Consultation Snapshot — Using statins in an older patient
Published in Health News and Evidence
Date published: About this date
This is a new series delivering practical evidence-based solutions to some challenging clinical problems. Each column will present a clinical problem commonly encountered in primary care and offer some key practice points and information to give your patients.
To coincide with our recent program Older & Wiser: Promoting safe use of medicines in older people, the first Consultation Snapshot focuses on statins in an older person.
Mr Carson is a 78-year-old man with severe COPD who lives alone and is treated with home oxygen (2 L/min). His other medical conditions include hypertension which is well-controlled, hypercholesterolaemia (pre-treatment total cholesterol:HDL ratio = 7), gout and depression. Although at a high cardiovascular risk, Mr Carson has no history of cardiovascular events.
Mr Carson was hospitalised recently for an infective exacerbation of his COPD (his third exacerbation in the last year) and he was prescribed clarithromycinA (250 mg twice daily) and prednisolone (50 mg, once daily) for 7 days.
Today he complains of worsening aches and pains for which he requests analgesia. In passing, he describes difficulty getting out of his chair and walking to the kitchen which he relates to old age.
His regular medicines are:
- tiotropium 18 micrograms, one capsule inhaled once daily
- fluticasone 250/salmeterol 25 micrograms inhaled, one puff twice daily via spacer
- salbutamol 5 mg, one nebule once every 4 hours or as required
- diltiazem 180 mg, once daily
- atorvastatinB 40 mg, once daily
- perindopril 4 mg, once daily
- calcium and vitamin D (600 mg/500 IU), twice daily
- sertraline 50 mg, once daily
B. Mr Carson has been taking a statin for nearly 20 years.
Mr Carson’s latest symptoms include muscular aches and pains and he mentions having trouble getting around. When using medicines in older people, consider current medicines as a possible cause of new symptoms before looking elsewhere. Do not assume the symptoms are just related to old age.
Could this issue actually be a medicines-related problem?
Muscle-related adverse events are common
In post-marketing studies statin users reported more mild-to-moderate muscle-related adverse events including myalgias, muscle weakness, muscle cramps and less frequently rhabdomyolysis compared with non users — atorvastatin carries an intermediate risk compared with other statins.3
Interactions with drugs that inhibit cytochrome p450 3A4
Atorvastatin is a substrate for the cytochrome p450 3A4 enzyme (CYP3A4). In a person taking a statin, the risk for muscle-related complications is influenced by commonly prescribed medicines that inhibit hepatic CYP3A4 statin metabolism and thereby increase atorvastatin concentration.4
Although Mr Carson has been taking a statin for many years, the clarithromycin prescribed to treat the exacerbation of his COPD is known to inhibit metabolism of atorvastatin which may explain his current symptoms.
What other possible interactions might you be concerned about?
Reduction in cardiovascular risk
The strongest evidence from pooled analysis of clinical trials in older people supports statin use for secondary prevention of cardiovascular events and death from 65 years to over 80 years of age,10 and in people with a very high risk of cardiovascular disease or confirmed coronary artery disease who are over 64 years.11
Although Mr Carson is already at an increased risk of cardiovascular disease based on his age, the benefits of a statin for primary prevention may no longer apply in a patient approaching 80 years of age with no prior cardiovascular events and a poor prognosis because of severe COPD.
Would you consider stopping the statin in this patient?
When evaluating the benefits and harms of medicines in older people consider life expectancy and weigh the potential benefits against the time needed to realise treatment targets in your patient.12
Consider withdrawal of statins when the potential benefits are no longer clinically relevant. For example, in old age or when life expectancy is shortened preserving function and avoiding frailty and injury in the short term may take priority over longer term goals such as preventing future cardiovascular events.13 Statins may also be withdrawn in frail older people who experience signs or symptoms of adverse effects from their use.14
There is limited clinical evidence to guide stopping medicines in older people but some broad principles are available and include:15
Step 1: Manage patient expectations
Discuss the potential for stopping medicines at the start of therapy.
Step 2: Recognise when to stop
Medicines may be stopped to reduce polypharmacy or adverse drug reactions and in response to a lack of efficacy or change in treatment goals.
Step 3: Prioritise medicines to stop
Stop one medicine at a time starting with the medicine implicated in adverse drug reactions or adverse events.
Step 4: Wean patient
Some medicines, such as those acting on the central nervous system, need to be tapered over weeks and months when stopping. Consider if the patient needs to be weaned and work out a plan for stopping.
