A Retrospective Observational Study to Determine Baseline Characteristics and Early Prescribing Patterns for Patients Receiving Alirocumab in UK Clinical Practice

Tim Reynolds, Peter Carey, Jacob George, Gerasimos Konidaris, Deepa Narayanan, Sudarshan Ramachandran, Luke Saunders, Adie Viljoen, Gordon Ferns (Lead / Corresponding author)

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Abstract

Background: Alirocumab is a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9) and has been previously shown, in the phase III ODYSSEY clinical trial program, to provide significant lowering of low-density lipoprotein cholesterol (LDL-C) and reduction in risk of major adverse cardiovascular events. However, real-world evidence to date is limited.

Objective: The primary objective was to describe baseline characteristics, clinical history, and prior lipid-lowering therapy (LLT) use of patients initiated on alirocumab in UK clinical practice following publication of health technology appraisal (HTA) body recommendations. Secondary objectives included description of alirocumab use and lipid parameter outcomes over a 4-month follow-up period.

Methods: In this retrospective, single-arm, observational, multicenter study, data were collected for 150 patients initiated on alirocumab.

Results: Mean (standard deviation; SD) age of patients was 61.4 (10.5) years and baseline median (interquartile range; IQR) LDL-C level was 4.8 (4.2-5.8) mmol/l. Alirocumab use occurred predominantly in patients with heterozygous familial hypercholesterolemia (HeFH) (n = 100/150, 66%) and those with statin intolerance (n = 123/150, 82%). Most patients started on alirocumab 75 mg (n = 108/150 [72%]) and 35 (23.3%) were up-titrated to 150 mg. Clinically significant reductions in atherogenic lipid parameters were observed with alirocumab, including LDL-C (median [IQR] change from baseline, - 53.6% [- 62.9 to - 34.9], P < 0.001).

Conclusion: This study highlights the unmet need for additional LLT in patients with uncontrolled hyperlipidemia and demonstrates the clinical utility of alirocumab in early real-world practice, where dosing flexibility is an important attribute of this therapeutic option.

Original languageEnglish
Pages (from-to)205-213
Number of pages9
JournalDrugs - real world outcomes
Volume6
Issue number4
Early online date18 Nov 2019
DOIs
Publication statusPublished - Dec 2019

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Observational Studies
Retrospective Studies
LDL Cholesterol
Lipids
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Phase III Clinical Trials
Biomedical Technology
Hyperlipoproteinemia Type II
alirocumab
Risk Reduction Behavior
Hyperlipidemias
Multicenter Studies
Publications
Therapeutics
Monoclonal Antibodies

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Reynolds, T., Carey, P., George, J., Konidaris, G., Narayanan, D., Ramachandran, S., ... Ferns, G. (2019). A Retrospective Observational Study to Determine Baseline Characteristics and Early Prescribing Patterns for Patients Receiving Alirocumab in UK Clinical Practice. Drugs - real world outcomes, 6(4), 205-213. https://doi.org/10.1007/s40801-019-00166-7
Reynolds, Tim ; Carey, Peter ; George, Jacob ; Konidaris, Gerasimos ; Narayanan, Deepa ; Ramachandran, Sudarshan ; Saunders, Luke ; Viljoen, Adie ; Ferns, Gordon. / A Retrospective Observational Study to Determine Baseline Characteristics and Early Prescribing Patterns for Patients Receiving Alirocumab in UK Clinical Practice. In: Drugs - real world outcomes. 2019 ; Vol. 6, No. 4. pp. 205-213.
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title = "A Retrospective Observational Study to Determine Baseline Characteristics and Early Prescribing Patterns for Patients Receiving Alirocumab in UK Clinical Practice",
abstract = "Background: Alirocumab is a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9) and has been previously shown, in the phase III ODYSSEY clinical trial program, to provide significant lowering of low-density lipoprotein cholesterol (LDL-C) and reduction in risk of major adverse cardiovascular events. However, real-world evidence to date is limited.Objective: The primary objective was to describe baseline characteristics, clinical history, and prior lipid-lowering therapy (LLT) use of patients initiated on alirocumab in UK clinical practice following publication of health technology appraisal (HTA) body recommendations. Secondary objectives included description of alirocumab use and lipid parameter outcomes over a 4-month follow-up period.Methods: In this retrospective, single-arm, observational, multicenter study, data were collected for 150 patients initiated on alirocumab.Results: Mean (standard deviation; SD) age of patients was 61.4 (10.5) years and baseline median (interquartile range; IQR) LDL-C level was 4.8 (4.2-5.8) mmol/l. Alirocumab use occurred predominantly in patients with heterozygous familial hypercholesterolemia (HeFH) (n = 100/150, 66{\%}) and those with statin intolerance (n = 123/150, 82{\%}). Most patients started on alirocumab 75 mg (n = 108/150 [72{\%}]) and 35 (23.3{\%}) were up-titrated to 150 mg. Clinically significant reductions in atherogenic lipid parameters were observed with alirocumab, including LDL-C (median [IQR] change from baseline, - 53.6{\%} [- 62.9 to - 34.9], P < 0.001).Conclusion: This study highlights the unmet need for additional LLT in patients with uncontrolled hyperlipidemia and demonstrates the clinical utility of alirocumab in early real-world practice, where dosing flexibility is an important attribute of this therapeutic option.",
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Reynolds, T, Carey, P, George, J, Konidaris, G, Narayanan, D, Ramachandran, S, Saunders, L, Viljoen, A & Ferns, G 2019, 'A Retrospective Observational Study to Determine Baseline Characteristics and Early Prescribing Patterns for Patients Receiving Alirocumab in UK Clinical Practice', Drugs - real world outcomes, vol. 6, no. 4, pp. 205-213. https://doi.org/10.1007/s40801-019-00166-7

