Operationalisation and frequency estimation of a statin intolerance

>Sanofi-Aventis Deutschland GmbH

Statistical AnalysesPharmacotherapy

The occurrence of muscle pain is a known side effect of statin treatment and usually requires a switch to another statin or lipid-lowering therapy. There is little data on the frequency of occurrence of this side effect.

The aim of the study is to determine the incidence and prevalence of statin intolerance for Germany. This will initially be carried out in a pilot study based on the statutory health insurance sample AOK Hesse/KV Hesse, an 18.75% random sample of insured persons from AOK Hesse. Afterwards, the methodology developed in the pilot study, the operationalisations for statin intolerance, which is not documented as such, will be transferred in the main study to a large nationwide SHI database, the DaTraV data at DIMDI.

Database: DaTraV-data; continuously between 2009 and 2011 insured persons aged 18 and over (52.9 million). Study population: Incidental statin recipients in 2010 (ATC: C10AA, C10BA, C10BX) with documentation of a lipid metabolism disorder (E78 except E78.1, E78.3, E78.6) in eight quarters before incidence. Definition of a statin associated myopathy (SAM): ICD 10 diagnoses G72.0, G72.8, G72.9, M60.8, M60.9, M79.1 in the quarter of incidence or in one of the three following quarters. The exposure time with statins was determined assuming one DDD daily.

Result: 1.9% of the 531,672 resident statin recipients underwent SAM. The proportion varies according to the use of the statins: In statin recipients with a one-time prescription it was 1.3%. For statin recipients with an exposure for 365 days and a change of statin, the proportion was highest with 5% SAM.

Conclusion: Routine data can be used to estimate the frequency of SAM - even for different medication patterns - under everyday conditions.

Duration: 2015–2015
Methods: Statistical Analyses
Topics: Pharmacotherapy, Supply curves
Data: Claims data


Ihle P, Dippel F-W, Schubert I.
Statin-associated myopathy. Assessment of frequency based on data of all statutory health insurance funds in Germany. Pharmacology Research & Perspectives 2018; 6(3): e00404

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