Introduction: Low-density lipoprotein cholesterol (LDL-C) is associated with heightened risk of m... more Introduction: Low-density lipoprotein cholesterol (LDL-C) is associated with heightened risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with peripheral artery disease (PAD). Strategies that lower LDL-C levels reduce this risk. Hypothesis: We hypothesized that real-world PAD patients are overall undertreated with lipid lowering therapies (LLT) but that LLT use and achieved LDL-C are improved in high risk patients with ischemic events. Methods: Patients with PAD in the MarketScan database linked to PROGNOS lab data from January 1, 2014 through December 31, 2018 were examined. Outcomes included use of LLT, defined as high intensity (HI) (high intensity statin, any statin plus ezetimibe, or any use of a PCSK9 inhibitor), low intensity (LI) (any other lipid regimen), or no therapy, and follow up LDL-C level. Goal LDL-C was defined as <70 mg/dl. Results: Among 18,747 PAD patients, 25% were on HI LLT, 43% were on LI LLT, and 32% were on no therapy at baseline (Figure A). The median LDL-C was 91 mg/dl (IQR 70, 118), and 25% of patients were at goal (Figure B). After a median follow up of 18 months, use of HI LLT increased by 4%, the median LDL-C decreased by 5 mg/dl, and an additional 3% of patients were at goal LDL-C. Greater use of HI LLT was observed among patients with a MACE (55%) or MALE (41%) event during follow up compared with patients without an ischemic event (26%) during follow up (Figure C). Follow up LDL-C levels remained above goal for most patients (post-MACE: median LDL-C 77 mg/dl, 42% patients at goal; post-MALE: median LDL-C 80 mg/dl, 36% patients at goal). Conclusions: In PAD patients, use of LLT is suboptimal, and LDL-C levels remain elevated. After an ischemic event, LLT use is intensified, with greater use of HI LLT observed after MACE than MALE. Despite this, LLT remains underutilized, with >50% of patients not at goal LDL-C. Strategies to better implement proven therapies to reduce risk in this high risk population are needed.
American Journal of Tropical Medicine and Hygiene, May 9, 2018
The prevalence of public health and global health (PH/GH) curricular offerings appear to be incre... more The prevalence of public health and global health (PH/GH) curricular offerings appear to be increasing in terms of undergraduate curricula and in the context of liberal arts education in the United States. Liberal arts colleges (LACs) represent stand-alone institutions, which exclusively focus on undergraduate education. The objective of this study was to assess the prevalence of PH/GH study pathways and PH/GH course offerings among LACs. All LACs identified through the US News and World Report (USNWR) college rankings were contacted with a survey about the
Journal of the American College of Cardiology, Jun 1, 2021
BACKGROUND Low-density lipoprotein cholesterol (LDL-C) is associated with heightened risk of majo... more BACKGROUND Low-density lipoprotein cholesterol (LDL-C) is associated with heightened risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in peripheral artery disease (PAD). Lipid-lowering therapies (LLT) that reduce LDL-C decrease this risk. OBJECTIVES The authors examined LLT use and actual achieved LDL-C in PAD. METHODS PAD patients in MarketScan from 2014 to 2018 were identified. Outcomes included LLT use, defined as high-intensity (HI) (high-intensity statin, statin plus ezetimibe, or PCSK9 inhibitor), low-intensity (any other lipid regimen), or no therapy, and follow-up LDL-C. Factors associated with LDL-C <70 mg/dl were identified with multivariable logistic regression. RESULTS Among 250,103 PAD patients, 20.5% and 39.5% were treated at baseline with HI and low-intensity LLT, respectively; 40.0% were on no LLT. Over a 15-month median follow-up period, HI LLT use increased by 1.5%. Among 18,747 patients with LDL-C data, at baseline, 25.1% were on HI LLT, median LDL-C was 91 mg/dl, and 24.5% had LDL-C <70 mg/dl. Within the HI LLT subgroup, median LDL-C was 81 mg/dl, and 64% had LDL-C ≥70 mg/dl. At follow-up, HI LLT use increased by 3.7%, median LDL-C decreased by 4.0 mg/dl, and an additional 4.1% of patients had LDL-C <70 mg/dl. HI LLT use was greater after follow-up MACE (55.0%) or MALE (41.0%) versus no ischemic event (26.1%). After MACE or MALE, LDL-C was <70 mg/dl in 41.5% and 36.1% of patients, respectively, versus 27.1% in those without an event. Factors associated with follow-up LDL-C <70 mg/dl included smoking, hypertension, diabetes, prior lower extremity revascularization, and prior myocardial infarction but not prior acute or critical limb ischemia. CONCLUSIONS In PAD, LLT use is suboptimal, LDL-C remains elevated, and LLT intensity is a poor surrogate for achieved LDL-C. Less aggressive lipid management was observed in PAD versus cardiovascular disease, highlighting missed opportunities for implementation of proven therapies in PAD.
