* For medical professionals reading only
This is a patient with heart failure who has repeated multiple admissions and low basal blood pressure. After meeting the conditions, they took Vilixigua treatment and gradually titrated to a 10mg target dose as planned. There were no symptomatic hypotension and other adverse events in during the entire study. They had good compliance. I would like to share my application experience with you here.
Comments Expert
Dong Jian-in-chief Professor
Director of Heart Failure Center of Beijing Anzhen Hospital Affiliated to Capital Medical University
Director of Cardiovascular Disease Hospital, First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Zhengzhou University Director of Hereditary Cardiovascular Disease Prevention and Treatment and Reproductive Guidance Center
Chinese Society of Biomedical Engineering Director of
Central Rhythm Branch of the Chinese Society of Biomedical Engineering,
Deputy Chairman of the Heart Failure Professional Committee of the Chinese Medical Association,
Central Cardiology Branch of the Chinese Medical Association and leader of the precision medicine group
Chairman of the Cardiovascular Disease Branch of Henan Medical Association,
How to treat heart failure effectively and safely?
The high incidence, high mortality and high hospitalization rate of heart failure have brought heavy burdens to the patients' families and society. In addition, the study shows that about 12.1 million heart failure patients aged ≥25 in my country, and the incidence rate is still increasing year by year [1].
Although currently, in improving the symptoms and prognosis of patients with heart failure (HFrEF) with ejection fraction , drug treatment (GDMT) guided by the guidelines can achieve better results, , heart failure is always progressing and worsening. Traditional heart failure drugs will still be ineffective. Moreover, in clinical practice, since heart failure patients often have multiple diseases, it will also restrict the use of some classic drugs, and anti-heart failure drugs of different mechanisms are still of great significance.
When choosing heart failure treatment drugs in this case, not only should the treatment effect be considered, but also the safety and tolerability should be paid attention to to help improve patient compliance. However, clinicians often face treatment contradictions where the efficacy of the drug is not met and the patient cannot tolerate it.
In the previous case, 's first soluble guanylate cyclase (sGC) stimulator for heart failure showed significant efficacy in reducing aggravated re-hospitalization in patients with heart failure. So how is Vilixigua performing in terms of safety of use and patient compliance? Let's take a look together.
Vilixigua treatment has significant efficacy and good safety, high patient compliance
Case provider
Lu Qiang Professor
Deputy Director of Heart Failure Center of Beijing Anzhen Hospital Affiliated to Capital Medical University
Member of Heart Failure Professional Committee of National Cardiovascular Disease Expert Committee
Deputy Chairman of Cardiovascular Branch of Lean Diagnosis and Treatment Expert Committee of National Telemedicine and Internet Medical Center
Expert Member of Hypertension Professional Committee of Beijing Medical Association Member of the Youth Committee of the Association
Standing Committee of the Professional Committee of the Cardiovascular Disease Prevention and Rehabilitation of the Chinese Association of Elderly Health Care
National Cardiovascular Disease Management Capacity Assessment and Improvement Project Member of the Expert Committee of the Heart Failure Center
Member of the Professional Committee of the Chinese Research Hospital Society for Ultramicro and Molecular Pathology
Case Information
Basic situation: patient, male, 58 years old.
main complaint: has difficulty breathing for 3 years.
medical history: patients had dyspnea in 2015, and appeared during active activities, accompanied by cough without sputum, night paroxysmal dyspnea and sitting upright breathing , and went to the local hospital for diagnosis of "diffusion cardiomyopathy and heart failure". After being discharged from the hospital, they did not take the medicine regularly and were hospitalized repeatedly.In June 2018, our hospital was given spironolactone 20mg/d, furosemide 20mg/d, digoxin 0.125mg/d, enalapril 2.5mg/day, and metoprolol succinate sustained release tablets 11.875mg/d. However, after treatment, the patient still had dyspnea and paroxysmal dyspnea at night, and needed 2 pillows to fall asleep at night. So on August 7, 2018, he came to our hospital for hospitalization.
Past history: Smoking history for 30 years, quit smoking for 1 year, drinking for 30 years, and quit drinking for 3 years. Denied the history of surgery.
Physical examination: blood pressure is 107/58mmHg, and heart rate is 54 beats/min.
assisted examination
cardiac magnetic resonance enhancement: the anterior and posterior diameter of left atrium is 35.38mm, the anterior and posterior diameter of the right atrium is 35.74mm, the end-diastolic inner diameter of the left ventricular is about 71.27mm, and the end-diastolic inner diameter of the right ventricular is about 28.35mm. The ejection fraction was 16% (EF), and the basal to mid-section of the left ventricular septum was fibrosis, and non-ischemic cardiomyopathy was considered. (Figure 1)
Figure 1 Patient's cardiac magnetic resonance enhancement image
admission diagnosis: chronic heart failure (cardiac function level II), dilated cardiomyopathy, arrhythmia , 2 diabetes , old cerebral infarction for 1 year, kidney stones , hyperuricemia. Before enrolling in the patient, enalapril 2.5 mg qd, metoprolol succinate sustained release tablets 11.875 mg qd, spironolactone 20 mg qd, digoxin 0.125 mg qd and torasemide 20 mg qd for treatment of heart failure. At the same time, other combined medications were given, including reglinide tablets 1 mg tid, potassium chloride sustained release tablets 1 g bid, amiodarone hydrochloride 0.2 g qd, and potassium magnesium aspartate 2 tablets tid.
treatment and follow-up status of Vilixigua:
After being discharged from the hospital, the patient agreed to be admitted to the Vilixigua Phase III Victoria study during the outpatient follow-up visit on September 26, 2018. The overall treatment process is shown in Table 1.
