SPANISH EXPERTS OFFER GUIDANCE ON THE USE OF STATINS IN PEOPLE AT RISK OF DEVELOPING DIABETES MELLITUS
NEW GUIDANCE PUBLISHED IN ATHEROSCLEROSIS SUPPLEMENTS
Madrid, Spain, 29th May 2014: A paper published in Atherosclerosis Supplements, which is currently available online and is available in print from 2nd June, offers additional reassurance and guidance for primary care physicians on the use of statins in people with or at risk of developing Type 2 diabetes (T2D). The paper, which is developed by a group of leading international cardiology experts, including three from Spain, with the support of Kowa Pharmaceutical Europe Co. Ltd. is a summary of the evidence and key milestones relating to the diabetogenicity of statins and includes more detailed guidance for physicians than has previously existed.
Statins are the recommended first-line lipid-lowering drugs for the majority of patients with any elevated level of cardiovascular risk. In recent years there have been a number of studies that have looked at the diabetogenic effects of statins and there is now sufficient evidence of a link between statin therapy and an increased risk of T2D. This led the European Medicines Agency (EMA) in 2012 to issue guidance on a small increased risk of T2D with the statin class. This paper is the first document to summarise, in detail, the evidence that led to these changes. Entitled ‘The use of statins in people at risk of developing diabetes mellitus: Evidence and guidance for clinical practice’, this paper is intended to offer another level of detail for physicians as well as provide further, more in-depth, guidance on how to manage patients.
Commenting on the importance of the paper co-author Xavier Garcia-Moll (Cardiology Department, Hospital de la Santa Creu i Sant Pau, Autònoma University Barcelona) said “There has already been a lot of good work in Spain to raise awareness of the link between statins and the increased risk of T2D. Yet despite this work, there may still be some physicians who need further knowledge as well as reassurance on the continued use of statins with their patients and we hope this paper is able to provide that.”
Co-author Prof. Rafael Carmena, