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Articles by Andrew M. Tershakovec
Total Records ( 13 ) for Andrew M. Tershakovec
  Adrian Dobs , Michael Miller , Paul T. DeLucca , Karen E. Ramsey , Andrew M. Tershakovec and Wendy Horn
 

Background

Low-density lipoprotein cholesterol (LDL-C) has been identified as the primary target of cholesterol-lowering therapy, with the LDL-C goal set at ≤100 mg/dL for patients at high risk, such as those with diabetes.

Objective

To evaluate the efficacy of simvastatin (S) in achieving LDL-C levels <70 mg/dL in patients with type 2 diabetes mellitus (DM).

Methods

This was a post-hoc analysis of a multicenter, randomized, double-blind, three-way crossover, placebo (PL)-controlled study that evaluated S80 mg or S40 mg versus PL for increasing high-density lipoprotein cholesterol (HDL-C). Patients with type 2 DM (n = 151), LDL-C >100 mg/dL, HDL-C <40 mg/dL, and triglycerides (TG) >150 and <700 mg/dL were randomized to daily S80 mg, S40 mg, or PL for three 6-week periods. The percentage of patients reaching LDL-C <70 mg/dL and the percentage reaching TG <150 mg/dL after 6 weeks was assessed.

Results

After 6 weeks, 59% (82 of 140) of patients in the S80 mg group achieved LDL-C <70 mg/dL versus 43% (60 of 139) receiving S40 m, and 0% (0 fo 140) in the PL group (P < 0.001 for S80 mg and S40 mg vs PL, and S80 mg vs S40 mg). In patients with coronary heart disease (CHD) (n = 32), 63% (20 of 32) receiving S80 mg reached LDL-C <70 mg/dL, versus 50% (15 of 30) in the S40 mg and 0% (0 of 32) in the PL group (P <0.001 for S80 mg and S40 mg vs PL, and P = 0.063 for S80 mg vs S40 mg). For TG levels, 27% (35 of 132) of the S80 mg patients and 23% (30 of 130) of the S40 mg patients reached a goal of TG <150 mg/dL. The dual goal of LDL-C level <70 mg/dL and TG level <150 mg/dL was attained by 14.7% of patients in the S80 mg, 7.8% in the S40 mg, and 0% in the PL group.

Conclusion

S40 mg or S80 mg daily allowed 43% to 59% of patients with type 2 DM at risk of CHD to reach the goal of lowering LDL-C levels to the National Cholesterol Education Program Adult Treatment Panel III optional target level of <70 mg/dL. Reaching TG goals may require additional therapeutic considerations.

  Ruth S. Weinstock , Ronald B. Goldberg , John R. Guyton , Theodore Mazzone , Adam Polis , Joanne E. Tomassini , Jianxin Lin , Arvind Shah and Andrew M. Tershakovec
 

Background

In addition to low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non–HDL-C), apolipoprotein B (ApoB), and high-sensitivity C-reactive protein (hs-CRP) are considered predictive for cardiovascular disease in type 2 diabetes mellitus (T2DM) patients.

Objective

To assess the proportion of T2DM patients with hypercholesterolemia who attained the optional target level of LDL-C (<70 mg/dL) and additionally non-HDL-C (<100 mg/dL), ApoB (<90 mg/dL), and hs-CRP (<2 mg/L), following treatment with ezetimibe/simvastatin (E/S) vs atorvastatin (A).

Methods

This post-hoc analysis of a multicenter, randomized, double-blind, 6-week parallel study assessed the proportion of T2DM patients who attained specified LDL-C levels and non-HDL-C, ApoB, and hs-CRP with usual, recommended starting doses of E/S (10/20 mg) vs A (10 or 20 mg) and next highest doses of E/S (10/40 mg) vs A (40 mg) by logistic regression. Baseline triglyceride and hs-CRP effects were also evaluated.

Results

Significantly higher percentages of patients treated with E/S compared to A achieved individual and concurrent target levels of LDL-C (<70 mg/dL), non-HDL-C (<100 mg/dL), and ApoB (<90 mg/dL) at all dose comparisons (P < 0.05 to P < 0.001). Baseline triglyceride levels had no effect on reaching LDL-C levels. Attainment of non-HDL-C (<100 mg/dL), and ApoB (<90 mg/dL) was lower at triglycerides ≥200 mg/dL than <200 mg/dL. Achievement of hs-CRP level (<2 mg/L) was comparable for both treatments. Significantly more patients attained both LDL-C (<70 mg/dL) and hs-CRP (<2 mg/L) at all E/S doses compared to A (P < 0.05 to P < 0.001), regardless of baseline CRP levels.

Conclusion

E/S provides a therapeutic option to T2DM patients for lowering not only LDL-C, but also non-HDL-C, ApoB, and hs-CRP. These factors may help guide assessment and treatment of cardiovascular disease risk in these patients.

  John R. Guyton , Ronald B. Goldberg , Theodore Mazzone , Ruth S. Weinstock , Adam Polis , Elizabeth Rosenberg and Andrew M. Tershakovec
 

Background

Type 2 diabetes mellitus (T2DM) is associated with a high risk for coronary heart disease (CHD). A variety of lipoprotein and apolipoprotein (Apo) ratios have been proposed that may reflect the balance of cholesterol delivery and removal at the arterial wall and provide an assessment of CHD risk that is supplemental to low-density lipoprotein cholesterol (LDL-C), the primary guide for cholesterol-lowering therapy in patients at risk.

Objective

To examine changes in lipoprotein and apolipoprotein ratios in the VYTAL trial of hypercholesterolemic patients with T2DM.

Methods

Changes in the ratios LDL-C/high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC)/HDL-C, non-HDL-C/HDL-C, and ApoB/ApoA-I were assessed in this randomized, double-blind, parallel-group study that enrolled T2DM patients with LDL-C ≥100 mg/dL for 6-week treatments with either the usual daily starting doses of atorvastatin (ATORVA) 10 or 20 mg or ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg, or the next highest doses (ATORVA 40 mg, EZE/SIMVA 10/40 mg). Changes in lipoprotein and apolipoprotein ratios, prespecified exploratory endpoints, were analyzed using analysis of variance.

Results

Efficacy results were based on 1198 patients with sufficient data among 1229 randomized patients. Baseline lipoproteins, apolipoproteins, and ratios were comparable among treatment groups. EZE/SIMVA produced significantly greater reductions compared with ATORVA in each lipoprotein or apolipoprotein ratio at each dose comparison (P < 0.001). For example, reductions from baseline in TC/HDL-C were ATORVA 10 mg, −30.2%; ATORVA 20 mg −34.9%; EZE/SIMVA 10/20 mg, −41.6%; ATORVA 40 mg, −37.9%; and EZE/SIMVA 10/40 mg, −43.5%. Tolerability of the two treatments was similar.

Conclusion

For the doses assessed, EZE/SIMVA was more effective compared with ATORVA in lowering the lipoprotein and apolipoprotein ratios that might be considered secondary measures of CHD risk.

  Nicola Abate , Alberico L. Catapano , Christie M. Ballantyne , Michael H. Davidson , Adam Polis , Steven S. Smugar and Andrew M. Tershakovec
 

Background

Patients with diabetes mellitus (DM) and metabolic syndrome (MS) are at increased risk of developing coronary heart disease.

Objective

To compare the effects of ezetimibe/simvastatin (E/S) combination therapy, atorvastatin, and rosuvastatin in patients with DM, MS without DM, or neither disease.

