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Cost-effectiveness of extended-release niacin/laropiprant added to a stable simvastatin dose in secondary prevention patients not at cholesterol goal in Germany.

ABSTRACT: Coronary heart disease (CHD) remains the leading cause of death in Germany despite statin use to reduce low-density lipoprotein cholesterol (LDL-C) levels; improving lipids beyond LDL-C may further reduce cardiovascular risk. A fixed-dose combination of extended-release niacin (ERN) with laropiprant (LRPT) provides comprehensive lipid management. We adapted a decision-analytic model to evaluate the economic value (incremental cost-effectiveness ratio [ICER] in terms of costs per life-years gained [LYG]) of ERN/LRPT 2 g over a lifetime in secondary prevention patients in a German setting. Two scenarios were modelled: (1) ERN/LRPT 2 g added to simvastatin 40 mg in patients not at LDL-C goal with simvastatin 40 mg; (2) adding ERN/LRPT 2 g compared with titration to simvastatin 40 mg in patients not at LDL-C goal with simvastatin 20 mg. In both scenarios, adding ERN/LRPT was cost-effective relative to simvastatin monotherapy at a commonly accepted threshold of €30,000 per LYG; ICERs for ERN/LRPT were €13,331 per LYG in scenario 1 and €17,684 per LYG in scenario 2. Subgroup analyses showed that ERN/LRPT was cost-effective in patients with or without diabetes, patients aged ? 65 or >65 years and patients with low baseline high-density lipoprotein cholesterol levels; ICERs ranged from €10,342 to €15,579 in scenario 1, and from €14,081 to €20,462 in scenario 2. In conclusion, comprehensive lipid management with ERN/LRPT 2 g is cost-effective in secondary prevention patients in Germany who have not achieved LDL-C goal with simvastatin monotherapy.

SUBMITTER: Michailov GV

PROVIDER: S-EPMC3343242 | biostudies-other | 2012 Jun

REPOSITORIES: biostudies-other

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Cost-effectiveness of extended-release niacin/laropiprant added to a stable simvastatin dose in secondary prevention patients not at cholesterol goal in Germany.

Michailov Galin V GV Davies Glenn M GM Krobot Karl J KJ

The European journal of health economics : HEPAC : health economics in prevention and care 20110405 3

Coronary heart disease (CHD) remains the leading cause of death in Germany despite statin use to reduce low-density lipoprotein cholesterol (LDL-C) levels; improving lipids beyond LDL-C may further reduce cardiovascular risk. A fixed-dose combination of extended-release niacin (ERN) with laropiprant (LRPT) provides comprehensive lipid management. We adapted a decision-analytic model to evaluate the economic value (incremental cost-effectiveness ratio [ICER] in terms of costs per life-years gaine ...[more]

PMID: 21465286

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Project description:Niacin is an antidyslipidemic agent that may cause blood sugar elevation in patients with diabetes, but its effects on glucose and insulin values in nondiabetic statin-treated subjects with cardiovascular disease and at high risk for diabetes are less well known.This was a prespecified, intent-to-treat analysis of the Atherothrombosis Intervention in Metabolic syndrome with low high-density lipoprotein/high triglycerides: Impact on Global Health outcomes trial which randomized 3,414 participants at 92 centers in the US and Canada to extended-release niacin (ERN) plus simvastatin/ezetimibe (ERN) or simvastatin/ezetimibe plus placebo (Placebo). Baseline and annual fasting glucose and insulin values were measured. Those experiencing an adverse event indicative of diabetes or starting medications for diabetes were considered to have confirmed diabetes. In addition, nondiabetic subjects with 2 annual follow-up glucose measurements were categorized into normal, impaired fasting glucose or newly diagnosed diabetes (presumed or confirmed) states.Compared with placebo, ERN increased annual fasting glucose from baseline to 1 year in both those with normal (7.9 ± 15.8 vs 4.3 ± 10.3 mg/dL; P < .001) and impaired fasting glucose (4.1 ± 18.7 vs 1.4 ± 14.9; P < .02) and increased insulin levels. Both effects waned over the next 2 years. There were less consistent effects in those with baseline diabetes. There was an increased risk of progressing from normal to presumed or confirmed impaired fasting glucose (ERN 197/336) cases (58.6%) vs placebo 135/325 cases (41.5%; P < .001) over time, but no difference in diabetes development in the 2 treatment groups except in those with normal fasting glucose at baseline.The addition of ERN to simvastatin/ezetimibe had marginal effects on glycemia in those with diabetes at baseline, and there was a trend toward increased development of new-onset diabetes. In addition, ERN increased the risk of developing impaired fasting glucose, which may have deleterious consequences over time and warrants further study.

