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Nov 17th, 2024

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LBS 01: CELEBRATING A CENTURY OF CARDIOVASCULAR SCIENCE

Intensive blood pressure control, tirzepatide and novel gene editing therapy.



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Trial results were presented for new approaches to managing blood pressure in
diabetes, HFpEF and obesity, and transthyretin amyloid cardiomyopathy at the
Opening Session on Saturday. They found:

 * Intensive blood pressure control strategy may improve cardiovascular outcomes
   in patients with type 2 diabetes.
 * Tirzepatide shows clinical benefit in patients with heart failure with
   preserved ejection fraction and obesity.
 * Novel gene editing therapy shows promise for patients with transthyretin
   amyloid cardiomyopathy.

An intensive blood pressure control strategy for patients with type 2 diabetes
may be considered

There is a lack of consensus on blood pressure reduction targets in patients
with type 2 diabetes and current clinical guidelines offer inconsistent
recommendations due to limited evidence from well-conducted clinical trials.
Still, results of the Intensive Blood-Pressure Control in Patients with Type 2
Diabetes (BPROAD) trial contribute to the body of evidence supporting more
intensive systolic blood pressure control in patients with type 2 diabetes for
the prevention of major cardiovascular events.

Guang Ning, MD, PhDThe multicenter, open-label, parallel-group clinical trial
randomized 12,821 patients with type 2 diabetes and elevated systolic blood
pressure and increased cardiovascular risk from 145 clinical sites in mainland
China between February 2019 and December 2021 to intensive treatment (6,414
patients) or standard treatment (6,407 patients) for up to five years.

Systolic blood pressure was targeted to <120 mmHg in the intensive treatment
group and <140 mmHg in the standard treatment group. Mean age of patients was
63.8 years; 45.3% were women and 22.5% had a self-reported history of
cardiovascular disease at baseline. Median follow-up was 4.2 years. The primary
outcome was major cardiovascular events defined as the composite endpoint of the
first occurrence of non-fatal stroke, non-fatal myocardial infarction, treated
or hospitalized heart failure and cardiovascular death. 

Following randomization, the intensive treatment was associated with a
significant 21% reduction in risk of cardiovascular disease compared with
patients receiving the standard treatment during up to five years of follow-up.
At one year, the mean (median) systolic blood pressure was 121.6 mm Hg (118.3mm
Hg) in the intensive-treatment group and 132.2 mm Hg (135.0 mm Hg) in the
standard-treatment group. 

Primary outcome events occurred in 393 patients (1.65 events per 100
person-years) in the intensive group and 492 patients (2.09 events per 100
person-years) in the standard treatment group (HR = 0.79; 95% CI; 0.69 to 0.90;
p < 0.001). Serious adverse events were generally similar between the two
groups. However, symptomatic hypotension and hyperkalemia occurred more
frequently in the intensive-treatment group.

“For most people with type 2 diabetes with an elevated cardiovascular disease
risk, intensive treatment to lower systolic blood pressure to a level less than
120 mmHg might have additional benefits in the prevention of major
cardiovascular diseases compared with standard treatment to lower systolic blood
pressure to a level less than 140 mmHg,” said Guang Ning, MD, PhD, the study’s
principal investigator and the Guang Qi Professor at Shanghai Jiao Tong
University School of Medicine in China. “Meanwhile, although it is generally
safe, hypotension and hyperkalemia should be monitored and prevented during
intensive blood pressure reduction.”

Ning noted that BPROAD’s results are consistent with findings from the SPRINT
study, which found a significant 27% reduction in the incidence of
cardiovascular diseases in patients with hypertension but without diabetes.
“Future clinical practice guidelines should consider these lines of evidence
when making recommendations of blood pressure treatment in patients with type 2
diabetes,” he said. The study was published in the New England Journal of
Medicine following the presentation. 



Weight-loss drug reduced worsening heart failure in people with obesity 

Tirzepatide, a long-acting agonist of glucose-dependent insulinotropic
polypeptide and glucagon-like peptide-1 receptors, significantly reduced the
risk of a composite of cardiovascular death or worsening heart failure and
improved health status in patients with heart failure with preserved ejection
fraction (HFpEF) and obesity, according to Tirzepatide for Patients With Heart
Failure With Preserved Ejection Fraction and Obesity: The SUMMIT Trial. 



Milton Packer, MDTirzepatide and other incretin-based drugs are approved for use
in adults with type 2 diabetes and for patients with obesity or overweight in
the presence of at least one weight-related comorbid condition, such as
cardiovascular disease. “Data were lacking on the effects of incretin-based
drugs on cardiovascular outcomes in patients with heart failure, but we now have
compelling information about the influence of these drugs on the clinical course
of patients with heart failure and preserved ejection fraction with obesity,”
said Milton Packer, MD, distinguished scholar in cardiovascular science at
Baylor University Medical Center in Dallas and the study’s principal
investigator. 

The international, multicenter, double-blind randomized placebo-controlled trial
randomly assigned 731 patients with heart failure, ejection fraction ≥50% and
body mass index ≥30 kg/m2 1:1 to tirzepatide up to 15 mg subcutaneously weekly
or placebo for a median of 104 weeks. 

