Issue 96 - 2016Making Education Easy

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Welcome to the latest issue of Cardiology Research Review.This month we present a report of the rates of stopping and restarting statin treatment in the UK, an analysis of SPRINT data for target BP levels in the elderly, and a review of the outcomes of patients presenting with hypertensive urgency in primary care. We also report that cardiac MRI is more useful than SPECT scanning for prediction of MACE in patients with coronary artery disease, and we finish with a study of fludrocortisone for recurrent vasovagal syncope.

We hope you find these and the other selected studies interesting, and look forward to receiving any feedback you may have.

Kind Regards,

Associate Professor John Amerenajohn.amerena@researchreview.com.au

Discontinuation and restarting in patients on statin treatmentAuthors: Vinogradova Y et al.

Summary: This cohort study used a primary care database to estimate rates of discontinuation and restarting of statins in the UK. A search of the Clinical Practice Research Datalink 2002–2013 identified 431,023 patients prescribed statins for primary prevention and 139,314 patients prescribed statins for secondary prevention. In the primary prevention group, 204,622 (47%) discontinued statin treatment during a median 137 weeks follow-up and 147,305 (72%) of those who discontinued restarted. In the secondary prevention group, 57,791 (41%) discontinued treatment during a median 182 weeks follow-up, and 43,211 (75%) of those who discontinued restarted. Younger patients (≤50 years), older patients (≥75 years), females, and patients with chronic liver disease were more likely to discontinue statins and less likely to restart.

Comment: It is sometimes difficult to get good adherence to medication when it is used to treat an asymptomatic condition such as hyperlipidaemia. This study shows that statin discontinuation is common, but that restarting is also common, especially in patients with other asymptomatic diseases such as hypertension and type 2 diabetes mellitus, who are presumably on therapy for these conditions. The reasons for discontinuation were not discussed, but if it was perceived adverse effects or intolerance, this has big implications, as the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are now available. These agents do not seem to have the side effects associated with statins and are extremely effective in lowering cholesterol, but at great expense.

Reference: BMJ 2016;353:i3305Abstract

Intensive vs standard blood pressure control and cardiovascular disease outcomes in adults aged ≥75 yearsAuthors: Williamson J et al., for the SPRINT Research Group

Summary: This analysis of SPRINT data compared the effects of intensive vs standard BP targets in elderly hypertensive patients. 2636 patients aged ≥75 years were randomised to a systolic BP (SBP) target of <120mm Hg (intensive treatment group) or <140mm Hg (standard treatment group). The primary cardiovascular disease outcome was a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes. After a median follow-up of 3.14 years, there was a significantly lower rate of the primary composite outcome (HR, 0.66) and all-cause mortality (HR, 0.67) in the intensive treatment group compared with the standard treatment group. The overall rate of serious adverse events did not differ between groups, but rates of hypotension (HR, 1.71), syncope (HR, 1.23), electrolyte abnormalities (HR, 1.51), and acute kidney injury (HR, 1.41) were higher in the intensive treatment group.

Comment: The SPRINT study showed that a lower SBP of <120mm Hg was associated with better outcomes in elderly nondiabetic patients but the applicability of its results to clinical practice have been questioned. BP measurement in SPRINT was done by “unattended automated BP measurement” which is quite appropriate for a research study, but this is not the way BP is measured in most practices in Australia. In SPRINT there was more hypotension and adverse events in the intensive treatment group, and there is concern that if physicians try to drive SBP to <120 using traditional clinical measurement, there will be even more adverse events. If one was to adopt this target SBP in the elderly (as recommended by the most recent Australian hypertension guidelines), it is important that the BP be measured the same way as in the study.

Reference: JAMA 2016;315(24):2673-82Abstract

Research ReviewTM

Cardiology

BP = blood pressure; CTCA = computed tomography coronary angiography;FFRCT = fractional flow reserve using CTCA; HR = hazard ratio;ICD = implantable cardioverter-defibrillator;MACE = major adverse cardiovascular events;MRI = magnetic resonance imaging;SPECT = single-photon emission computed tomography;VT = ventricular tachycardia.