Methods

Subgroup analysis of data from two 6-week, randomized, double-blind trials comparing E/S 10/10, 10/20, 10/40, or 10/80 mg with either atorvastatin 10, 20, 40, or 80 mg (Study 1), or rosuvastatin 10, 20, or 40 mg (Study 2). Treatments were compared by pooling across all doses for effects on low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-HDL-C, apolipoprotein B (ApoB), LDL-C:HDL-C, TC:HDL-C, and LDL-C goal attainment.

Results

E/S provided greater improvements than atorvastatin or rosuvastatin in LDL-C, TC, HDL-C (vs atorvastatin only), non-HDL-C, LDL-C:HDL-C, TC:HDL-C, and ApoB in all disease subgroups. There were no interactions of treatment by disease subgroup for these parameters, indicating a consistent treatment difference favoring E/S effect across the disease subgroups. A greater percentage of patients receiving E/S than atorvastatin or rosuvastatin attained their individual National Cholesterol Education Program Adult Treatment Panel III LDL-C goals, LDL-C <100 mg/dL, LDL-C <70 mg/dL, and non-HDL-C goals regardless of subgroup. All treatments were well-tolerated, with generally similar adverse experience rates.

Conclusions

Overall, E/S generally provided greater efficacy than either atorvastatin or rosuvastatin that was consistent across the subgroups of patients with DM, MS, or neither, in agreement with the results from the full study cohorts.

  Michael H. Davidson , Nicola Abate , Christie M. Ballantyne , Alberico L. Catapano , Xia Xu , Jianxin Lin , Elizabeth Rosenberg and Andrew M. Tershakovec
 

Background

Recent evidence suggests that in addition to low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non-HDL-C), some lipoprotein ratios, and C-reactive protein (CRP) are predictive of coronary heart disease (CHD) risk. This post-hoc analysis of two trials comparing single-tablet ezetimibe/simvastatin (EZE/SIMVA) to atorvastatin (ATORVA) or rosuvastatin (ROSUVA) evaluates the proportion of patients attaining LDL-C <70 mg/dL and specific levels of these emerging risk factors.

Methods

These were double-blind, 6-week, parallel group trials of hypercholesterolemic patients randomized to milligram equivalent doses of ATORVA versus EZE 10 mg/SIMVA, or to usual starting, next higher, and maximum doses of ROSUVA versus EZE/SIMVA. This analysis examined the percent of patients in prespecified dose comparisons and overall achievement of LDL-C <70 mg/dL and/or Apo-B <90 mg/dL, total cholesterol (TC)/HDL-C <4.0, or Apo-B/Apo-A-I <0.7 among all treated patients, non-HDL-C <100 mg/dL among patients with baseline triglycerides ≥200 mg/dL, or CRP <2.0 mg/L among patients with baseline CRP ≥2.0 mg/L.

Results

Within each trial, baseline characteristics were similar among groups. At all dose comparisons, significantly more patients receiving EZE/SIMVA reached LDL-C <70 mg/dL and achieved both LDL-C <70 mg/dL and either Apo-B <90 mg/dL, TC/HDL-C <4.0, or Apo-B/Apo-A-I <0.7 (EZE/SIMVA versus ATORVA) compared to ATORVA and ROSUVA. For most dose comparisons, significantly more patients receiving EZE/SIMVA attained both LDL-C <70 mg/dL and either non-HDL-C <100 mg/dL or CRP <2 mg/L compared to ATORVA or ROSUVA.

Conclusion

The greater efficacy related to changes in blood lipids of EZE/SIMVA compared with both ATORVA and ROSUVA extends to changes in many emerging risk factors. Ultimate clinical implications of these findings still need to be defined.

  JoAnne M. Foody , Shiva G. Sajjan , X. Henry Hu , Dena R. Ramey , David R. Neff , Andrew M. Tershakovec , Joanne E. Tomassini , Chuck Wentworth and Kaan Tunceli
 

Background

Guidelines recommend a low-density lipoprotein cholesterol (LDL-C) measurement of <70 mg/dL as a reasonable goal in high-risk patients with coronary heart disease (CHD) or atherosclerotic vascular disease (AVD).

