Birkhoelzer S, et al. J Geriatr Cardiol. 2018 Nov;15(11):708-709.
LIVE: LIFE is a multicentre, open-label, prospective, observational study estimating health related QoL and functional endpoints with initiation of Ivabradine in older patients. The main results exhibited consequential enhancements in Health-Related Quality of Life (HRQoL) and functional status following 6 months of treatment of Ivabradine (primary end point). Birkhoelzer S, et al., conducted a study to present the long term (average of 15 months) use and tolerability of Ivabradine from the LIVE: LIFE study.
The main objective was to analyse HRQoL in older patients (age at least 70 years) with initiation of Ivabradine for treatment of CHF under the care of specialist cardiology, elderly care or community services and followed up for six months after clinically indicated.
240 patients were enlisted from 44 UK sites from December 2013 to March 2015. Study visits were done at baseline (V1), 2 months (V2) and 6 months (V3) alongside usual clinical care. At V1-3, data was collected including patient demographics, clinical and HRQoL (MLWHFQ, SF-12), current medications, reasons for changes, hospitalisations and deaths. A 5-point scale (very well, quite well, somewhat well, not well or not at all) was used by both patient and responsible healthcare professional to assess tolerability of Ivabradine. Patients’ long-term data (V4) were collected after follow-up of at least 12 months (data collection between March 2015 to September 2016) through review of medical notes and comprised hospitalisations, deaths, HF medications and the 5-point scale was used to analysed healthcare professional’s tolerability. The current study group was formed with data of 163 patients at both V3 and V4. At V4, 61% were male with the mean age of 78 ± 6 years. Ischaemic heart disease was the general cause of heart failure (60%). Co-morbidities were common: 58% had history of hypertension, 33% had diabetes and 44% had asthma/COPD. Polypharmacy was frequent with daily mean prescribed medication of 9 at V3 and 11 at V4. At V3, 88% (143) patients were taking Ivabradine (doses: 2.5 mg b.d. n = 46; 5 mg b.d. n = 82; 7.5 mg b.d. n = 15). At V4, 75% (119) patients remained on Ivabradine use from 159 patients with data available concerning Ivabradine use (doses: 2.5 mg b.d. n = 29; 5 mg b.d. n = 76; 7.5 mg b.d. n = 14).
Patients gaining relatively low rates of disease modifying drugs, showed a therapeutic challenge within the cohort: At V4, less than 3/5 of patients received beta blockers, an angiotensin-converting- enzyme inhibitor/angiotensin receptor blocker were taken by around 2/3 patients and 2/5 patients received mineralocorticoid receptor antagonist. From 159 patients, 75% remained on Ivabradine with data available concerning Ivabradine use at V4. But, Ivabradine was stopped by 40 patients before V4. The majority of reason to discontinue Ivabradine was because of haemodynamic concern. These data assembled on the original SHIFT study clinicians with further evidence on Ivabradine which can enlightened patient-centered discussion on effect on HRQoL and drug tolerability in typical older heart failure patients.
It was concluded that Ivabradine is effectively tolerated in the longer-term (around 15 months follow up) in the majority of elderly patients with heart failure, regardless of the existence of multiple co-morbidities and polypharmacy.
LIVE-LIFE: oLder heart failure patients Initiated on iVabradinE in the UK: quaLIty of liFE
