicolaisen, Jens S Nielsen, Diana H Christensen, Kurt Højlund, Henning Beck-Nielsen, Jørgen Rungby, Søren G Friborg, Ivan Brandslund, Jens S Christiansen, Peter Vestergaard, Niels Jessen, Michael H Olsen, Mette K Andersen, Torben Hansen, Charlotte Brøns, Allan Vaag, Reimar W Thomsen, Henrik T Sørensen
Purpose: This paper provides an overview of the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) cohort and biobank, including baseline characteristics of participants enrolled up to 2023, and post-enrollment rates of cardiovascular disease outcomes and mortality.
Methods: Since 2010, the DD2 project has enrolled individuals with type 2 diabetes mellitus (T2DM) recently diagnosed by general practitioners and by hospital-based clinicians across Denmark. Data from questionnaires, clinical examinations, and biological samples are collected at enrollment. Additional baseline and longitudinal follow-up data are accessed via linkage to health registries.
Results: Between 2010 and 2023, the DD2 project enrolled 11,369 participants (41.3% women, median age 61.4 years). Median T2DM duration at enrollment was 1.3 years, and median BMI was 31.6 kg/m2 for women and 30.5 kg/m2 for men. 18.3% were smokers, 5.7% consumed more than 14/21 units of alcohol weekly (women/men), and 17.9% reported leisure-time physical inactivity. Original midwife records dating back >80 years revealed that 20.2% of cohort participants had birth weights <3000 g. Based on complete hospital contact history 10 years before enrollment, 20.7% of cohort participants had macrovascular complications, 17.0% had microvascular complications, and 21.7% had kidney disease based on eGFR or urine albumin-creatinine measurements. At enrollment, statins were used by 68.2%, antihypertensive drugs by 69.9%, and glucose-lowering drugs by 86.5% of individuals. Median HbA1c was 48 mmol/mol and median LDL cholesterol 2.2 mmol/L. Genome-wide genotyping and biomarker data have been analyzed for over 9000 individuals. During the current follow-up time from the enrollment date (median 7.9 years), incident cardiovascular disease rate has been 13.8 per 1000 person-years and the mortality rate has been 17.6 per 1000 person-years.
Conclusion: The DD2 cohort, with its detailed information and long-term follow up, can improve our understanding of the progression and prevention of complications among individuals with newly diagnosed T2DM.
{"title":"The Danish Centre for Strategic Research in Type 2 Diabetes (DD2) Project Cohort and Biobank from 2010 Through 2023-A Cohort Profile Update.","authors":"Frederik P B Kristensen, Sia K Nicolaisen, Jens S Nielsen, Diana H Christensen, Kurt Højlund, Henning Beck-Nielsen, Jørgen Rungby, Søren G Friborg, Ivan Brandslund, Jens S Christiansen, Peter Vestergaard, Niels Jessen, Michael H Olsen, Mette K Andersen, Torben Hansen, Charlotte Brøns, Allan Vaag, Reimar W Thomsen, Henrik T Sørensen","doi":"10.2147/CLEP.S469958","DOIUrl":"https://doi.org/10.2147/CLEP.S469958","url":null,"abstract":"<p><strong>Purpose: </strong>This paper provides an overview of the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) cohort and biobank, including baseline characteristics of participants enrolled up to 2023, and post-enrollment rates of cardiovascular disease outcomes and mortality.</p><p><strong>Methods: </strong>Since 2010, the DD2 project has enrolled individuals with type 2 diabetes mellitus (T2DM) recently diagnosed by general practitioners and by hospital-based clinicians across Denmark. Data from questionnaires, clinical examinations, and biological samples are collected at enrollment. Additional baseline and longitudinal follow-up data are accessed via linkage to health registries.