Methods

This retrospective, cross-sectional study examined LDL-C goal attainment monthly trends from January 1, 2004, to August 31, 2008, in a large, managed-care claims database in the United States. High-risk CHD or AVD patients who had at least one LDL-C test during that time period were included (N = 284,915). Average LDL-C values and percent of patients not achieving LDL-C goal (LDL-C ≥70 mg/dL) were obtained by averaging patient level LDL-C values for each month. A linear trend analysis with first-order autocorrelated errors was conducted.

Results

The proportion of patients treated with lipid-lowering therapy gradually increased from 58.5% in 2004 to 70.5% in 2008. Mean LDL-C values in patients treated with lipid-lowering therapy decreased from 100.4 to 96.4 mg/dL, whereas LDL-C remained relatively constant in untreated patients (114.3 mg/dL). In treated patients, the percentage with LDL-C ≥70 mg/dL decreased from 87.5% in January 2004 to 73.8% in December 2006 (P < .0001), then gradually declined between January 2007 (79.6%) and August 2008 (76.2%; P < .0001). Among untreated patients, 92.9% had LDL-C levels ≥70 mg/dL in January 2004 and 93.0% in August 2008.

Conclusion

In conclusion, the percentage of high-risk patients with CHD or AVD treated with lipid-lowering therapy who achieve LDL-C <70 mg/dL levels has increased since 2004, although a large proportion of these patients still do not meet this goal. Additionally, 1 of 4 high-risk patients otherwise eligible for lipid-lowering therapy remains untreated. These data suggest the need for renewed efforts to support guideline-based LDL-C lowering in high-risk patients.

  Kaan Tunceli , Shiva G. Sajjan , Dena R. Ramey , David R. Neff , Andrew M. Tershakovec , X. Henry Hu , Joanne E. Tomassini and JoAnne M. Foody
 

Background

The availability of generic simvastatin in 2006 has prompted substantial changes in formulary recommendations for lipid-management agents.

Objective

To assess the impact of switches from high-efficacy lipid-lowering therapy to simvastatin on low-density lipoprotein cholesterol (LDL-C) and goal attainment in coronary heart disease (CHD) or CHD risk-equivalent patients in a managed care setting.

Methods

In this retrospective observational study, we estimated the least squares mean difference in the percent change from baseline LDL-C and the odds ratios for LDL-C goal attainment rates (<100 mg/dL and <70 mg/dL) at follow-up for each baseline high-efficacy lipid-lowering therapy with the analysis of covariance and logistic regressions, respectively.

Results

We identified 18,061 patients who, between September 1, 2004 and October 31, 2008, were either switched from or remained on their initial high-efficacy LDL-C lowering therapy: ezetimibe/simvastatin fixed-dose combination (E/S), rosuvastatin, or atorvastatin. The difference in percent change in LDL-C levels from baseline were 25.2 (95% confidence interval 21.2−29.2), 13.0 (6.0−20.0), and 3.1 (0.3−5.9) greater in switchers to simvastatin in the E/S, rosuvastatin, and atorvastatin comparisons, respectively, after adjusting for age, sex, and starting dose of the initial therapy. For switchers, the percent of patients at LDL-C <100 mg/dL at follow-up decreased from 83.5% to 63.8% in the E/S, 67.7% to 52.7% in the rosuvastatin, and 65.1% to 60.2% in the atorvastatin cohorts. The percent of patients at LDL-C <70 mg/dL at follow-up was lower for all switcher groups compared with nonswitchers.

Conclusions

Among CHD/CHD risk-equivalent patients, switching to simvastatin was associated with increases in LDL-C levels and lower LDL-C goal attainment rates. The public health impact of this phenomenon on population risk and CHD events remains to be determined.

