CLINICAL RESEARCH STUDY

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1 CLINICAL RESEARCH STUDY Determining Triglyceride Reductions Needed for Clinical Impact in Severe Hypertriglyceridemia Jennifer B. Christian, PharmD, MPH, PhD, a Bhakti Arondekar, BPharm, MBA, PhD, b Erin K. Buysman, MS, c Terry A. Jacobson, MD, d Rose G. Snipes, MD, e Ralph I. Horwitz, MD f a Clinical Effectiveness and Safety, GlaxoSmithKline, Durham, NC; b US Health Outcomes, GlaxoSmithKline, Philadelphia, Pa; c Health Economics and Outcomes, OptumInsight, Eden Prairie, Minn; d Department of Medicine, Emory University, Atlanta, Ga; e Medicines Discovery & Development, GlaxoSmithKline, Durham, NC; f Clinical Effectiveness and Safety, GlaxoSmithKline, Philadelphia, Pa. ABSTRACT BACKGROUND: Patients with severe hypertriglyceridemia have an increased risk of cardiovascular disease and pancreatitis. Target triglyceride levels associated with clinical benefit for patients with severe hypertriglyceridemia are not currently known. This study evaluates the association between lower follow-up triglyceride levels and incidence of clinical events for patients with severe hypertriglyceridemia. METHODS: By using claims data from 2 large US healthcare databases, we conducted a retrospective cohort study and identified 41,210 adults with severe hypertriglyceridemia (triglycerides 500 mg/dl) between June 2001 and September The date of the first severe hypertriglyceridemia laboratory result was the index date. Patients were categorized into 1 of 5 triglyceride ranges (<200 mg/dl, mg/dl, mg/dl, mg/dl, and 500 mg/dl) based on a follow-up triglyceride level assessed 6 to 24 weeks after initial triglyceride levels were measured. Adjusted Cox regression models were developed to evaluate the impact of follow-up triglyceride levels on rates of pancreatitis episodes and cardiovascular events. RESULTS: The mean age of patients was 50 years, 72% were male, and the mean follow-up was 825 days. Patients with severe hypertriglyceridemia with follow-up triglyceride levels <200 mg/dl experienced a lower rate of pancreatitis episodes (adjusted incidence rate ratio, 0.45; 95% confidence interval, ) and cardiovascular events (adjusted incidence rate ratio, 0.71; 95% confidence interval, ) with some clinical benefit in adults with severe hypertriglyceridemia with follow-up triglyceride levels 200 to 299 mg/dl and 300 to 399 mg/dl (P <.001 for trend). CONCLUSIONS: We observed the greatest impact on clinical events among patients with severe hypertriglyceridemia with the lowest follow-up triglyceride levels. Ó 2014 Elsevier Inc. All rights reserved. The American Journal of Medicine (2014) 127, KEYWORDS: Cardiovascular; Epidemiology; Pancreatitis; Severe hypertriglyceridemia There are approximately 3 to 4 million adults in the United States with severe hypertriglyceridemia, defined as having triglyceride levels 500 mg/dl. 1 Triglyceride levels 150 mg/dl are associated with an increased risk of Funding: This study was supported by GlaxoSmithKline. Conflict of Interest: JBC, BA, RS, and RH are employees of and own stock in GlaxoSmithKline. TJ is a consultant for Abbott, Amarin, GlaxoSmithKline, and Merck. EKB has no conflict of interest to report. Authorship: All authors had access to the data and played a role in writing this manuscript. Requests for reprints should be addressed to Jennifer B. Christian, PharmD, MPH, PhD, GlaxoSmithKline, 5 Moore Drive, B.3116, Durham, NC address: Jennifer.B.Christian@GSK.com cardiovascular disease in men and women. 2 Severe hypertriglyceridemia is associated with an even greater risk of acute pancreatitis, 3 premature coronary heart disease, 4,5 and mortality due to cardiovascular disease. 6 Some of the risk factors associated with severe hypertriglyceridemia include genetic disorders, lifestyle factors (eg, excess alcohol intake, cigarette smoking, physical inactivity, and high carbohydrate diets), certain drugs (eg, hormone therapy), and other diseases (eg, type 2 diabetes, chronic renal failure, and metabolic syndrome). 7 The current guidelines from the National Cholesterol Education Program Adult Treatment Panel III 7 recommend reducing triglycerides to less than 500 mg/dl to prevent acute pancreatitis before addressing issues related to /$ -see front matter Ó 2014 Elsevier Inc. All rights reserved.