Journal of the American College of Cardiology, Nov 1, 2019
BACKGROUND The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholester... more BACKGROUND The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol guideline includes recommendations for intensive lipid-lowering therapy in patients at very high risk for atherosclerotic cardiovascular disease (ASCVD) events. OBJECTIVES This study sought to estimate event rates among adults with a history of ASCVD who met and did not meet the definition of very high risk in the 2018 AHA/ACC cholesterol guideline.
Introduction: Limited access to healthcare during the COVID-19 pandemic prompted patients to seek... more Introduction: Limited access to healthcare during the COVID-19 pandemic prompted patients to seek care using telehealth. In this study, we assessed whether treatment patterns differed for patients with psoriasis (PsO) or psoriatic arthritis (PsA) initiating apremilast by either a telehealth or an in-person visit. Methods: We estimated adherence and persistence among US patients in the MerativeÓ Mar-ketScanÓ Commercial and Supplemental Medicare Databases who newly initiated apremilast between April and June 2020, categorized by the type of visit (telehealth or in-person) when apremilast was first prescribed. Adherence was defined as the proportion of days covered (PDC), with PDC C 0.80 considered to indicate high adherence. Persistence was defined as having apremilast available to take without a 60-day gap during follow-up. Factors associated with high adherence and persistence were estimated with logistic and Cox regression. Results: Among apremilast initiators (n = 505), the mean age was 47.6 years, 57.8% were female, and the majority had PsO (79.6%). Telehealth index visits were more likely among patients residing in Northeast USA (odds ratio [OR] 3.31, 95% confidence interval [CI] 1.63-6.71) and Western USA (OR 2.52, 95% CI 1.07-5.93]), those with a prescribing rheumatologist (OR 2.27, 95% CI 1.10-4.68), and those with any baseline telehealth visit (OR 1.91, 85% CI 1.20-3.04). Those initiating apremilast with a telehealth visit (n = 141) had similar mean PDC to those initiating apremilast with an in-person visit (n = 364) (0.695 vs. 0.728; p = 0.272). At the end of the 6-month follow-up, 54.3% of the overall population had high adherence (PDC C 0.80) and 65.1% were persistent. After adjusting for potential confounders, patients initiating apremilast via telehealth had similar full
TUPE0414 Four cities modelling: #5 simulated effect of HSV-2 prophylactic vaccines on population-... more TUPE0414 Four cities modelling: #5 simulated effect of HSV-2 prophylactic vaccines on population-level HIV incidence in sub-Saharan Africa E.E. Freeman, R.G. White, K.K. Orroth, R. Bakker, A. Buve, J.D.F. Habbema, M.C. Boily, R.G. Hayes, J.R. Glynn London School of Hygiene and Tropical Medicine / Harvard Medical School, Boston, United States, London School of Hygiene and Tropical Medicine, Infectious Disease Epidemiology Unit, London, United Kingdom, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands, Institute of Tropical Medicine, STD/HIV Research and Intervention Unit, Antwerp, Belgium, Imperial College, London, United Kingdom Background: HSV-2 may play an important role in HIV transmission in sub-Saharan Africa. This project explores the effect of a potential prophylactic HSV-2 vaccine on the HIV epidemic in model simulations. Methods: Epidemiological, behavioural, and demographic data from a cross-sectional population based study in four cities (Cotonou, Benin; Yaounde, Cameroon; Kisumu, Kenya; and Ndola, Zambia) were used to inform model parameters. An individual-based stochastic microsimulation model simulated the HSV-2 and HIV epidemics in the four sites. A prophylactic HSV-2 vaccine was introduced into the model in 1997; HIV incidence ten years later was compared to default scenarios. Results: Assuming continuous vaccination of 14y olds and an initial mass vaccination campaign among 14-30y olds, each with 80% coverage, and 15y average duration of immunity, simulated reductions in population-level HIV incidence in the four cities after ten years were 18-25% for a vaccine with 80% efficacy. This decreased to 10-16% and 610% for efficacies of 50% and 30% respectively. Without the initial mass vaccination campaign, the reduction in HIV incidence for 80% efficacy was only 8-9%, demonstrating the importance of a mass campaign for short-term impact on HIV. Conclusions: HSV-2 vaccines of high or moderate efficacy could have a substantial impact on population-level HIV incidence if delivered with high coverage. Initial mass campaigns targeting a wide age-range will greatly hasten the impact of vaccination.
