Repatha Drug Information
Generic name: EVOLOCUMAB
PCSK9 Inhibitor [EPC]
Uses of Repatha
- REPATHA is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
Dosage & Administration of Repatha
Recommended Dosage
In adults at increased risk for CV events or with hypercholesterolemia: The recommended dosage of REPATHA is either 140 mg every 2 weeks OR 420 mg once monthly administered subcutaneously. If switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen. In adults and pediatric patients aged 10 years and older with HoFH: The initial recommended dosage of REPATHA is 420 mg once monthly administered subcutaneously.
The dosage can be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks. Patients on lipid apheresis may initiate treatment with 420 mg every 2 weeks to correspond with their apheresis schedule. Administer REPATHA after the apheresis session is complete.
Assess LDL-C when clinically appropriate. The LDL-lowering effect of REPATHA may be measured as early as 4 weeks after initiation. When monitoring LDL-C for patients receiving REPATHA 420 mg once monthly, note that LDL-C can vary during the dosing interval in some patients; recommend measuring LDL-C just prior to the next scheduled dose.
- Missed Doses If a dose is missed: Within 7 days from the missed dose, instruct the patient to administer REPATHA and resume the patient's original schedule.
- More than 7 days after the missed dose: For an every 2-week dose, instruct the patient to wait until the next dose on the original schedule. For a once-monthly dose, instruct the patient to administer the dose and start a new schedule based on this date.
Important Administration Instructions REPATHA is available as prefilled single-dose SureClick ® autoinjectors and prefilled single-dose syringes that either contain dry natural rubber (a derivative of latex) in the needle cover or are not made with natural rubber latex. Consider prescribing a presentation of REPATHA that does not contain dry natural rubber for individuals that are sensitive to latex. Train patients and/or caregivers on how to prepare and administer REPATHA, according to the Instructions for Use and instruct them to read and follow the Instructions for Use each time they use REPATHA.
Prior to use, allow REPATHA to warm to room temperature for at least 30 minutes for the prefilled single-dose pen, prefilled single-dose SureClick ® autoinjector, or prefilled single-dose syringe if REPATHA has been refrigerated. Visually inspect REPATHA prior to administration. REPATHA is a clear to opalescent, colorless to pale yellow solution.
Do not use if the solution is cloudy, discolored, or contains particles. For use in adult and pediatric patients aged 10 years and older: Administer REPATHA subcutaneously into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. Avoid injecting into areas with scars or stretch marks.
Rotate injection sites for each administration. The 420 mg dose of REPATHA can be administered: by giving 3 injections consecutively within 30 minutes using the prefilled single-dose pen, prefilled single-dose SureClick ® autoinjector, or prefilled single-dose syringe.
Side Effects of Repatha
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in a 52 - Week Controlled Trial In a 52-week, double-blind, randomized, placebo-controlled trial, 599 patients received 420 mg of REPATHA subcutaneously once monthly. Adverse reactions reported in at least 3% of REPATHA-treated patients, and more frequently than in placebo-treated patients are shown in Table 1.
Adverse reactions led to discontinuation of treatment in 2.2% of REPATHA-treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to REPATHA treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for REPATHA and placebo, respectively). Table 1.
Table 2. Adverse Reactions Occurring in ≥ 1% of REPATHA-treated Patients and More Frequently than with Placebo in Pooled 12-Week Trials Adverse Reactions in Eight Pooled Controlled Trials (Seven 12 - Week Trials and One 52 - Week Trial) The adverse reactions described below are from a pool of the 52-week trial and seven 12-week trials. The mean and median exposure durations of REPATHA in this pool of eight trials were 20 weeks and 12 weeks, respectively.
Local Injection Site Reactions Injection site reactions occurred in 3.2% and 3.0% of REPATHA-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. The proportions of patients who discontinued treatment due to local injection site reactions in REPATHA-treated patients and placebo-treated patients were 0.1% and 0%, respectively.
Hypersensitivity Reactions Hypersensitivity reactions occurred in 5.1% and 4.7% of REPATHA-treated and placebo-treated patients, respectively. Adverse Reactions in the CV Outcomes Trial In a double-blind, randomized, placebo-controlled CV outcomes trial, 27,525 patients received at least one dose of REPATHA or placebo. The safety profile of REPATHA in this trial was generally consistent with the safety profile described above in the 12- and 52-week controlled trials involving patients with primary hypercholesterolemia.
Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with REPATHA compared with 7.7% in patients that received placebo. No new adverse reactions were observed during the open-label extension study.
Postmarketing Experience
The following additional adverse reactions have been identified during post-approval use of REPATHA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity reactions: Angioedema Influenza-like illness
| Placebo (N = 302) % | REPATHA (N = 599) % | |
|---|---|---|
| Nasopharyngitis | 9.6 | 10.5 |
| Upper respiratory tract infection | 6.3 | 9.3 |
| Influenza | 6.3 | 7.5 |
| Back pain | 5.6 | 6.2 |
| Injection site reactions includes erythema, pain, bruising | 5.0 | 5.7 |
| Cough | 3.6 | 4.5 |
| Urinary tract infection | 3.6 | 4.5 |
| Sinusitis | 3.0 | 4.2 |
| Headache | 3.6 | 4.0 |
| Myalgia | 3.0 | 4.0 |
| Dizziness | 2.6 | 3.7 |
| Musculoskeletal pain | 3.0 | 3.3 |
| Hypertension | 2.3 | 3.2 |
| Diarrhea | 2.6 | 3.0 |
| Gastroenteritis | 2.0 | 3.0 |
| Placebo (N = 1224) % | REPATHA 140 mg every 2 weeks and 420 mg once monthly combined (N = 2052) % | |
|---|---|---|
| Nasopharyngitis | 3.9 | 4.0 |
| Back pain | 2.2 | 2.3 |
| Upper respiratory tract infection | 2.0 | 2.1 |
| Arthralgia | 1.6 | 1.8 |
| Nausea | 1.2 | 1.8 |
| Fatigue | 1.0 | 1.6 |
| Muscle spasms | 1.2 | 1.3 |
| Urinary tract infection | 1.2 | 1.3 |
| Cough | 0.7 | 1.2 |
| Influenza | 1.1 | 1.2 |
| Contusion | 0.5 | 1.0 |
Warnings & Cautions for Repatha
Hypersensitivity Reactions
Hypersensitivity reactions, including angioedema, have been reported in patients treated with REPATHA. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with REPATHA, treat according to the standard of care, and monitor until signs and symptoms resolve. REPATHA is contraindicated in patients with a history of serious hypersensitivity reactions to evolocumab or any excipient in REPATHA.
The prefilled single-dose SureClick ® autoinjector and prefilled single-dose syringe presentations of REPATHA that contain dry natural rubber (a derivative of latex) in the needle cover may cause an allergic reaction in individuals sensitive to latex. Instruct patients to inform their healthcare provider if they are sensitive to latex. Consider prescribing a presentation of REPATHA that does not contain dry natural rubber for individuals that are sensitive to latex.
Pregnancy Safety for Repatha
Pregnancy Risk Summary Available data from clinical trials and postmarketing reports on REPATHA use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, there were no effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times the exposure at the maximum recommended human dose of 420 mg every month. In a similar study with another drug in the PCSK9 inhibitor antibody class, humoral immune suppression was observed in infant monkeys exposed to that drug in utero at all doses.
The exposures where immune suppression occurred in infant monkeys were greater than those expected clinically. No assessment for immune suppression was conducted with evolocumab in infant monkeys. Measurable evolocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that evolocumab, like other IgG antibodies, crosses the placental barrier.
Monoclonal antibodies are transported across the placenta in increasing amounts especially near term; therefore, evolocumab has the potential to be transmitted from the mother to the developing fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
There is a pregnancy safety study for REPATHA. If REPATHA is administered during pregnancy, healthcare providers should report REPATHA exposure by contacting Amgen at 1-800-77-AMGEN (1-800-772-6436) or https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting. Data Animal Data In cynomolgus monkeys, no effects on embryo-fetal or postnatal development (up to 6 months of age) were observed when evolocumab was dosed during organogenesis to parturition at 50 mg/kg once every 2 weeks by the subcutaneous route at exposures 30- and 12-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC.
No test of humoral immunity in infant monkeys was conducted with evolocumab.
