Summary of research progress in the field of cardiovascular disease (03.15)
March 15, 2018 Source: WuXi PharmaTech
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Recently, Sanofi and Regeneron Pharmaceuticals announced that the joint development of Praluent (alirocumab) reached the primary end point in a clinical phase 3 trial called ODYSSEY OUTCOMES. In patients with cardiovascular disease who have developed acute coronary syndrome (ACS), the drug significantly reduces the risk of major adverse cardiovascular events (MACE) in patients.
Coronary artery disease is the most common form of heart disease and the leading cause of death worldwide, and high cholesterol is a key cause of coronary artery disease. The current standard drug for the treatment of high cholesterol is statin, but many patients still do not have effective control of cholesterol levels after using the maximum tolerated dose of statins.
Alirocumab is a monoclonal antibody against the PCSK9 protein. It binds to PCSK9 protein and prevents PCSK9 from binding to low-density lipoprotein (LDL) receptors, allowing more LDL receptors to be transported to the surface of liver cells to bind to LDL cholesterol and to clear LDL cholesterol from the blood.
In this clinical phase 3 trial, 18,924 hypercholesterolemia patients were randomized to long-term treatment with alirocumab or placebo. These patients have developed ACS within 12 months of treatment and are already taking the highest tolerated dose of statins. The trial results showed that alirocumab reduced the risk of MACE in patients by 15% (p=0.0003) and the risk of death from all causes was reduced by 15% (p=0.026). For high-risk patients with blood LDL cholesterol levels above 100 mg/dl (mg/dl), alirocumab is able to reduce the risk of developing MACE by 24% and reduce the risk of death for all causes by 29%. This clinical trial found no new side effects associated with alirocumab.
"This clinical trial shows that alirocumab provides more benefits for patients with higher cholesterol levels," said Dr. George D. Yancopoulos, president and chief scientific officer of Regeneration Corporation. "Many have had heart attacks and other coronary events. Patients are still unable to reduce their LDL cholesterol levels below 100 mg/dl. These patients are in desperate need of new treatment options because of the significant increased risk of recurrence. In this clinical trial, these patients are using maximum tolerance. Treatment with alirocumab in addition to doses of statins can significantly reduce their risk."
2. Portable doctor! Apple Watch's strap peripherals monitor atrial fibrillation and hyperkalemia
AliveCor, which specializes in the development of personal electrocardiogram (ECG) devices, recently announced the results of two new studies that further support the use of the company's portable ECG devices for breakthrough health monitoring capabilities.
A Cleveland Clinic study, accepted by the Journal of the American College of Cardiology, evaluated the use of wearable devices in monitoring strokes. This is the first Apple Watch to go through the healthcare arena. The peer-reviewed study aimed to determine whether the Apple Watch's KardiaBand can distinguish between atrial fibrillation (AFib) and normal heart rhythm. The results show that KardiaBand is able to accurately detect the main cause of stroke, namely AFib. KardiaBand is the first and only FDA-approved Apple Watch medical device accessory developed by AliveCor for the Apple Watch. The researchers found that KardiaBand successfully detected atrial fibrillation and normal sinus rhythm (normal sinus rhythm), the exact level of which is comparable to the doctor who interprets the electrocardiogram. In this study, KardiaBand's algorithm correctly interprets AFib and normal sinus rhythm with a sensitivity of 93% and a specificity of 84%. When the doctor reviewed the KardiaBand record, the sensitivity increased to 99%.
Other results released recently show that when used in conjunction with new artificial intelligence (AI) technology, AliveCor's ECG devices enable non-invasive testing of blood to monitor hyperkalemia. The study used more than 2 million ECGs, 4 million blood potassium values ​​collected between 1994 and 2017, and prospective data from AliveCor smartphone ECG devices to develop an AI algorithm for detecting hyperkalemia. The sensitivity of the algorithm for detecting hyperkalemia ranges from 90% to 94%. Hyperkalemia is divided into acute and chronic, and if the acute hyperkalemia is not rescued in time, it may lead to sudden cardiac arrest. Hyperkalemia is usually associated with congestive heart failure, chronic kidney disease, diabetes, and drugs used to treat these diseases. Because it is often asymptomatic, testing is challenging. So far, the only way to detect hyperkalemia is through blood tests. The non-intrusive testing provided by AliveCor will help users control their health in real time and prevent adverse consequences.
