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Real-world titration and treatment patterns of sacubitril/valsartan in germany, a retrospective cohort study using a longitudinal pharmacy database

Session Patient management - From oral treatment to transplant

Speaker Associate Professor Rolf Wachter

Congress : Heart Failure 2018

  • Topic : heart failure
  • Sub-topic : Chronic Heart Failure: Pharmacotherapy
  • Session type : Rapid Fire Abstracts
  • FP Number : 1544

Authors : R Wachter (Leipzig,DE), S Klebs (Nuremberg,DE), B Balas (Basel,CH), CC Proenca (Basel,CH), M Dworak (Nuremberg,DE), R Schlienger (Basel,CH), J Engelhard (Frankfurt,DE), T Maier (Basel,CH), S Bruce Wirta (Stockholm,SE), K Kostev (Frankfurt,DE)


R Wachter1 , S Klebs2 , B Balas3 , CC Proenca4 , M Dworak2 , R Schlienger3 , J Engelhard5 , T Maier3 , S Bruce Wirta6 , K Kostev5 , 1Universitätsklinikum Leipzig - Leipzig - Germany , 2Novartis Pharma GmbH - Nuremberg - Germany , 3Novartis Pharma AG - Basel - Switzerland , 4Wellmera AG - Basel - Switzerland , 5IQVIA - Frankfurt - Germany , 6Novartis Sweden AB - Stockholm - Sweden ,


Background: The angiotensin receptor neprilysin inhibitor sacubitril/valsartan (s/v) was launched in Germany in January 2016 for the treatment of symptomatic heart failure (HF) with reduced ejection fraction.
Purpose: To characterize real-world titration and treatment patterns of s/v patients in Germany. 
Methods: Patients with at least one s/v prescription (Rx) between January 2016 and June 2017 were identified in the German longitudinal pharmacy database (IMS LRx), covering ~60% of all dispensed Rx from statutory insured patients. Prescriber specialty and first recorded s/v dose were analysed (date of first Rx = index date). Titration patterns were defined as "stably up-titrated" (with no subsequent down-titration), "stably down-titrated" (with no subsequent up-titration), and "up-titrated" and "down-titrated" (with a mix of up- and down-titration).
Results: A total of 26,191 patients (=18 years) fulfilled the inclusion criteria. General practitioners (GPs) accounted for the majority (~80%) of the 127,803 s/v Rx, while cardiologists accounted for ~15% of Rx. Patients with a first s/v Rx by GPs were on average older (mean±sd 73±12 vs 69±11 years) and more often female (27% vs. 20%) versus those with first s/v Rx from cardiologists. Overall, there was high usage of HF drugs prior to s/v index (angiotensin-converting enzyme inhibitor/angiotensin receptor blocker 92%, beta-blocker 89%, mineralocorticoid receptor antagonist 63%).
Of the 12,082 patients with 12 months pre-index activity (defined by any Rx every 6 months) and a minimum of 6 months follow-up, 64% had a first observed Rx of 50 mg bid, 32% had 100 mg bid and 4% had 200 mg bid. During the first 6 months, 26% of patients with a first cardiologist Rx received the target dose of 200 mg bid, compared to 19% of patients with another specialty at index (p<0.001).
In patients starting on 50 mg bid, 47% were up-titrated, of which 80% maintained a stable dose of either 100 or 200 mg bid. In patients on 100 mg bid at index, 38% were up-titrated, of which 77% maintained the target dose, whereas 5% were stably down-titrated. In patients with target dose at index, 10% were down-titrated to a stable lower dose, and 8% were down-titrated at some point, but then back-titrated to the target dose. The mean (sd) time to first titration was 54 days (44) while the mean time to reach the target dose varied from 79 days (44) to 57 days (47) for patients on 50mg and 100 mg bid at index, respectively (p<0.05). Results were similar across specialty at index.
Conclusion: There were no attempts to up-titrate s/v in the majority of patients, while for patients up-titrated, the overall proportion of stable up-titration was 80%. Overall, only 20% of patients received the target dose of 200 mg bid. Titration took longer than what is recommended in the EU summary of product characteristics. The barriers for up-titration must be further explored and educational efforts to promote up-titration have to be intensified.

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