Abbreviations used in this issue:

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In this issue: > Stopping and restarting statins

> BP targets in the elderly

> Hypertensive urgency in the office setting

> Cardiac MRI better than SPECT

> Complications after ICD implantation

> VT ablation vs drug escalation

> Sodium intake and hypertension

> Ivabradine vs beta-blockers before CTCA

> FFRCT-guided care in suspected coronary disease

> Fludrocortisone for syncope

Independent commentary by Associate Professor John Amerena, FRACP, FACC,FCSANZ, Dept. of Clinical and Biomedical Science, University of Melbourne (Geelong).

Cardiology

Research ReviewTM

Email geoff@researchreview.com.au Phone 1300 132 322

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Characteristics and outcomes of patients presenting with hypertensive urgency in the office settingAuthors: Patel K et al.

Summary: This retrospective cohort study examined the prevalence and outcomes of hypertensive urgency (systolic BP ≥180mm Hg and/or diastolic BP ≥110mm Hg), and determined whether referral to hospital has better outcomes than outpatient management. Of a total 2,199,019 patients who presented to a doctor’s office in the Cleveland Clinic Healthcare system in 2008–2013, 4.6% met the definition of hypertensive urgency. Mean age of these patients was 63.1 years, 57.7% were female, and 76.0% were white. Mean body mass index was 31.1 kg/m2; mean systolic BP was 182.5mm Hg and mean diastolic BP was 96.4mm Hg. In a propensity-matched analysis, 852 patients who were sent home were compared with 426 patients who were referred to hospital. In this analysis, there were no significant between-group differences in MACE at 7 days, 8–30 days, or 6 months. Patients who were sent home were more likely to have uncontrolled hypertension at 1 month (86.3% vs 81.9%; p=0.04) but not at 6 months (64.6% vs 66.6%; p=NS), and had lower hospital admission rates at 7 days (4.7% vs 8.2%; p=0.01) and 8–30 days (6.9% vs 11.3%; p=0.009).

Comment: Physicians often panic when we see marked BP elevation (>180 systolic) in patients as there is concern about stroke risk. This study shows that the risk of an acute event with short term elevated BP is extremely low, and suggests that hospital admission has little to offer. Starting appropriate antihypertensive agents that have an immediate BP-lowering effect, such as calcium channel blockers or labetalol, is important as well as referral for outpatient follow-up and investigation. However, it appears that in the setting where this study was conducted these interventions were not widely applied, as most patients still had poorly controlled hypertension 6 months later.

Reference: JAMA Intern Med 2016;176(7):981-88Abstract

Prognostic value of cardiovascular magnetic resonance and single-photon emission computed tomography in suspected coronary heart diseaseAuthors: Greenwood J et al.

Summary: This long-term cohort study compared the abilities of cardiac MRI and SPECT to predict MACE. 752 patients with suspected coronary heart disease were followed-up annually for a minimum of 5 years. 744 (99%) of the 752 recruited patients had complete follow-up. Of 628 who underwent cardiac MRI, SPECT, and the reference standard test of X-ray angiography, 104 (16.6%) had at least 1 MACE. Abnormal findings on cardiac MRI (HR, 2.77; p<0.001) and SPECT (HR, 1.62; p=0.014) were both strong and independent predictors of MACE. After adjustment for other cardiovascular risk factors, angiography result, or stratification for initial patient treatment, only cardiac MRI remained a significant predictor of MACE.

Comment: Cardiac MRI has multiple applications, and this study suggests that it is more useful than SPECT scanning for prediction of MACE in patients with coronary artery disease. SPECT is not commonly used in Australia for this indication, but is often used to assess propensity for ischaemia in patients with chest pain syndromes, or to evaluate fitness for surgery in patients with known coronary artery disease. It would thus be interesting to see how MRI performed in this context, although it is not currently funded through the Health Insurance Commission (HIC) for cardiac indications.

Reference: Ann Intern Med 2016;165(1):1-9Abstract

Long-term risk for device-related complications and reoperations after implantable cardioverter-defibrillator implantationAuthors: Ranasinghe I et al.