</p><p><strong>Results: </strong>Between 2010 and 2023, the DD2 project enrolled 11,369 participants (41.3% women, median age 61.4 years). Median T2DM duration at enrollment was 1.3 years, and median BMI was 31.6 kg/m<sup>2</sup> for women and 30.5 kg/m<sup>2</sup> for men. 18.3% were smokers, 5.7% consumed more than 14/21 units of alcohol weekly (women/men), and 17.9% reported leisure-time physical inactivity. Original midwife records dating back >80 years revealed that 20.2% of cohort participants had birth weights <3000 g. Based on complete hospital contact history 10 years before enrollment, 20.7% of cohort participants had macrovascular complications, 17.0% had microvascular complications, and 21.7% had kidney disease based on eGFR or urine albumin-creatinine measurements. At enrollment, statins were used by 68.2%, antihypertensive drugs by 69.9%, and glucose-lowering drugs by 86.5% of individuals. Median HbA1c was 48 mmol/mol and median LDL cholesterol 2.2 mmol/L. Genome-wide genotyping and biomarker data have been analyzed for over 9000 individuals. During the current follow-up time from the enrollment date (median 7.9 years), incident cardiovascular disease rate has been 13.8 per 1000 person-years and the mortality rate has been 17.6 per 1000 person-years.</p><p><strong>Conclusion: </strong>The DD2 cohort, with its detailed information and long-term follow up, can improve our understanding of the progression and prevention of complications among individuals with newly diagnosed T2DM.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"641-656"},"PeriodicalIF":3.4,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11439366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-25eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S469816
Christian Madelaire, Thomas Gerds, Lars Køber, Finn Gustafsson, Charlotte Andersson, Søren Lund Kristensen, Jawad Haider Butt, Deewa Zahir Anjum, Ann Banke, Emil Loldrup Fosbøl, Gunnar Gislason, Christian Torp-Pedersen, Morten Schou
Background: Heart failure (HF) is associated with increased risk of death and a hospitalization, but for patients initiating guideline directed medical therapy, it is unknown how high these risks are compared to the general population - and how this may vary depending on age and comorbidity.
Methods: In this retrospective cohort study, we identified patients diagnosed with HF in the period 2011-2017, surviving the initial 120 days after diagnosis. Patients who were on angiotensin converting enzyme inhibitor (ACEi)/ angiotensin receptor blocker (ARB) and beta-blocker were included and matched to 5 non-HF individuals from the background population each based on age and sex. We assessed the 5-year risk of all-cause death, HF and non-HF hospitalization according to sex and age and baseline comorbidity.
Results: We included 35,367 patients with HF and 176,835 matched non-HF individuals. Patients with HF had a five-year excess risk (absolute risk difference) of death of 13% (31% [for HF] - 18% [for non-HF]), of HF hospitalization of 17% and of non-HF hospitalization of 24%. Excess risk of death increased with increasing age, whereas the relative risk decreased - for women in their twenties, the excess risk was 7%, risk ratio 7.2, while the excess risk was 18%, risk ratio 1.5 for women in their eighties. Having HF as a 60-year old man was associated with a five-year risk of death similar to a 75-year old man without HF. Further, HF was associated with an excess risk of non-HF hospitalization, ranging from 8% for patients >85 years to 30% for patients <30 years.
Conclusion: Regardless of age, sex and comorbidity, HF was associated with excess risk of mortality and non-HF hospitalizations, but the relative risk ratio diminishes sharply with advancing age, which may influence allocation of resources for medical care across populations.
