Ami Vyas

Cholesterol target value attainment and lipid-lowering therapy in patients with stable or acute coronary heart disease: Results from the Dyslipidemia International Study II

BACKGROUND AND AIMSnLow-density lipoprotein cholesterol (LDL-C) is a major contributor to cardiovascular disease. In the Dyslipidemia International Study II (DYSIS II), we determined LDL-C target value attainment, use of lipid-lowering therapy (LLT), and cardiovascular outcomes in patients with stable coronary heart disease (CHD) and those suffering from an acute coronary syndrome (ACS).nnnMETHODSnDYSIS II included patients from 18 countries. Patients with either stable CHD or an ACS were enrolled if they were ≥18 years old and had a full lipid profile available. Data were collected at a physician visit (CHD cohort) or at hospital admission and 120 days later (ACS cohort).nnnRESULTSnA total of 10,661 patients were enrolled, 6794 with stable CHD and 3867 with an ACS. Mean LDL-C levels were low at 88xa0mg/dl and 108xa0mg/dl for the CHD and ACS cohorts respectively, with only 29.4% and 18.9% displaying a level below 70xa0mg/dl. LLT was utilized by 93.8% of the CHD cohort, with a mean daily statin dosage of 25xa0±xa018xa0mg. The proportion of the ACS cohort treated with LLT rose from 65.2% at admission to 95.6% at follow-up. LLT-treated patients, who were female, obese, or current smokers, were less likely to achieve an LDL-C level of <70xa0mg/dl, while those with type 2 diabetes, chronic kidney disease, or those taking a higher statin dosage were more likely.nnnCONCLUSIONSnFew of these very high-risk patients achieved the LDL-C target, indicating huge potential for improving cardiovascular outcome by use of more intensive LLT.

Do acute coronary events affect lipid management and cholesterol goal attainment in Germany

SummaryObjectiveTo document utilization of lipid-lowering therapy, attainment of low-density lipoprotein cholesterol target values, and cardiovascular outcomes in patients hospitalized for acute coronary syndrome in Germany.MethodsThe Dyslipidemia International Studyxa0II was axa0multicenter, observational study of the prevalence of dyslipidemia and lipid target value attainment in patients surviving any acute coronary syndrome event. Among patients on lipid-lowering therapy for ≥3xa0months, use of lipid-lowering therapy and lipid profiles were assessed at admission and again at 120u202f±u200915xa0days after admission (the follow-up time point). Multivariate logistic regression was used to identify variables predictive of low-density lipoprotein cholesterol target value attainment in patients using lipid-lowering therapy.ResultsA total of 461 patients hospitalized for acute coronary syndrome were identified, 270 (58.6%) of whom were on lipid-lowering therapy at admission. Among patients on lipid-lowering therapy, 90.7% and 85.9% were receiving statin monotherapy at admission and follow-up, respectively. Mean (SD) low-density lipoprotein cholesterol levels in patients on lipid-lowering therapy were 101 (40) mg/dl and 95 (30) mg/dl at admission and follow-up, respectively. In patients with data at both admission and follow-up (nu202f=u200961), low-density lipoprotein cholesterol target value attainment rates were the same (19.7%) at both time points. Smoking was associated with axa077% lower likelihood of attaining the low-density lipoprotein cholesterol target value.ConclusionHospitalization for an acute event does not greatly alter lipid management in acute coronary syndrome patients in Germany. Both lipid-lowering therapy doses and rates of low-density lipoprotein cholesterol target value attainment remained essentially the same several months after the event.

Prevalence of lipid abnormalities and cholesterol target value attainment in Egyptian patients presenting with an acute coronary syndrome