Pediatric Use of Repatha
Pediatric Use The safety and effectiveness of REPATHA in combination with diet and other LDL-C-lowering therapies for the treatment of HoFH have been established in pediatric patients aged 10 years and older. Use of REPATHA for this indication is supported by evidence from an adequate and well-controlled trial in adults and pediatric patients aged 13 years and older with HoFH (including 7 pediatric patients treated with REPATHA) and from open-label studies which included an additional 19 pediatric patients aged 11 years and older with HoFH not previously treated with REPATHA. The safety and effectiveness of REPATHA as an adjunct to diet and other LDL-C-lowering therapies for the treatment of HeFH have been established in pediatric patients aged 10 years and older.
Use of REPATHA for this indication is based on data from a 24-week, randomized, placebo-controlled, double-blind trial in pediatric patients with HeFH. The safety and effectiveness of REPATHA have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hypercholesterolemia.
Contraindications for Repatha
REPATHA is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in REPATHA. Serious hypersensitivity reactions including angioedema have occurred in patients treated with REPATHA.
Clinical Studies of Repatha
The median follow-up duration was 26 months. Overall, 99.2% of patients were followed until the end of the trial or death. Regarding prior diagnoses of CVD, 81% had prior myocardial infarction, 19% prior non-hemorrhagic stroke, and 13% had symptomatic peripheral arterial disease.
Most patients were on a high- (69%) or moderate-intensity (30%) statin therapy at baseline, and 5% were also taking ezetimibe. On stable background lipid-lowering therapy, the median LDL-C at baseline was 92 mg/dL; the mean (SD) was 98 mg/dL. REPATHA significantly reduced the risk for the primary composite endpoint (time to first occurrence of CV death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; p < 0.0001) and the key secondary composite endpoint (time to first occurrence of cardiovascular death, myocardial infarction, or stroke; p < 0.0001).
The Kaplan-Meier estimates of the cumulative incidence of the primary and key secondary composite endpoints over time are shown in Figure 1 and Figure 2 below. The results of primary and secondary efficacy endpoints are shown in Table 3 below. Table 3.
Effect of REPATHA on CV Events in Patients with Established CVD in FOURIER from baseline to Week and from baseline to Week In EBBINGHAUS (NCT02207634), a substudy of 1974 patients enrolled in the FOURIER trial, REPATHA was non-inferior to placebo on selected cognitive function domains as assessed with the use of neuropsychological function tests over a median follow-up of 19 months. Primary Hypercholesterolemia Study 2 (LAPLACE-2, NCT01763866) was a multicenter, double-blind, randomized controlled 12-week trial in which patients were initially randomized to an open-label specific statin regimen for a 4-week lipid stabilization period followed by random assignment to subcutaneous injections of REPATHA 140 mg every 2 weeks, REPATHA 420 mg once monthly, or placebo for 12 weeks. The trial included 1896 patients with hypercholesterolemia who received REPATHA, placebo, or ezetimibe as add-on therapy to daily doses of statins (atorvastatin, rosuvastatin, or simvastatin).
Ezetimibe was also included as an active control only among those assigned to background atorvastatin. After 4 weeks of background statin therapy, the mean baseline LDL-C ranged between 77 and 127 mg/dL across the five background therapy arms. The difference between REPATHA and placebo in mean percent change in LDL-C from baseline to Week p < p ˂ 0.0001 for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively.
For additional results, see Table 4 and Figure 3. Table 4. Effect of REPATHA on Lipid Parameters in Patients with Hypercholesterolemia on Background Statin Regimens Mean % Change from Baseline to Week 12 in LAPLACE Study 3 (DESCARTES, NCT01516879) was a multicenter, double-blind, randomized, placebo-controlled, 52-week trial that included 901 patients with hypercholesterolemia who received protocol-determined background lipid-lowering therapy of a cholesterol-lowering diet either alone or in addition to atorvastatin (10 mg or 80 mg daily) or the combination of atorvastatin 80 mg daily with ezetimibe.
After stabilization on background therapy, patients were randomly assigned to the addition of placebo or REPATHA 420 mg administered subcutaneously once monthly. After stabilization on the assigned background therapy, the mean baseline LDL-C ranged between 90 and 117 mg/dL across the four background therapy groups. In these patients with hypercholesterolemia on a protocol-determined background therapy, the difference between REPATHA 420 mg once monthly and placebo in mean percent change in LDL-C from baseline to Week p ˂ 0.0001 (Table 5 and Figure 4).
