In a Phase 2 trial, patients with very high to severely high triglycerides who were treated with the investigational drug, volanesorsen (Akcea Therapeutics), a second-generation antisense inhibitor of apolipoprotein C-III (ApoC3) synthesis, achieved mean reductions of up to 80% in ApoC3 and up to 71% in triglycerides. HDL-C levels increased, on average, up to 46%. The trial was double-blinded, randomized, placebo-controlled, and conducted over 13 weeks to assess the safety and activity of volanesorsen as monotherapy and as an add-on to fibrates. Phase 3 study (APPROACH) is ongoing in patients with familial chylomicronemia syndrome (FCS) and another Phase 3 study is planned for later this year in patients with familial partial lipodystrophy (FPL). Read more
A new quality measure has been submitted for consideration by the National Minority Quality Forum (NMQF) to the National Quality Forum (NQF), that if approved, will help ensure that African Americans living with heart failure (HF) will not die prematurely because they are not receiving the standard of care. Public comment began on July 23 and members of the general public are encouraged to support the proposal and comment by August 12 via the NQF’s webpage.
This past March, Dr. Keith C. Ferdinand spoke on the prevalence and severity of HF in African Americans at the Best of the CMHC Regional Conference Series.
“The harsh reality is that African Americans suffer from earlier onset and more prevalent and severe heart failure, with higher readmissions,” Dr. Ferdinand said. “These real and unfortunate disparities demand the appropriate application of evidence-based, guideline-supported pharmacotherapy in blacks. Clinicians, public health leaders, and policymakers cannot overlook this necessary responsibility to ensure the best therapy for all patients where indicated.” Plan on attending the 10th Annual CMHC Boston, October 21-24, 2015 to hear more perspective on the topic.
The new quality measure is fully supported by the Association of Black Cardiologists as well as ACC/AHA guidelines and emphasizes the importance of adherence to the current standard of care for African Americans with HF. More than 550,000 African Americans are living with HF, of whom more than 150,000 should be prescribed fixed-dose hydralazine and isosorbide dinitrate, a drug regimen proven to reduce mortality in African Americans by 43% and first-time hospitalizations for HF by 33%.
Few, however, are actually receiving this regimen. According to Dr. Gary Puckrein, CEO of the NMQF and the proposed measure’s steward, “Astonishingly, only a very small portion, about 7%, of African Americans who are clinically eligible for the therapy are getting it.”
View Dr. Keith Ferdinand’s One-Minute Clinician video interview for more insight.