Summary: This observational study evaluated the long-term risk of complications after ICD implantation. 114,484 patients aged ≥65 years who received an ICD for the first time in 2006–2010 were included. During a median follow-up of 2.7 years, 40,072 patients died (12.6 deaths per 100 patient-years of follow-up). When the risk of death was accounted for, there were 6.1 ICD-related complications per 100 patient-years that required reoperation or hospitalisation and 3.9 reoperations per 100 patient-years for reasons other than complications. Overall, 10 patients had complications or reoperation per 100 patient-years of follow-up. Younger age at implantation, receipt of cardiac resynchronisation therapy + defibrillator device versus a single-chamber device, female sex, and black race were associated with the greatest increased risks for ICD-related complications.

Comment: Non-implanting physicians have a low threshold for recommending ICD implantation +/- cardiac resynchronisation therapy, and often err on the side of caution when the indications for implantation are relatively soft. This study shows that there is significant morbidity associated with ICDs which we don’t see as the complications are handled by the electrophysiologists. This being the case, it is essential that the risks and benefits of implantation are discussed with patients before insertion, especially when the indications are not strong.

Reference: Ann Intern Med 2016;165(1):20-9Abstract

Ventricular tachycardia ablation versus escalation of antiarrhythmic drugsAuthors: Sapp J et al.

Summary: This study compared the use of catheter ablation and escalated antiarrhythmic drug therapy in patients with ischaemic cardiomyopathy and an ICD who had VT despite the use of antiarrhythmic drugs. 259 patients were randomised to receive either catheter ablation (ablation group) with continuation of baseline antiarrhythmic medications or escalated antiarrhythmic drug therapy (escalated-therapy group). The escalated-therapy group had amiodarone (up to 300mg) added if another agent had been used previously; mexiletine was added if patients were already taking amiodarone 300 mg/day. The primary outcome was a composite of death, ≥3 documented episodes of VT within 24 hours, or appropriate ICD shock. During a mean 27.9 months of follow-up, the primary outcome occurred in 59.1% of patients in the ablation group and 68.5% of those in the escalated-therapy group (HR, 0.72; p=0.04). The mortality rate did not differ significantly between groups.

Comment: Although antiarrhythmic therapy may suppress some arrhythmias and reduce shocks in susceptible patients with ICDs, there are also pro-arrhythmic effects that could explain why ablating the source of VT results in better outcomes than escalation of antiarrhythmic medication in patients with resistant VT and ischaemic cardiomyopathy. This field is rapidly evolving but is still limited to highly specialised centres.

Reference: N Engl J Med 2016;375:111-21Abstract

See approved Product Information before prescribing. Approved Product Information available on request. For the most up to date Product Information go to http://www.novartis.com.au/products_healthcare.html.