Pharmacoepidemiology and Drug Safety, Dec 20, 2021
PurposeClinical trials have demonstrated efficacy of proprotein convertase subtilisin/kexin type ... more PurposeClinical trials have demonstrated efficacy of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) in reducing risk of cardiovascular disease events, but effectiveness in routine clinical care has not been well‐studied. We used negative control outcomes to assess potential confounding in an observational study of PCSK9i versus ezetimibe or high‐intensity statin.MethodsUsing commercial claims, we identified U.S. adults initiating PCSK9i, ezetimibe, or high‐intensity statin in 2015–2018, with other lipid‐lowering therapy (LLT) use in the year prior (LLT cohort) or atherosclerotic cardiovascular disease (ASCVD) in the past 90 days (ASCVD cohort). We compared initiators of PCSK9i to ezetimibe and high‐intensity statin by estimating one‐year risks of negative control outcomes influenced by frailty or health‐seeking behaviors. Inverse probability of treatment and censoring weighted estimators of risk differences (RDs) were used to evaluate residual confounding after controlling for covariates.ResultsPCSK9i initiators had lower one‐year risks of negative control outcomes associated with frailty, such as decubitus ulcer in the ASCVD cohort (PCSK9i vs. high‐intensity statin RD = −3.5%, 95% confidence interval (CI): −4.6%, −2.5%; PCSK9i vs. ezetimibe RD = −1.3%, 95% CI: −2.1%, −0.6%), with similar but attenuated associations in the LLT cohort. Lower risks of accidents and fractures were also observed for PCSK9i, varying by cohort. Risks were similar for outcomes associated with health‐seeking behaviors, although trended higher for PCSK9i in the ASCVD cohort.ConclusionsObserved associations suggest lower frailty and potentially greater health‐seeking behaviors among PCSK9i initiators, particularly those with a recent ASCVD diagnosis, with the potential to bias real‐world analyses of treatment effectiveness.
Purpose:The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol ... more Purpose:The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol guideline defines very high atherosclerotic cardiovascular disease (ASCVD) risk as a history of ≥2 major ASCVD events or 1 major ASCVD event and multiple high-risk conditions. We tested if a simplified approach, having a history of a major ASCVD event, would identify a high proportion of patients that meet the 2018 AHA/ACC cholesterol guideline criteria for very high risk.Methods:We analyzed data from US adults with health insurance in the MarketScan database who had experienced an acute coronary syndrome in the past year (recent ACS, n=3,626), a myocardial infarction (MI) other than a recent ACS (n=7,572), an ischemic stroke (n=3,551) or symptomatic peripheral artery disease (PAD, n=5,919). Patients were followed from January 1, 2016 through December 31, 2017 for recurrent ASCVD events.Results:Among 16,344 patients with a history of a major ASCVD event, 94.0% met the 2018 AHA/ACC cholesterol guideline definition for very high risk including 92.9%, 96.5%, 93.1%, and 96.2% with a recent ACS, history of MI, history of stroke and symptomatic PAD, respectively. The incidence of ASCVD events per 1,000 person-years was 50.4 (95% CI: 47.6-53.3) among all patients with a history of a major ASCVD event versus 53.1 (95% CI: 50.1-56.1) among patients who met the 2018 AHA/ACC cholesterol guideline definition of very high risk.Conclusion:The vast majority of patients with a recent ACS, history of MI, ischemic stroke or symptomatic PAD meet the 2018 AHA/ACC cholesterol guideline definition of very high risk.