Table 1 Vilixigua treatment After
follow-up, the patient did not recurrence of heart failure, his blood pressure was stable, his renal function was improved, and his blood potassium and liver function were not affected. After the study, the patient was followed up again on May 25, 2022. His symptoms were stable, the EF value remained at 30%, and there were no obvious abnormalities in liver and renal function and blood potassium levels.
★ Expert comments
Dong Jianzeng Professor
This patient has been hospitalized many times due to heart failure. When he was admitted to the group, his basic blood pressure was low, his mental state was poor, his communication was difficult, and his appetite was poor. After nearly one year of treatment with Vilixigua, the patient's symptoms have improved significantly and he did not enter the hospital due to worsening heart failure. Moreover, no adverse reactions such as hypotension and occurred, and liver and kidney function was not affected, and treatment compliance was good.
This patient received sufficient standard of treatment before enrollment. In 2022, the American Society of Cardiology (ACC)/American Heart Association (AHA)/American Heart Failure Association (HFSA) Heart Failure Guidelines" [2] recommends verixagua for patients with high-risk HFrEF and heart failure aggravated heart failure to reduce heart failure hospitalization and cardiovascular death. In addition, after evaluation of the patient, it was found that his eGFR was 73.4 ml/min/1.73m, which was greater than 15 ml/min/1.73m, and there were comorbidities, meeting the criteria for receiving Vilixigua in the group.
was initially given to the patient with a 2.5 mg qd dose of Vilixigua. During the treatment process, the dosage of Vilixigua must be adjusted according to his blood pressure. According to the precautions for use of Vilixigua [3,4], the patient's blood pressure was 104/64 mmHg at the first follow-up, and the systolic blood pressure of 100 mmHg, and the dose was adjusted to 5 mg qd; at the second follow-up two weeks later, the patient's systolic blood pressure was still 100 mmHg, so it continued to smoothly adjust to the target dose of 10 mg qd.
In terms of adjustment of other drugs, the patient's dose of other therapeutic drugs was lower due to poor tolerance before enrolling. After treatment with Vilixigua, the patient can tolerate the increase in doses of enalapril and other drugs. The reason for this may be because Vilicigua can promote the recovery of myocardial and vascular function, allowing patients to tolerate higher doses of other drugs.
During the overall treatment period, the patient's mental state and appetite improved significantly, and no further aggravated heart failure was found to be admitted to the hospital, and the efficacy was significant. But in addition to efficacy, patient tolerance is also a focus of clinical concern.From this case, we can see that although the patient's basal blood pressure is low, the blood pressure of the patient was stable during the treatment process. After titration to the 10mg qd target dose, it can be maintained until the end of follow-up, and has good tolerability.
It should also be emphasized that the patients had hyperuricemia in the past, but their creatinine and BUN were both downward during the study, and the blood potassium level was stable. The study medication was not adjusted due to renal function, which shows that Vilixigua is safe. and its convenience of taking meals once a day can also effectively improve patient compliance, and during the treatment process, the patient's compliance reached 100%.
Overall, after receiving Vilixigua treatment, the patient was able to titrate to the target dose smoothly, and was well tolerated under the premise of significant efficacy, which well reflects the advantages of Vilixigua in both efficacy and safety in the treatment of heart failure, and can provide new ideas and examples for clinical heart failure treatment.
New Drug Express
VICTORIA Research [5] As the first innovative study specifically targeting the aggravated events of heart failure, it verixugu, the first sGC stimulator for heart failure, can bring multiple benefits to the currently unmet heart failure treatment through the mechanism of nitric oxide (NO)-sGC-cyclic guanosine phosphate (cGMP) pathway, thus opening a new era of joint management of multi-pathways in heart failure.
VICTORIA study suggested that after 10.8 months of median follow-up, compared with the placebo group, the absolute risk of cardiovascular death or first heart failure in patients in Vilixigua group was significantly reduced by 4.2%, and the number of cases required for treatment (NNT) = 24.
Another preset safety endpoint results of clinical concern showed that there was no significant difference in the incidence of symptomatic hypotension (9.1% vs 7.9%) and syncope (4% vs 3.5%) in the placebo group, and there was only a small difference in the mean systolic blood pressure change in the placebo group (1-1.5 mmHg).
Vilixigua was approved for marketing in my country in May this year for patients with symptomatic chronic heart failure patients with stable ejection fraction (45%) after recent heart failure decompensation, which brings more benefits and more peace of mind to patients with heart failure.
References:
[1]Wang H, et al. Circ Heart Fail. 2021 Oct; 14(10): e008406.
[2]Writing Committee Members. J Card Fail. 2022 May;28(5):e1-e167.
[3] Armstrong PW, et al. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator: The VICTORIA Trial. JACC Heart Fail. 2018;6(2):96-104.
[4]Armstrong PW, et al. Vericiguat in patients with heart failure with reduced ejection fraction. N Engl J Med.
[5]Armstrong PW, et al. N Engl J Med. 2020;382(20):1883-1893.
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