Step 5: Monitor
Monitor patient for withdrawal or rebound syndromes, recurrence of illness, cognitive changes and quality of life.
- Inform older patients that muscle-related adverse effects with statins are common and discuss the severity of symptoms in the context of impact on quality of life and any associated risks to the patient (e.g. falls).
- Reassess treatment goals in partnership with older people and make a shared decision about stopping medicines in partnership with the patient or their carers.
- Discuss with older people the reasons for stopping the medicines and explain about expected benefits and risks.
- Encourage older people to raise any concerns they have about stopping a medicine.
- Reassure the patient that you will continue to monitor their health and if necessary the medicine can be resumed.
Over 40% of Australians over 75 years of age take a statin,16 although, like Mr Carson, these patients often have multiple comorbidities and require multiple medicines which can make the benefits of medicines less certain and susceptibility to harms greater.17 Consequently, managing lipids and cardiovascular risk becomes more complicated and whether or not statins should be continued becomes an important question to consider as part of good medicines management.18
- Read more about the risks of polypharmacy.
In older people (≥ 75 years) treatment with statins should be guided by the benefits and risks of treatment, lipid measures and clinical judgements about comorbidities which may make statin use inappropriate.1,2
- Read more about benefits and risks of statin use in older people.
Conduct a medicines review in partnership with your patient to ensure they get the most from their medicines.
- Find out more about medicines management in older people.
The case study for this article was developed in consultation with Justin Turner (School of Pharmacy and Medical Sciences, University of South Australia) and Dr Tilenka Thynne (Clinical Pharmacology Registrar, Royal Adelaide Hospital).
- National Institute for Health and Clinical Evidence. NICE clinical guideline 67: Lipid modification-cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. 2010. [Full text] (accessed 6 August 2013).
- National Vascular Disease Prevention Alliance. Absolute cardiovascular disease management. Wuick reference guide for health professionals. National Stroke Foundation, 2012. [Full text] (accessed 6 August 2013).
- Hoffman KB, Kraus C, Dimbil M, et al. A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class. PLoS One 2012;7:e42866. [PubMed]
- Amsden GW, Kuye O, Wei GC. A study of the interaction potential of azithromycin and clarithromycin with atorvastatin in healthy volunteers. J Clin Pharmacol 2002;42:444–9. [PubMed]
- Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7–22. [PubMed]
- Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005;366:1267–78. [PubMed]
- Mihaylova B, Emberson J, Blackwell L, et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012;380:581-90. [PubMed]
- Taylor F, Huffman MD, Macedo AF, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev 2013;1:CD004816. [PubMed]
- Sontheimer D. Review: statins reduce all-cause mortality in elderly patients with coronary heart disease. ACP J Club 2008;148:3. [PubMed]
- Afilalo J, Duque G, Steele R, et al. Statins for secondary prevention in elderly patients: a hierarchical bayesian meta-analysis. J Am Coll Cardiol 2008;51:37–45. [PubMed]
- Roberts CG, Guallar E, Rodriguez A. Efficacy and safety of statin monotherapy in older adults: a meta-analysis. J Gerontol A Biol Sci Med Sci 2007;62:879–87. [PubMed]
- Holmes HM, Hayley DC, Alexander GC, et al. Reconsidering medication appropriateness for patients late in life. Arch Intern Med 2006;166:605–9. [PubMed]
- Hilmer SN, Gnjidic D. Statins in older adults. Aust Prescr 2013; 36: 78–82. [Full text] (accessed 25 July 2013).
- Hilmer SN, Gnjidic D, Le Couteur DG. Thinking through the medication list: Appropriate prescribing and deprescribing in robust and frail older patients. Aust Fam Physician 2012;41:924–8. [Full text]
- Le Couteur DG. Deprescribing. Aust Prescr 2011;34:182–5. [Full text] (accessed 1 August 2013).
- Morgan TK, Williamson M, Pirotta M, et al. A national census of medicines use: a 24-hour snapshot of Australians aged 50 years and older. Med J Aust 2012;196:50–3. [PubMed]
- Holmes HM, Min LC, Yee M, et al. Rationalizing prescribing for older patients with multimorbidity: considering time to benefit. Drugs Aging 2013;30:655–66. [PubMed]
- Petersen LK, Christensen K, Kragstrup J. Lipid-lowering treatment to the end? A review of observational studies and RCTs on cholesterol and mortality in 80+-year olds. Age Ageing 2010;39:674–80. [PubMed]