  Ngoc-Anh Le , Monica Farkas-Epperson , Ran Jin , Andrew M. Tershakovec , David R. Neff , Robert Wolfert , Joanne E. Tomassini and Peter Wilson
  High levels of lipoprotein-associated phospholipase A2 (LpPLA2) are associated with increased risk of cardiovascular disease. LpPLA2 is an inflammatory enzyme marker and is less prone to effects of systemic infection as are other inflammatory markers such as C-reactive protein (hsCRP). In a previously reported study, co-administration of ezetimibe/simvastatin (E/S) 10/20 mg with extended-release niacin up to 2 g/day (N) reduced low-density lipoprotein cholesterol and increased high-density lipoprotein cholesterol levels significantly more than E/S and N alone in patients with type IIa/IIb hyperlipidemia (T2HLP) during 24 weeks.
  Ngoc-Anh Le , Ran Jin , Andrew M. Tershakovec , David R. Neff , Joanne E. Tomassini , James Otvos and Peter Wilson
  Intervention with concomitant high-density lipoprotein cholesterol (HDL-C)−raising and low-density lipoprotein cholesterol (LDL-C)−lowering therapies may be beneficial in reducing cardiovascular disease risk. The effects of these therapies on lipoprotein particle numbers have not been well-studied in patients with type II hyperlipidemia (T2HLP). Niacin is currently the most effective agent available for increasing HDL-C and also modestly reduces TG, Lp(a), and LDL-C. In numerous studies, ezetimibe/simvastatin (E/S) was shown to enhance LDL-C lowering and improve other lipids and hsCRP compared with statin therapy in hypercholesterolemic patients.
  Jennifer G. Robinson , Christie M. Ballantyne , Willa A. Hsueh , Jeffrey B. Rosen , Jianxin Lin , Arvind K. Shah , Joanne E. Tomassini , Robert S. Lowe and Andrew M. Tershakovec
 

Background

Treatment response to lipid-lowering therapy can vary in patients with the metabolic syndrome (MetS) due to various patient demographic and baseline characteristics.

Objective

This study assessed the relationships between baseline characteristics and changes in lipid variables, high-sensitivity C-reactive protein (hs-CRP) and attainment of prespecified low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) levels in MetS patients treated with ezetimibe/simvastatin and atorvastatin.

Methods

This is a post-hoc analysis of a multicenter, double-blind, randomized, 6-week parallel study in >1000 hypercholesterolemic subjects (median age of 59 years) with MetS and moderately high/high coronary heart disease risk who were treated with ezetimibe/simvastatin (10/20 and 10/40 mg) or atorvastatin (10, 20, 40 mg). Factors that could affect these treatments were assessed by multivariate analysis.

Results

Increasing age, abdominal obesity (waist circumference ≥40/35 inches for men/women), and lower baseline hs-CRP were significant predictors of greater reductions in LDL-C, non-HDL-C, apolipoprotein B, total cholesterol, triglycerides, and very-low-density lipoprotein cholesterol but not for changes in HDL-C or apolipoprotein AI; effects of race and baseline triglycerides, non-HDL-C, LDL-C, or HDL-C levels were more limited. Age ≥65 years (versus <65 years) was also associated with significantly greater attainment of all LDL-C and non-HDL-C targets, whereas abdominal obesity, gender (female > male) and lower baseline LDL-C, non-HDL-C, triglycerides, and hs-CRP were associated with improved attainment for some of these targets. Blood pressure, fasting glucose, Homeostasis Model Assessment of Insulin Resistance tertiles, and diabetes did not predict response for any efficacy variable. Ezetimibe/simvastatin treatment (versus atorvastatin) was a significant predictor for change in most efficacy variables.

Conclusions

Treatment responses to ezetimibe/simvastatin and atorvastatin in at-risk patients with the MetS were related to age (≥65 years), abdominal obesity, and lower baseline hs-CRP. Ezetimibe/simvastatin treatment was found to be consistently more effective than atorvastatin at the specified dose comparisons across these subgroups. The clinical value of predictive factors requires further study in outcome trials.