“As our team continues to drive innovation in digital health, we are changing the way we detect AFib and hyperkalemia, and expanding the way products like Apple Watch play a role in the future of healthcare.†AliveCor Chief Executive Mr. Vic Gundotra said.
3. The results of the second phase of the new drug for cardiomyopathy are all positive, and will enter phase 3
MyoKardia recently announced the full positive results of a new phase 2 clinical trial of symptomatic, obstructive hypertrophic cardiomyopathy (oHCM) in the new drug mavacamten. The results of this time included data from the low dose patient cohort (Cohort B).
According to the American Heart Association (AHA), hypertrophic cardiomyopathy is a very common cardiovascular disease and a common cause of cardiac arrest in young people. Most patients do not have any symptoms in their daily lives. However, a small number of patients may have symptoms such as myocardial obstruction, and their disease is also called symptomatic, obstructive hypertrophic cardiomyopathy. Although this part of the patient is rare, it suffers from great health risks and requires new drugs for treatment. Mavacamten is an innovative oral myocardial myosin allosteric modulator that is expected to reduce the symptoms of excessive contraction in these patients.
In a Phase 2 clinical study called PIONEER-HCM, the researchers evaluated the safety, tolerability, pharmacokinetics, and efficacy of mavacamten. The test consisted of two dose groups. The first group of subjects received mavacamten and discontinued other beta-blocker drugs. The second group of subjects will receive a low dose of mavacamten and will not stop the beta blocker treatment. During the 12-week treatment period of the first group, all 10 subjects achieved an average LVOT (left ventricular outflow tract) pressure gradient peak from baseline reduced by 125 mmHg. This also provides a basis for the second group of low-dose studies.
The primary goal of PIONEER-HCM Cohort B was to evaluate the efficacy and safety of lower doses of mavacamten (2 mg and 5 mg) in patients with oHCM. Both cohorts of PIONEER-HCM reached the primary endpoint, reducing post-exercise LVOT gradient from baseline to week 12 and were statistically significant (cohort A p=0.002, cohort B p=0.020). Specifically, the LVOT gradient after exercise was observed to decrease from the baseline 86 mmHg mean to 64 mmHg at week 12. In addition, the resting LVOT gradient decreased from 86 mmHg at baseline to 38 mmHg at week 12 (p = 0.004). Left ventricular ejection fraction (LVEF) at rest was relatively small from baseline, and patients in cohort B maintained an ejection fraction above 50%. Several key secondary endpoints, including the New York Heart Association (NYHA) classification and improvement in dyspnea scores, also reached statistical significance in each cohort. Cohort A showed statistical significance at the secondary endpoint of changes in exercise capacity (VO2 peak), and cohort B showed a positive trend of improvement. In summary, data from the PIONEER-HCM study indicate that the optimal daily dose for most patients is between 5 and 15 mg. These data are the three key clinical trials of the MyoKardia program, EXPLORER-HCM, which provides initial dose and guided dose adjustment using mavacamten in symptomatic oHCM patients. EXPLORER-HCM is expected to begin in the second quarter of 2018.
“The data from the two cohorts of PIONEER-HCM studies gave us a better understanding of the relationship between mavacamten's dose and pharmacodynamic effects in treating oHCM patients,†said Dr. Marc Semigran, Chief Medical Officer of MyoKardia. We entered the key Phase 3 EXPLORER-HCM trial and we believe we can optimize the treatment of mavacamten to improve the patient's symptoms and function while maintaining the left ventricular ejection fraction."
Note: This article title source 123RF
Reference materials:
[1] Sanofi, Regeneron's Praluent pulls off PCSK9 coup with 29% cut to death risks in most vulnerable patients
[2] Cleveland Clinic Study Affirms Accurate Detection of Atrial Fibrillation by KardiaBand for Apple Watch
[3] MyoKardia Sees Positive Results in Mid-Stage Heart Trial
Original Title: Summary of Research Progress in the Field of Cardiovascular Diseases (No. 25)
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