The two primary outcomes were the time to first cardiovascular death or
worsening heart failure events and the change in the Kansas City Cardiomyopathy
Questionnaire Clinical Summary Score (KCCQ-CSS) at 52 weeks. Scores ranged from
0 to 100, with higher scores indicating better health status.  

Overall, tirzepatide benefited patients with HFpEF and obesity compared with
placebo. Cardiovascular death or worsening heart failure events occurred in 9.9%
of patients in the tirzepatide group and 15.3% in the placebo group (HR 0.62;
P=0.026). 

Worsening heart failure events occurred in 8% of patients in the tirzepatide
group and 14.2% in the placebo group (HR 0.54, P=0.008), with no apparent
differences between groups in cardiovascular death. At 52 weeks, the mean change
in KCCQ-CSS was 19.5 in the tirzepatide group compared with 12.7 in the placebo
group (P<0.001).

Tirzepatide was also well tolerated; 6.3% of patients in the tirzepatide group
stopped the drug due to adverse events (mainly gastrointestinal), compared with
1.4% in the placebo group.

“The SUMMIT Trial’s impressive outcomes data shows that tirzepatide doesn’t just
make people with obesity feel better, it changes the clinical trajectory of
heart failure with preserved ejection fraction in these patients,” Packer said. 

Packer noted that the SUMMIT Trial’s results can’t be extrapolated to patients
with heart failure with reduced ejection fraction (HFrEF); these patients were
not enrolled in the trial. “For the heart failure benefits of incretin-based
drugs, the type of heart failure matters,” he said. The study was published
simultaneously in the New England Journal of Medicine. 



Novel gene editing therapy shows promise for patients with transthyretin
amyloidosis with cardiomyopathy

Despite earlier diagnosis and currently available therapies, transthyretin
amyloidosis with cardiomyopathy (ATTR-CM) remains a progressive and ultimately
fatal disease with significant unmet need. But a single dose of Nexiguran
ziclumeran (nex-z), previously known as NTLA-2001, an investigational
CRISPR/Cas9-based in vivo gene editing therapy, demonstrated favorable safety,
tolerability, durable reductions in serum TTR levels with very low variability
among patients, and evidence of disease stabilization, according to CRISPR-Cas9
Gene Editing with Nexiguran Ziclumeran for ATTR Cardiomyopathy therapy for
patients with ATTR-CM: interim report of the Phase 1 study.

Marianna Fontana, MD, PhDIn the open label trial, 36 patients with ATTR-CM, 50%
New York Heart Association (NYHA) class 1-III; 31% variant ATTR-CM, received a
weight-based (0.7 or 1.0mg/kg) or fixed dose (55mg) of nex-z as a one-time IV
infusion and completed at least 12 months of follow-up. The primary outcome
assessed nex-z safety and serum TTR levels. Secondary endpoints included nex-z
effect on N-terminal pro-B-type natriuretic peptide (NT-proBNP),
high-sensitivity cardiac troponin T (hs-Troponin-T), 6-minute walk test (6MWT)
distance in addition to changes in NYHA class, measurements of cardiac
remodeling on echocardiography and cardiovascular magnetic resonance imaging
(CMR), cardiopulmonary exercise testing (CPET) and KCCQ score.

Reductions in TTR were accompanied by stability or improvement of several
disease markers. Mean 95% CI percent change from baseline in serum TTR levels at
day 28 and month 12 was -89% and 90%, respectively. Geometric mean (95% CI) fold
change from baseline to month 12 in NT-proBNP and hs-Troponin-T was 1.02 (0.88
to 1.17) and 0.95 (0.89 to 1.01), respectively. Median interquartile range
change from baseline to month 12 in 6MWT distance was 5 meters and 92% of
patients experienced an improvement or no change in NYHA class. Mild to
moderate, transient infusion-related reactions were the most common
treatment-related adverse events. 

Nex-z is a single-guide RNA molecule that targets the human TTR gene and the
human-codon–optimized mRNA sequence encoding the Streptococcus pyogenes Cas9
protein, encapsulated in a lipid nanoparticle (LNP). Following IV administration
of the LNP, nex-z is transported directly to the liver and taken up via the LDL
receptor on hepatocytes. The Cas9 mRNA is translated, producing the Cas9 enzyme,
which interacts with the single guide RNA to form a complex that binds to the
TTR gene and leads to precise cleavage in the targeted TTR gene sequence to
reduce TTR production. 

“For the results we’ve seen thus far, patients would only need a one-time nex-z
treatment to obtain, rapid, deep and durable knockdown of TTR, which translates
into a clinically meaningful benefit without the need for long-term therapy,”
said Marianna Fontana, MD, PhD, professor of cardiology and honorary consultant
cardiologist at the National Amyloidosis Center at University College London,
the study’s principal investigator. Although results will need to be confirmed
in a randomized controlled trial, “this therapy is a potential game changer for
patients with ATTR-CM,” Fontana said.
The study was simultaneously published in the New England Journal of Medicine. 
 



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