A Retrospective Observational Study to Determine Baseline Characteristics and Early Prescribing Patterns for Patients Receiving Alirocumab in UK Clinical Practice. / Reynolds, Tim; Carey, Peter; George, Jacob; Konidaris, Gerasimos; Narayanan, Deepa; Ramachandran, Sudarshan; Saunders, Luke; Viljoen, Adie; Ferns, Gordon (Lead / Corresponding author).

In: Drugs - real world outcomes, Vol. 6, No. 4, 12.2019, p. 205-213.

Research output: Contribution to journalArticle

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T1 - A Retrospective Observational Study to Determine Baseline Characteristics and Early Prescribing Patterns for Patients Receiving Alirocumab in UK Clinical Practice

AU - Reynolds, Tim

AU - Carey, Peter

AU - George, Jacob

AU - Konidaris, Gerasimos

AU - Narayanan, Deepa

AU - Ramachandran, Sudarshan

AU - Saunders, Luke

AU - Viljoen, Adie

AU - Ferns, Gordon

N1 - This study was funded by Sanofi.

PY - 2019/12

Y1 - 2019/12

N2 - Background: Alirocumab is a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9) and has been previously shown, in the phase III ODYSSEY clinical trial program, to provide significant lowering of low-density lipoprotein cholesterol (LDL-C) and reduction in risk of major adverse cardiovascular events. However, real-world evidence to date is limited.Objective: The primary objective was to describe baseline characteristics, clinical history, and prior lipid-lowering therapy (LLT) use of patients initiated on alirocumab in UK clinical practice following publication of health technology appraisal (HTA) body recommendations. Secondary objectives included description of alirocumab use and lipid parameter outcomes over a 4-month follow-up period.Methods: In this retrospective, single-arm, observational, multicenter study, data were collected for 150 patients initiated on alirocumab.Results: Mean (standard deviation; SD) age of patients was 61.4 (10.5) years and baseline median (interquartile range; IQR) LDL-C level was 4.8 (4.2-5.8) mmol/l. Alirocumab use occurred predominantly in patients with heterozygous familial hypercholesterolemia (HeFH) (n = 100/150, 66%) and those with statin intolerance (n = 123/150, 82%). Most patients started on alirocumab 75 mg (n = 108/150 [72%]) and 35 (23.3%) were up-titrated to 150 mg. Clinically significant reductions in atherogenic lipid parameters were observed with alirocumab, including LDL-C (median [IQR] change from baseline, - 53.6% [- 62.9 to - 34.9], P < 0.001).Conclusion: This study highlights the unmet need for additional LLT in patients with uncontrolled hyperlipidemia and demonstrates the clinical utility of alirocumab in early real-world practice, where dosing flexibility is an important attribute of this therapeutic option.

AB - Background: Alirocumab is a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9) and has been previously shown, in the phase III ODYSSEY clinical trial program, to provide significant lowering of low-density lipoprotein cholesterol (LDL-C) and reduction in risk of major adverse cardiovascular events. However, real-world evidence to date is limited.Objective: The primary objective was to describe baseline characteristics, clinical history, and prior lipid-lowering therapy (LLT) use of patients initiated on alirocumab in UK clinical practice following publication of health technology appraisal (HTA) body recommendations. Secondary objectives included description of alirocumab use and lipid parameter outcomes over a 4-month follow-up period.Methods: In this retrospective, single-arm, observational, multicenter study, data were collected for 150 patients initiated on alirocumab.Results: Mean (standard deviation; SD) age of patients was 61.4 (10.5) years and baseline median (interquartile range; IQR) LDL-C level was 4.8 (4.2-5.8) mmol/l. Alirocumab use occurred predominantly in patients with heterozygous familial hypercholesterolemia (HeFH) (n = 100/150, 66%) and those with statin intolerance (n = 123/150, 82%). Most patients started on alirocumab 75 mg (n = 108/150 [72%]) and 35 (23.3%) were up-titrated to 150 mg. Clinically significant reductions in atherogenic lipid parameters were observed with alirocumab, including LDL-C (median [IQR] change from baseline, - 53.6% [- 62.9 to - 34.9], P < 0.001).Conclusion: This study highlights the unmet need for additional LLT in patients with uncontrolled hyperlipidemia and demonstrates the clinical utility of alirocumab in early real-world practice, where dosing flexibility is an important attribute of this therapeutic option.

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