Use of fixed-dose combination antihypertensives in Germany between 2016 and 2020: an example of guideline inertia

Abstract

Background The 2018 European Society of Cardiology (ESC)/European Society of Hypertension (ESH) guidelines for the management of hypertension highlight the importance of fixed-dose combinations (FDC) for the treatment of hypertension and recommend initial single-pill combination therapy in almost all patients. However, data on the implementation of these recommendations in clinical practice are scarce. Methods Data from the German Institute for Drug Use Evaluation (DAPI) were analyzed and extrapolated accounting for approximately 88% of Germany’s population (approximately 73.3 million subjects). All antihypertensive (AHT) FDC products available on the German market were included in the analyses. We examined the time course of dispensed packages between January 2016 and December 2020. Results FDCs accounted for 15.4% of all AHT in 2016 and for 10.9% in 2020. While dispensing of all AHT increased slightly from year to year (2016: 143.8 million, 2020: 153.2 million packs), dispensing of FDCs decreased from 22.2 million (2016) to 16.6 million (2020) packs. Dispensing of FDCs containing hydrochlorothiazide (HCT) declined considerably from 2016 to 2020 (Q1 2016: 4.65 million, Q4 2020: 3.13 million packs). Accordingly, the proportion of HCT-containing combinations in all FDCs decreased from 85.3 to 74.2% from Q1 2016 to Q4 2020. Patients younger than 80 years were prescribed FDCs more frequently (14.6% of all AHT, based on the entire evaluation period) than patients 80 years and older (10.0%). In both age groups, this proportion decreased continuously over time. Conclusions Almost 2 years following the release of the 2018 ESC/ESH guidelines, only 10.9% of the prescribed packs of antihypertensive drugs in 2020 were FDC products, documenting underutilization of current guideline recommendations on pharmacotherapy in hypertension. Structured programs to evidence-based decision support are required to improve guideline inertia and patient outcomes, eventually. Graphical abstract

The Impact of International Nonproprietary Names Integration on Prescribing Reimbursement Medicines for Arterial Hypertension and Analysis of Medication Errors in Latvia

“…The ESC/ESH guideline recommendations on pharmacotherapy in hypertension recommend FDC drugs to simplify the regimen and improve adherence and blood pressure outcomes compared with monocomponent pill combinations [ 7 ]. While low (10.9%) FDC medication prescribing was observed in Germany, this study demonstrated relatively high (66.5%) FDC drug use for arterial hypertension treatment, conceivably because Latvia has a relatively high penetration rate of generics in the market [ 17 , 18 ]. Moreover, more varying dosages and new combinations have become available, for example, FDC with HMG-CoA reductase inhibitors.…”

Trends in Ezetimibe Prescriptions as Monotherapy or Fixed-Dose Combination in Germany 2012–2021

“…The database contains anonymized dispensing data on medications prescribed at the expense of the statutory health insurance (SHI) funds. The available data were extrapolated by regional factors to represent all SHI-insured persons (approximately 88% of the total German population—that is, 73.3 million people) ( 6 , 10 ). Prescriptions for privately insured patients are not covered, and no data on individual patients, treatment indication, duration, or dosages were available.…”

“…Fixed-dose combinations (FDC) of ezetimibe with several statins are available. In patients with arterial hypertension, FDC have been shown to improve medication adherence and blood pressure control ( 6 , 7 ). In the 2018 ESC/ESH guidelines on hypertension, the initiation of antihypertensive treatment with FDC is recommended (class I) ( 8 ).…”

Sicht der Apothekerschaft: Gedanken zur Qualität der Arzneimittelversorgung in Deutschland

“…Neben der beeinträchtigten AMTS sind die Translation von Evidenz in die Primärversorgung (Katzmann et al 2022;Mahfoud et al 2022) und mangelnde Einnahmetreue in der medikamentösen Therapie weitere große Herausforderungen (Laufs et al 2011).…”

“…Die Forderung nach einer konsequenten Evaluation der Inhalte sowie der Effekte von Leitlinien wurde im Übrigen bereits vor 25 Jahren erhoben (Gerlach 1997). Dieses Phänomen wird international auch als guideline inertia bezeichnet (Gradl et al 2021;Mahfoud et al 2022).…”