2 Christian et al Triglyceride Levels and Clinical Impact 37 nonehigh-density lipoprotein cholesterol and low-density lipoprotein cholesterol for patients with severe hypertriglyceridemia. Indeed, one study 8 found that 20% of patients with severe hypertriglyceridemia experience at least 1 episode of acute pancreatitis, the majority of which were considered severe. Therefore, the primary clinical recommendations for patients with severe hypertriglyceridemia are to decrease triglycerides to first reduce the risk of acute pancreatitis, with a secondary focus on decreasing cardiovascular risk. Guideline recommendations for reducing triglycerides include the use of triglyceride-lowering treatments (eg, fibrates, niacin, and omega-3 fatty acids), in addition to lifestyle modification (eg, weight control and increased physical activity). Although lowering triglyceride levels is recommended to reduce the risk of coronary heart disease and cardiovascular events, 9 there is little evidence to demonstrate the impact of triglyceride reductions on the risk of clinical events in patients with severe CLINICAL SIGNIFICANCE hypertriglyceridemia In addition, among patients with severe hypertriglyceridemia, the level of triglyceride reduction that is associated with a reduced risk is not currently known. The primary objective of this study was to examine the association between the follow-up triglyceride levels and the incidence of pancreatitis episodes and cardiovascular events among patients with severe hypertriglyceridemia. Although target triglyceride levels associated with clinical benefit for patients with severe hypertriglyceridemia (500 mg/dl) currently are not known, our study showed that patients with severe hypertriglyceridemia who decreased their triglyceride levels to <200 mg/dl experienced the greatest benefit. Patients with triglycerides of <200 mg/ dl at follow-up had lower rates of pancreatitis and cardiovascular events, such as acute myocardial infarction, ischemic stroke, heart failure, revascularization procedures, and acute coronary syndrome. The results reflect real-world, objective clinical data from a large geographically diverse patient population over 2 years. All study data were accessed using techniques compliant with the Health Insurance Portability and Accountability Act of 1996, 13 and no identifiable protected health information was extracted during the course of the study. Because this study involved analysis of preexisting, de-identified data, institutional review board approval was not required. Study Patient Identification We identified 104,817 adult patients who had at least 1 triglyceride laboratory result 500 mg/dl during the study period between June 1, 2001, and September 30, 2010; had continuous enrollment with medical and pharmacy claims for 6 months before the index date and at least 90 days after the index date; and had no medical claims indicating pregnancy. The index date was the date of the first severe hypertriglyceridemia laboratory result during the study period. We then limited our sample to the 41,210 patients who had at least 1 followup triglyceride laboratory result during a period of 6 to 24 weeks after the index date. The date of the earliest triglyceride laboratory result in this period was set as the follow-up laboratory date. Patients were then categorized into 1 of 5 follow-up triglyceride level ranges on the basis of their follow-up triglyceride laboratory result (<200 mg/dl, mg/dl, mg/dl, mg/dl, and 500 mg/dl). MATERIALS AND METHODS Data Sources This was a retrospective cohort study using medical, pharmacy, laboratory, and enrollment claims information from 2 large, US health care claims databases (Optum s Research Database; IMPACT National Benchmarking Database [formerly known as IHCIS]). Individuals covered by these health plans have medical and pharmacy benefits through commercial or Medicare Advantage insurance and are geographically diverse across the United States. Medical (professional, facility) claims included International Classification of Diseases, 9th Revision, Clinical Modification (ICD- 9-CM) diagnosis codes, ICD-9 procedure codes, Current Procedural Terminology, Version 4 procedure codes, Healthcare Common Procedure Coding System procedure codes, and site of service codes. Outpatient pharmacy claims provided National Drug Codes for dispensed medications, quantity dispensed, drug strength, and number of days of supply. Study Measures Patient Demographics and Baseline Clinical Characteristics. The patient characteristics that were examined included age, gender, insurance type, geographic location, and length of the follow-up period (days). The baseline clinical characteristics that were collected during the 6 months preceding the index date included the Quan- Charlson comorbidity score, 14 history of cardiovascular disease, hypertension, dyslipidemia, diabetes mellitus, pancreatitis, chronic kidney disease, end-stage renal disease, and medication use (statins, triglyceride-lowering agents, hormone replacement therapy, steroids, and beta-blockers). The use of statins and triglyceride-lowering medications also was evaluated during the period between the index triglyceride result and the follow-up triglyceride result. Also examined were baseline triglycerides, total cholesterol, high-density lipoprotein, and nonehigh-density lipoprotein values.