Background Effective management of hyperlipidemia is of utmost importance for prevention of recurring cardiovascular events after an acute coronary syndrome (ACS). Indeed, guidelines recommend a low-density lipoprotein cholesterol (LDL-C) level of <70u202fmg/dL for such patients. The Dyslipidemia International Study II (DYSIS II) – Egypt was initiated in order to quantify the prevalence and extent of hyperlipidemia in patients presenting with an ACS in Egypt. Methods In this prospective, observational study, we documented patients presenting with an ACS at either of two participating centers in Egypt between November 2013 and September 2014. Individuals were included if they were over 18u202fyears of age, had a full lipid profile available (recorded within 24u202fh of admission), and had either been taking lipid-lowering therapy (LLT) for ≥3u202fmonths at time of enrollment or had not taken LLT. Data regarding lipid levels and LLT were recorded on admission to hospital and at follow-up 4u202fmonths later. Results Of the 199 patients hospitalized for an ACS that were enrolled, 147 were on LLT at admission. Mean LDL-C at admission was 127.1u202fmg/dL, and was not significantly different between users and non-users of LLT. Only 4.0% of patients had an LDL-C level of <70u202fmg/dL, with the median distance to this target being 61.0u202fmg/dL. For the patients with LDL-C information available at both admission and follow-up, LDL-C target attainment rose from 2.8% to 5.6%. Most of the LLT-treated patients received statin monotherapy (98.6% at admission and 97.3% at follow-up), with the mean daily statin dose (normalized to atorvastatin) increasing from admission (30u202fmg/day) to follow-up (42u202fmg/day). Conclusions DYSIS II revealed alarming LDL-C goal attainment, with none of the patients with follow-up information available reaching the target of LDL-C <70u202fmg/dL, either at hospital admission or 4u202fmonths after their ACS event. Improvements in guideline adherence are urgently needed for reducing the burden of cardiovascular disease in Egypt. Strategies include the effective use of statins at high doses, or combination with other agents recommended by guidelines.

Use of guideline-recommended management in established coronary heart disease in the observational DYSIS II study

BACKGROUNDnGuidelines recommend lifestyle modification and medications to control risk factors in coronary heart disease (CHD). Using data from the observational DYSIS II study, we sought to evaluate the use of guideline-recommended treatments at discharge for acute coronary syndromes (ACS) or in the chronic phase for CHD, and participation in rehabilitation/secondary prevention programs.nnnMETHODS AND RESULTSnBetween 2013 and 2014, 10,661 patients (3867 with ACS, 6794 with stable CHD) were enrolled in 332 primary and secondary care centers in 18 countries (Asia, Europe, Middle East). Patients with incident ACS were younger and more likely to be smokers than patients with recurrent ACS or stable CHD (both pu202f<u202f0.0001). Sedentary lifestyle was common (44.4% of ACS patients; 44.2% of stable CHD patients); 22.8% of ACS patients and 24.3% of stable CHD patients were obese. Prevalence of low high-density lipoprotein cholesterol (<40u202fmg/dL in men/50u202fmg/dL in women) was 46.9% in chronic CHD and 55.0% in ACS. Rates of secondary prevention medications were lower among CHD versus ACS (all pu202f<u202f0.0001): antiplatelet 94.3% vs 98.0%, beta-blocker 72.0% vs 80.0%, lipid-lowering therapy 94.7 vs 97.5%, and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers 69.4% vs 73.7%, respectively. Attendance at cardiac rehabilitation (16.8% of patients with a first ACS, 10.8% with recurrent ACS) or a secondary prevention program (3.7% of ACS and 11.7% of stable CHD patients) was infrequent.nnnCONCLUSIONSnThe high prevalence of risk factors in all CHD patients and reduced rates of secondary prevention medications in stable CHD offer areas for improvement.nnnTRANSLATIONAL ASPECTSnThe findings of DYSIS II may reinforce the importance of adopting a healthy lifestyle and prescribing (by clinicians) and adhering (by patients) to evidence-based medications in the management of CHD, not only during the short term but also over the longer term after a cardiac ischemic event. The results may help to increase the proportion of ACS patients who are referred to cardiac rehabilitation centres.

Low-density lipoprotein cholesterol target attainment in patients with stable or acute coronary heart disease in the Asia-Pacific region: results from the Dyslipidemia International Study II

