Related Experiment Videos
[The ATLAS study (Assessment of Treatment with Lisinopril and Survival); justification and objectives]
M Komajda1, M C Wimart, E Thibout
1Service de cardiologie, CHU Pitié-Salpêtrière, Paris.
Insights
The ATLAS study compared two lisinopril dosages for heart failure patients. It aims to find the optimal dose for improved survival and reduced morbidity in cardiac failure (CF) treatment.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Angiotensin-converting enzyme (ACE) inhibitors improve cardiac failure (CF) prognosis, as shown in CONSENSUS I, SOLVD, and V HEFT II trials.
- Previous trials used fixed average doses (e.g., enalapril 15-20 mg/day), but clinical practice often uses lower doses (e.g., enalapril 7.5 mg/day).
- Optimal ACE inhibitor dosing for CF remains an area for investigation.
Purpose of the Study:
- To compare the effects of two different lisinopril dosages on morbidity and mortality in patients with cardiac failure (CF).
- To determine the optimal dosage of lisinopril for managing CF.
- To assess the impact of varying lisinopril doses on patient outcomes.
Main Methods:
- The ATLAS study is an international, multicenter, randomized, double-blind, parallel-group trial.
- It aims to enroll 3,000 patients aged over 18 with NYHA Classes II-IV and ejection fraction ≤ 30%.
- Patients undergo an initial open-label tolerance assessment (5-15 mg/day lisinopril) before randomization to either a standard or high-dose lisinopril regimen (up to 35 mg/day) for 3-4.5 years.
Main Results:
- The abstract does not contain specific results, as it focuses on the study's design and objectives.
- The study is designed to provide data on the comparative efficacy of different lisinopril doses.
- Further analysis will be required to determine the main results regarding morbidity and mortality.
Conclusions:
- The ATLAS study is designed to optimize ACE inhibitor use in cardiac failure (CF) by comparing specific lisinopril dosages.
- Findings are expected to guide clinical practice towards more effective lisinopril dosing strategies.
- The study will contribute valuable data on the relationship between lisinopril dose and patient outcomes in CF.
Abstract:
Treatment with ACE inhibitors has improved the prognosis of cardiac failure (CF). The results of CONSENSUS I, SOLVD and V HEFT II show clinical improvement and longer survival with this therapeutic class of drugs. However, the search for the optimal dosage was not undertaken in these trials (a standard dose was fixed at the onset, average dose of enalapril from 15 to 20 mg/day). In clinical practice, patients are prescribed lower doses of ACE inhibitors (enalapril: 7.5 mg/day) than the averages used in large scale trials. In order to optimise the use of ACE inhibitors, the ATLAS study (Assessment of Treatment with Lisinopril and Survival) was undertaken with the precise objective of comparing two dosages (2.5 to 5 mg/day vs 32.5 to 35 mg/day) of lisinopril on the morbidity and mortality of patients with CF. This international, multicenter, randomised, double-blind parallel group trial aims to include 3,000 patients over 18 years of age with NYHA Classes II, III and IV, and an ejection fraction < or = 30% and to follow them up for 3 to 4.5 years. Nearly 30 French centres will participate in this trial. After an initial, open period of evaluation of tolerance (5 mg to 15 mg/day of lisinopril in France), the patients will be randomised to two groups. After randomisation, all patients will receive 5 mg per day of lisinopril. The "high dose" group will receive 20 mg/day for two weeks, then 30 mg/day in addition to the "open dosage". In cases of intolerance, the dosage may be reduced to 20 mg/day or 10 mg/day, or the drug may be withdrawn.(ABSTRACT TRUNCATED AT 250 WORDS)