3 38 The American Journal of Medicine, Vol 127, No 1, January 2014 Outcomes. The follow-up period began with the day after the follow-up laboratory date and ended with patient disenrollment, pregnancy, or study end (December 31, 2010), whichever occurred first. The clinical outcomes examined during the follow-up period included pancreatitis episodes and composite and individual cardiovascular events. Episodes of pancreatitis were determined using the primary diagnosis in a patient s medical claim of ICD-9-CM or Claims for cardiovascular events were identified with a primary diagnosis or procedure code indicating acute myocardial infarction, stroke (ischemic or hemorrhagic), heart failure, coronary revascularization procedures (percutaneous coronary intervention, coronary artery bypass graft, percutaneous transluminal angioplasty), acute coronary syndrome, or sudden death. If patients had multiple cardiovascular events, the time to the first event was captured for each type of event. An overall cardiovascular event measure was captured on the basis of the presence of any of individual events described earlier. The codes used to identify all of the clinical outcomes in this study are included in Appendix Table 1 (online). Analysis. Patient demographics and baseline clinical characteristics were analyzed descriptively. For each outcome of interest, crude incidence rate ratios (IRRs) were calculated and multivariate Cox proportional hazards models were developed to adjust for key confounders. Hazard ratios were interpreted as adjusted IRRs (IRR adj ). Covariates for each model were selected on the basis of clinical relevance and model fit, and are listed in Appendix Table 2 (online). Patients whose triglyceride levels remained elevated 500 mg/dl at the follow-up laboratory measurement were considered the reference group for all IRR adj. In addition, several post hoc analyses were conducted to determine the number of patients who developed pancreatitis in the follow-up period with baseline and follow-up triglyceride levels 1000 mg/dl. The study population was stratified by baseline triglyceride levels of 500 to 999 mg/dl and 1000 mg/dl to compare crude incidence rates and IRRs of pancreatitis episodes by follow-up triglyceride level, including an additional follow-up group of triglyceride level 1000 mg/dl. A second post hoc analysis was conducted to assess the risk of pancreatitis in patients with no evidence of pancreatitis in the baseline period. RESULTS Figure 1 displays the criteria used in the patient selection process. After applying all of the selection criteria, 41,210 patients were included in the study. Patients had an average of 94 days between the date of their index severe hypertriglyceridemia value and their follow-up triglyceride result. Approximately 79% of the patients with severe hypertriglyceridemia (n ¼ 32,717) experienced a reduction in triglyceride levels to <500 mg/dl between the index date and the follow-up laboratory date. Approximately 25% of patients had a follow-up triglyceride level <200 mg/dl. Table 1 displays the baseline patient demographics and clinical characteristics for the entire sample and for each of the 5 triglyceride groups based on their follow-up triglyceride levels. Patients were followed for an average of 825 days after the follow-up laboratory date. Overall, 72% were male with a mean age of 50 years, 91% of all patients were commercially insured, and 53% of all patients were living in the South. The overall mean Quan-Charlson comorbidity index score was 0.89, and the overall percentage of patients with each baseline comorbidity of interest included