MINIMUM PRODUCT INFORMATION Entresto (sacubitril/valsartan) Indication: Treatment of chronic heart failure (NYHA Class II-IV) with reduced ejection fraction. Contraindications: Hypersensitivity to sacubitril, valsartan, or excipients. ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor. Angioedema related to previous ACE inhibitor or ARB therapy. Use with aliskiren in patients with Type 2 diabetes. Severe hepatic impairment, biliary cirrhosis and cholestasis. Pregnancy. Precautions: Dual blockade of the Renin-Angiotensin-Aldosterone System (RAAS): Do not administer with an ACE inhibitor due to the risk of angioedema. Do not initiate until 36 hours after taking the last dose of ACE inhibitor therapy. If treatment is stopped, ACE inhibitor therapy must not be initiated until 36 hours after the last dose. Caution is required while co-administering with direct renin inhibitors such as aliskiren. Do not administer with aliskiren in patients with Type 2 diabetes. Should not be co-administered with an ARB. Hypotension: May cause symptomatic hypotension, especially in patients ≥75 years old, patients with renal disease and in patients with systolic BP <112 mmHg. Use in patients with systolic BP <100 mmHg at the time of initiation is not recommended. Monitor BP when initiating therapy or during dose titration, Patients with an activated RAAS, such as volume- and/or salt-depleted patients (e.g., high doses of diuretics), are at greater risk. If hypotension occurs, dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g. hypovolaemia) should be considered. If hypotension persists, consider dose reduction or temporary discontinuation. Sodium and/or volume depletion should be corrected before starting treatment. Impaired renal function: May be associated with decreased renal function. In patients whose renal function depends upon the activity of the RAAS (e.g., severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death. Assess renal function before initiation and during treatment. Closely monitor serum creatinine, and down-titrate or interrupt in patients who develop a clinically significant decrease in renal function. May increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis. In patients with renal artery stenosis, monitor renal function. Patients with mild and moderate renal impairment are more at risk of developing hypotension. Patients with severe renal impairment may be at greatest risk of hypotension. Caution with severe renal impairment. Not recommended with end-stage renal disease. Hyperkalaemia: Should not be initiated if the serum potassium level is >5.4 mmol/l. Hyperkalaemia may occur. Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption may be required. Medications known to raise potassium levels (e.g. potassium-sparing diuretics, potassium supplements) should be used with caution. If clinically significant hyperkalaemia occurs, measures such as reducing dietary potassium, or adjusting the dose of concomitant medications should be considered. In addition, if serum potassium level is >5.4 mmol/l, discontinuation should be considered. Angioedema: If angioedema occurs, immediately discontinue, and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms. Patients with a prior history of angioedema may be at higher risk, caution is recommended. Black patients may have increased susceptibility to develop angioedema. Patients with renal artery stenosis: Caution and monitoring of the renal function is recommended. Patients with NYHA functional classification IV: Caution should be exercised. Patients with hepatic impairment: Caution in patients with moderate hepatic impairment or with AST/ALT values more than twice the upper limit of the normal range, exposure may be increased and safety is not established. Do not use in patients with severe hepatic impairment, biliary cirrhosis or cholestasis. Caution in driving or operating machinery. Use in lactation: Not recommended. Females of child-bearing potential: Use contraception during treatment and for 1 week after their last dose. Interactions: Aliskiren in patients with Type 2 diabetes, ACE inhibitors/ARB. Caution with statins, sildenafil, lithium, potassium-sparing diuretics including mineral corticoid antagonists (e.g. spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, NSAIDs including selective COX-2 Inhibitors, frusemide, inhibitors of OATP1B1, OATP1B3, OAT3 (e.g. rifampin, cyclosporine) or MPR2 (e.g. ritonavir) and metformin. Dosage and administration: Target dose one oral tablet of 97 mg/ 103 mg twice daily. Starting dose is one tablet of 49 mg/ 51 mg twice daily. Starting dose of one tablet of 24 mg/ 26 mg taken twice daily is recommended for naive patients or those not currently taking an ACE inhibitor/ARB, patients with severe renal impairment, patients with moderate hepatic impairment, and in patients ≥ 75 years old. Also consider for patients who have risk factors for hypotension and patients with low systolic BP ≥100 to 110 mmHg. Double every 2-4 weeks to the target dose. Side effects: Very common (≥10%): Cardiac failure, hyperkalaemia, renal impairment and hypotension. Common (1 to <10%): Anaemia, angina pectoris, atrial fibrillation, cardiac failure chronic, cardiac failure congestive, ventricular tachycardia, constipation, diarrhoea, nausea, asthenia, cardiac death, fatigue, non-cardiac chest pain, oedema peripheral, bronchitis, influenza, nasopharyngitis, pneumonia, upper respiratory tract infection, urinary tract infection, diabetes mellitus, gout, hyperuricaemia, hypokalaemia, arthralgia, back pain, pain in extremity, dizziness, headache, syncope, insomnia, renal failure, chronic obstructive pulmonary disease, cough, dyspnoea and hypertension. (ent200116m). References: 1. ENTRESTO® Product Information. TGA-approved Product Information. Novartis Pharmaceuticals Australia Pty Limited. 20 January 2016. 2. McMurray JJ et al. N

Engl J Med 2014;371:993–1004. 3. Yancy et al. J Am Coll Cardiol 2016 [epub ahead of print]. 4. Ponikowski P et al. Eur Heart J 2016 [epub ahead of print]. Novartis Pharmaceuticals Pty Limited. 54 Waterloo Road, Macquarie Park NSW 2113. Ph (02) 9805 3555. For medical enquiries please contact 1800 671 203 (phone) or medinfo.phauno@novartis.com (email). ENT0097. NOV4612. Prepared July 2016.