TUAC0401-Four cities modelling: #2 the dynamic impact of male circumcision and curable STIs on th... more TUAC0401-Four cities modelling: #2 the dynamic impact of male circumcision and curable STIs on the heterogeneity of HIV epidemics in sub-Saharan Africa-simulation results
ImportanceLipoprotein(a) (Lp[a]) is a genetically determined risk-enhancing factor for atheroscle... more ImportanceLipoprotein(a) (Lp[a]) is a genetically determined risk-enhancing factor for atherosclerotic cardiovascular disease (ASCVD). The Lp(a) distribution among the diverse Hispanic or Latino community residing in the US has not been previously described, to the authors’ knowledge.ObjectiveTo determine the distribution of Lp(a) levels across a large cohort of diverse Hispanic or Latino adults living in the US and by key demographic groups.Design, Setting, and ParticipantsThe Hispanic Community Health Study/Study of Latinos (HCHS/SOL) is a prospective, population-based, cohort study of diverse Hispanic or Latino adults living in the US. At screening, participants aged 18 to 74 years were recruited between 2008 and 2011 from 4 US metropolitan areas (Bronx, New York; Chicago, Illinois; Miami, Florida; San Diego, California). HCHS/SOL included 16 415 noninstitutionalized adults recruited through probability sampling of randomly selected households. The study population represents His...
Background: Understanding how statins, ezetimibe, and PCSK9i (proprotein convertase subtilisin/ke... more Background: Understanding how statins, ezetimibe, and PCSK9i (proprotein convertase subtilisin/kexin type 9 serine protease inhibitors) are prescribed after a myocardial infarction (MI) or elective coronary revascularization may improve lipid-lowering therapy (LLT) intensification and reduce recurrent atherosclerotic cardiovascular disease events. We described the use and intensification of LLT among US veterans who had a MI or elective coronary revascularization between July 24, 2015, and December 9, 2019, within 12 months of hospital discharge. Methods: LLT intensification was defined as increasing statin dose, or initiating a statin, ezetimibe, or a PCSK9i, overall and among those with an LDL-C (low-density lipoprotein cholesterol) ≥ 70 or 100 mg/dL. Poisson regression was used to determine patient characteristics associated with a greater likelihood of LLT intensification following hospitalization for MI or elective coronary revascularization. Results: Among 81 372 index events ...
Journal of Acquired Immune Deficiency Syndromes, 2004
Objective: To determine whether population differences can explain the contrasting impacts on HIV... more Objective: To determine whether population differences can explain the contrasting impacts on HIV observed in the Mwanza trial of sexually transmitted disease (STD) syndromic treatment (ST), the Rakai trial of STD mass treatment (MT), and the Masaka trial of information, education, and communication (IEC) with and without ST as well as to predict the effectiveness of each intervention strategy in each population. Methods: Stochastic modeling of the transmission of HIV and 6 STDs was used with parameters fitted to demographic, sexual behavior, and epidemiological data from the trials and general review of STD/HIV biology. Results: The baseline trial populations could be simulated by assuming higher risk behavior in Uganda compared with Mwanza in the 1980s, followed by reductions in risk behavior in Uganda preceding the trials. In line with trial observations, the projected HIV impacts were larger for the ST intervention in Mwanza than for the MT intervention in Rakai or the IEC and IEC + ST interventions in Masaka. All 4 simulated intervention strategies were more effective in reducing incidence of HIV infection in Mwanza than in either Rakai or Masaka. Conclusions: Population differences in sexual behavior, curable STD rates, and HIV epidemic stage can explain most of the contrast in HIV impact observed between the 3 trials. This study supports the hypothesis that STD management is an effective HIV prevention strategy in populations with a high prevalence of curable STDs, particularly in an early HIV epidemic.