Project description:OBJECTIVES: Despite the scientific evidence of reducing cardiac events with HMG Co-A reductase inhibitors (statins) therapy in both primary and secondary preventions, these therapies continue to be underutilized in patients receiving convictional care. Simvastatin, a HMG Co-A inhibitor agent, is the most commonly used statin in Sultan Qaboos University Hospital. The aim of this study is to review the safety and the effectiveness of achieving LDL-C targets with Simvastatin according to the NCEP-ATP3 guidelines in patients with different cardiovascular risk categories at Sultan Qaboos University Hospital. METHODS: A retrospective chart review was conducted for 160 patients. Patients were identified by outpatient prescriptions provided by pharmacy department from April 2008 to May 2008. RESULTS: 98% of the patients were prescribed simvastatin 20 mg and only 2% received 40 mg. The mean age of patients was 57 years +/- 12. While 49% of the patients were male and 45% had diabetes mellitus, 50% had cardiovascular disease, 2.5% were smokers, 67% were hypertensive, and 3% had positive family history of coronary artery disease. 75% of patients were classified as high risk, 7% moderate risk and 18% low risk for coronary artery disease. Among all lipid profiles, only LDL-C was changed from baseline with simvastatin treatment in all patients (3.60±1.03 to 3.25±1.34 mmol/L). LDL-C level at baseline was higher in the high risk group (4.11±1.06 mmol/L) compared to low and moderate risk groups (3.68±0.89, 3.42±1.15) respectively. Achievement of LDL-C goals was achieved in only 43% for high risk, 50% in moderate risk, and 90% in low risk patients. There was no significant increase in liver enzymes and creatinine kinase. CONCLUSION: This study identified that more than half of the high risk patients were not at the target LDL-C goals which place them at a continuous risk of coronary heart disease. More appropriate lipid lowering therapy using more potent statins or combination therapy should be optimized to improve achievement of LDL-C goals according to ATP-III guidelines.

Project description:Background and aims Cardiovascular mortality is high in Germany. For patients with high or very high cardiovascular risk, the European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines recommend intensive lipid lowering therapy (LLT). This study aimed to assess dyslipidaemia management and achievement of the ESC/EAS guideline-recommended low-density lipoprotein cholesterol (LDL-C) goals. Methods This European 18-country, cross-sectional, observational DA VINCI study (EUPAS22075) collected data during a single visit between June 2017 and November 2018 and included LLT in the preceding 12 months and the patients' most recent LDL-C measurement. Achievement of the risk-based 2016 and 2019 ESC/EAS LDL-C goals while receiving stabilized LLT was assessed. Data from the German cohort are presented here. Results Seven German sites enrolled a total of 421 primary and secondary prevention patients, 327 were receiving stabilized LLT at the time of LDL-C measurement, i.e. statin monotherapy of high (16%; n = 53), moderate (49%; n = 160) or low (7%; n = 24) intensity, ezetimibe combination (18%; n = 58), proprotein convertase subtilisin/kexin type 9 antibody combination (3%; n = 9), and other LLT (7%; n = 23). The 2016 and 2019 risk-based LDL-C goals were attained by 46% (n = 149) and 28% (n = 92) of patients, respectively. Conclusions There is a large gap between ESC/EAS recommendations and LDL-C goal achievement in routine clinical practice in high and very high-risk patients in Germany. Low-to-moderate-intensity statin monotherapy was the most frequently used LLT; use of high-intensity statins and combination therapy was limited. In addition to optimizing statin intensity, combination with non-statin LLT may be needed in most of these patients. Graphical abstract Image 1 Highlights • This study evaluated lipid-lowering therapy use and dyslipidemia burden in Germany.• Attainment of LDL-C goals set by the 2016 and 2019 EAS/ESC guidelines was evaluated.• In Germany, more than half of patients did not achieve their 2016 LDL-C goals.• Attainment of the more stringent 2019 LDL-C goals was <30%.• Intense combination therapy in Germany could lead to better LDL-C goal attainment.

Dataset Information

Cost-effectiveness of extended-release niacin/laropiprant added to a stable simvastatin dose in secondary prevention patients not at cholesterol goal in Germany.

Publications

Cost-effectiveness of extended-release niacin/laropiprant added to a stable simvastatin dose in secondary prevention patients not at cholesterol goal in Germany.

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