PBS Information: This product is not listed on the PBS.

ENTRESTO® provides, vs. enalapril

NEW

NEW

20%20%RRRRRR

in death from CV causes2

21%21%RRRRRR

in hospitalisation for HF2

(p<0.001 for both; composite primary endpoints)

For patients with HF-rEF who remain symptomatic,

ENTRESTO® IS THE SUPERIOR* RECOMMENDED† REPLACEMENT OF AN ACEI OR ARB

*to further reduce the risk of death, HF hospitalisations and symptomatic worsening vs. enalapril2–4

†2016 ESC HF guidelines, 2016 US HF guidelines update.

Patients on ENTRESTO® experienced more hypotension (rarely requiring discontinuation) vs. enalapril.2 Fewer patients on ENTRESTO® stopped their study medication because of an AE vs. enalapril.2

36-hour washout period required when switching patients from an ACEI to ENTRESTO®.1

ACEI: angiotensin-converting enzyme inhibitor; AE: adverse event; ARB: angiotensin-receptor blocker; CV: cardiovascular; ESC: European Society of Cardiology; HF: heart failure; HF-rEF: heart failure with reduced ejection fraction; RRR: relative risk reduction; US: United States.

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© 2016 RESEARCH REVIEW 4

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Research Reviews are prepared with an independent commentary from relevant specialists. To become a reviewer please email geoff@researchreview.com.au.Research Review Australia Pty Ltd is an independent Australian publisher. Research Review receives funding from a variety of sources including Government depts., health product companies, insurers and other organisations with an interest in health. Journal content is created independently of sponsor companies with assistance from leading local specialists. Privacy Policy: Research Review will record your email details on a secure database and will not release them to anyone without your prior approval. Research Review and you have the right to inspect, update or delete your details at any time. Disclaimer: This publication is not intended as a replacement for regular medical education but to assist in the process. The reviews are a summarised interpretation of the published study and reflect the opinion of the writer rather than those of the research group or scientific journal. It is suggested readers review the full trial data before forming a final conclusion on its merits. Research Review publications are intended for Australian health professionals.

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Associations of urinary sodium excretion with cardiovascular events in individuals with and without hypertensionAuthors: Mente A et al., for the PURE, EPIDREAM and ONTARGET/TRANSCEND Investigators

Summary: This pooled analysis of data from 4 studies examined the association between sodium intake and cardiovascular disease events and all-cause mortality in patients with or without hypertension. Data for 133,118 individuals (63,559 with hypertension and 69,559 without hypertension) participating in 4 large prospective studies were pooled. The relationship between 24-h urinary sodium excretion and the composite outcome of death and major cardiovascular disease events was assessed over a median 4.2 years of follow-up. Increased sodium intake was found to be associated with greater increases in systolic BP in individuals with hypertension than in those without hypertension (2.08 vs 1.22mm Hg change per g; p<0.0001). In patients with hypertension, sodium excretion of ≥7 g/day (HR, 1.23; p<0.0001) and <3 g/day (HR, 1.34; p<0.0001) were both associated with increased risk compared with sodium excretion of 4–5 g/day (reference). In individuals without hypertension, higher sodium excretion was not associated with risk of the primary composite outcome, but an excretion of <3 g/day was associated with a significantly increased risk (HR 1.26; p=0.0009).

Comment: This interesting study again confirms that a high salt intake is associated with adverse outcomes in hypertensive patients, but has no deleterious effect in normotensive patients. As well, it showed an adverse effect of low sodium intake in normotensive patients which could reflect activation of the renin-angiotensin system. It therefore seems reasonable to not recommend salt restriction in normotensive patients, but to concentrate our efforts on reducing sodium intake in hypertensive patients.

