From the Guidelines
Ranolazine (Renexa) can be used safely in patients with Acute Coronary Syndrome (ACS) as an adjunctive therapy after standard treatments have been initiated. The primary consideration for using ranolazine in ACS patients is its role in managing chronic stable angina, particularly when symptoms persist despite other antianginal medications. According to the 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes 1, ranolazine is indicated for the treatment of chronic angina, with a recommended initial dose of 500 mg orally twice daily, which can be uptitrated to a maximum of 1000 mg orally twice daily. Ranolazine works by inhibiting the late sodium current in cardiac cells, reducing calcium overload without significantly affecting heart rate or blood pressure, making it particularly useful in patients who cannot tolerate hemodynamic changes from other antianginals. Some key points to consider when using ranolazine include:
- Dose adjustment for patients with moderate hepatic impairment (starting at 500 mg once daily)
- Avoiding use in severe hepatic or renal impairment
- Being cautious with concomitant use of CYP3A4 inhibitors
- Baseline and follow-up ECG monitoring due to the potential for QT interval prolongation, especially in patients with risk factors for QT prolongation. A recent expert consensus document published in Nature Reviews Cardiology in 2018 1 also highlights the effectiveness of ranolazine in reducing symptoms of chronic stable angina and its potential benefits in specific populations such as those with microvascular angina. However, it's crucial to note that ranolazine does not improve outcomes of patients with chronic stable angina or non-ST-segment elevation acute coronary syndrome, as evidenced by the MERLIN trial 1 and the RIVER-PCI trial 1. Therefore, the use of ranolazine in ACS patients should be carefully considered, taking into account the individual patient's needs and the potential benefits and risks associated with its use.
From the FDA Drug Label
A large clinical trial in acute coronary syndrome patients was unsuccessful in demonstrating a benefit for Ranolazine Extended-Release Tablets, but there was no apparent proarrhythmic effect in these high-risk patients [see Clinical Studies (14.2)].
The use of Ranolazine (Renexa) in patients with Acute Coronary Syndrome (ACS) did not show a benefit in a large clinical trial, but it did not appear to have a proarrhythmic effect in these high-risk patients 2. Ranolazine can be considered safe in terms of not increasing the risk of arrhythmias in ACS patients. However, its effectiveness in this specific patient population is not established.
From the Research
Safety of Ranolazine in ACS Patients
- The safety of Ranolazine (Renexa) in patients with Acute Coronary Syndrome (ACS) has been evaluated in several studies 3, 4, 5, 6, 7.
- According to the study published in 2015, Ranolazine reduced the risk of recurrent ischemia following admission regardless of whether patients had or did not have percutaneous coronary intervention (PCI) 4.
- The study also found that Ranolazine reduced the risk of cardiovascular death, myocardial infarction, and recurrent ischemia in patients with chronic angina, regardless of whether they had PCI or not 4.
- Another study published in 2008 found that Ranolazine ER did not reduce the incidence of major cardiovascular events in patients with non-ST-elevation acute coronary syndromes, but it did reduce the incidence of recurrent ischemia 7.
- The studies suggest that Ranolazine is generally well tolerated, with the most commonly reported adverse events including dizziness, nausea, asthenia, and constipation 3, 5, 7.
- Ranolazine has also been found to be associated with modest increases in the corrected QT interval, but it does not appear to be associated with an excess of arrhythmias 3, 5, 7.
Use of Ranolazine in ACS Patients
- Ranolazine may be considered a useful alternative and adjunct to conventional hemodynamic antianginal therapy in the treatment of chronic stable angina 3.
- The drug has been found to be effective in reducing angina frequency and improving exercise performance in patients with chronic stable angina 3, 5, 7.
- Ranolazine has also been found to be effective in patients with chronic angina who have undergone PCI for ACS 4.
- The studies suggest that Ranolazine can be used as add-on therapy in patients with chronic stable angina whose symptoms are not controlled with first-line antianginal therapy or who do not tolerate first-line antianginal agents 5, 7.