CARDIOVASCULAR JOURNAL OF AFRICA • Volume 30, No 4, July/August 2019
AFRICA
215
28. Olfert ED, Cross BM, McWilliam AA. Guide to the care and use of
experimental animals. Volume 1: Appendix V. (1993). Accessed on
May 22, 2017 from
https://www.aaalac.org/accreditation/RefResources/CCAC_Experimental_Animals_Vol1.pdf
29. Stary HC, Chandler AB, Dinsmore RE, Fuster V, Glagov S, Insull W
Jr
, et al.
A definition of advanced types of atherosclerotic lesions and a
histological classification of atherosclerosis. A report from the commit-
tee on vascular lesions of the Council on Arteriosclerosis, American
Heart Association
. Circulation
1995;
92
(5): 1355–1374. PMID: 7648691.
30. Belknap WM, Dietschy JM. Sterol synthesis and low density lipoprotein
clearance in vivo in the pregnant rat, placenta, and fetus. Sources for
tissue cholesterol during fetal development
.
J Clin Invest
1988;
82
(6):
2077–2085. PMID: 3198766. 442791.
31. Palinski W, D’Armiento FP, Witztum JL, de Nigris F, Casanada F,
Condorelli M
, et al.
Maternal hypercholesterolemia and treatment
during pregnancy influence the long-term progression of atheroscle-
rosis in offspring of rabbits
.
Circ Res
2001;
89
(11): 991–996. PMID:
11717155.
32. Leiva A, de Medina CD, Salsoso R, Saez T, San Martin S, Abarzua
F
, et al.
Maternal hypercholesterolemia in pregnancy associates with
umbilical vein endothelial dysfunction: role of endothelial nitric oxide
synthase and arginase II
.
Arterioscler Thromb Vasc Biol
2013;
33
(10):
2444–2453. PMID: 23950140.
33. Frantz E, Menezes HS, Lange KC, Abegg MP, Correa CA, Zangalli
L
, et al.
The effect of maternal hypercholesterolemia on the placenta
and fetal arteries in rabbits
.
Acta Cir Bras
2012;
27
(1): 7–12. PMID:
22159432.
34. Lemne C, Jogestrand T, de Faire U. Carotid intima–media thickness and
plaque in borderline hypertension
.
Stroke
1995;
26
(1): 34–39. PMID:
7839394.
35. Tonstad S, Joakimsen O, Stensland-Bugge E, Leren TP, Ose L, Russell D
,
et al.
Risk factors related to carotid intima–media thickness and plaque
in children with familial hypercholesterolemia and control subjects
.
Arterioscler Thromb Vasc Biol
1996;
16
(8): 984–991. PMID: 8696963.
36. Magnussen CG, Carotid artery intima–media thickness and hyperten-
sive heart disease: a short review
.
Clin Hypertens
2017;
23
: 7. PMID:
28373912. PMC5376487.
37. Shindo J, Ishibashi T, Yokoyama K, Nakazato K, Ohwada T, Shiomi
M
, et al.
Granulocyte-macrophage colony-stimulating factor prevents
the progression of atherosclerosis via changes in the cellular and extra-
cellular composition of atherosclerotic lesions in watanabe heritable
hyperlipidemic rabbits
.
Circulation
1999;
99
(16): 2150–2156. PMID:
10217656.
38. Zoccali C, Mallamaci F. Cocoa flavanols: a magic potion for protecting
the endothelium in kidney failure?
Clin J Am Soc Nephrol
2016;
11
(1):
9–11. PMID: 26681133.
39. 39. Heiss C, Kleinbongard P, Dejam A, Perré S, Schroeter H, Sies H,
Kelm M. Acute consumption of flavanol-rich cocoa and the reversal
of endothelial dysfunction in smokers.
J Am Coll Cardiol
2005;
46
(7):
1276–1283. PMID: 16198843.
…continued from page 197
The report says Esperion, which plans to set a $3 500
list price for bempedoic acid, believes it can play interloper.
The list prices of PCSK9 treatments, which currently exceed
$14 000 a year, have limited their use in the three years since
they hit the market. Esperion’s drug doesn’t lower LDL
as well as PCSK9 blockers, which can roughly halve bad
cholesterol levels, but it would be cheaper and wouldn’t
require an injection.
But cracking the market may not be so simple. Earlier
this year, Sanofi and Regeneron struck a deal with Express
Scripts in which they’ll discount their drugs by more than
50% in exchange for an easier path to patients. And, last
week, Amgen made an unprecedented move to slash the list
price of its treatment to $5 850 a year by 2020. According
to the report, that could create a difficult market dynamic
for Esperion. Zetia prescriptions, like statins, are practically
free for patients with insurance, and each has an established
effect on preventing heart attacks and strokes in the long
term. The PCSK9 treatments have demonstrated dramatic
long-term benefits of their own, and their impending price
decreases could put them within reach of more patients than
ever before.
Bempedoic acid has established that it can reduce LDL
cholesterol levels, but its effects on cardiovascular health
won’t be known until a 13 000-patient trial reads out in 2022.
That could leave Esperion struggling to make its case in a
crowded market.
‘I’m still not totally convinced that there’s an obvious
place for this drug,’ said Dr Ethan Weiss, a cardiologist at
the University of California – San Francisco Medical Centre,
who wasn’t involved in the study. ‘We have a good drug with
modest efficacy in statins, and then two drugs with significant
efficacy in PCSK9. If you’re a marketer, I don’t know where
you aim your gun at this one.’
The report says Esperion believes bempedoic acid will
have plenty of room to compete. Despite the established
benefits of PCSK9 therapy, only about 20 000 people are
getting the drugs, Esperion CEO Tim Mayleben said. And
that suggests there’s pent-up demand for an alternative.
‘There are 13 million people in the US who have elevated
LDL cholesterol levels and have had a cardiovascular event
and need more cholesterol lowering,’ Mayleben said. ‘The
fact that the price of PCSK9s is being lowered, that’s great.
But it’s still almost twice the list price of our drug.’
Source:
Stat News report 2018