{"title":"Excess Risk of Mortality and Hospitalization in Patients with Heart Failure According to Age and Comorbidity - A Nationwide Register Study.","authors":"Christian Madelaire, Thomas Gerds, Lars Køber, Finn Gustafsson, Charlotte Andersson, Søren Lund Kristensen, Jawad Haider Butt, Deewa Zahir Anjum, Ann Banke, Emil Loldrup Fosbøl, Gunnar Gislason, Christian Torp-Pedersen, Morten Schou","doi":"10.2147/CLEP.S469816","DOIUrl":"https://doi.org/10.2147/CLEP.S469816","url":null,"abstract":"<p><strong>Background: </strong>Heart failure (HF) is associated with increased risk of death and a hospitalization, but for patients initiating guideline directed medical therapy, it is unknown how high these risks are compared to the general population - and how this may vary depending on age and comorbidity.</p><p><strong>Methods: </strong>In this retrospective cohort study, we identified patients diagnosed with HF in the period 2011-2017, surviving the initial 120 days after diagnosis. Patients who were on angiotensin converting enzyme inhibitor (ACEi)/ angiotensin receptor blocker (ARB) and beta-blocker were included and matched to 5 non-HF individuals from the background population each based on age and sex. We assessed the 5-year risk of all-cause death, HF and non-HF hospitalization according to sex and age and baseline comorbidity.</p><p><strong>Results: </strong>We included 35,367 patients with HF and 176,835 matched non-HF individuals. Patients with HF had a five-year excess risk (absolute risk difference) of death of 13% (31% [for HF] - 18% [for non-HF]), of HF hospitalization of 17% and of non-HF hospitalization of 24%. Excess risk of death increased with increasing age, whereas the relative risk decreased - for women in their twenties, the excess risk was 7%, risk ratio 7.2, while the excess risk was 18%, risk ratio 1.5 for women in their eighties. Having HF as a 60-year old man was associated with a five-year risk of death similar to a 75-year old man without HF. Further, HF was associated with an excess risk of non-HF hospitalization, ranging from 8% for patients >85 years to 30% for patients <30 years.</p><p><strong>Conclusion: </strong>Regardless of age, sex and comorbidity, HF was associated with excess risk of mortality and non-HF hospitalizations, but the relative risk ratio diminishes sharply with advancing age, which may influence allocation of resources for medical care across populations.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"631-640"},"PeriodicalIF":3.4,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11439342/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: Drug-induced gynecomastia significantly affects patient health and quality of life. This study aimed to perform an exploratory analysis of gynecomastia reports and the most commonly associated medications within the FAERS database. Patients and Methods: A comprehensive analysis of the FAERS from January 2004 to December 2023 was conducted. Disproportionality analysis and subsequent sensitivity analysis were performed to identify drugs potentially associated with gynecomastia, utilizing the reported odds ratio (ROR). Logistic regression analysis was employed to assess potential risk factors. The Weibull shape parameter (WSP) test was used to assess the time-to-onset characteristics of the top drugs associated with gynecomastia. Results: The study identified 30,265 cases of gynecomastia, primarily associated with nervous system drugs, accounting for 85.50% of cases. Notably, risperidone accounted for 80.81% of the total cases. Among the 165 agents with ≥ 5 cases of gynecomastia, the strongest signals were exhibited by risperidone (ROR 602.38, 95% CI 585.07– 620.20), dutasteride (ROR 17.18, 95% CI 15.55– 18.89), spironolactone (ROR 15.8, 95% CI 13.99– 17.83), and paliperidone (ROR 7.16, 95% CI 6.55– 7.84). In the sensitivity analysis of disproportionality, unexpected associations were observed, such as montelukast (n = 21, ROR 1.94, 95% CI 1.26– 2.98). The logistic regression analysis indicated that the risk of risperidone-induced gynecomastia was significantly lower in adults compared to pediatric patients (OR 0.12, 95% CI 0.09– 0.15) and in patients with higher body weight than in those with lower body weight (OR 5.24, 95% CI 3.62– 7.76). The WSP test showed that gynecomastia induced by most of the top 10 common agents tends to occur in an early failure mode. Conclusion: The rankings and signal strengths of drugs associated with gynecomastia were extracted from the FAERS. The age distribution and time-to-onset distribution of the top 10 drugs linked to gynecomastia were investigated, which can facilitate accurate clinical recognition of drug-induced gynecomastia.