  Peter P. Toth , Christie M. Ballantyne , Michael H. Davidson , Joanne E. Tomassini , Dena Rosen Ramey , David Neff , Andrew M. Tershakovec , X. Henry Hu and Kaan Tunceli
 

Background

Recent trends suggest a decreased use of ezetimibe/simvastatin combination and coadministered ezetimibe plus statin therapies.

Objective

This analysis evaluated changes in prescription patterns for ezetimibe/simvastatin, ezetimibe plus statins, and statin therapies and expected effects on low-density lipoprotein cholesterol (LDL-C) lowering during 2007 to 2008.

Methods

Prescription pattern changes were assessed by the use of patient-level data from the IMS Health Longitudinal Rx database during two time periods, July 14, 2007 to January 13, 2008 (n = 8,813,674) and January 14, 2008 to July 13, 2008 (n = 9,131,030), 6 months before and after reporting of the results of The Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression trial (ENHANCE) trial on January 14, 2008. Expected LDL-C reductions were estimated using data from previous controlled clinical trials.

Results

During 6 months post-ENHANCE, greater proportions of patients were switched from ezetimibe/simvastatin and ezetimibe plus statins to other lipid-lowering therapies by health care providers than 6 months pre-ENHANCE (21.1% vs 6.0% and 46.9% vs 38.5%, differences: −15.06% [95% confidence interval −15.14%, −14.97%] and −8.43% [95% confidence interval −8.70%, −8.17%], respectively). Greater proportions of these patients switched to statin monotherapy in the later than earlier period. Prescription patterns were similar for statins during both time periods, although fewer patients switched to ezetimibe/simvastatin and ezetimibe plus statin therapies post-ENHANCE. In both time periods, greater proportions of patients on ezetimibe/simvastatin and ezetimibe plus statins switched to less-than-equivalent LDL-C lowering efficacy doses of statins than those on statin therapy. On the basis of previous clinical data for these therapies, smaller LDL-C reductions would be expected in patients who switched from ezetimibe/simvastatin and ezetimibe plus statins to statins, despite a trend toward switching to greater statin doses in the later time period.

Conclusions

More patients switched from ezetimibe/simvastatin and ezetimibe plus statin to statin monotherapy 6 months after the reporting of the ENHANCE trial, the majority of which were prescribed less potent, LDL-C-lowering therapies. On the basis of the known LDL-C lowering efficacies for these therapies, such changes would be expected to increase LDL-C levels in these patients and may reduce the proportion of patients who achieve guideline-recommended LDL-C goals.

  Jennifer G. Robinson , Christie M. Ballantyne , Willa Hsueh , Jeffrey Rosen , Jianxin Lin , Arvind Shah , Robert S. Lowe , Mary E. Hanson and Andrew M. Tershakovec
 

Background

Metabolic syndrome (MetS) and atherosclerotic vascular disease (AVD) are associated with increased coronary heart disease risk.

Objective

To assess percent change from baseline in lipids and high-sensitivity C-reactive protein (hs-CRP) levels and the proportion of subjects reaching specified low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (HDL-C) and apolipoprotein B (Apo B) single, dual, and triple targets and hs-CRP <2 mg/L among subjects with and without AVD treated with ezetimibe/simvastatin or atorvastatin for 6 weeks.

Methods

Adults (N = 1143) with MetS and hypercholesterolemia were randomized to starting and next higher doses of ezetimibe/simvastatin (10/20 or 10/40 mg) or atorvastatin (10, 20, or 40 mg).