dyslipidemia (41%), hypertension (32%), diabetes (21%), cardiovascular disease history (11%), chronic kidney disease/end-stage renal disease (3%), and pancreatitis (<1%). A significantly greater percentage of patients with a follow-up triglyceride level 500 mg/dl had a history of diabetes and pancreatitis when compared with each of the other 4 triglyceride groups. Medication use during the baseline period is shown in Table 1. Medication use in the total sample included statins (31%), triglyceride-lowering medications (14%), betablockers (21%), steroids (12%), and hormone replacement therapy (4%). Patients with a follow-up triglyceride level 500 mg/dl were more often prescribed at least 1 triglyceride-lowering medication in the baseline period when compared with each of the other 4 triglyceride groups (10%, <200 mg/dl; 13%, mg/dl; 15%, mg/dl; 16%, mg/dl; 20%, 500 mg/dl; P <.001, all triglyceride groups). In the period between the index triglyceride result and the follow-up laboratory date ( index period), the use of triglyceride-lowering therapy was significantly higher among patients with follow-up triglyceride levels between 200 and 299 mg/dl (36%; P <.001) and <200 mg/dl (43%; P <.001) compared with patients with follow-up triglyceride levels 500 mg/dl (30%). Figure 2 shows the mean and interquartile range for baseline and follow-up laboratory results for each of the 5 follow-up triglyceride level groups. Because low-density lipoprotein cholesterol cannot be measured reliably in patients with severe hypertriglyceridemia, nonehighdensity lipoprotein cholesterol was calculated as total cholesterol minus high-density lipoprotein cholesterol. The mean baseline laboratory values across all patients were 761 mg/dl for triglycerides, 250 mg/dl for total cholesterol, 213 mg/dl for nonehigh-density lipoprotein, and 37 mg/dl for high-density lipoprotein. The mean follow-up laboratory values across all patients were 385 mg/dl for triglycerides, 200 mg/dl for total cholesterol, 160 mg/dl for none high-density lipoprotein, and 40 mg/dl for high-density lipoprotein. Figure 3 displays the crude incidence rates, per 100 person-years, for each clinical outcome of interest in the follow-up period. The incidence rates for pancreatitis ranged from 0.40 per 100 person-years for patients with follow-up triglyceride levels <200 mg/dl to 1.09 per 100 person-years for patients with follow-up triglyceride levels 500 mg/dl.

4 Christian et al Triglyceride Levels and Clinical Impact 39 Figure 1 Patient selection. Likewise, the incidence rates for overall cardiovascular events ranged from 3.62 per 100 person-years among patients with follow-up triglyceride levels <200 mg/dl to 6.06 per 100 person-years among patients with follow-up triglyceride levels 500 mg/dl. A trend test indicated that there was a significant linear trend associated with patients with lower follow-up triglyceride levels for the crude rates associated with each of the clinical events in the follow-up period (P <.001) for all outcomes except for hemorrhagic stroke and sudden death (data not shown). The incidence rates for each of the clinical events in the follow-up period increased with increasing triglyceride levels tested at the follow-up laboratory date. Figure 4 displays the IRR adj for each of the clinical outcomes in the follow-up period. Cox proportional hazards models were used to adjust the IRRs for clinically important covariates. Patients with severe hypertriglyceridemia with follow-up triglyceride levels <200 mg/dl were significantly less likely to experience all of the clinical events in the follow-up period when compared with the patients