目的:药物引起的妇科炎症严重影响患者的健康和生活质量。本研究旨在对 FAERS 数据库中的妇科炎症报告和最常见的相关药物进行探索性分析:对 2004 年 1 月至 2023 年 12 月的 FAERS 进行了全面分析。利用报告的几率比(ROR)进行了比例失调分析和随后的敏感性分析,以确定可能与妇科乳腺增生有关的药物。采用逻辑回归分析评估潜在的风险因素。采用Weibull形状参数(WSP)检验来评估与妇科乳腺增生相关的主要药物的发病时间特征:研究发现了30265例妇科乳腺增生病例,其中85.50%的病例主要与神经系统药物有关。值得注意的是,利培酮占总病例数的 80.81%。在妇科肿瘤病例数≥5 例的 165 种药物中,利培酮(ROR 602.38,95% CI 585.07-620.20)、度他雄胺(ROR 17.18,95% CI 15.55-18.89)、螺内酯(ROR 15.8,95% CI 13.99-17.83)和帕利培酮(ROR 7.16,95% CI 6.55-7.84)的信号最强。在比例失调的敏感性分析中,观察到了意想不到的关联,如孟鲁司特(n = 21,ROR 1.94,95% CI 1.26-2.98)。逻辑回归分析表明,利培酮诱发妇科肿瘤的风险在成人患者中显著低于儿童患者(OR 0.12,95% CI 0.09-0.15),在体重较高的患者中显著低于体重较低的患者(OR 5.24,95% CI 3.62-7.76)。WSP测试表明,在前10种常见药物中,大多数药物诱发的妇科炎症往往发生在早期失效模式:结论:从 FAERS 中提取了与妇科乳腺增生有关的药物的排名和信号强度。结论:从 FAERS 中提取了与妇科肿瘤相关药物的排名和信号强度,研究了与妇科肿瘤相关的前 10 种药物的年龄分布和发病时间分布,有助于临床准确识别药物诱发的妇科肿瘤。
{"title":"Drug-Induced Gynecomastia: Data Mining and Analysis of the FDA Adverse Event Reporting System Database","authors":"Xiuli Yang, Xiaochun Zheng, Miaomiao Zhang, Jinlong Huang, Ping Huang, Jiangfeng Wang","doi":"10.2147/clep.s470959","DOIUrl":"https://doi.org/10.2147/clep.s470959","url":null,"abstract":"<strong>Purpose:</strong> Drug-induced gynecomastia significantly affects patient health and quality of life. This study aimed to perform an exploratory analysis of gynecomastia reports and the most commonly associated medications within the FAERS database.<br/><strong>Patients and Methods:</strong> A comprehensive analysis of the FAERS from January 2004 to December 2023 was conducted. Disproportionality analysis and subsequent sensitivity analysis were performed to identify drugs potentially associated with gynecomastia, utilizing the reported odds ratio (ROR). Logistic regression analysis was employed to assess potential risk factors. The Weibull shape parameter (WSP) test was used to assess the time-to-onset characteristics of the top drugs associated with gynecomastia.<br/><strong>Results:</strong> The study identified 30,265 cases of gynecomastia, primarily associated with nervous system drugs, accounting for 85.50% of cases. Notably, risperidone accounted for 80.81% of the total cases. Among the 165 agents with ≥ 5 cases of gynecomastia, the strongest signals were exhibited by risperidone (ROR 602.38, 95% CI 585.07– 620.20), dutasteride (ROR 17.18, 95% CI 15.55– 18.89), spironolactone (ROR 15.8, 95% CI 13.99– 17.83), and paliperidone (ROR 7.16, 95% CI 6.55– 7.84). In the sensitivity analysis of disproportionality, unexpected associations were observed, such as montelukast (n = 21, ROR 1.94, 95% CI 1.26– 2.98). The logistic regression analysis indicated that the risk of risperidone-induced gynecomastia was significantly lower in adults compared to pediatric patients (OR 0.12, 95% CI 0.09– 0.15) and in patients with higher body weight than in those with lower body weight (OR 5.24, 95% CI 3.62– 7.76). The WSP test showed that gynecomastia induced by most of the top 10 common agents tends to occur in an early failure mode.<br/><strong>Conclusion:</strong> The rankings and signal strengths of drugs associated with gynecomastia were extracted from the FAERS. The age distribution and time-to-onset distribution of the top 10 drugs linked to gynecomastia were investigated, which can facilitate accurate clinical recognition of drug-induced gynecomastia.<br/><br/><strong>Keywords:</strong> drug-induced, gynecomastia, FAERS, risperidone, time-to-onset<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"26 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Johann Kuhn, Valérie Olié, Clémence Grave, Yann Le Strat, Christophe Bonaldi, Pierre Joly
