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Dear Doctor,
Today, we want to share with you the patient profile of Tanmay, who had an MI 2 years back, and recently he has been admitted to the hospital with chest pain; his ECG showed ST segment elevation that suggested acute STEMI. |
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| As you know, patients like Tanmay with multiple Mls are at high risk for major vascular events, The higher the CV risk, the lower the recommended LDL-C treatment goal.1,2 |
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| Current Treatment |
Atorvastatin 40 mg |
| LDL-C level |
80 mg/dL (2.1 mmol/L) |
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| For patients like Tanmay, Repatha® added to a statin is proven to reduce the risk of another Ml by dramatically lowering LDL-C.1 |
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Repatha® in patients with multiple MI
FOURIER study subanalysis1 |
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| Repatha® added to a statin substantially reduced recurrent major CV events in patients with a history of MI1 |
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^Composite of CV death, MI, or stroke1
¶FOURIER was a randomized, double-blind, placebo-controlled trial that enrolled 27,564 patients age 40-85 years with clinically evident atherosclerotic cardiovascular disease (prior MI, prior non-hemorrhagic stroke, or symptomatic peripheral arterial disease) and additional risk factors placing them at increased cardiovascular risk as previously described. Patients were required to have an LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL during screening while taking an optimized lipid-lowering regimen (at least atorvastatin 20 mg daily or its equivalent, with or without ezetimibe). Within the broad group of patients with prior MI, the authors hypothesized that readily ascertainable features would identify subsets that derive greater clinical risk reduction with evolocumab. The 22,351 patients with a prior MI were characterized based on time from most recent MI, number of prior MIs, and presence of residual multivessel coronary artery disease (≥40% stenosis in ≥2 large vessels). The relative and absolute risk reductions in major vascular events including the primary endpoint (CV death, MI, stroke, hospitalization for unstable angina, or coronary revascularization) and the key secondary endpoint (CV death, MI or stroke) with evolocumab in these subgroups were compared.1 |
| When administered in hospital, Repatha® added to atorvastatin 40 mg helped patients get below guideline-recommended LDL-C thresholds/ goals in 8 weeks2,3 |
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| †The purpose of this study was to assess the feasibility, safety, and LDL-C-lowering efficacy of evolocumab initiated during the in-hospital phase of ACS. The authors conducted an investigator-initiated, randomized, double-blind, placebo-controlled trial involving 308 patients hospitalized for ACS with elevated LDL-C levels (≥1.8 mmol/l on high-intensity statin for at least 4 weeks; ≥2.3 mmol/l on low- or moderate-intensity statin; or ≥3.2 mmol/l on no stable dose of statin). Patients were randomly assigned 1:1 to receive subcutaneous evolocumab 420 mg or matching placebo, administered in-hospital and after 4 weeks, on top of atorvastatin 40 mg, The primary endpoint was percentage change in calculated LDL-C from baseline to 8 weeks.3 |
| ESC/EAS 2019 Guidelines Recommendations for the LDL-C Treatment goals for ASCVD patients who experience a second vascular event2: |
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| Recommendations |
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Level |
| For patients with ASCVD who experience a second vascular event within 2 years (not necessarily of the same type as the first event) while taking maximally tolerated statin-based therapy, an LDL-C goal of <1.0 mmol/L (<40 mg/dL) may be considered. |
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| For patients who present with an ACS and whose LDL-C levels are not at goal, despite already taking a maximally tolerated statin dose and ezetimibe, the addition of a PCSK9 inhibitor early after the event (during hospitalization for the ACS event if possible) should be considered. |
lla |
C |
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| Abbreviations: ECG, Electrocardiogram; MI, Myocardial infarction; CV, Cardiovascular; LDL C, Low Density Lipoprotein Cholesterol; STEMI, ST Elevation myocardial infarction; RRR, Relative Risk Reduction; HR, Hazard Ratio; CI, Confidence Interval; ESC, European Society of Cardiology; EAS, European Atherosclerosis Society; ASCVD, Atherosclerotic Cardiovascular Disease; ACS, Acute Coronary Syndrome; PCSK 9, Proprotein Convertase Subtilisin/Kexin.9 |
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ABBREVIATED PRODUCT INFORMATION REPATHA®
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 140 MG REPATHA® SOLUTION FOR INJECTION IN PRE-FILLED AUTOINJECTOR 140 MG |