with severe hypertriglyceridemia whose follow-up triglyceride levels were 500 mg/dl: pancreatitis IRR adj : 0.45 [95% confidence interval {CI}, ]; cardiovascular event IRR adj : 0.71 [95% CI, ]; acute myocardial infarction IRR adj : 0.64 [95% CI, ]; ischemic stroke IRR adj : 0.64 [95% CI, ]; heart failure IRR adj : 0.66 [95% CI, ]; revascularization IRR adj : 0.62 [95% CI, ]; and acute coronary syndrome IRR adj : 0.72 [95% CI, ]. Hemorrhagic stroke and sudden death were excluded from the multivariate analysis given the limited number of total events in these categories. Also when adjusted for key covariates, patients with severe hypertriglyceridemia with follow-up triglyceride

5 Table 1 Baseline Demographics and Clinical Characteristics Follow-Up Triglyceride Level <200 mg/dl (N ¼ 10,074) mg/dl (N ¼ 9950) (N ¼ 7709) mg/dl (N ¼ 4984) 500 mg/dl (N ¼ 8493) Total (N ¼ 41,210) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Age, y 50.4 (11.2) 49.9 (11.1) 50.7 (11.3) 50.8 (11.3) 51.2 (11.4) 50.1 (11.1) Follow-up (d) (722.8) (703.6) (722.3) (712.8) (741.7) (742.4) Quan-Charlson 0.9 (1.4) 0.7 (1.2) 0.8 (1.4) 0.9 (1.5) 1.0 (1.6) 1.1 (1.6) Age Groups, y n (%) n (%) n (%) n (%) n (%) n (%) ,500 (30.3) 3200 (31.8) 2981 (30.0) 2287 (29.7) 1383 (27.7) 2649 (31.2) ,614 (59.7) 5991 (59.5) 5953 (59.8) 4596 (59.6) 3038 (61.0) 5036 (59.3) (9.9) 883 (8.8) 1016 (10.2) 826 (10.7) 563 (11.3) 808 (9.5) Gender n (%) n (%) n (%) n (%) n (%) n (%) Male 29,596 (71.8) 7547 (74.9) 7075 (71.1) 5304 (68.8) 3479 (69.8) 6191 (72.9) Female 11,614 (28.2) 2527 (25.1) 2875 (28.9) 2405 (31.2) 1505 (30.2) 2302 (27.1) Baseline comorbidities n (%) n (%) n (%) n (%) n (%) n (%) Cardiovascular disease history 4356 (10.6) 901 (8.9) 1021 (10.3) 896 (11.6) 576 (11.6) 962 (11.3) Hypertension 13,127 (31.8) 2982 (29.6) 3161 (31.8) 2533 (32.9) 1667 (33.4) 2784 (32.8) Dyslipidemia 16,946 (41.1) 3999 (39.7) 4129 (41.5) 3223 (41.8) 2072 (41.6) 3523 (41.5) Diabetes (type 1 or 2) 8790 (21.3) 1574 (15.6) 1962 (19.7) 1729 (22.4) 1215 (24.4) 2310 (27.2) Pancreatitis 214 (0.5) 44 (0.4) 29 (0.3) 31 (0.4) 26 (0.5) 84 (1.0) Chronic kidney disease/end-stage renal disease 1177 (2.9) 214 (2.1) 270 (2.7) 236 (3.1) 155 (3.1) 302 (3.6) Baseline medication use n (%) n (%) n (%) n (%) n (%) n (%) Statins 12,742 (30.9) 2915 (28.9) 3040 (30.5) 2453 (31.8) 1626 (32.6) 2708 (31.9) Triglyceride-lowering medication 5952 (14.4) 1054 (10.5) 1276 (12.8) 1144 (14.8) 773 (15.5) 1705 (20.1) Hormone replacement therapy 1692 (4.1) 307 (3.0) 419 (4.2) 336 (4.4) 235 (4.7) 395 (4.6) Steroids 5134 (12.5) 1139 (11.3) 1266 (12.7) 989 (12.8) 640 (12.8) 1100 (12.9) Beta-blockers 8555 (20.8) 1681 (16.7) 1965 (19.7) 1724 (22.4) 1224 (24.6) 1961 (23.1) Index medication use n (%) n (%) n (%) n (%) n (%) n (%) Statins 15,509 (37.6) 3774 (37.5) 3779 (38.0) 2955 (38.3) 1909 (38.3) 3092 (36.4) Triglyceride-lowering medication 14,356 (34.8) 4314 (42.8) 3606 (36.2) 2389 (31.0) 1479 (29.7) 2568 (30.2) SD ¼ standard deviation. 40 The American Journal of Medicine, Vol 127, No 1, January 2014

6 Christian et al Triglyceride Levels and Clinical Impact 41 Figure 2 Laboratory results stratified by follow-up triglyceride level (mg/dl). levels between 200 and 299 mg/dl experienced a lower rate of pancreatitis episodes (IRR adj : 0.46 [95% CI, ]), overall cardiovascular events (IRR adj : 0.81 [95% CI, ]), acute myocardial infarction (IRR adj : 0.77 [95% CI, ]), heart failure (IRR adj : 0.77 [95% CI, ]), revascularization (IRR adj : 0.79 [95% CI, Figure 3 Crude incidence rates (per 100 person-years) for clinical events in the follow-up period stratified by follow-up triglyceride level (mg/dl).