Results

Ezetimibe/simvastatin produced significantly greater reductions in evaluated lipids than atorvastatin for most prespecified dose comparisons. More subjects without AVD achieved LDL-C levels <100 mg/dL, non-HDL-C levels <130 mg/dL, and dual LDL-C/non-HDL targets (83%-92% vs 62%-76%) and Apo B <90 mg/dL or triple targets (65%-75% vs 41%-49%) with 40 mg of atorvastatin or 10/20-40 mg of ezetimibe/simvastatin compared with 10 or 20 mg of atorvastatin, respectively. More subjects with AVD achieved LDL-C<70 mg/dL and non-HDL-C<100 mg/dL single and dual targets (65%-80%) and Apo B <80 mg/dL (53%-63%) with 10/20-40 mg of ezetimibe/simvastatin than with 40 mg of atorvastatin (40%-49%). More subjects achieved triple lipid targets with 10/20-40 mg of ezetimibe/simvastatin versus 10–40 mg of atorvastatin (50%-63% vs 24%-40%). Achievement of hs-CRP <2 mg/L was similar across all doses regardless of AVD status.

Conclusions

More intensive therapy was required for >80% of subjects to achieve LDL-C <100 mg/dL and non-HDL-C <130 mg/dL and for the majority of subjects to achieve lower levels of LDL-C <70 mg/dL, non-HDL-C <100 mg/dL, and/or Apo B <90 mg/dL. The effect of ezetimibe on cardiovascular risk reduction has yet to be established. (Clintrials.gov no: NCT00409773)

  Peter P. Toth , JoAnne M. Foody , Joanne E. Tomassini , Shiva G. Sajjan , Dena R. Ramey , David R. Neff , Andrew M. Tershakovec , X. Henry Hu and Kaan Tunceli
 

Background

Statin combination therapy and statin uptitration have been shown to be efficacious in low-density lipoprotein cholesterol (LDL-C) lowering and are recommended for patients with high-risk coronary heart disease (CHD) who do not reach guideline-endorsed LDL-C goals on statin monotherapy.

Objective

This analysis evaluated treatment practice patterns and LDL-C lowering for patients with CHD/CHD risk equivalent on statin monotherapy in a real-world practice setting in the United States.

Methods

In this retrospective, observational study, patients with CHD/CHD risk equivalent on statin therapy were identified during 2004 to 2008 in a US managed care database. Prescribing patterns and effect of switching from statin monotherapy to combination ezetimibe/simvastatin therapy vs uptitration to higher statin dose/potency level and no change from initial statin potency on LDL-C lowering were assessed. Percentage of change from baseline in LDL-C levels and odds ratios for LDL-C goal attainment were estimated with analyses of covariance and logistic regression.

Results

Of 27,919 eligible patients on statin therapy, 2671 (9.6%) switched to ezetimibe/simvastatin therapy, 11,035 (39.5%) uptitrated statins, and 14,213 (50.9%) remained on the same statin monotherapy. LDL-C reduction from baseline and attainment of LDL-C <100 and <70 mg/dL were substantially greater for patients who switched to ezetimibe/simvastatin therapy (−24.0%, 81.2%, and 35.2%, respectively) than for patients who titrated (−9.6%, 68.0%, and 18.4%, respectively) or remained on initial statin therapy (4.9%, 72.2%, and 23.7%, respectively). The odds ratios for attainment of LDL-C <100 and <70 mg/dL were also higher for patients who switched than for patients who uptitrated and had no therapy change than for patients who titrated vs no therapy change. Similarly, among a subgroup of patients not at LDL-C <100 mg/dL on baseline therapy, attainment of LDL-C <100 and <70 mg/dL was greater for patients who switched than for statin uptitration vs no change, as well as for patients who uptritrated statins vs no therapy change.

Conclusion

In this study, LDL-C lowering and goal attainment rates improved substantially for patients with high-risk CHD on statin monotherapy who switched to combination ezetimibe/statin or uptitrated their statin therapies; however, approximately one-third of these patients still did not attain the optional recommended LDL-C goal of <70 mg/dL. Moreover, these higher efficacy lipid-lowering therapies were infrequently prescribed, indicating the need for further assessment of barriers to LDL-C goal attainment in actual practice settings.

 
 
 
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