Introduction: Low-density lipoprotein cholesterol (LDL-C) is associated with heightened risk of m... more Introduction: Low-density lipoprotein cholesterol (LDL-C) is associated with heightened risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with peripheral artery disease (PAD). Strategies that lower LDL-C levels reduce this risk. Hypothesis: We hypothesized that real-world PAD patients are overall undertreated with lipid lowering therapies (LLT) but that LLT use and achieved LDL-C are improved in high risk patients with ischemic events. Methods: Patients with PAD in the MarketScan database linked to PROGNOS lab data from January 1, 2014 through December 31, 2018 were examined. Outcomes included use of LLT, defined as high intensity (HI) (high intensity statin, any statin plus ezetimibe, or any use of a PCSK9 inhibitor), low intensity (LI) (any other lipid regimen), or no therapy, and follow up LDL-C level. Goal LDL-C was defined as &amp;amp;lt;70 mg/dl. Results: Among 18,747 PAD patients, 25% were on HI LLT, 43% were on LI LLT, and 32% were on no therapy at baseline (Figure A). The median LDL-C was 91 mg/dl (IQR 70, 118), and 25% of patients were at goal (Figure B). After a median follow up of 18 months, use of HI LLT increased by 4%, the median LDL-C decreased by 5 mg/dl, and an additional 3% of patients were at goal LDL-C. Greater use of HI LLT was observed among patients with a MACE (55%) or MALE (41%) event during follow up compared with patients without an ischemic event (26%) during follow up (Figure C). Follow up LDL-C levels remained above goal for most patients (post-MACE: median LDL-C 77 mg/dl, 42% patients at goal; post-MALE: median LDL-C 80 mg/dl, 36% patients at goal). Conclusions: In PAD patients, use of LLT is suboptimal, and LDL-C levels remain elevated. After an ischemic event, LLT use is intensified, with greater use of HI LLT observed after MACE than MALE. Despite this, LLT remains underutilized, with &amp;amp;gt;50% of patients not at goal LDL-C. Strategies to better implement proven therapies to reduce risk in this high risk population are needed.
American Journal of Tropical Medicine and Hygiene, May 9, 2018
The prevalence of public health and global health (PH/GH) curricular offerings appear to be incre... more The prevalence of public health and global health (PH/GH) curricular offerings appear to be increasing in terms of undergraduate curricula and in the context of liberal arts education in the United States. Liberal arts colleges (LACs) represent stand-alone institutions, which exclusively focus on undergraduate education. The objective of this study was to assess the prevalence of PH/GH study pathways and PH/GH course offerings among LACs. All LACs identified through the US News and World Report (USNWR) college rankings were contacted with a survey about the
Journal of the American College of Cardiology, Jun 1, 2021
BACKGROUND Low-density lipoprotein cholesterol (LDL-C) is associated with heightened risk of majo... more BACKGROUND Low-density lipoprotein cholesterol (LDL-C) is associated with heightened risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in peripheral artery disease (PAD). Lipid-lowering therapies (LLT) that reduce LDL-C decrease this risk. OBJECTIVES The authors examined LLT use and actual achieved LDL-C in PAD. METHODS PAD patients in MarketScan from 2014 to 2018 were identified. Outcomes included LLT use, defined as high-intensity (HI) (high-intensity statin, statin plus ezetimibe, or PCSK9 inhibitor), low-intensity (any other lipid regimen), or no therapy, and follow-up LDL-C. Factors associated with LDL-C <70 mg/dl were identified with multivariable logistic regression. RESULTS Among 250,103 PAD patients, 20.5% and 39.5% were treated at baseline with HI and low-intensity LLT, respectively; 40.0% were on no LLT. Over a 15-month median follow-up period, HI LLT use increased by 1.5%. Among 18,747 patients with LDL-C data, at baseline, 25.1% were on HI LLT, median LDL-C was 91 mg/dl, and 24.5% had LDL-C <70 mg/dl. Within the HI LLT subgroup, median LDL-C was 81 mg/dl, and 64% had LDL-C ≥70 mg/dl. At follow-up, HI LLT use increased by 3.7%, median LDL-C decreased by 4.0 mg/dl, and an additional 4.1% of patients had LDL-C <70 mg/dl. HI LLT use was greater after follow-up MACE (55.0%) or MALE (41.0%) versus no ischemic event (26.1%). After MACE or MALE, LDL-C was <70 mg/dl in 41.5% and 36.1% of patients, respectively, versus 27.1% in those without an event. Factors associated with follow-up LDL-C <70 mg/dl included smoking, hypertension, diabetes, prior lower extremity revascularization, and prior myocardial infarction but not prior acute or critical limb ischemia. CONCLUSIONS In PAD, LLT use is suboptimal, LDL-C remains elevated, and LLT intensity is a poor surrogate for achieved LDL-C. Less aggressive lipid management was observed in PAD versus cardiovascular disease, highlighting missed opportunities for implementation of proven therapies in PAD.