7 42 The American Journal of Medicine, Vol 127, No 1, January 2014 Figure 4 Adjusted IRRs* for clinical events in the follow-up period stratified by follow-up triglyceride level (mg/dl). Reference group is follow-up triglyceride levels 500 mg/dl ]), and acute coronary syndrome (IRR adj : 0.76 [95% CI, ]) compared with patients with severe hypertriglyceridemia with follow-up laboratory results >500 mg/dl. In addition, patients with severe hypertriglyceridemia with a follow-up triglyceride level between 300 and 399 mg/dl had a significantly lower adjusted incidence for pancreatitis (IRR adj : 0.64 [95% CI, ]); overall cardiovascular events (IRR adj : 0.88 [CI, ]); and heart failure (IRR adj : 0.77 [CI, ]) compared with patients with a follow-up triglyceride level that remained elevated at 500 mg/dl. In contrast, the event rates for patients with follow-up triglyceride levels between 400 and 499 mg/dl were not significantly different from the patients with follow-up triglyceride levels 500 mg/dl, except for ischemic stroke (IRR adj : 0.67 [95% CI, ]) in the follow-up period. The post hoc analysis of the risk of pancreatitis in patients without evidence of prior pancreatitis at baseline showed similar results of the analysis in the overall sample. Adjusted incidence rates among patients without evidence of prior pancreatitis at baseline indicated lower risk of pancreatitis in patients who decreased their triglycerides to 300 to 399 mg/dl (IRR adj : 0.60 [95% CI, ]), 200 to 299 mg/dl (IRR adj : 0.45 [95% CI, ]), and <200 mg/dl (IRR adj : 0.43 [95% CI, ]) compared with patients with triglyceride levels 500 mg/dl. Other post hoc results indicated that although patients with baseline triglyceride levels 1000 mg/dl experienced higher

8 Christian et al Triglyceride Levels and Clinical Impact 43 crude incidence rates of pancreatitis, they had similar IRRs as patients with baseline triglyceride levels 500 to 999 mg/dl (data not shown) when compared by follow-up triglyceride levels. DISCUSSION In this large retrospective claims study, we found that lower follow-up triglyceride levels were associated with a lower incidence of important clinical events for patients with severe hypertriglyceridemia. Some clinical benefit was found for patients with severe hypertriglyceridemia whose follow-up triglyceride levels were <400 mg/dl. However, the greatest clinical benefit was observed among those patients whose follow-up triglyceride level was <200 mg/dl, which included a significant reduction in the rates of pancreatitis and overall and individual cardiovascular events. Although severe hypertriglyceridemia treatment guidelines focus on lowering triglyceride levels to reduce the risk of acute pancreatitis and cardiovascular disease, 7 clear evidence has been lacking for the extent to which reduced triglyceride levels could decrease the rate of cardiovascular outcomes. 9 Indeed, the independent relationship of elevated triglycerides and increased risk of future cardiovascular events has long been controversial. Some studies have found that the beneficial effects of reducing triglyceride levels on cardiovascular disease were attenuated after adjusting for established risk factors, such as blood pressure, total cholesterol, low-density lipoprotein cholesterol, and low levels of high-density lipoprotein cholesterol Furthermore, although the benefit of lowering triglyceride levels has been recognized, target triglyceride levels that are associated with a reduced risk of cardiovascular disease have not been identified, particularly in patients with severe hypertriglyceridemia. 9 Study Limitations Our previous study used a threshold follow-up triglyceride laboratory value of <500 mg/dl based on current guidelines and examined the association between follow-up triglyceride levels <500 mg/dl and clinical outcomes and their associated costs. 