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Consumption and Market Share of Cholesterol- Lowering Drugs in High Open access Original research BMJ Open: first published as 10.1136/bmjopen-2020-036769 on 20 November 2020. Downloaded from Consumption and market share of cholesterol- lowering drugs in high- risk patients before and after the release of the 2013 ACC/AHA cholesterol guidelines: a retrospective observational study Tzu- Tsen Kuo,1,2 Yaw- Bin Huang ,1 Ching- Jung Hsieh 3 To cite: Kuo T- T, Huang Y- ABSTRACT Strengths and limitations of this study B, Hsieh C- J. Consumption Objective We examined the use of cholesterol- lowering and market share of drugs in Taiwan in high- risk patients before and after the cholesterol- lowering drugs ► Only high- risk patients in the Kaohsiung Chang Gung release of the 2013 American College of Cardiology and in high- risk patients before Memorial Hospital were included as a representative and after the release of the the American Heart Association (ACC/AHA) cholesterol sample of patients. guidelines. 2013 ACC/AHA cholesterol ► Using database records for 2012 and 2015, we guidelines: a retrospective Design Retrospective observational study. extensively analysed practical changes in the us- observational study. BMJ Open Setting Kaohsiung Chang Gung Memorial Hospital age of cholesterol- lowering drugs among the study 2020;10:e036769. doi:10.1136/ database, Kaohsiung City, Taiwan. participants. bmjopen-2020-036769 Outpatients aged ≥20 years with Participants ► This study provides data on the changing growth ► Prepublication history and atherosclerosis cardiovascular disease, familial and decline in the use of fixed- dose combinations additional materials for this hypercholesterolaemia and diabetes. along with the utilisation of their constituents, which paper is available online. To Primary and secondary outcome measures Data on is currently warranted. view these files, please visit brand and generic names, use and dosage of cholesterol- ► Some important data were excluded; two sets of the journal online (http:// dx. doi. lowering drugs in 2012 and 2015 were compiled and data from 2012 and four sets of data from 2015 org/ 10. 1136/ bmjopen- 2020- the total amount used was calculated. Differences in lacked information on age and were therefore ex- http://bmjopen.bmj.com/ 036769). usage and market share were compared. Usage rates of cluded from our analysis. Received 02 January 2020 single and fixed- dose combination (FDC) products were ► Patients’ out- of- pocket expenses were not con- Revised 19 August 2020 compared. sidered, as these involved some uncertainties (eg, Accepted 20 August 2020 Results The number of patients receiving ambulatory medications purchased by patients ‘out- of- pocket’ care increased from 36 367 in 2012 to 41 807 in 2015. may not necessarily be intended for themselves). Single (3 679 979–4 568 086 tablets) and FDC (540 522– 572 954 tablets) product use increased from 2012 to 2015, respectively. Statins were the most commonly prescribed study. Furthermore, these changes were associated with on October 1, 2021 by guest. Protected copyright. medications in 2012 (71.14%) and 2015 (72.91%). The increased effectiveness and reduced adverse effects. average monthly consumption of statin among high- risk patients in 2012 was 269 948.8 tablets, and it increased significantly to 343 975.3 tablets in 2015. The average INTRODUCTION monthly consumption of pitavastatin was 34 113.4 In 2013, the American College of Cardiology tablets in 2015, which was significantly higher than 0 in © Author(s) (or their and the American Heart Association (ACC/ employer(s)) 2020. Re- use 2012. Conversely, the highest decline was observed for AHA) published guidelines for clinical hyper- permitted under CC BY-NC. No fluvastatin use, with the average monthly consumption cholesterolaemia treatment, recommending being 38 754.3 tablets in 2015, which was significantly commercial re- use. See rights new therapeutic approaches for coronary and permissions. Published by lower than 45 929.8 tablets consumed in 2012. Regarding BMJ. FDC therapy for cholesterol- lowering drugs, Vytorin artery disease (CAD) involving primary and For numbered affiliations see (ezetimibe 10 mg + simvastatin 20 mg) use was the secondary preventions. These guidelines end of article. highest among all FDCs in 2015. recommend the use of fixed-dose, high- Conclusions The 2013 ACC/AHA cholesterol guidelines intensity and moderate-intensity HMGCR (3- Correspondence to hydroxy-3- methylglutaryl-coenzyme- A [CoA] Professor Yaw- Bin Huang; likely promoted the use of fixed- dose, high- intensity and yabihu@ kmu. edu. tw and moderate- intensity monotherapy and FDC therapy statins reductase) inhibitors (statins) to decrease Dr Ching- Jung Hsieh; in high- risk groups, and this was consistent with the use of