Author(s)
Kim N1, Farber HW2, Highland K3, Chakinala MM4, Hemnes AR5, Chin KM6, Zhao C7, Narayan V7, McLaughlin VV8
1University of California, San Diego, LA JOLLA, CA, USA, 2Tufts Medical Center, Boston, MA, USA, 3Cleveland Clinic, Cleveland, OH, USA, 4Washington University School of Medicine in St. Louis, St. Louis, MO, USA, 5Vanderbilt University Medical Center, Nashville, TN, USA, 6University of Texas Southwestern Medical Center, Dallas, TX, USA, 7Actelion Pharmaceuticals US, Inc., South San Francisco, CA, USA, 8University of Michigan, Ann Arbor, MI, USA
OBJECTIVES Hospitalizations are associated with subsequent death in patients with PAH. PAH-related hospitalizations are costly and readmission is common. Selexipag is a selective oral prostacyclin pathway agent that reduces the risk of morbidity and mortality events including PAH-related hospitalizations. We evaluated hospitalization rates and association with survival risk at baseline (selexipag initiation) in the real-world setting. METHODS This analysis included the first 500 patients enrolled in the US selexipag registry SPHERE (NCT03278002). Baseline risk assessment was conducted using the REVEAL 2.0 risk calculator. All-cause hospitalization and re-hospitalization rates, and time to first hospitalization were evaluated and compared between risk groups. RESULTS Disease characteristics at baseline were: median age 61.0 years; low (41.8%), intermediate (29.6%) or high (28.6%) risk group; 65.3% receiving combination therapy (including 10.3% on triple therapy). Median duration of selexipag treatment was 17.8 months. Overall, 36.4% of patients had at least one hospitalization and 12.6% had a re-hospitalization (>1 hospitalization). The annualized hospitalization rate (95% CI) was 0.64 (0.53, 0.77), and annualized re-hospitalization rate was 0.11 (0.08, 01.4). For low/intermediate/high risk patients: the proportion of patients hospitalized were 25.5%/36.6%/60.4%; annualized hospitalization rates (95% CI) were 0.29 (0.19, 0.44)/0.65 (0.52, 0.81)/1.49 (0.89, 2.48); annualized re-hospitalization rates were 0.04 (0.02, 0.09)/0.12 (0.09, 0.16), 0.25 (0.14, 0.44). Time to first hospitalization analysis showed that risk of hospitalization increases with higher risk. Compared to low risk patients, risk increased by 70% (HR [95% CI]: 1.70 [1.16, 2.50], p-value 0.0070) in intermediate risk patients and by 199% (HR [95% CI]: 2.99 [2.10, 4.25], p-value <0.0001) in high risk patients. CONCLUSIONS SPHERE analysis demonstrates that intermediate/high risk at baseline is associated with higher hospitalization and re-hospitalization rates compared to low risk and that REVEAL 2.0 risk category is prognostic of hospitalization outcome in the real-world setting.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PCV3
Topic
Clinical Outcomes, Economic Evaluation
Topic Subcategory
Clinical Outcomes Assessment
Disease
Cardiovascular Disorders