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- | Juxtapid (lomitapide) / Amryt, Novelion, Kynamro (mipomersen) / Kastle
Journal: New Therapeutic Approaches for Familial Hypercholesterolemia. (Pubmed Central) - Sep 18, 2019
Between 2012 and 2015, the US Food and Drug Administration approved four novel LDL-C-lowering agents for use in patients with FH based on the pronounced LDL-C-lowering efficacy of these medicines. We review the four novel approved agents, as well as promising LDL-C-lowering agents in clinical development, with a focus on their mechanism of action, efficacy in FH cohorts, and safety.
- || Kynamro (mipomersen) / Kastle
8/other treatments after statins include fibrates, carnitine, mipomersen (not available in USA), extreme instances Plasmapharesis (Twitter) - Sep 6, 2019
- | Kynamro (mipomersen) / Kastle
Clinical, Journal: Effects of Mipomersen, an apoB100 antisense, on Lp(a) metabolism in healthy subjects. (Pubmed Central) - Sep 4, 2019
We review the four novel approved agents, as well as promising LDL-C-lowering agents in clinical development, with a focus on their mechanism of action, efficacy in FH cohorts, and safety. Mipomersen treatment decreases Lp(a) levels mainly by increasing FCR of Lp(a), although changes in Lp(a) PR were significant predictors of reductions in Lp(a) levels in some subjects.
- | Kynamro (mipomersen) / Kastle
Journal: The Effects of Mipomersen on Inhibiting Hepatic VLDL Apolipoprotein B100 Synthesis and Propensity for Hepatic Steatosis. (Pubmed Central) - Sep 1, 2019
Mipomersen treatment decreases Lp(a) levels mainly by increasing FCR of Lp(a), although changes in Lp(a) PR were significant predictors of reductions in Lp(a) levels in some subjects. No abstract available
- | Kynamro (mipomersen) / Kastle
Clinical, Journal: Effect of mipomersen on LDL-cholesterol in patients with severe LDL-hypercholesterolaemia and atherosclerosis treated by lipoprotein apheresis: Corrections of the report on the randomized MICA-study. (Pubmed Central) - Jul 13, 2019
No abstract available No abstract available
- | Kynamro (mipomersen) / Kastle
Clinical, Journal: Reply to: "Effect of mipomersen on LDL-cholesterol in patients with severe LDL-hypercholesterolaemia and atherosclerosis treated by lipoprotein apheresis: Corrections of the report on the randomized MICA-study". (Pubmed Central) - Jul 13, 2019
No abstract available No abstract available
- | Clinical data, Journal: Safety and tolerability of injectable lipid-lowering drugs: an update of clinical data. (Pubmed Central) - Jun 30, 2019
Clinical data prove the favorable risk-benefit profile of evolocumab, alirocumab, and inclisiran. Mipomersen, volanesorsen, ISIS 681257, evinacumab, and IONIS-ANGPTL3 safety is currently less extensively studied, especially in patients with comorbidities and polypharmacotherapy.
- | Juxtapid (lomitapide) / Amryt, Novelion
Journal: Target achievement and cardiovascular event rates with Lomitapide in homozygous Familial Hypercholesterolaemia. (Pubmed Central) - Apr 17, 2019
P3
There were fewer major CV events per 1000 patient months of treatment in patients taking lomitapide, mipomersen or evolocumab than reported in the mipomersen cohort prior to starting mipomersen. These results support the hypothesis that novel lipid-lowering therapies may reduce CV events in HoFH patients by lowering LDL-C further.
- | Juxtapid (lomitapide) / Amryt, Novelion, Kynamro (mipomersen) / Kastle
Journal: What special considerations must be made for the pharmacotherapeutic management of heterozygous familial hypercholesterolemia? (Pubmed Central) - Apr 2, 2019
These results support the hypothesis that novel lipid-lowering therapies may reduce CV events in HoFH patients by lowering LDL-C further. No abstract available
- | Kynamro (mipomersen) / Kastle Therap, Exondys 51 (eteplirsen) / Sarepta Therap
Review, Journal: FDA-Approved Oligonucleotide Therapies in 2017. (Pubmed Central) - Feb 21, 2018
Of all the molecules evaluated as of January 2017, the regulatory authorities assessed that six provided clear clinical benefit in rigorously controlled trials. The story of these six is given in this review.
