Patient decision aid: Heart failure ACE inhibitor treatment

Transcription

1 Patient decision aid: Heart failure ACE inhibitor treatment What this patient decision aid is for This patient decision aid is intended to assist healthcare professionals in consultations with patients who have chronic heart failure (CHF) due to left ventricular systolic dysfunction (LVSD). It relates to patients considering whether or not to take an angiotensin-converting enzyme inhibitor (ACEI). An information leaflet for patients explaining CHF including management and treatments can be found on the Clinical Knowledge Summaries website failure. How much does taking an ACEI improve outcomes in patients with CHF caused by LVSD? The recommendation that all patients with heart failure due to LVSD should be considered for ACEI treatment is given by all heart failure guidelines. 1-3 This recommendation is based on evidence from systematic reviews of randomised controlled trials (RCTs) which demonstrate that ACEIs improve symptoms, reduce the risk of hospitalisation for HF, and increase life expectancy compared with placebo. 4 One systematic review that included five RCTs (n=12 763) found that compared with placebo over a median follow up of 35 months, ACEIs were associated with lower rates of death (23.0% vs 26.8%; odds ratio [OR] 0.80; 95% confidence interval [CI] ; number needed to treat [NNT] 26; p<0.001) and readmission for heart failure (13.7% vs 18.9%; OR 0.67; 95% CI ; NNT 19; p<0.001). 5 The benefits were observed early after the start of therapy and persisted long term, and were independent of age, sex, and baseline use of diuretics, aspirin and beta blockers. 4,5 The diagrams on the next page, (Cates plots), give a pictorial representation of these figures and predicts what may happen with and without ACEI treatment in a group of 100 people with heart failure due to LVSD. The median follow up of trials in the systematic review was 35 months so the assumption is made that these data reflect outcomes for approximately 3 years of treatment. Heart Failure PDA ACEI final.doc 31/03/2009 Page 1 of 5

2 Side effects of ACEIs 2 Asymptomatic low blood pressure (BP) This does not usually require any change in therapy. Symptomatic hypotension If dizziness, light-headedness and/or confusion and a low BP, reconsider need for nitrates, calcium-channel blockers and other vasodilators. Calcium-channel blockers should be discontinued unless absolutely essential. If no signs/symptoms of congestion consider reducing diuretic dose. Cough Cough is often seen in patients with HF, many of whom may also have smoking related lung disease. Cough is also a symptom of pulmonary oedema which should be excluded when a new or worsening cough develops. ACEI cough rarely requires treatment discontinuation. 1,2 Estimates of the incidence of ACEI induced cough vary. Approximately 6% of patients in the SOLV-D study discontinued treatment due to a cough. 6 When a very troublesome cough does develop (eg one stopping the patient from sleeping) and can be proven to be due to ACE inhibition (ie recurs after ACEI withdrawal and rechallenge) substitution of an angiotensin-2 receptor antagonist (A2RA) should be made. However, in the ONTARGET trial which compared the A2RA telmisartan, ramipril or both in patients at high risk of vascular events, 4.2% of patients in the ramipril group stopped treatment due to cough compared with 1.1% in the telmisartan group. This is an absolute difference of 3.1% and a number needed to harm (NNH) of 32. 7,8 Worsening renal function Some rise in urea, creatinine and potassium is to be expected after initiation of an ACEI. An increase in creatinine of up to 50% above baseline, or 266 µmol/l whichever is smaller, is acceptable. An increase in potassium to =5.5 mmol/l is acceptable. If urea, creatinine or potassium do rise excessively, consider stopping concomitant nephrotoxic drugs (eg non-steroidal anti-inflammatory drugs [NSAIDs]), other potassium supplements/retaining agents and, if no signs of congestion, reducing the dose of diuretic. Heart Failure PDA ACEI final.doc 31/03/2009 Page 2 of 5

