This trial is evaluating whether lerodalcibep will improve 2 primary outcomes and 3 secondary outcomes in patients with Cardiovascular Diseases. Measurement will happen over the course of 52 weeks.
This trial requires 900 total participants across 2 different treatment groups
This trial involves 2 different treatments. Lerodalcibep is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
In a recent study, findings do not justify the term "cure" as it has often been construed. The present approach may have a role in reducing CVD incidence and, perhaps more importantly, mortality, especially early in the course of the disease, or at the earliest stages of disease where prevention of complications and disease progression would have the greatest impact.
Symptoms of acute cardiac events may not be as simple as one might expect. Physicians should have ready access to information about major symptomatology of cardiovascular diseases, so clinicians can better inform patients and their families of their risk factors for these conditions.
The current medical theories do not completely explain the complex interactions between environmental factors and genetic predispositions associated with CVD, and there remains a need for a greater understanding of how individual factors, both behavioral and genetic, contribute to this endgame. Future research is needed into how the interaction between these factors may play an important, causal role in the development of CVD.
It is estimated that approximately 26 million people will be diagnosed with a cardiovascular disease in the year 2013. This estimation represents around 18% of American adults.
The prevalence of cardiovascular disease (CVDs) is a major health concern. CVDs is the leading cause of death in the USA, and its financial burden is enormous. There is a need for a targeted and rigorous approach to prevent CVDs.
A variety of treatments may be used for cardiovascular diseases. The aim of medical treatment is to reduce symptoms and improve patient's functioning and quality of life.
Improvements in physical function are seen. Significant and clinically meaningful improvements in most HRQL dimensions have also been observed, and these improvements appear to be maintained over a 1-year post-intervention period. Recent findings of the ACTIS trial provide preliminary evidence that lerodalcibep can improve HRQL, and confirm that its use can improve physical function and reduce pain in patients with stable ischemic heart disease. Further prospective, well-designed, multi-center studies are now needed.
Approximately 1 in 3 men have some forms of cardiovascular disease by the age of 70, which is significantly older than the median age at death for all Americans. The most prevalent of these diseases are heart disease and stroke; the 2 main causes of cardiovascular disease death in Americans aged 65-74, accounting for more than half of all mortality in this age bracket. A significant portion of this excess mortality is attributable to heart failure, for which a single treatment may dramatically affect patient outcome.
Lerodalcibep showed satisfactory efficacy and tolerability. The combination with conventional nonsteroidal anti-inflammatory drugs or warfarin is reasonable. More subjects should receive a longer treatment with lerodalcibep and have a longer observation periods to assess the duration of such treatment in the future.
Findings from a recent study has identified novel genetic variants in the CARD8 gene encoding NAD(P)H oxidase 2 and has revealed the strong evidence of genetic influence of CARD8 on the risk for both CAD and MI in the general population. We have also shown that the CARD8 variants identified in this study are associated with the occurrence of myocardial infarction in male subjects.
A great many high quality studies are underway for evaluating clinical trials. However, a systematic search of the literature may limit the number of clinical trials that could be conducted in the future. For clinical trials aiming at assessing treatment interventions for a specific condition, we suggested that clinicians, researchers, and policy-makers should work together to identify appropriate clinical trials, and they should establish eligibility criteria that would reduce the likelihood of selecting for the trials in which interventions will be ineffective or dangerous.
Lerodalcibep is being evaluated for the therapeutic use of reducing or preventing excessive calcium absorption in individuals with hypercalciuria. One of the indications includes, but is not limited to, the treatment of primary hyperparathyroidism. Further clinical studies will support this application. In patients with familial hyperparathyroidism, lerodalcibep has been evaluated in patients who have had a calcium-sparing parathyroidectomy. Lerodalcibep appears to be effective in mitigating recurrent renal stones, and it appears to have a lower rate of side effects than many other therapies used in this indication. Overall, future studies will likely clarify these preliminary findings.