Aim: Myocardial infarction (MI) is a cardiovascular disease caused by necrosis of the myocardium, which places a heavy burden on patients. In France, the proportion of daily smokers remains high, reaching at 25.5% in 2020. We evaluated the impact of smoking reduction scenarios on the projection of MI prevalence, mean age of incident cases and number of MI prevented cases until 2035. Methods and Results: The French government has introduced smoking cessation policies that have led to an annual decrease in smoking prevalence. Based on this annual decline, we implemented three scenarios (SC) simulating an annual decrease in the proportion of smokers aged over 35 (SC1: 1%, ie, natural evolution without intervention, SC2: 2%, SC3: 9.87%) and a fourth scenario (SC4) in which there is a complete discontinuation of smoking from 2024 onwards using MI hospitalization and demographic data, estimations for the proportion of daily smokers between 35 and 95 years and multi-state models. Between 2023 and 2035, MI prevalence increased from 3.18% to 4.23% in males and from 1.00% to 1.46% in females under SC1. MI prevalence was equal to 4.21%, 4.06%, and 3.82% in males and 1.45%, 1.40%, and 1.34% in females in 2035 according to SC2, SC3, and SC4, respectively. Compared with SC1, 0.68% MI cases would be prevented with SC2, 4.52% with SC3 and 10.34% with SC4, with almost half of cases being prevented before 65 years of age. The increase in the mean age of MI incident cases ranged from 3 to 4 years among males and from 1 to 2 years among females. Conclusion: While reducing tobacco use could substantially reduce the number of MI cases prevented, its prevalence would continue to increase due to the ageing population. An integrated prevention strategy that includes the leading cardiovascular risk factors should more efficiently reduce the future burden of MI.
{"title":"Impact of Smoking Reduction Scenarios on the Burden of Myocardial Infarction in the French Population Until 2035","authors":"Johann Kuhn, Valérie Olié, Clémence Grave, Yann Le Strat, Christophe Bonaldi, Pierre Joly","doi":"10.2147/clep.s440815","DOIUrl":"https://doi.org/10.2147/clep.s440815","url":null,"abstract":"<strong>Aim:</strong> Myocardial infarction (MI) is a cardiovascular disease caused by necrosis of the myocardium, which places a heavy burden on patients. In France, the proportion of daily smokers remains high, reaching at 25.5% in 2020. We evaluated the impact of smoking reduction scenarios on the projection of MI prevalence, mean age of incident cases and number of MI prevented cases until 2035.<br/><strong>Methods and Results:</strong> The French government has introduced smoking cessation policies that have led to an annual decrease in smoking prevalence. Based on this annual decline, we implemented three scenarios (SC) simulating an annual decrease in the proportion of smokers aged over 35 (SC1: 1%, ie, natural evolution without intervention, SC2: 2%, SC3: 9.87%) and a fourth scenario (SC4) in which there is a complete discontinuation of smoking from 2024 onwards using MI hospitalization and demographic data, estimations for the proportion of daily smokers between 35 and 95 years and multi-state models. Between 2023 and 2035, MI prevalence increased from 3.18% to 4.23% in males and from 1.00% to 1.46% in females under SC1. MI prevalence was equal to 4.21%, 4.06%, and 3.82% in males and 1.45%, 1.40%, and 1.34% in females in 2035 according to SC2, SC3, and SC4, respectively. Compared with SC1, 0.68% MI cases would be prevented with SC2, 4.52% with SC3 and 10.34% with SC4, with almost half of cases being prevented before 65 years of age. The increase in the mean age of MI incident cases ranged from 3 to 4 years among males and from 1 to 2 years among females.<br/><strong>Conclusion:</strong> While reducing tobacco use could substantially reduce the number of MI cases prevented, its prevalence would continue to increase due to the ageing population. An integrated prevention strategy that includes the leading cardiovascular risk factors should more efficiently reduce the future burden of MI.<br/><br/><strong>Keywords:</strong> myocardial infarction, prevalence, burden, projection, tobacco control, smoking prevalence<br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"3 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-04eCollection Date: 2024-01-01DOI: 10.2147/CLEP.S493274
Avid Wijaya, Endang Sri Dewi Hastuti Suryandari, Dea Allan Karunia Sakti, Tsalits Maulidah Hariez, Harinto Nur Seha
