Date: 2014-11-18
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the annual American Heart Association meeting in Chicago, IL
Company: Genzyme (USA - MA), a Sanofi company - Isis Pharmaceuticals (USA - CA)
Product: Kynamro® (mipomersen)
Action
mechanism: Mipomersen is a first-in-class apo-B synthesis inhibitor and acts by blocking the production of apolipoprotein B (apoB), the protein that provides the structural core for these atherogenic particles, including LDL and lipoprotein-a (Lp(a)).
Disease: familial hypercholesterolemia
Therapeutic area: Cardiovascular diseases - Genetic diseases
Country:
Trial details:
Latest
news: * On November 18, 2014, Genzyme, a Sanofi company, and Isis Pharmaceuticals announced that new two-year data from a phase 3 long-term extension study of Kynamro® (mipomersen sodium) injection was presented at a scientific session at the annual American Heart Association meeting in Chicago, IL. In the study, a retrospective analysis showed that patients treated with Kynamro® for a mean of two years had a significant reduction in Major Adverse Cardiovascular Events (MACE) compared to two years prior to therapy.This retrospective analysis included 104 patients who enrolled in the long-term extension study of Kynamro® after having completed one of the Kynamro® phase 3 blinded, randomized, placebo-controlled 6-month trials in patients with homozygous and heterozygous FH. All patients who completed at least two years of treatment with Kynamro® were included in the analysis. The rate of MACE in patients treated with Kynamro® for two years were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with Kynamro®. Number of MACE in Number of MACE in p<0.0001 The marked reduction in MACE coincided with the absolute mean reductions in LDL cholesterol levels (-49 to -113 mg/dL) reported for the phase 3 FH clinical trials.
In this analysis, MACE were identified in 62% of patients during two years prior to Kynamro® treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with Kynamro®. MACE were defined as myocardial infarction (MI), stroke, unstable angina (UA) and revascularization procedures (PCI/CABG).
Event
patients two years prior to
treatment with KYNAMRO
patients after two years on
treatment with KYNAMRO
MI
39
2
PCI/CABG
99
6
UA
5
4
Stroke
3
0
Total
146
12
MACE rate
(per 1000 patient-months)
25.7*
3.6*