Journal of the American College of Cardiology, Nov 1, 2019
BACKGROUND The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholester... more BACKGROUND The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol guideline includes recommendations for intensive lipid-lowering therapy in patients at very high risk for atherosclerotic cardiovascular disease (ASCVD) events. OBJECTIVES This study sought to estimate event rates among adults with a history of ASCVD who met and did not meet the definition of very high risk in the 2018 AHA/ACC cholesterol guideline.
Introduction: Limited access to healthcare during the COVID-19 pandemic prompted patients to seek... more Introduction: Limited access to healthcare during the COVID-19 pandemic prompted patients to seek care using telehealth. In this study, we assessed whether treatment patterns differed for patients with psoriasis (PsO) or psoriatic arthritis (PsA) initiating apremilast by either a telehealth or an in-person visit. Methods: We estimated adherence and persistence among US patients in the MerativeÓ Mar-ketScanÓ Commercial and Supplemental Medicare Databases who newly initiated apremilast between April and June 2020, categorized by the type of visit (telehealth or in-person) when apremilast was first prescribed. Adherence was defined as the proportion of days covered (PDC), with PDC C 0.80 considered to indicate high adherence. Persistence was defined as having apremilast available to take without a 60-day gap during follow-up. Factors associated with high adherence and persistence were estimated with logistic and Cox regression. Results: Among apremilast initiators (n = 505), the mean age was 47.6 years, 57.8% were female, and the majority had PsO (79.6%). Telehealth index visits were more likely among patients residing in Northeast USA (odds ratio [OR] 3.31, 95% confidence interval [CI] 1.63-6.71) and Western USA (OR 2.52, 95% CI 1.07-5.93]), those with a prescribing rheumatologist (OR 2.27, 95% CI 1.10-4.68), and those with any baseline telehealth visit (OR 1.91, 85% CI 1.20-3.04). Those initiating apremilast with a telehealth visit (n = 141) had similar mean PDC to those initiating apremilast with an in-person visit (n = 364) (0.695 vs. 0.728; p = 0.272). At the end of the 6-month follow-up, 54.3% of the overall population had high adherence (PDC C 0.80) and 65.1% were persistent. After adjusting for potential confounders, patients initiating apremilast via telehealth had similar full
TUPE0414 Four cities modelling: #5 simulated effect of HSV-2 prophylactic vaccines on population-... more TUPE0414 Four cities modelling: #5 simulated effect of HSV-2 prophylactic vaccines on population-level HIV incidence in sub-Saharan Africa E.E. Freeman, R.G. White, K.K. Orroth, R. Bakker, A. Buve, J.D.F. Habbema, M.C. Boily, R.G. Hayes, J.R. Glynn London School of Hygiene and Tropical Medicine / Harvard Medical School, Boston, United States, London School of Hygiene and Tropical Medicine, Infectious Disease Epidemiology Unit, London, United Kingdom, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands, Institute of Tropical Medicine, STD/HIV Research and Intervention Unit, Antwerp, Belgium, Imperial College, London, United Kingdom Background: HSV-2 may play an important role in HIV transmission in sub-Saharan Africa. This project explores the effect of a potential prophylactic HSV-2 vaccine on the HIV epidemic in model simulations. Methods: Epidemiological, behavioural, and demographic data from a cross-sectional population based study in four cities (Cotonou, Benin; Yaounde, Cameroon; Kisumu, Kenya; and Ndola, Zambia) were used to inform model parameters. An individual-based stochastic microsimulation model simulated the HSV-2 and HIV epidemics in the four sites. A prophylactic HSV-2 vaccine was introduced into the model in 1997; HIV incidence ten years later was compared to default scenarios. Results: Assuming continuous vaccination of 14y olds and an initial mass vaccination campaign among 14-30y olds, each with 80% coverage, and 15y average duration of immunity, simulated reductions in population-level HIV incidence in the four cities after ten years were 18-25% for a vaccine with 80% efficacy. This decreased to 10-16% and 610% for efficacies of 50% and 30% respectively. Without the initial mass vaccination campaign, the reduction in HIV incidence for 80% efficacy was only 8-9%, demonstrating the importance of a mass campaign for short-term impact on HIV. Conclusions: HSV-2 vaccines of high or moderate efficacy could have a substantial impact on population-level HIV incidence if delivered with high coverage. Initial mass campaigns targeting a wide age-range will greatly hasten the impact of vaccination.