For additional results, see Table 5. Table 5. Effect of REPATHA on Lipid Parameters in Patients with Hypercholesterolemia Prior to randomization, patients were stabilized on background therapy consisting of a cholesterol-lowering diet either alone or in addition to atorvastatin (10 mg or 80 mg daily) or the combination of atorvastatin 80 mg daily with ezetimibe. (Mean % Change from Baseline to Week 52 in DESCARTES), NCT01763827 was a multicenter, double-blind, randomized, placebo- and active-controlled, 12-week trial that included 614 patients with hypercholesterolemia who were not taking lipid-lowering therapy at baseline.
Blinded administration of ezetimibe was also included as an active control. The mean baseline LDL-C was 143 mg/dL. For additional results, see Table 6.
Table 6. Effect of REPATHA on Lipid Parameters in Patients with Hypercholesterolemia (Mean % Change from Baseline to Week 12 in MENDEL, NCT01763918) was a multicenter, double-blind, randomized, placebo-controlled, 12-week trial in 329 patients with HeFH on statins with or without other lipid-lowering therapies. Patients were randomized to receive subcutaneous injections of REPATHA 140 mg every two weeks, 420 mg once monthly, or placebo.
HeFH was diagnosed by the Simon Broome criteria. In Study 5, 38% of patients had clinical atherosclerotic CVD. The average LDL-C at baseline was 156 mg/dL with 76% of the patients on high-intensity statin therapy.
For additional results, see Table 7 and Figure 5. Table 7. Effect of REPATHA on Lipid Parameters in Patients with HeFH Mean % Change from Baseline to Week 12 in RUTHERFORD Pediatric Patients with HeFH Study 6 (HAUSER-RCT, NCT02392559) was a randomized, multicenter, placebo-controlled, double-blind, 24-week trial in 157 pediatric patients aged 10 to 17 years with HeFH.
HeFH was diagnosed by diagnostic criteria for HeFH or by genetic testing. Patients were required to be on a low-fat diet and optimized background lipid-lowering therapy. For additional results, see Table 8 and Figure 6. on Lipid Parameters in Pediatric Patients with HeFH (Mean % Change from Baseline to Week 24 in HAUSER-RCT) Adults and Pediatric Patients with HoFH Study 7 (TESLA, NCT01588496) was a multicenter, double-blind, randomized, placebo-controlled, 12-week trial in 49 patients (not on lipid-apheresis therapy) with HoFH.
In this trial, 33 patients received subcutaneous injections of 420 mg of REPATHA once monthly and 16 patients received placebo as an adjunct to other lipid-lowering therapies (e.g., statins, ezetimibe). The mean LDL-C at baseline was 349 mg/dL with all patients on statins (atorvastatin or rosuvastatin) and 92% on ezetimibe. The diagnosis of HoFH was made by genetic confirmation or a clinical diagnosis based on a history of an untreated LDL-C concentration > 500 mg/dL together with either xanthoma before 10 years of age or evidence of HeFH in both parents.
For additional results, see Table 9. Patients known to have two LDL-receptor negative alleles (little to no residual function) did not respond to REPATHA. Table 9.
Effect of REPATHA on Lipid Parameters in Patients with HoFH (Mean % Change from Baseline to Week 12 in TESLA) Study 8 (TAUSSIG, NCT01624142) was a multicenter, open-label 5-year extension study with REPATHA in 106 patients with HoFH, who were treated with REPATHA as an adjunct to other lipid-lowering therapies. The study included 14 pediatric patients (ages 13 to 17 years). All patients in the study were initially treated with REPATHA 420 mg once monthly except for those receiving lipid apheresis at enrollment, who began with REPATHA 420 mg every 2 weeks.
Dose frequency in non-apheresis patients could be titrated up to 420 mg once every 2 weeks based on LDL-C response and PCSK9 levels. Study 9 (HAUSER-OLE, NCT02624869) was an open-label, single-arm, multicenter, 80-week study to evaluate the safety, tolerability, and efficacy of REPATHA for LDL-C reduction in pediatric patients aged 10 to 17 years with HoFH. Overall, 12 patients with HoFH received 420 mg REPATHA subcutaneously once monthly.
Median (Q1, Q3) LDL-C at baseline was 398 mg/dL, and all patients were on statins (atorvastatin or rosuvastatin) and ezetimibe. No patients were receiving lipid apheresis. The diagnosis of HoFH was made by genetic confirmation in all patients but enrollment by a clinical diagnosis was permitted.