3 If greater rises in creatinine and potassium persist despite adjustment of concomitant medications the dose of ACEI should be halved and blood urea, creatinine and electrolytes rechecked within 1 2 weeks. If potassium rises to =5.5 mmol/l or creatinine increases by =100% or to above 310 µmol/l the ACEI should be stopped and specialist advice sought. Any suspected adverse drug reactions with ACEI treatment should be reported through the yellow card scheme. References 1. National Institute for Health and Clinical Excellence (NICE). Chronic heart failure: Management of chronic heart failure in adults in primary and secondary care. Clinical Guideline 5. July 2003.Available from: [last accessed 16 December 2008]. 2. Scottish Intercollegiate Guidelines Network (SIGN). Management of chronic heart failure. Guideline 95. February Available from: [last accessed 16 December 2008]. 3. European Society of Cardiology (ESC). Heart failure guideline Available from: [last accessed 16 December 2008]. 4. National Prescribing Centre (NPC). Chronic heart failure: overview of diagnosis and drug treatment in primary care. MeReC Bulletin February 2008;(18):3. Available from: [last accessed 16 December 2008]. 5. Flather MD et al. Long-term ACE-inhibitor therapy in patients with heart failure or leftventricular dysfunction: a systematic overview of data from individual patients. Lancet 2000;355: The SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. New Engl J Med 1991;325: The ONTARGET investigators. Telmisartan, ramipril or both in patients at high risk for vascular events. New Engl J Med 2008;358: National Prescribing Centre (NPC). ACE-I plus ARB misses the target. MeReC Rapid Review April Available from: [last accessed 16 December 2008]. Source of images The images have been produced using Dr Chris Cates s software VisualRx 2.0. More information can be obtained from the website Heart Failure PDA ACEI final.doc 31/03/2009 Page 3 of 5

4 Effect of ACEI treatment on risk of death over 3 years for people with CHF due to LVSD Imagine 100 people with CHF due to LVSD. In the next 3 years about 27 of them will die, 73 of them will not die ( = 73; Figure A). However, if those same 100 people each take an ACEI for 3 years (Figure B): About 4 people will be saved from dying by taking an ACEI (the yellow faces). About 73 people will not die but would not have done so even if they had not taken an ACEI (the green faces). About 23 people will still die even though they take an ACEI (the red faces). But remember It is impossible to know for sure what will happen to each individual person. All 100 people will have to take the ACEI for 3 years. Figure A Figure B not die within 3 years whether or not they take an ACEI. saved from dying within 3 years because they take an ACEI. die within 3 years whether or not they take an ACEI. England. Any person not employed by the NHS, or who is working for the NHS outside England, who wishes to download/copy NPC materials for Heart Failure PDA ACEI final.doc 31/03/2009 Page 4 of 5

5 Effect of ACEI treatment on risk of readmission for heart failure over 3 years for people with CHF due to LVSD Imagine 100 people with CHF due to LVSD. In the next 3 years about 19 of them will be readmitted to hospital for HF; so 81 of them will not be readmitted to hospital ( = 81; Figure C). However, if those same 100 people each take an ACEI for 3 years (Figure D): About 5 people will be saved from being readmitted for heart failure by taking an ACEI (the yellow faces). About 81 people will not be readmitted to hospital for heart failure but would not have done so even if they had not taken an ACEI (the green faces). About 14 people will still be readmitted to hospital for heart failure even though they take an ACEI (the red faces). But remember It is impossible to know for sure what will happen to each individual person. All 100 people will have to take the ACEI for 3 years. Figure C Figure D not be readmitted to hospital for HF whether or not they take an ACEI. saved from being readmitted to hospital because they take an ACEI. admitted to hospital for HF whether or not they take an ACEI. England. Any person not employed by the NHS, or who is working for the NHS outside England, who wishes to download/copy NPC materials for Heart Failure PDA ACEI final.doc 31/03/2009 Page 5 of 5