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| Composition: Each pre-filled Sureclick autoinjector contains 140 mg of evolocumab in 1 mL of solution. Therapeutic Indication: Indicated for Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 years and over in combination with other lipid-lowering therapies. In adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. In adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Dosage: a) In established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) and Primary hypercholesterolemia and mixed dyslipidaemia in adults: The recommended dose of Repatha™ is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent. b) Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 years and over: The initial recommended dose is 420 mg once monthly. After 12 weeks of treatment, dose frequency can be up-titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved. Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule. c) Patients with renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment. d) Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment. e) Elderly patients (age ≥ 65 years): No dose adjustment is necessary in elderly patients. f) Paediatric population: The safety and efficacy of Repatha in children aged less than 18 years has not been established in the indication for primary hypercholesterolaemia and mixed dyslipidaemia. No data are available. The safety and efficacy of Repatha in children aged less than 12 years has not been established in the indication for homozygous familial hypercholesterolaemia. No data are available. Administration: Repatha™ is for subcutaneous injection into the abdomen, thigh or upper arm region. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red, or hard. Repatha™ must not be administered intravenously or intramuscularly. The 140 mg dose should be delivered using a single pre-filled autoinjector. The 420 mg dose once monthly or every 2 weeks should be delivered using three pre-filled autoinjectors administered consecutively within 30 minutes. Repatha™ is intended for patient self-administration after proper training. Each pre-filled autoinjector is for single use only. Contraindications: Hypersensitivity to the active substance or to any of the excipients such as Proline, Glacial acetic acid, Polysorbate 80, Sodium hydroxide, Water for injections. Warnings and Precautions: Repatha™ should be used with caution in patients with severe renal impairment. Patients with moderate hepatic impairment require close monitoring. Repatha™ should be used with caution in patients with severe hepatic impairment. Use in Special population: Pregnancy: There are no or limited amount of data from the use of Repatha™ in pregnant women. Repatha™ should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab. Lactation: It is unknown whether evolocumab is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Repatha therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Drug Interactions: No formal drug-drug interaction studies have been conducted for Repatha™. The pharmacokinetic interaction between statins and Repatha™ was evaluated in the Repatha™ clinical trials. An approximately 20% increase in the clearance of Repatha™ was observed in patients co-administered statins. Undesirable effects: The most common side effects with Repatha™ during pivotal clinical trials at recommended doses are nasopharyngitis, upper respiratory tract infection, influenza, back pain, arthralgia and injection site reactions. Overdosage: No adverse effects were observed in animal studies at exposures up to 300-fold higher than those in patients treated with Repatha™ at 420 mg once monthly. There is no specific treatment for Repatha™ overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. |
API version number & Date of Revision: INREPPI06, January 18, 2024
Further information is available on request. For more information, please refer to the full prescribing information.
Repatha distributed by Dr. Reddys in India under authorization by Amgen. The trademark Repatha® is owned by Amgen. |
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| GGI-CO-A1-AQS-NPINDFY190002-LB-C24-0462 |
| For the use of registered medical practitioner or hospital or laboratory only. |
References: 1. Sabatine MS, De Ferrari GM, Giugliano RP, et al, Clinical Benefit of Evolocumab by Severity and Extent of Coronary Artery Dis ease: Analysis From FOURIER, Circulation, 2018;138(8):756-766.
2. Mach F, Baigent C, Catapano AL, et al, 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to re duce cardiovascular risk, Eur Heart J, 2020;41(1):111-188.
3. Koskinas KC, Windecker S, Pedrazzini G, et al, Evolocumab for Early Reduction of LDL Cholesterol Levels in Patients With Acut e C oronary Syndromes (EVOPACS), J Am Coll Cardiol, 2019 Nov 19;74(20):2452-2462. |
| INDIA OFFICE: Dr. Reddy's Laboratories Ltd., Greenlands, 7-1-27, Ameerpet, Hyderabad, Telangana 500 016, India. |
| Biologics: Dr. Reddy's Laboratories Ltd., Survey No. 47 Bachupally, Outubullapur, RR Dist - 500 090, Telangana, India. Tel: +91-40-44644000 Fax: +91-4023041418. |
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