Coronary artery disease (CAD) leading to stable symptoms (i.e., stable angina) is a leading contributor to death and disability among older adults with multiple chronic conditions. Treatment options for stable angina include both medications and invasive procedures, without any difference in rates of death or heart attacks across the different treatment approaches. Current guideline recommendations suggest that doctors should first treat patients with medications to improve symptoms from stable angina, but multiple medication options exist with varying side effect profiles and treatment effects. Both beta-blockers (for example Metoprolol/Toprol XL) and calcium channel blockers (for example amlodipine/Norvasc) are widely used to treat older adults with this condition, but have not been specifically evaluated in older adults (>75 years old) with multiple chronic conditions. Furthermore, older adults with multiple chronic conditions may experience different effects from these medicines than younger patients without multiple conditions. The impact of these therapies on patients’ overall quality of life is uncertain. Many older adults have caregivers and the effect on caregiver burden of the available therapies is also unknown. The question facing older adults with stable angina is which medication should be used first to improve their overall quality of life, i.e., to LIVE BETTER?
Thus, the goal of the LIVE BETTER trial is to establish the effectiveness and tolerability of medical therapy for stable angina in older adults or 75 years or older with multiple chronic conditions. The trial will compare the effectiveness of medications to improve the symptoms, function, and quality of life of older adults with multiple chronic conditions presenting with stable symptoms of CAD. To address this question, the team will randomly administer either beta-blockers (for example Metoprolol/Toprol XL) or calcium channel blockers (for example amlodipine/Norvasc) to eligible patients. Patients with contraindications or clear indications for one treatment or another, such as patients with heart failure or recent heart attacks, will not be included. To determine the effectiveness of these therapies, the team will assess a summary of function, symptoms, and quality of life at 45 days after starting treatment, as well as at 6 and 12 months using a variety of different measures. Importantly, the team will also assess mobility at 45 days with a walking test and caregiver burden by administering a survey to patients’ caregivers. In addition, the team will compare the tolerability and safety of these commonly used medications by determining how frequently patients can stay on them by 6 months after starting the medicine, as well as rates of side effects, medication burden, medication adherence, and impact on cognition. Finally, the team will explore the long-term effects of these medications on events like heart attacks, strokes, and death after one year, assessed via the electronic health record.
The results of this study will be relevant to the millions of older adults currently living with coronary artery disease in the United States and across the world. Better evidence for or against these two commonly used medications for this condition has the potential to improve the care of a uniquely vulnerable patient population while also establishing realistic expectations for both efficacy and tolerability of these treatments for the outcomes that matter most. A racially and geographically diverse patient population will be recruited from five high-quality sites across the continental United States. At the foundation of LIVE BETTER are the patients and caregivers for whom this research is dedicated. For this reason, engagement with and input from real patients and caregivers living with this condition will inform LIVE BETTER from beginning to end of the trial.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.