JCEM: Abapapatide is safe for cardiovascular risk in postmenopausal women with osteoporosis (ACTIVE study)

Abaparatide, whose English name is Abaloparatide, is a new type of parathyroid hormone-related peptide (PTHrP) developed by Radius Health .

New parathyroid hormone related peptide (PTHrP), can increase bone mineral content, bone mineral density and bone strength, promote bone formation subcutaneous injection therapy in the risk of fracture or osteoporosis in postmenopausal women after other treatments ineffective, and may Effectively reduce the rate of new vertebral body and non-vertebral body fractures

Research background: Abappatide is a parathyroid hormone-related peptide approved by the U.

Study objective: To evaluate the cardiovascular safety of abaparatide

Assessing the cardiovascular safety of abaparatide

Plan design: Review heart rate (HR), blood pressure (BP) and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACE) and heart failure (HF)

(A) ACTIVE (NCT01343004): A phase 3 trial in which 2463 postmenopausal osteoporotic women were randomly given abaparatide, teriparatide or placebo for 18 months;

(B) ACTIVExtend (NCT01657162): Participants in the abaparatide group and placebo group received alendronate treatment for 2 years;

ACTIVExtend (NCT01657162):

(C) This project is also a pharmacological study on 55 healthy adults

Results: Abbapatide and teriparatide can temporarily increase HR relative to placebo

Temporarily increase HR

Table 1 The average change of heart rate in patients with ACTIVE from before administration to 1 hour after administration

In healthy volunteers, the increased heart rate disappeared within 4 hours

If your heart rate increases within 4 hours, it will disappear

Figure 1 Heart rate changes (90% CI) of healthy subjects within 24 hours after a single administration of abaparatide and placebo;

BPM is judged as the expected variation of resting heart rate of healthy subjects

The corresponding changes in the mean systolic and diastolic blood pressures in the lying position 1 hour after treatment were -2.

Table 2 Changes in blood pressure from before administration to 1 hour after administration

The proportions of severe cardiac AEs were similar among the groups (0.

The proportions of severe cardiac AEs were similar among the groups

Table 3 Treatment emergency adverse events that may be related to increased heart rate in ACTIVE

In a retrospective analysis, abaparatide (P = 0.

The first occurrence of MACE + HF takes longer

Table 4 MACE and MACE + HF in ACTIVE

Figure 2 The time of first onset of MACE and MACE + HF in ACTIVE and ACTIVExtend

A) ACTIVE and ACTIVExtend MACE; B) ACTIVE and ACTIVExtend MACE + HF

ABL Abbaparatide; ALN Alendronate Sodium; HF: Heart Failure; MACE: Major Cardiovascular Adverse Events; Mo Month; PBO Placebo; TPTD Teriparatide

Conclusion: Abapapatide is associated with transient heart rate acceleration and small drop in blood pressure in postmenopausal women with osteoporosis, but does not increase the risk of severe cardiac AEs, MACE or heart failure

After Aba Pa peptide women with postmenopausal osteoporosis brief heart rate and blood pressure related to a small decline, but no increased risk for serious cardiac AEs, MACE risk of heart failure or post-menopausal osteoporosis with Aba Pa peptide women's short rapid heart rate It is related to a small drop in blood pressure, but does not increase the risk of serious cardiac AEs, MACE or heart failure

Note: MACE is the abbreviation of Major Adverse Cardiovascular Events, that is, major adverse cardiovascular events, which mainly include three end-point events: cardiovascular death, myocardial infarction and stroke

Cardiovascular death, myocardial infarction and stroke

Original source:

Cosman F, Peterson LR, Towler DA, Mitlak B, Wang Y, Cummings SR.

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