Reference: Lancet 2016;388(10043):465-75Abstract

Efficacy of ivabradine versus β-blockers for heart rate reduction during computed tomography coronary angiographyAuthors: Qiu S et al.

Summary: This meta-analysis of randomised controlled trials examined the effects of pretreatment with ivabradine versus beta-blockers on heart rate during CTCA. A search of Medline, PubMed, Embase, SCI/SSCI/A&HCI, SAS Publishers, Web of Science, and the Cochrane Central Register identified 8 studies involving a total of 1,324 patients that were suitable for inclusion. Pooled analysis of the data showed that ivabradine was significantly more effective than beta-blockers at achieving the target heart rate (<65 beats/min) during CTCA (odds ratio 5.02; p<0.00001). Ivabradine had no significant effect on either systolic or diastolic BP.

Comment: CTCA relies on ECG gating to get high quality delineation of the coronary arteries while keeping radiation dose low. Relative tachycardia reduces the resolution of the images so heart rate-slowing medication is usually prescribed to be taken before the test or during it. Beta-blockers and non-dihydropyridine calcium channel blockers (verapamil or diltiazem) are usually used for this but can lower BP. Ivabradine is therefore an attractive alternative as it has no effect on BP, but unfortunately it is not listed for this indication if the patient is in sinus rhythm.

Reference: Cardiology 2016;135:133-40Abstract

1-year outcomes of FFRCT-guided care in patients with suspected coronary diseaseAuthors: Douglas P et al.

Summary: Estimation of fractional flow reserve using CTCA (FFRCT) has been shown to effectively guide initial care in patients with stable chest pain. The PLATFORM study investigated the longer term benefits of FFRCT-guided care in patients with suspected coronary disease. 584 consecutive patients with stable, new onset chest pain were managed by either usual testing or CTCA with selective FFRCT; 581 patients (99.5%) completed 1-year of follow-up. MACE events were infrequent during follow-up (2 in each arm of the planned invasive group and 1 in the usual care cohort). In the planned invasive group, mean costs were 33% lower with CTCA and selective FFRCT ($US8,127 vs $US12,145 with usual care; p<0.0001). QOL scores improved overall at 1 year (p<0.001), with similar improvements in both groups.

Comment: The ability to assess functional significance of coronary stenoses detected on CTCA without resorting to formal invasive angiography is very attractive. The reliability, reproducibility and cost of FFRCT have been the subject of much discussion but this study suggests that it is a cost-effective strategy. If these results can be reproduced and the technology not too expensive and can be used on conventional CT scanners, this may be the way of the future.

Reference: J Am Coll Cardiol 2016;68(5):435-45Abstract

Fludrocortisone for the prevention of vasovagal syncopeAuthors: Sheldon R et al.

Summary: The multicentre POST 2 study investigated the effect of fludrocortisone on vasovagal syncope. 210 patients with a history of recurrent syncope were randomised to receive fludrocortisone at the highest tolerated dose (0.05–0.2 mg/day) or matching placebo for 1 year. 96 patients had ≥1 syncope recurrence during the 1-year treatment period. There was a marginally nonsignificant reduction in syncope in the fludrocortisone group (HR, 0.69; p=0.069), although in a multivariable model the drug was found to significantly reduce the likelihood of syncope (HR, 0.63; p=0.024). When the analysis was restricted to outcomes after 2 weeks of dose stabilisation, fludrocortisone had a significant benefit (HR, 0.51; p=0.019).

Comment: Managing patients with recurrent vasovagal syncope is always challenging. Fludrocortisone is sometimes used but until now had mainly anecdotal reports of success. This randomised trial looked at this intervention more systematically, and although it did not meet its primary end-point (>40% reduction in syncope), there were favourable trends after dose stabilisation. These results suggest that fludrocortisone is a useful therapeutic option in this population.

Reference: J Am Coll Cardiol 2016;68(1):1-9Abstract

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