Pharmacoepidemiology and Drug Safety, Dec 20, 2021
PurposeClinical trials have demonstrated efficacy of proprotein convertase subtilisin/kexin type ... more PurposeClinical trials have demonstrated efficacy of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) in reducing risk of cardiovascular disease events, but effectiveness in routine clinical care has not been well‐studied. We used negative control outcomes to assess potential confounding in an observational study of PCSK9i versus ezetimibe or high‐intensity statin.MethodsUsing commercial claims, we identified U.S. adults initiating PCSK9i, ezetimibe, or high‐intensity statin in 2015–2018, with other lipid‐lowering therapy (LLT) use in the year prior (LLT cohort) or atherosclerotic cardiovascular disease (ASCVD) in the past 90 days (ASCVD cohort). We compared initiators of PCSK9i to ezetimibe and high‐intensity statin by estimating one‐year risks of negative control outcomes influenced by frailty or health‐seeking behaviors. Inverse probability of treatment and censoring weighted estimators of risk differences (RDs) were used to evaluate residual confounding after controlling for covariates.ResultsPCSK9i initiators had lower one‐year risks of negative control outcomes associated with frailty, such as decubitus ulcer in the ASCVD cohort (PCSK9i vs. high‐intensity statin RD = −3.5%, 95% confidence interval (CI): −4.6%, −2.5%; PCSK9i vs. ezetimibe RD = −1.3%, 95% CI: −2.1%, −0.6%), with similar but attenuated associations in the LLT cohort. Lower risks of accidents and fractures were also observed for PCSK9i, varying by cohort. Risks were similar for outcomes associated with health‐seeking behaviors, although trended higher for PCSK9i in the ASCVD cohort.ConclusionsObserved associations suggest lower frailty and potentially greater health‐seeking behaviors among PCSK9i initiators, particularly those with a recent ASCVD diagnosis, with the potential to bias real‐world analyses of treatment effectiveness.
Purpose:The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol ... more Purpose:The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol guideline defines very high atherosclerotic cardiovascular disease (ASCVD) risk as a history of ≥2 major ASCVD events or 1 major ASCVD event and multiple high-risk conditions. We tested if a simplified approach, having a history of a major ASCVD event, would identify a high proportion of patients that meet the 2018 AHA/ACC cholesterol guideline criteria for very high risk.Methods:We analyzed data from US adults with health insurance in the MarketScan database who had experienced an acute coronary syndrome in the past year (recent ACS, n=3,626), a myocardial infarction (MI) other than a recent ACS (n=7,572), an ischemic stroke (n=3,551) or symptomatic peripheral artery disease (PAD, n=5,919). Patients were followed from January 1, 2016 through December 31, 2017 for recurrent ASCVD events.Results:Among 16,344 patients with a history of a major ASCVD event, 94.0% met the 2018 AHA/ACC cholesterol guideline definition for very high risk including 92.9%, 96.5%, 93.1%, and 96.2% with a recent ACS, history of MI, history of stroke and symptomatic PAD, respectively. The incidence of ASCVD events per 1,000 person-years was 50.4 (95% CI: 47.6-53.3) among all patients with a history of a major ASCVD event versus 53.1 (95% CI: 50.1-56.1) among patients who met the 2018 AHA/ACC cholesterol guideline definition of very high risk.Conclusion:The vast majority of patients with a recent ACS, history of MI, ischemic stroke or symptomatic PAD meet the 2018 AHA/ACC cholesterol guideline definition of very high risk.