The median (Q1, Q3) percent change in LDL-C from baseline to Week Two of the 3 subjects with < 5% LDLR activity responded to evolocumab treatment.
| Placebo | REPATHA | REPATHA vs. Placebo | |||
|---|---|---|---|---|---|
| N = 13780 n (%) | Incidence Rate (per 100 patient years) | N = 13784 n (%) | Incidence Rate (per 100 patient years) | Hazard Ratio (95% CI) | |
| Primary composite endpoint | |||||
| Time to first occurrence of CV death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina | 1563 (11.3) | 5.2 | 1344 (9.8) | 4.5 | 0.85 (0.79, 0.92) |
| Key secondary composite endpoint | |||||
| Time to first occurrence of CV death, myocardial infarction, stroke | 1013 (7.4) | 3.4 | 816 (5.9) | 2.7 | 0.80 (0.73, 0.88) |
| Other secondary endpoints | |||||
| Time to CV death | 240 (1.7) | 0.8 | 251 (1.8) | 0.8 | 1.05 (0.88, 1.25) |
| Time to death by any cause Time to death by any cause is not a component of either the primary composite endpoint or key secondary composite endpoint. | 426 (3.1) | 1.4 | 444 (3.2) | 1.5 | 1.04 (0.91, 1.19) |
| Time to first fatal or non-fatal myocardial infarction | 639 (4.6) | 2.1 | 468 (3.4) | 1.6 | 0.73 (0.65, 0.82) |
| Time to first fatal or non-fatal stroke | 262 (1.9) | 0.9 | 207 (1.5) | 0.7 | 0.79 (0.66, 0.95) |
| Time to first coronary revascularization | 965 (7.0) | 3.2 | 759 (5.5) | 2.5 | 0.78 (0.71, 0.86) |
| Time to first hospitalization for unstable angina Not a prespecified endpoint; an ad hoc analysis was performed to ensure results are provided for each individual component of the primary endpoint. | 239 (1.7) | 0.8 | 236 (1.7) | 0.8 | 0.99 (0.82, 1.18) |
| Treatment Group | LDL-C | Non-HDL-C | Apo B | Total Cholesterol |
|---|---|---|---|---|
| Estimates based on a multiple imputation model that accounts for treatment adherence | ||||
| REPATHA every 2 weeks vs. Placebo every 2 weeks (Background statin: atorvastatin 10 mg or 80 mg; rosuvastatin 5 mg or 40 mg; simvastatin 40 mg) | ||||
| Placebo every 2 weeks (n = 281) | 8 | 6 | 5 | 4 |
| REPATHA 140 mg every 2 weeks 140 mg every 2 weeks or 420 mg once monthly yield similar reductions in LDL-C (n = 555) | -63 | -53 | -49 | -36 |
| Mean difference from placebo (95% CI) | -71 (-74, -67) | -59 (-62, -55) | -55 (-58, -52) | -40 (-43, -38) |
| REPATHA once monthly vs. Placebo once monthly (Background statin: atorvastatin 10 mg or 80 mg; rosuvastatin 5 mg or 40 mg; simvastatin 40 mg) | ||||
| Placebo once monthly (n = 277) | 4 | 5 | 3 | 2 |
| REPATHA 420 mg once monthly (n = 562) | -59 | -50 | -46 | -34 |
| Mean difference from placebo (95% CI) | -63 (-68, -57) | -54 (-58, -50) | -50 (-53, -47) | -36 (-39, -33) |
| REPATHA every 2 weeks vs. Ezetimibe 10 mg daily (Background statin: atorvastatin 10 mg or 80 mg) | ||||
| Ezetimibe 10 mg daily (n = 112) | -17 | -16 | -14 | -12 |
| REPATHA 140 mg every 2 weeks (n = 219) | -63 | -52 | -49 | -36 |
| Mean difference from Ezetimibe (95% CI) | -45 (-52, -39) | -36 (-41, -31) | -35 (-40, -31) | -24 (-28, -20) |
| REPATHA once monthly vs. Ezetimibe 10 mg daily (Background statin: atorvastatin 10 mg or 80 mg) | ||||
| Ezetimibe 10 mg daily (n = 109) | -19 | -16 | -11 | -12 |
| REPATHA 420 mg once monthly (n = 220) | -59 | -50 | -46 | -34 |