- Kynamro (mipomersen) / Kastle Therap
Phase classification: Dose-escalating Safety Study in Subjects on Stable Statin Therapy (clinicaltrials.gov) - Aug 3, 2016
P2a, N=74, Completed, Sponsor: Kastle Therapeutics, LLC
The story of these six is given in this review. Phase classification: P2 --> P2a
- ||||||| Kynamro (mipomersen) / Kastle Therap
Trial completion: FOCUS FH: A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol (clinicaltrials.gov) - Jun 16, 2016
P3, N=310, Completed, Sponsor: Genzyme, a Sanofi Company
Phase classification: P2 --> P2a Active, not recruiting --> Completed
- |||| Kynamro (mipomersen) / Kastle Therap
Trial primary completion date: FOCUS FH: A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol (clinicaltrials.gov) - Dec 12, 2015
P3, N=300, Active, not recruiting, Sponsor: Genzyme, a Sanofi Company
Active, not recruiting --> Completed Trial primary completion date: Feb 2015 --> Feb 2016
- Kynamro (mipomersen) / Kastle Therap
Trial completion: MICA: Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis (clinicaltrials.gov) - Sep 3, 2015
P3, N=17, Completed, Sponsor: Ludwig-Maximilians - University of Munich
Trial primary completion date: Feb 2015 --> Feb 2016 Active, not recruiting --> Completed
- |||| Kynamro (mipomersen) / Kastle Therap
Trial primary completion date: An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia (clinicaltrials.gov) - Feb 5, 2015
P3, N=142, Completed, Sponsor: Genzyme, a Sanofi Company
Active, not recruiting --> Completed Trial primary completion date: Mar 2014 --> Sep 2014
- Kynamro (mipomersen) / Kastle Therap
Enrollment closed, Trial primary completion date: MICA: Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis (clinicaltrials.gov) - Dec 30, 2014
P3, N=17, Active, not recruiting, Sponsor: Ludwig-Maximilians - University of Munich
Trial primary completion date: Mar 2014 --> Sep 2014 Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2014 --> Apr 2015
- ||||||| Kynamro (mipomersen) / Kastle Therap
Trial completion: An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia (clinicaltrials.gov) - Sep 28, 2014
P3, N=145, Completed, Sponsor: Genzyme, a Sanofi Company
Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2014 --> Apr 2015 Active, not recruiting --> Completed
- ||||| Kynamro (mipomersen) / Kastle Therap
Enrollment closed: FOCUS FH: A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol (clinicaltrials.gov) - Apr 6, 2014
P3, N=300, Active, not recruiting, Sponsor: Genzyme, a Sanofi Company
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||||| Kynamro (mipomersen) / Kastle Therap
Enrollment change: FOCUS FH: A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol (clinicaltrials.gov) - Nov 3, 2013
P3, N=300, Active, not recruiting, Sponsor: Genzyme, a Sanofi Company
Recruiting --> Active, not recruiting N=480 --> 300
- | Kynamro (mipomersen) / Kastle Therap
Trial completion: Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects (clinicaltrials.gov) - Feb 3, 2013
P1, N=20, Completed, Sponsor: Genzyme, a Sanofi Company
N=480 --> 300 Active, not recruiting --> Completed
- Kynamro (mipomersen) / Kastle Therap
Enrollment open: MICA: Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis (clinicaltrials.gov) - Nov 8, 2012
P3, N=17, Recruiting, Sponsor: Ludwig-Maximilians - University of Munich
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- Kynamro (mipomersen) / Kastle Therap
New P3 trial: MICA: Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis (clinicaltrials.gov) - May 13, 2012
P3, N=17, Recruiting, Sponsor: Ludwig-Maximilians - University of Munich
- | Kynamro (mipomersen) / Kastle Therap
Trial completion: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers (clinicaltrials.gov) - Apr 12, 2012
P1, N=20, Completed, Sponsor: Genzyme, a Sanofi Company
Not yet recruiting --> Recruiting Recruiting --> Completed
- | Kynamro (mipomersen) / Kastle Therap
Trial completion: Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia (clinicaltrials.gov) - Jan 16, 2012
P2, N=21, Completed, Sponsor: Genzyme, a Sanofi Company
Recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Kynamro (mipomersen) / Kastle Therap
New P3 trial: FOCUS FH: A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol (clinicaltrials.gov) - Nov 17, 2011
P3, N=300, Active, not recruiting, Sponsor: Genzyme, a Sanofi Company
- ||||| Kynamro (mipomersen) / Kastle Therap
Enrollment closed: An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia (clinicaltrials.gov) - Aug 15, 2011
P3, N=145, Active, not recruiting, Sponsor: Genzyme, a Sanofi Company
Active, not recruiting --> Completed Enrolling by invitation --> Active, not recruiting
- | Kynamro (mipomersen) / Kastle Therap
New P1 trial: Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects (clinicaltrials.gov) - Aug 9, 2011
P1, N=20, Completed, Sponsor: Genzyme, a Sanofi Company