Background & Aim

The 2021 European Society of Cardiology guidelines recommend 4 foundational therapies for patients with heart failure (HF) and a reduced ejection fraction: beta-blockers (BB), ACE inhibitors, angiotensin receptor-neprilysin inhibitors (ARNI), mineralocorticoid receptor antagonists (MRA), and sodium-glucose co-transporter 2 inhibitors (SGLT2i). In patients experiencing worsening HF events, the soluble guanylate cyclase stimulator vericiguat should be considered as add-on therapy. There are no German real-world data about adherence and persistence to vericiguat.

Methods

The IQVIA^TM LRx database includes longitudinal information on, among others, the prescribed drug, date of prescription and dose, and covers ~80% of persons insured in the statutory health insurance system thus allowing to analyze outpatient prescription claims over time. From this database, new users of vericiguat were identified between Sep 2021 and Dec 2022. Adherence was estimated by the medication possession ratio (MPR, calculated as the ratio of number of days a patient is stocked with medication by the number of days per treatment episode) and persistence was reported as time to discontinuation.

Results

During the 16-month study period since the launch of vericiguat in September 2021, initiation of vericiguat was observed in n=2,916 patients in the IQVIA^TM LRx database: median age 75 years (Q1-Q3: 65-83), 28% female. During a median follow-up of 150 days (Q1-Q3: 73-253 days) 33% reached the 5 mg dose, and 36% the 10 mg. The respective median time to up-titration to 5 mg and 10 mg was 17 days (Q1-Q3: 11-33 days) and 37 days (Q1-Q3: 25-64 days), respectively.

In 87% of patients initiating vericiguat the adherence was high as indicated by MPR >80%. Uninterrupted use of vericiguat through the first 12-month period was observed in 67% of patients. Discontinuation predominantly occurred during the first two months after treatment initiation (i.e., in 19% of cases), while discontinuation thereafter was 15% (Figure). Prior to initiation of vericiguat, use of single components of foundational therapies was high: 79% BB, 54% MRA, 51% SGLT2i, 79% renin-angiotensin blockers (57% ARNI, 17% ACEi, 13% ARB). The combination of all 4 foundational therapies was observed in 29% prior to initiation of vericiguat but increased to 44% thereafter.

Conclusion

Vericiguat adherence and persistence were satisfactory, but titration to target dose was reached only in one third of patients. Interestingly, only 29% of patients were on all recommended foundational therapies prior to vericiguat prescription, but this increased to 44 % thereafter. Barriers for limiting up-titration of vericiguat and profiles of patients and physicians prescribing vericiguat before establishing foundational therapy need to be identified in future research. 

Figure 1: Persistence of vericiguat use*