| Mean difference from Ezetimibe (95% CI) | -41 (-47, -35) | -35 (-40, -29) | -34 (-39, -30) | -22 (-26, -19) |
| Treatment Group | LDL-C | Non-HDL-C | Apo B | Total Cholesterol |
|---|---|---|---|---|
| Estimates based on a multiple imputation model that accounts for treatment adherence | ||||
| Placebo once monthly (n = 302) | 8 | 8 | 2 | 5 |
| REPATHA 420 mg once monthly (n = 599) | -47 | -39 | -38 | -26 |
| Mean difference from placebo (95% CI) | -55 (-60, -50) | -46 (-50, -42) | -40 (-44, -37) | -31 (-34, -28) |
| Treatment Group | LDL-C | Non-HDL-C | Apo B | Total Cholesterol |
|---|---|---|---|---|
| Estimates based on a multiple imputation model that accounts for treatment adherence | ||||
| Placebo every 2 weeks (n = 76) | 1 | 0 | 1 | 0 |
| Ezetimibe 10 mg daily (n = 77) | -17 | -14 | -13 | -10 |
| REPATHA 140 mg every 2 weeks 140 mg every 2 weeks or 420 mg once monthly yield similar reductions in LDL-C (n = 153) | -54 | -47 | -44 | -34 |
| Mean difference from placebo (95% CI) | -55 (-60, -50) | -47 (-52, -43) | -45 (-50, -41) | -34 (-37, -30) |
| Mean difference from Ezetimibe (95% CI) | -37 (-42, -32) | -33 (-37, -29) | -32 (-36, -27) | -23 (-27, -20) |
| Placebo once monthly (n = 78) | 1 | 2 | 2 | 0 |
| Ezetimibe 10 mg daily (n = 77) | -18 | -16 | -13 | -12 |
| REPATHA 420 mg once monthly (n = 153) | -56 | -49 | -46 | -35 |
| Mean difference from placebo (95% CI) | -57 (-61, -52) | -51 (-54, -47) | -48 (-52, -44) | -35 (-38, -32) |
| Mean difference from Ezetimibe (95% CI) | -38 (-42, -34) | -32 (-36, -29) | -33 (-36, -29) | -23 (-26, -20) |
| Treatment Group | LDL-C | Non-HDL-C | Apo B | Total Cholesterol |
|---|---|---|---|---|
| Estimates based on a multiple imputation model that accounts for treatment adherence | ||||
| Placebo every 2 weeks (n = 54) | -1 | -1 | -1 | -2 |
| REPATHA 140 mg every 2 weeks 140 mg every 2 weeks or 420 mg once monthly yield similar reductions in LDL-C (n = 110) | -62 | -56 | -49 | -42 |
| Mean difference from placebo (95% CI) | -61 (-67, -55) | -54 (-60, -49) | -49 (-54, -43) | -40 (-45, -36) |
| Placebo once monthly (n = 55) | 4 | 4 | 4 | 2 |
| REPATHA 420 mg once monthly (n = 110) | -56 | -49 | -44 | -37 |
| Mean difference from placebo (95% CI) | -60 (-68, -52) | -53 (-60, -46) | -48 (-55, -41) | -39 (-45, -33) |
| Treatment Group | LDL-C | Non-HDL-C | Apo B | Total Cholesterol |
|---|---|---|---|---|
| All adjusted p-values < 0.0001. | ||||
| n = number of patients randomized and dosed in the full analysis set. | ||||
| Placebo once monthly (n = 53) | -6 | -6 | -2 | -5 |
| REPATHA 420 mg once monthly (n = 104) | -44 | -41 | -35 | -32 |
| Mean difference from placebo (95% CI) | -38 (-45, -31) | -35 (-42, -28) | -32 (-39, -26) | -27 (-32, -21) |
| Treatment Group | LDL-C | Non-HDL-C | Apo B | Total Cholesterol |
|---|---|---|---|---|
| Estimates based on a multiple imputation model that accounts for treatment adherence | ||||
| Placebo once monthly (n = 16) | 9 | 8 | 4 | 8 |
| REPATHA 420 mg once monthly (n = 33) | -22 | -20 | -17 | -17 |
| Mean difference from placebo (95% CI) | -31 (-44, -18) | -28 (-41, -16) | -21 (-33, -9) | -25 (-36, -14) |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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