TUAC0401-Four cities modelling: #2 the dynamic impact of male circumcision and curable STIs on th... more TUAC0401-Four cities modelling: #2 the dynamic impact of male circumcision and curable STIs on the heterogeneity of HIV epidemics in sub-Saharan Africa-simulation results
ImportanceLipoprotein(a) (Lp[a]) is a genetically determined risk-enhancing factor for atheroscle... more ImportanceLipoprotein(a) (Lp[a]) is a genetically determined risk-enhancing factor for atherosclerotic cardiovascular disease (ASCVD). The Lp(a) distribution among the diverse Hispanic or Latino community residing in the US has not been previously described, to the authors’ knowledge.ObjectiveTo determine the distribution of Lp(a) levels across a large cohort of diverse Hispanic or Latino adults living in the US and by key demographic groups.Design, Setting, and ParticipantsThe Hispanic Community Health Study/Study of Latinos (HCHS/SOL) is a prospective, population-based, cohort study of diverse Hispanic or Latino adults living in the US. At screening, participants aged 18 to 74 years were recruited between 2008 and 2011 from 4 US metropolitan areas (Bronx, New York; Chicago, Illinois; Miami, Florida; San Diego, California). HCHS/SOL included 16 415 noninstitutionalized adults recruited through probability sampling of randomly selected households. The study population represents His...
Background: Understanding how statins, ezetimibe, and PCSK9i (proprotein convertase subtilisin/ke... more Background: Understanding how statins, ezetimibe, and PCSK9i (proprotein convertase subtilisin/kexin type 9 serine protease inhibitors) are prescribed after a myocardial infarction (MI) or elective coronary revascularization may improve lipid-lowering therapy (LLT) intensification and reduce recurrent atherosclerotic cardiovascular disease events. We described the use and intensification of LLT among US veterans who had a MI or elective coronary revascularization between July 24, 2015, and December 9, 2019, within 12 months of hospital discharge. Methods: LLT intensification was defined as increasing statin dose, or initiating a statin, ezetimibe, or a PCSK9i, overall and among those with an LDL-C (low-density lipoprotein cholesterol) ≥ 70 or 100 mg/dL. Poisson regression was used to determine patient characteristics associated with a greater likelihood of LLT intensification following hospitalization for MI or elective coronary revascularization. Results: Among 81 372 index events ...
Journal of Acquired Immune Deficiency Syndromes, 2004
Objective: To determine whether population differences can explain the contrasting impacts on HIV... more Objective: To determine whether population differences can explain the contrasting impacts on HIV observed in the Mwanza trial of sexually transmitted disease (STD) syndromic treatment (ST), the Rakai trial of STD mass treatment (MT), and the Masaka trial of information, education, and communication (IEC) with and without ST as well as to predict the effectiveness of each intervention strategy in each population. Methods: Stochastic modeling of the transmission of HIV and 6 STDs was used with parameters fitted to demographic, sexual behavior, and epidemiological data from the trials and general review of STD/HIV biology. Results: The baseline trial populations could be simulated by assuming higher risk behavior in Uganda compared with Mwanza in the 1980s, followed by reductions in risk behavior in Uganda preceding the trials. In line with trial observations, the projected HIV impacts were larger for the ST intervention in Mwanza than for the MT intervention in Rakai or the IEC and IEC + ST interventions in Masaka. All 4 simulated intervention strategies were more effective in reducing incidence of HIV infection in Mwanza than in either Rakai or Masaka. Conclusions: Population differences in sexual behavior, curable STD rates, and HIV epidemic stage can explain most of the contrast in HIV impact observed between the 3 trials. This study supports the hypothesis that STD management is an effective HIV prevention strategy in populations with a high prevalence of curable STDs, particularly in an early HIV epidemic.
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Papers by Kate Orroth