Background As mortality due to cardiovascular disease increases throughout the world, accurate data on risk factors such as hyperlipidemia are required. This is lacking in the Asia-Pacific region. Design The observational Dyslipidemia International Study (DYSIS) II was established to quantify the extent of hyperlipidemia in adults with acute and stable coronary heart disease globally. Methods Patients with stable coronary heart disease or hospitalised with an acute coronary syndrome were enrolled across nine Asia-Pacific countries from July 2013 to October 2014. Lipid-lowering therapy and low-density lipoprotein cholesterol target attainment (<70u2009mg/dL) were assessed. The acute coronary syndrome cohort was followed up 4 months post-discharge. Results Of the 4592 patients enrolled, 2794 had stable coronary heart disease and 1798 were admitted with an acute coronary syndrome. In the coronary heart disease cohort, the mean low-density lipoprotein cholesterol level was 86.9u2009mg/dL, with 91.7% using lipid-lowering therapy and 31% achieving low-density lipoprotein cholesterol of less than 70u2009mg/dL. In the acute coronary syndrome cohort at admission, the corresponding values were 103.2u2009mg/dL, 63.4% and 23.0%, respectively. Target attainment was significantly higher in lipid-lowering therapy-treated than non-treated patients in each cohort (32.6% vs. 12.9% and 31.1% vs. 9.0%, respectively). Mean atorvastatin-equivalent dosages were low (20u2009±u200915 and 22u2009±u200918u2009mg/day, respectively), with little use of non-statin adjuvants (13.0% and 6.8%, respectively). Low-density lipoprotein cholesterol target attainment had improved by follow-up for the acute coronary syndrome patients, but remained low (41.7%). Conclusions Many patients in Asia at very high risk of recurrent cardiovascular events had a low-density lipoprotein cholesterol level above the recommended target. Although lipid-lowering therapy was common, it was not used to its full potential.

Contemporary data on treatment practices for low-density lipoprotein cholesterol in 6794 patients with stable coronary heart disease across the world

DYSIS II CHD was a longitudinal, observational study in 6794 patients from 18 countries. They were attending an outpatient physician appointment for coronary heart disease (CHD). 6370 patients (93.8%) were on active lipid lowering therapy (LLT). The mean atorvastatin dose equivalent was 25u202fmg per day and 10.5% received ezetimibe in combination with a statin. The mean low-density lipoprotein cholesterol (LDL-C) level was 88u202fmg/dL, with 29.4% of patients displaying a level below the 70u202fmg/dL target for very high-risk subjects. Conclusion While more than 90% of patients with CHD were on lipid lowering drugs, only three out of ten patients achieved their LDL-C target value.

Contemporary data on treatment practices for low-density lipoprotein cholesterol in 3867 patients who had suffered an acute coronary syndrome across the world

DYSIS II ACS was a longitudinal, observational study in 3867 patients from 18 countries. They were being hospitalized after suffering an acute coronary syndrome. Evaluations were performed at the time of admission and again 120±15 days following the date of admission (the follow-up time point). 2521 patients were on active lipid lowering treatment (LLT) at admission. Mean atorvastatin dose was 22 mg per day and 2.7% received ezetimibe in combination with a statin. At discharge from hospital, 3767 patients received LLT expressed as a mean atorvastatin dose of 36 mg per day with 4.8% receiving ezetimibe on top of a statin. After 120 days, intensity in lipid lowering treatment was reduced to 32 mg per day with 4.9% of the patients receiving ezetimibe and a statin. Of note, during this 4-month follow up period, only 32% of all patients received laboratory lipid testing. 37% attained the low density lipoprotein cholesterol (LDL-C) target value of <70 mg/dl after 120 days. There are differences in the therapy administered as well as in the switch strategies when comparing the data from the respective countries studied. Conclusions Only one in three patients achieved the LDL-C target value following only marginal improvements in atorvastatin dose or combination therapy after an ACS event.

Frequency and predictors of cholesterol target attainment in patients with stable coronary heart disease in Belgium: results from the Dyslipidemia International Study II (DYSIS II CHD)

ABSTRACT Objectives: To document the frequency and predictors of low-density lipoprotein cholesterol (LDL-C) target value attainment among patients with coronary heart disease (CHD) in Belgium. Methods: The second Dyslipidemia International Study (DYSIS II) was an observational study of the prevalence of dyslipidemias and lipid target value attainment. Patients in this analysis were aged ≥ 18, had documented CHD, and had a full lipid profile. Use of lipid-lowering therapy (LLT), lipid profile, and LDL-C target value attainment (< 70 mg/dL) were assessed cross-sectionally at the enrollment visit. The distribution of LLTs was assessed among treated patients. Multivariate logistic regression was used to identify variables predictive of LDL-C target value attainment in treated patients. Results: We identified 409 patients with CHD in Belgium, 387 (94.6%) of whom were on LLT at the time of the lipid profile. Among treated patients, the rate of LDL-C target value attainment was 40.6%, and statin monotherapy was the most commonly used LLT (79.3%). Among users of statin monotherapy or combination therapy, simvastatin was the most commonly used treatment (41.6% of patients). Diabetes was associated with higher odds of LDL-C target value attainment (OR 2.29, 95% CI 1.33–3.93), and female gender was associated with lower odds (OR 0.48, 95% CI 0.24–0.97). Conclusion: Rates of LDL-C target value attainment are low in patients with CHD in Belgium. Intensifying statin therapy or combining it with non-statins is essential in Belgian patients for optimal LDL-C reduction.