10 The current study focused on the relationship between follow-up triglyceride level ranges and their associated rates of clinical outcomes. Our results suggest that <500 mg/dl may represent a critical threshold for lower cardiovascular events in patients with severe hypertriglyceridemia, but follow-up triglyceride levels <200 mg/dl could result in even greater clinical benefit for the patient. Although it is beyond the scope of our database analysis to measure and examine the impact of different interventions on lower follow-up triglyceride levels, we did find a greater proportion of patients with follow-up laboratory results <300 mg/dl initiating triglyceridelowering medications between the baseline and the followup laboratory period compared with patients with severe hypertriglyceridemia with follow-up triglyceride levels 500 mg/dl (<200 mg/dl: 43%; mg/dl: 36%; 500 mg/dl 30%, P <.001). However, our claims database does not capture many variables that are often associated with reducing (or increasing) triglyceride levels, such as lifestyle modifications (eg, diet and exercise), restricted alcohol and fat intake, smoking cessation, improved management of comorbidities, and normal physiologic variations in triglyceride levels. Also, ethnicity, smoking, and body mass index were not available in our claims database. However, the intent of this study was to evaluate the association between follow-up triglyceride levels and incidence of clinical events rather than specific interventions used to reduce triglycerides. Another limitation is that fasting status is not available in claims data, so the triglyceride laboratory results may have included elevated triglyceride levels that were not an accurate reflection of the patient s true triglyceride level, with the subsequent assignment of some patients to the incorrect follow-up triglyceride level group. However, this bias would result in more patients being classified as having falsely higher follow-up triglyceride levels, which would likely attenuate the results. In addition, recent studies have suggested that elevated nonfasting triglyceride levels may be a better predictor of cardiovascular events than fasting triglyceride levels. 19,20 Finally, some patients with severe hypertriglyceridemia may have been excluded from this study because of missing triglyceride laboratory results, and some of the laboratory results may have been missing for those patients who did have laboratory data. However, missing laboratory results are a function of the processing center that supplies the results; therefore, it is expected that patients with missing laboratory results should not be systematically different from the patients without missing laboratory results. Despite the potential limitations, this study provides a real-world view of the relationship between triglyceride levels and the incidence of important clinical events. Our study had a large sample of patients with continuous followup for an average of 2.2 years, and data are based on claims rather than self-report. The databases used in this study contain claims from a wide geographic distribution of patients across the United States; therefore, our results are applicable to members of managed care populations at a national level. CONCLUSIONS In this large retrospective claims study, we observed that lower levels of triglycerides at follow-up were associated with larger reductions in incidence of important clinical events for patients with severe hypertriglyceridemia. Some clinical benefit was observed for patients with severe hypertriglyceridemia with follow-up triglyceride levels <400 mg/dl. However, the greatest clinical benefit was found for patients with severe hypertriglyceridemia with triglyceride levels <200 mg/dl at follow-up, which included a reduction in the incidence rates of pancreatitis,

9 44 The American Journal of Medicine, Vol 127, No 1, January 2014 overall cardiovascular events, acute myocardial infarction, ischemic stroke, heart failure, revascularization, and acute coronary syndrome. ACKNOWLEDGMENTS The authors thank Paul Buzinec, MS, Randall Gerdes, and Jonathan Kurlander, MS, who provided programming and analytic support, and Virginia M. Rosen, PhD, and Dawn Nicewarner, PhD, who provided editorial assistance on behalf of OptumInsight, which was contracted by Glaxo- SmithKline to conduct this study. References 1. Christian JB, Bourgeois N, Snipes R, Lowe KA. Prevalence of severe (500 to 2,000 mg/dl) hypertriglyceridemia in United States adults. Am J Cardiol. 2011;107: Austin MA, Hokanson JE, Edwards KL. Hypertriglyceridemia as a cardiovascular risk factor. Am J Cardiol. 1998;81(4A):7B-12B. 3. Gan SI, Edwards AL, Symonds CJ, Beck PL. Hypertriglyceridemiainduced pancreatitis: a case-based review. World J Gastroenterol. 