Mipomersen, an apolipoprotein B synthesis inhibitor, lowers low-density lipoprotein cholesterol in high-risk statin-intolerant patients: a randomized, double-blind, placebo-controlled trial Full Text
European Heart Journal,  Clinical Article

Visser ME et al. – The present data suggest that mipomersen is a potential therapeutic option in statin–intolerant patients at high risk for cardiovascular disease (CVD). The long–term follow–up of liver safety is required.

Methods
  • 33 subjects, not receiving statin therapy because of statin intolerance, received a weekly subcutaneous dose of 200 mg mipomersen or placebo (2:1 randomization) for 26 weeks.
  • The primary endpoint was per cent change in LDL cholesterol (LDL–c) from the baseline to Week 28.
  • The other efficacy endpoints were per cent change in apoB and lipoprotein a [Lp(a)].
  • Safety was determined using the incidence of treatment–emergent adverse events (AEs) and clinical laboratory evaluations.
  • After 26 weeks of mipomersen administration, LDL–c was reduced by 47 ± 18% (P < 0.001 vs. placebo). apoB and Lp(a) were also significantly reduced by 46 and 27%, respectively (P < 0.001 vs. placebo).
  • Four mipomersen (19%) and two placebo subjects (17%) discontinued dosing prematurely due to AEs.

Results
  • Persistent liver transaminase increases ≥3× the upper limit of normal were observed in seven (33%) subjects assigned to mipomersen.
  • In selected subjects, liver fat content was assessed, during and after treatment, using magnetic resonance spectroscopy.
  • Liver fat content in these patients ranged from 0.8 to 47.3%.
  • Liver needle biopsy was performed in two of these subjects, confirming hepatic steatosis with minimal inflammation or fibrosis.

Please login or register to follow this author.
Are you sure you want to Unfollow this Author?
► Click here to access Full Text, PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Family Medicine

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Family Medicine Articles

1 Effect of caffeine on exercise capacity and function in prostate cancer survivors Medicine and Science in Sports and Exercise, July 9, 2014    Clinical Article

2 Circumcision plus antibiotic, anti-inflammatory, and α-blocker therapy for the treatment for chronic prostatitis/chronic pelvic pain syndrome: A prospective, randomized, multicenter trial World Journal of Urology, July 16, 2014    Clinical Article

3 Changes in circulating leptin levels during acute stress and associations with craving in abstinent smokers: A preliminary investigation Psychoneuroendocrinology, June 20, 2014    Clinical Article

4 Vasectomy may increase risk of aggressive prostate cancer Harvard Gazette - Health News, July 11, 2014

5 Treating concurrent chronic low back pain and depression with low-dose venlafaxine: an initial identification of easy-to-use clinical predictors of early response Pain Medicine, July 8, 2014    Clinical Article

6 Physical activity motivation mediates the association between depression symptoms and moderate-to-vigorous physical activity Preventive Medicine, July 2, 2014    Clinical Article

7 Yoga as an adjunctive treatment for posttraumatic stress disorder: a randomized controlled trial The Journal of Clinical Psychiatry, July 7, 2014    Clinical Article

8 Biopsy characteristics in men with a preoperative diagnosis of prostatic adenocarcinoma with high Gleason Score (GS = 8-10) predict pathologic outcome in radical prostatectomy Human Pathology, July 22, 2014    Review Article

9 Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications BMJ, July 3, 2014    Evidence Based Medicine

10 Effects of homocysteine lowering with B vitamins on cognitive aging: meta-analysis of 11 trials with cognitive data on 22,000 individuals American Journal of Clinical Nutrition, July 8, 2014    Evidence Based Medicine

11 Adjuvant radiotherapy versus wait-and-see after radical prostatectomy: 10-year follow-up of the ARO 96–02/AUO AP 09/95 Trial Full Text European Urology, July 18, 2014    Free full text    Clinical Article

12 Curcumin for the treatment of major depression: A randomised, double-blind, placebo controlled study Journal of Affective Disorders, July 16, 2014    Clinical Article

13 Tea consumption and leukemia risk: A meta-analysis Tumor Biology, February 12, 2014    Evidence Based Medicine    Clinical Article

14 The effect of green tea on blood pressure and lipid profile: A systematic review and meta-analysis of randomized clinical trials Nutrition, Metabolism & Cardiovascular Diseases, March 27, 2014    Evidence Based Medicine    Review Article

15 Plasmakinetic enucleation of the prostate compared with open prostatectomy for prostates larger than 100 grams: A randomized noninferiority controlled trial with long-term results at 6 years Full Text European Urology, July 28, 2014    Free full text    Clinical Article

16 Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies CNS Spectrums, July 1, 2014    Clinical Article

17 Tea consumption and the risk of five major cancers: A dose-response meta-analysis of prospective studies Full Text BMC Cancer, March 18, 2014    Free full text    Evidence Based Medicine    Review Article

18 Prospective study of breakfast eating and incident coronary heart disease in a cohort of male US health professionals Full Text Circulation, July 24, 2013    Free full text    Clinical Article

19 Coffee consumption and prostate cancer risk: An updated meta-analysis Cancer Causes and Control, March 3, 2014    Evidence Based Medicine    Clinical Article

20 A prospective, blinded comparison of magnetic resonance (MR) imaging–ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: The PROFUS trial Full Text European Urology, July 14, 2014    Free full text    Clinical Article

Indexed Journals in Family Medicine: American Family Physician, Archives of Family Med, Annals of Family Medmore

Register now to view all the MDLinx contents (FREE)!

  • Stay current on the latest literature, research and clinical news
  • Get special communications and offers from MDLinx and our sponsors
  • Receive invitations to paid market research
View Samples and Register

Connect with us, stay current.

Receive the latest mecial news
updates for free via email

Sign up!

Subscribe to our free RSS feeds:

Get the latest news in your specialty automatically added to your newsreader or your personal My Yahoo!, Google, My MSN or My AOL page. Learn More

Close