20. Mr I complains that in June 2024 his consultant cardiologist failed to review his medication after he raised concerns that his prescription digoxin and atorvastatin was causing him severe side effects.
21. The ESC explains that for patients under the age of 70 years, clinicians do not base the decision to start a statin (for example atorvastatin) on age alone. Instead, they calculate an individualised assessment of a patient’s probability of experiencing a fatal or non-fatal heart attack. For patients over 70, clinicians make the decision to start statin treatment through a personalised, shared decision-making process with the patient, weighing the potential benefits against risks and individual circumstances.
22. Clinicians often use digoxin, ramipril and atorvastatin (NICE, BNF) together in clinical practice. These cardiac drugs can cause muscle aches and pains. The ESC explained that if patients take atorvastatin and digoxin together, the drugs can clog up the pathway, causing them to build up in the blood. Within the Journal of Clinical Pharmacology, clinical research compared the digoxin levels in patients taking atorvastatin 10mg and 80mg and found that only higher doses had an effect. A study by the AHA also states atorvastatin is the only statin that significantly increases digoxin levels in the blood, when patients take a high dose.
23. After a patient has suffered a heart, the body remains at risk of suffering another one. To prevent this, clinicians take steps to protect the heart and blood vessels. They use ramipril and atorvastatin as the two medications for protection because they work in different, complementary ways to treat the root causes of heart disease. According to ESC guidelines 2023, medical evidence and studies suggest that taking these two medications together does not cause significant harm, unless unexpected changes occur in how they work in the body. Clinicians commonly prescribe them together to manage cardiovascular health and consider them safe.
24. We reviewed Mr I’s medical records. In November 2022, a consultant implanted a loop recorder to monitor Mr I’s heart rate for irregular rhythms. Using the data gathered from the recording, the consultant cardiologist prescribed a small dose of bisoprolol 1.25mg (a beta-blocker) to manage the episodes of fast ventricular response in atrial fibrillation.
25. In April 2023, Mr I told his consultant he could not tolerate bisoprolol and amlodipine (a calcium channel blocker). The consultant changed his medication to ramipril and digoxin (0.625mg). Scientific research suggests ramipril could alter the levels or effects of digoxin in the body. However, according to ESC 2021 guidelines states that this rarely causes significant, harmful issues in clinical practice, and clinicians often recommend and prescribe these drugs together in patients with heart failure.
26. NG 196 identifies digoxin is a reasonable choice for the treatment of atrial fibrillation in elderly patients. It is useful in patients with limited tolerability to other medication. The medical records note Mr I could not tolerate beta-blockers when first tried. He was also no longer able to tolerate amlodipine. Our adviser explained the next option would have been try other calcium channel blockers but because Mr I could not tolerate them, the consultant did not consider this option. Therefore, the consultant’s decision to prescribe digoxin was reasonable and in line with NICE guidance.
27. Any drug can produce unwanted or unexpected adverse reaction in an individual. Some reactions can develop within hours of taking the medication, whereas others take weeks to develop. During a telephone appointment, the consultant noted Mr I did not raise concerns of joint pains or muscle cramps. At the time Mr I was taking ramipril 2.5mg, digoxin 62.5mg and atorvastatin 20mg. At a neurology appointment in February 2024, Mr I did not mention he had joint pains or any other illness.
28. On 2 July 2024, Mr I wrote to his consultant about the conflict between digoxin and atorvastatin and listed his concerns on digoxin and whether he should have prescribed it. He asked the consultant for a review of his medication. In a further letter dated 6 July to the consultant, Mr I wrote that after he started taking digoxin and atorvastatin, he developed muscle pain in his legs, stomach cramps, headaches, joint pains, muscle jerking and shaking hands. In August, Mr I informed the consultant that he stopped taking digoxin and his symptoms went away. When the Trust received Mr I’s correspondence, it acted on his request for a second opinion. A consultant cardiologist spoke to Mr I in August and went through the comments and questions he raised in his correspondence. The consultant also arranged to see him in clinic the following month.
29. Mr I’s pain went away after he stopped taking digoxin. This suggest that digoxin was the problem. However, our adviser explained that of the two medications, atorvastatin (NICE BNF guidance) is the one that causes muscle and joint pain. Mr I had episodes of very fast heart rate (around 190 beats per minutes) and even collapsed, therefore Mr I’s consultant hesitated to stop digoxin because it was prescribed to treat Mr I’s heart problem. For the two medications to interact, Mr I would have needed to take a high dose of atorvastatin (80mg) but he was only taking 20mg.
30. We find no indication of a failing in the medication prescribed. The consultant’s decision on prescribing was in line with NICE and ESC guidance, particularly given Mr I’s previous intolerance to alternative medications. While we recognise that Mr I’s symptoms resolved after he stopped taking digoxin, the clinical evidence does not support that an interaction between the two medications at these doses caused his symptoms.
31. The appropriate people addressed Mr I’s concerns. Following his correspondence the Trust arranged a second opinion, and a consultant cardiologist, who was clinically qualified, discussed his questions and the research material he provided with him in August 2024 before attending a clinic appointment. The Trust’s complaint response also touched on the research material provided and comments were obtained from the consultant cardiologist. We therefore see no indication of a failing here.
Conclusion
32. We acknowledge that Mr I experienced distressing symptoms and recognise that these resolved after he stopped taking digoxin. We do not wish to diminish his experience, and we understand why this led him to question his medications, however, having carefully reviewed the evidence, we see no indications of failings in the medication prescribed.