Hospital Pharmacy - April 2018 - 86

Hospital Pharmacy 53(2)

Table 1. New Treatment Options.
Generic name

Sponsor

Drug class

Ad5.hAC6 (RT-100)

Renova
Therapeutics

Gene therapy

Omecamtiv mecarbil

Amgen,
Cytokinetics

Myosin activator

Serelaxin

Novartis

Relaxin

Stresscopin (RT-400)

Renova
Therapeutics

Urocortin hormone

Ularitide

Cardiorentis AG

Natriuretic peptide

Comments
In a 56-patient, phase II trial, a single dose of RT-100 increased
left ventricular peak and ejection fraction compared with
placebo at 4 weeks. Ejection fraction remained elevated after
12 weeks in patients with nonischemic HF, but not ischemic
HF. There was no difference in treadmill walking times
between RT-100 and placebo.5
In a 606 ADHF patient, phase II trial, an intravenous infusion
of omecamtiv mecarbil did not improve dyspnea compared
with placebo, but a subgroup analysis suggested a possible
decrease with the highest dose.7 Omecamtiv mecarbil is
also being developed as an oral treatment for stable HF. A
recent 448-patient, phase II trial suggested the drug improved
cardiac function and ventricular remodeling.8
In a 1161 patient, phase III trial, serelaxin improved dyspnea
after the first 24 hours through day 5 and decreased CV
death and all-cause death at 6 months.9 Novartis announced
that in a 6600-patient, phase III trial, serelaxin was no
different than placebo in preventing further decompensation
over the first 5 days or in reducing CV death at 6-months.
In a 62-patient, phase II trial, stresscopin increased the cardiac
index and decreased systemic vascular resistance compared
with placebo in stable HF patients with a left ventricular
ejection fraction of 35% or less.10
In a phase III, 2157 ADHF patient trial, ularitide did not
improve HF symptoms during the first 48 hours or decrease
CV death at 15 months compared with placebo.11

Note. Information adapted from the Prescribe Right Pharmaceutical Pipeline Tracker database.12 ADHF = acute decompensated heart failure; HF = heart
failure; CV = cardiovascular.

dyspnea. Ularitide, a urodilatin analogue, is a vasodilator
that has not shown a benefit for acute decompensated heart
failure. Omecamtiv mecarbil is a cardiac myosin activator
that increases stroke volume. While omecamtiv mecarbil has
not shown a benefit in acute decompensated heart failure, the
drug may have potential for chronic heart failure.
Authors' Note
Information is summarized from selected materials; additional
information may be available from other sources. Due to the preapproval nature of the information, non-peer-reviewed data may be
utilized. The information provided is meant to provide a way to
assess the development status of a new drug and should not be used
in making patient care decisions.

Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship, and/or publication of this
article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

References
1. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA
guideline for the management of heart failure: executive
summary: a report of the American College of Cardiology
Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013;128(16):1810-1852.
2. Writing Group Members, Mozaffarian D, Benjamin EJ, et al.
Heart disease and stroke statistics-2016 update: a report from
the American Heart Association. Circulation. 2016;133(4):e38360.
3. Teerlink JR, Alburikan K, Metra M, Rodgers JE. Acute decompensated heart failure update. Curr Cardiol Rev. 2015;11(1):
53-62.
4. Bart BA, Goldsmith SR, Lee KL, et al. Ultrafiltration in
decompensated heart failure with cardiorenal syndrome. N
Engl J Med. 2012;367:2296-2304.
5. Hammond HK, Penny WF, Traverse JH, et al. Intracoronary
gene transfer of adenylyl cyclase 6 in patients with heart failure:
a randomized clinical trial. JAMA Cardiol. 2016;1(2):163-171.
6. Stirrat CG, Venkatasubramanian S, Pawade T, et al.
Cardiovascular effects of urocortin 2 and urocortin 3 in
patients with chronic heart failure. Br J Clin Pharmacol.
2016;82(4):974-982.
7. Teerlink JR, Felker GM, McMurray JJV, et al. Acute treatment
with omecamtiv mecarbil to increase contractility in acute

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