cholesterol levels in high-risk patients with c2607c@ ms56. hinet. net high- intensity or moderate- intensity statins in the present CAD. Treatment with moderate-intensity Kuo T- T, et al. BMJ Open 2020;10:e036769. doi:10.1136/bmjopen-2020-036769 1 Open access BMJ Open: first published as 10.1136/bmjopen-2020-036769 on 20 November 2020. Downloaded from statins lowered low- density lipoprotein cholesterol dates. The electronic database focused on the annual use (LDL- C) by approximately 30%–50% and high-intensity of drugs in four pharmaceutical drug categories (supple- statins lowered LDL- C by ≥50%.1 There were four high- mentary table S1) and presented single and fixed- dose risk groups, selected on the basis of related risk factors. combination (FDC) products. The first group consisted of patients with atherosclerotic cardiovascular disease (ASCVD), defined as acute coro- Study population nary syndromes, history of myocardial infarction, stable Data of individuals with familial hypercholesterolaemia, angina, coronary or other arterial revascularisation, DM, CAD, stroke and PAD designated as high- risk patients, stroke, transient ischaemic stroke, or peripheral arterial who were prescribed cholesterol-lowering drugs, were disease (PAD). All these conditions can lead to athero- compiled. The number of patients enrolled was 36 367 in sclerosis.1 The second group consisted of patients with 2012 and 41 807 in 2015. The inclusion criteria were (1) LDL- C level higher than or equal to 190 mg/dL. The presence of ASCVD, (2) familial hypercholesterolaemia, third group consisted of patients aged 40–75 years with (3) DM and (4) aged ≥20 years. Patients with cancer or diabetes mellitus (DM) and LDL-C level of 70–189 mg/ without medical records were excluded. The remainder dL. The fourth group consisted of patients aged 40–75 comprised patients who received cholesterol- lowering years without DM and LDL- C level of 70–189 mg/dL, and drugs at least once during the study period. Drug infor- those with <5% 10- year ASCVD risk.1 mation was used to extract distribution data from the elec- These guidelines were set in place to appropriately treat tronic database that contained all cholesterol-lowering high- risk groups, while also reducing the ASCVD risk by drug prescription records. increasing high- intensity or high-dose statin use.2 Data from the Department of Health and Welfare of Taiwan in Assessment indicators 2016 showed that heart disease, cerebrovascular disease, We calculated the total quantity and variety of cholesterol- DM, hypertension and renal disease are ranked second, lowering drugs used on a monthly basis, and items with fourth, fifth, eighth and ninth leading causes of death, the same ingredient were selected to estimate the total respectively, with cardiovascular disease accounting for monthly amount of each drug dispensed (see online 31.2% of total mortality.3 supplemental table S1). We calculated the annual Data on the direct association between CAD and hyper- consumption of all cholesterol- lowering drugs by product cholesterolaemia further encourage use of cholesterol- class. For cholesterol- lowering drug composition data, lowering drugs. Regardless of primary or secondary the frequency of consumption of Vytorin (ezetimibe prevention, a very low LDL- C is associated with a low inci- + simvastatin at either 10 or 20 mg), Linicor (lovastatin dence of coronary heart disease (CHD) events.4 5 In the + niacin) and Caduet (amlodipine + atorvastatin) was Cholesterol Treatment Trialists, a decrease in LDL- C of evaluated. The monthly consumption rate of various 1 mM reduced CHD risk by 22%.6 7 individual cholesterol- lowering drugs and FDCs in 2012 Use of cholesterol- lowering drugs has significantly and 2015 was calculated. The monthly mean (average http://bmjopen.bmj.com/ increased since the 2013 revision of the guidelines.8–10 monthly consumption of the year) and market share (the However, data on this trend in Taiwan have not been percentage of the market for a product or service that published. In November 2013, the ACC/AHA choles- a company supplies) of the cholesterol- lowering drugs terol guidelines relating to high- risk groups defined the were calculated and analysed in terms of relative changes effect of cholesterol treatment in cardiovascular events, between 2012 and 2015. The analysed drug categories but it is unclear how these guidelines influenced different were statins, niacin, cholesterol absorption inhibitors cholesterol- lowering drug use in Taiwan. Thus, we aimed and fibrates. Cholesterol-lowering drugs were catego- to explore the trend in cholesterol- lowering drug use rised according to prescription patterns and divided into on October 1, 2021 by guest. Protected copyright. before and after the release of the ACC/AHA cholesterol
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