Changes in Treatment Patterns and Incremental Health Care Utilization Due to P2Y12-Associated Complications in Patients with Acute Coronary Syndrome

BACKGROUNDnP2Y12 antiplatelet therapy (APT) is highly efficacious in reducing the incidence of ischemic events in patients with acute coronary syndrome (ACS); however, it is associated with several adverse complications. Data on P2Y12-associated complications and adherence to APT are sparse.nnnOBJECTIVEnTo describe the characteristics, frequency of P2Y12-associated complications, adherence and persistence to P2Y12 APT, and health care utilization among ACS patients on P2Y12 APT.nnnMETHODSnThis retrospective observational study of the MarketScan Commercial Claims and Encounters Database identified patients aged ≥ 18 years who were discharged from an ACS hospitalization in 2012-2014 and initiated P2Y12 APT (ticagrelor, prasugrel, or clopidogrel). The proportion of patients within each treatment group who experienced P2Y12-associated complications within 1 year and who were adherent to APT were determined. Frequencies of all-cause health care utilization (i.e., hospitalization, length of stay, emergency room [ER] visits, outpatient visits, cardiac events, and transfusions) were evaluated for each treatment group. Poisson regressions were conducted to evaluate the association between nonad-herence with P2Y12 APT and health care utilization, after adjusting for demographics (age and gender), health insurance type, and comorbidities.nnnRESULTSnAmong 11,629 ACS patients, most were male; 44.6% had hypertension; 20.6% had diabetes; and 53.4% had hyperlipidemia. Clopidogrel use was common (62.6%), with ticagrelor use less common (9.0%). Among all groups, approximately one third experienced P2Y12-associated complications. One-year adherence to APT was suboptimal (68% overall), with 73.3% adherence among prasugrel users, followed by 71.4% adherence among ticagrelor users and 65.6% adherence among clopidogrel users. Switching was most common with ticagrelor users. Inpatient hospitalizations, cardiac events, and transfusions were more common in clopidogrel users compared with prasugrel and ticagrelor users. Nonadherent patients experienced significantly more hospitalizations, ER visits, and transfusions (1.34, 1.09, and 1.85 [P < 0.05], respectively) compared with adherent patients. These trends of association remained consistent across all treatment groups. Also, patients not adherent to ticagrelor experienced 1.9 times as many cardiac events as adherent patients. However, this association was not significant for clopidogrel and prasugrel users. Patients not adherent to P2Y12 APT experienced significantly lower outpatient visits compared with adherent patients.nnnCONCLUSIONSnComplications associated with P2Y12 in ACS patients treated with P2Y12 APT were common, with dyspnea, heart block, and major or life-threatening bleeding as the most common. Adherence was significantly associated with lower health care utilization. Increased adherence to secondary prevention therapy among these very high-risk patients is crucial. Disease management strategies to improve adherence and reduce treatment-associated adverse events through individualized patient care, alternative secondary treatment options, and physician awareness should be designed, implemented, and sustained.nnnDISCLOSURESnData analysis was conducted by Merck & Co., the manufacturer of vorapaxar (ZONTIVITY). At the time of this study, Vyas was an employee of Rutgers University, which received grant funding from Merck & Co. for this study, and is now employed with the University of Rhode Island. Patel was employed by Symphony Solutions and the University of North Carolina during the drafting and revising of the manuscript. Bash is employed by Merck & Co. Simpson received consulting fees from Merck & Co. for work on this study and has received fees for research from Amgen and Pfizer. Study concept and design were contributed by Vyas, Bash, Patel, and Simpson. Patel took the lead in data collection, assisted by the other authors. All the authors contributed equally to data analysis and manuscript preparation. The abstract for this study was presented as a poster at the American Heart Association Scientific Sessions 2016; November 12-16, 2016; New Orleans, Louisiana.