2006;12: Greenberg BH, Blackwelder WC, Levy RI. Primary type V hyperlipoproteinemia. A descriptive study in 32 families. Ann Intern Med. 1977;87: Steiner G, Adelman AG, Silver MD. Early coronary atherosclerosis in primary type V hyperlipoproteinemia. Can Med Assoc J. 1971;105: Neil HA, Cooper J, Betteridge DJ, et al. All-cause and cardiovascular mortality in treated patients with severe hypertriglyceridaemia: a longterm prospective registry study. Atherosclerosis. 2010;211: National Cholesterol Education Program. Detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III): Final Report Available at: guidelines/cholesterol/index.htm. Accessed October 23, Lloret Linares C, Pelletier AL, Czernichow S, et al. Acute pancreatitis in a cohort of 129 patients referred for severe hypertriglyceridemia. Pancreas. 2008;37: Miller M, Stone NJ, Ballantyne C, et al. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011;123: Christian JB, Arondekar B, Buysman EK, Johnson SL, Seeger JD, Jacobson TA. Clinical and economic benefits observed when follow-up triglyceride levels are less than 500 mg/dl in patients with severe hypertriglyceridemia. J Clin Lipidol. 2012;6: Brunzell JD, Davidson M, Furberg CD, et al. Lipoprotein management in patients with cardiometabolic risk: consensus statement from the American Diabetes Association and the American College of Cardiology Foundation. Diabetes Care. 2008;31: Brunzell JD. Clinical practice. Hypertriglyceridemia. N Engl J Med. 2007;357: Health Insurance Portability and Accountability Act of Public law , 104th Congress. 2011/09/23/ Available at: Accessed October 23, Quan H, Sundararajan V, Halfon P, et al. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. MedCare. 2005;43: Hokanson JE, Austin MA. Plasma triglyceride level is a risk factor for cardiovascular disease independent of high-density lipoprotein cholesterol level: a meta-analysis of population-based prospective studies. J Cardiovasc Risk. 1996;3: Di Angelantonio E, Sarwar N, Perry P, et al. Major lipids, apolipoproteins, and risk of vascular disease. JAMA. 2009;302: Tirosh A, Rudich A, Shochat T, et al. Changes in triglyceride levels and risk for coronary heart disease in young men. Ann Intern Med. 2007;147: Miller M. Dyslipidemia and cardiovascular risk: the importance of early prevention. QJM. 2009;102: Bansal S, Buring JE, Rifai N, Mora S, Sacks FM, Ridker PM. Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA. 2007;298: Nordestgaard BG, Benn M, Schnohr P, Tybjaerg-Hansen A. Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA. 2007;298:

10 Christian et al Triglyceride Levels and Clinical Impact 44.e1 Appendix Table 1 Diagnosis Codes for Clinical Outcomes Condition ICD-9 Diagnosis ICD-9 Procedure CPT Pancreatitis 577.0, Cardiovascular events Acute myocardial infarction 410.xx Ischemic stroke , , , , , , , , Hemorrhagic stroke 430, 431, 432.x Heart failure , , , , , , , , , 428.xx Revascularization (percutaneous coronary interventions including, percutaneous transluminal coronary angioplasty, and 00.66, 36.1x, , , , S2205-S2209, , , G0290-G0291, coronary artery bypass graft) Acute coronary syndrome 411.xx Sudden death 427.5, 798.x CPT ¼ Current Procedural Terminology; ICD-9 ¼ International Classification of Diseases, 9th Revision. Appendix Table 2 Summary of the Covariates Included in Each Model Adjusted Cox Proportional Hazards Models Pancreatitis* Cardiovascular Event Baseline covariates Follow-up triglyceride level group x x Age category (18-44 y, y, >65 y) x x Gender x x Quan-Charlson comorbidity score x x Region (Northeast, Midwest, South, and West) x x High-density lipoprotein C x Nonehigh-density lipoprotein C x x Index triglycerides laboratory value x x Baseline diagnoses Pancreatitis x x Cardiovascular disease x Hypertension x Chronic kidney disease/end-stage renal disease x x Diabetes diagnosis x x Baseline medication use Statins x x Triglyceride-lowering drug x x Beta-blocker x Hormone replacement therapy x *Hormone replacement therapy and steroid use did not alter the adjusted estimate and therefore were not included in the pancreatitis final model. Includes acute myocardial infarction, ischemic stroke, hemorrhagic stroke, sudden death, acute coronary syndrome, revascularization, and heart failure events. Includes the use of omega-3-acid ethyl esters (Lovaza; GlaxoSmithKline, Brentford, UK), nicotinic acid, or fibric acid.

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