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Clinical Characteristics and Lipid Lowering Treatment of Patients Initiated on Proprotein Convertase Subtilisin- Kexin Type 9 Inhibitors: a Nationwide Cohort Study

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Clinical Characteristics and Lipid Lowering Treatment of Patients Initiated on Proprotein Convertase Subtilisin- Kexin Type 9 Inhibitors: a Nationwide Cohort Study Open access Research BMJ Open: first published as 10.1136/bmjopen-2018-022702 on 1 April 2019. Downloaded from Clinical characteristics and lipid lowering treatment of patients initiated on proprotein convertase subtilisin- kexin type 9 inhibitors: a nationwide cohort study Jakob Solgaard Jensen, 1 Peter Ejvin Weeke,2 Lia Evi Bang,1 Dan Eik Høfsten,1 Maria Sejersten Ripa,3,4 Anne-Marie Schjerning,3 Juliane Elizabeth Theilade,3 Lars Valeur Køber,1 Gunnar Hilmar Gislason,3 Jannik Pallisgaard3 To cite: Jensen JS, Weeke PE, ABSTRACT Strengths and limitations of this study Bang LE, et al. Clinical Objectives Given the novelty of proprotein convertase characteristics and lipid subtilisin-kexin type 9 inhibitors (PCSK9i), little is known ► In the present study, we utilised the Danish national lowering treatment of patients regarding overall implementation or clinical characteristics initiated on proprotein registries to perform a description of the characteris- among patients who initiate treatment. We aimed to convertase subtilisin-kexin tics of patients prescribed with PCSK9i on a national assess the total number of patients initiated on PCSK9i type 9 inhibitors: a nationwide basis. We were able to include an unselected cohort along with a description of the clinical characteristics and cohort study. BMJ Open of patients, with a great variety of comorbidities. 2019;9:e022702. doi:10.1136/ lipid lowering treatment (LLT) of such patients. ► The Danish nationwide registries include data on all Setting A register-based descriptive cohort study of bmjopen-2018-022702 residents regardless of participation in the labour patients receiving a PCSK9i in the time period from 01 Prepublication history and market, and therefore is not affected by selection ► January 2016 to 31 March 2017 using a cross linkage additional material for this bias caused by including selected age groups, hos- between three nationwide Danish registers. Information paper are available online. To pitals or health insurance systems. regarding PCSK9i prescriptions, patient demographics, view these files, please visit ► Patients with familial hypercholesterolaemia (FH), the journal online (http:// dx. doi. concurrent pharmacotherapy, comorbidities and previous who are also eligible for PCSK9i treatment, collect http://bmjopen.bmj.com/ coronary procedures was identified. org/ 10. 1136/ bmjopen- 2018- their PCSK9i at a specialised hospital unit and due to 022702). Results Overall, 137 patients initiated treatment with the design of the present study, we were not able to PCSK9i in the study period from 11 in the first quarter of identify patients with a diagnosis with FH. Received 29 April 2018 2016 to 40 in the first quarter of 2017. The majority had ► Due to the observational registry design of the study, Revised 11 September 2018 a history of ischaemic heart disease (IHD) (67.9%) with Accepted 3 January 2019 we were not able to retrieve data regarding bio- ischaemic stroke and diabetes mellitus being present chemical analyses, clinical arguments for initiation in 7.3% and 16.8% of patients, respectively. All patients of PCSK9i, LLT after initiation of PCSK9i or adverse initiated on PCSK9i had been previously prescribed events with LLT. statin treatment with atorvastatin and simvastatin being on September 27, 2021 by guest. Protected copyright. ► Due to a low diagnostic sensibility, we could not fully most frequently prescribed in 53% and 36% of patients, discriminate the indications for patients receiving respectively. The majority of patients had received both PCSK9i. statins and ezetimibe (94.9%) and approximately half of these patients had also received bile acid sequestrant (45.3%). Clinical characteristics mainly differed in patients receiving triple LLT compared with patients not receiving Low-density lipoprotein cholesterol (LDL-C) triple LLT in the regards of heart failure. is a well-established and modifiable constit- Conclusion Patients treated with PCSK9i were rare, uent in the pathogenesis of atherosclerosis © Author(s) (or their characterised by having IHD and had received various and epidemiological studies have established employer(s)) 2019. Re-use and intensive conventional LLT prior to PCSK9i initiation in LDL-C as one of the main risk factors for the permitted under CC BY-NC. No agreement with current international guidelines. development of atherosclerotic disease and commercial re-use. See rights 1–3 and permissions. Published by IHD. BMJ. Since the late 1980s, statins have been used For numbered affiliations see INTRODUCTIOn to lower LDL-C levels and reduce the risk of end of article. Atherosclerosis-related morbidity and cardiovascular events and related mortality mortality is reaching epidemic proportions across the spectrum of primary and secondary Correspondence to 4–6 Jakob Solgaard Jensen; worldwide and complications related to isch- prevention. jakob. solgaard. jensen@ regionh. aemic heart disease (IHD) are the leading Randomised trials have since targeted even dk cause of death under 65 years of age.1 lower LDL-C levels achieved by intensified Jensen JS, et al. BMJ Open 2019;9:e022702. doi:10.1136/bmjopen-2018-022702 1 Open access BMJ Open: first published as 10.1136/bmjopen-2018-022702 on 1 April 2019. Downloaded from LDL-C lowering treatment (ie, higher dosage, more METHODS potent statins or additional ezetimibe) in patients with In this register-based cohort study, information regarding IHD, which has shown to further reduce the risk of patient demographics, comorbidities, coronary proce- cardiovascular disease (CVD).7–10 dures and concurrent medication use was identified using Novel treatment options to further lower the LDL-C cross linkage between three different nationwide Danish levels are monoclonal antibodies to proprotein conver- registers. The Civil Registration System holds informa- tase subtilisin-kexin type 9 (PCSK9), which have shown tion on date of birth, sex and survival status. The Danish lowering of the LDL-C levels by 40%–60% and relative National Patient Register holds information on every reduction of cardiovascular events by 15% (CI: 0.79–0.92) hospital admission in Denmark since 1978, in which each when added to background statin treatment.11 hospitalisation is registered at discharge with one primary The European Society of Cardiology (ESC) and The American diagnosis and, if applicable, one or more secondary College of Cardiology (ACC) guidelines12 13 have endorsed diagnoses according to the International Classification PCSK9i treatment in patients at high risk and very high of Diseases, the 10th revision (ICD-10) since 1994. The risk of future cardiovascular events. Partly due to the high Danish National Patient Register also holds information cost of PCSK9i, most countries have established national on surgeries and procedures including percutaneous guidelines and committees to approve a prior authorisa- coronary intervention (PCI) and Coronary Artery Bypass tion application for medicine subsidy in the individual Grafting (CABG). Comprising data on date, quantity, patient. In Denmark, PCSK9i treatment were approved strength, formulation of all prescriptions dispensed from for medication subsidy in patients in very high risk of Danish pharmacies has been accurately registered in The future CVD (ie, patients with a history of acute coronary Danish Registry of Medicinal Product Statistics since 1995 syndrome, acute myocardial infarction, atherosclerotic and coded according to the Anatomical Therapeutic polyvascular disease or diabetes mellitus with IHD) and Chemical (ATC) classification system. in patients in high risk of future CVD (ie, patients with a All Danish patients with a prescription for PCSK9i (ATC history of stable angina pectoris or diabetes mellitus with code C10A×13 or C10A×14) between 1 January 2016 and either target organ damage, peripheral atherosclerotic 31 March 2017 were included in the study cohort on the artery disease, transitory cerebral ischaemia or ischaemic day they redeemed their prescription. Since 1 March cerebral infarction) who despite maximally tolerated lipid 2017, PCSK9i were collected at specialised units at Danish lowering treatment (LLT) required further reduction hospitals and prescriptions of PCSK9i in the time period of LDL-C levels. Established cut-off LDL-C values were from 1 March 2017 to 31 March 2017 were not registered 3.0 mmol/L (115 mg/dL) and 3.5 mmol/L (135 mg/dL) in the present study. in the very high-risk patients and high-risk patients, respec- Demographic information on age, sex and vital status tively (online supplementary appendix figure 1). Statin was identified using The Civil Registration System. Comor- http://bmjopen.bmj.com/ intolerance in these patients would also be approved for bidities and coronary procedures were identified using subsidy when treatment with at least three types of statin The Danish National Patient Register. Information on starting in low dosages titrated to maximum tolerated diabetes mellitus and hypertension was identified using dosage and ezetimibe and bile acid sequestrant had been The Danish Registry of Medicinal Product Statistics along attempted prior to PCSK9i initiation. The ESC and ACC with the concurrent medication (online supplementary guidelines further endorse additional clinical criteria (ie, appendix table 1). patients with a history of isolated peripheral atheroscle- rotic artery disease, isolated ischaemic cerebral infarction Statistics on September 27, 2021 by guest. Protected copyright. or diabetes mellitus with
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