{"title":"Using Routinely Collected Electronic Healthcare Record Data to Investigate Fibrotic Multimorbidity in England [Letter].","authors":"Avid Wijaya, Endang Sri Dewi Hastuti Suryandari, Dea Allan Karunia Sakti, Tsalits Maulidah Hariez, Harinto Nur Seha","doi":"10.2147/CLEP.S493274","DOIUrl":"10.2147/CLEP.S493274","url":null,"abstract":"","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"603-604"},"PeriodicalIF":3.4,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Gastrointestinal tumors represent a significant component of the cancer burden in Asia. This study aims to evaluate the burden of gastrointestinal tumors in Asia from 1990 to 2021 using data from the Global Burden of Disease Study 2021 (GBD 2021). Methods: The absolute incidence, mortality, and disability adjusted life years (DALYs) number and rate of six gastrointestinal tumors(colon and rectum cancer (CRC), stomach cancer (SC), pancreatic cancer (PC), esophageal cancer (EC), liver cancer (LC) and gallbladder and biliary tract cancer (GBTC)) in 48 Asian countries were extracted from GBD 2021. Differences were analyzed based on gender, age, year, location and socio-demographic index (SDI). Results: In 2021, SC accounted for the highest disease burden in Asia (DALYs=16.41million [95% UI: 13.70, 19.62]). From 1990 to 2021, the age-standardized incidence rates of EC, LC, and SC in Asia declined, while the incidence rates of CRC and PC increased significantly, with CRC showing the largest rise (AAPC=1.08 [95% CI: 1.02 to 1.12]). Gastrointestinal tumors DALY rates peaked at age 70 and above, with males generally exhibiting higher rates than females. Furthermore, East Asia bears a higher burden compared to other Asian subregions. A higher SDI correlates with increased DALY rates for PC, but no linear relationship was observed for other gastrointestinal tumors. Conclusion: The burden of gastrointestinal tumors in Asia remains high and may continue to increase. Therefore, effective prevention and treatment measures are essential to address the challenge posed by gastrointestinal tumors.
{"title":"Burden of Gastrointestinal Tumors in Asian Countries, 1990–2021: An Analysis for the Global Burden of Disease Study 2021","authors":"Donglin Jiang, Yangxue Wu, Ling Liu, Yajing Shen, Tiandong Li, Yin Lu, Peng Wang, Changqing Sun, Kaijuan Wang, Keyan Wang, Hua Ye","doi":"10.2147/clep.s472553","DOIUrl":"https://doi.org/10.2147/clep.s472553","url":null,"abstract":"<strong>Background:</strong> Gastrointestinal tumors represent a significant component of the cancer burden in Asia. This study aims to evaluate the burden of gastrointestinal tumors in Asia from 1990 to 2021 using data from the Global Burden of Disease Study 2021 (GBD 2021).<br/><strong>Methods:</strong> The absolute incidence, mortality, and disability adjusted life years (DALYs) number and rate of six gastrointestinal tumors(colon and rectum cancer (CRC), stomach cancer (SC), pancreatic cancer (PC), esophageal cancer (EC), liver cancer (LC) and gallbladder and biliary tract cancer (GBTC)) in 48 Asian countries were extracted from GBD 2021. Differences were analyzed based on gender, age, year, location and socio-demographic index (SDI).<br/><strong>Results:</strong> In 2021, SC accounted for the highest disease burden in Asia (DALYs=16.41million [95% <em>UI</em>: 13.70, 19.62]). From 1990 to 2021, the age-standardized incidence rates of EC, LC, and SC in Asia declined, while the incidence rates of CRC and PC increased significantly, with CRC showing the largest rise (AAPC=1.08 [95% <em>CI</em>: 1.02 to 1.12]). Gastrointestinal tumors DALY rates peaked at age 70 and above, with males generally exhibiting higher rates than females. Furthermore, East Asia bears a higher burden compared to other Asian subregions. A higher SDI correlates with increased DALY rates for PC, but no linear relationship was observed for other gastrointestinal tumors.<br/><strong>Conclusion:</strong> The burden of gastrointestinal tumors in Asia remains high and may continue to increase. Therefore, effective prevention and treatment measures are essential to address the challenge posed by gastrointestinal tumors.<br/><br/>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"55 1","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142203768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}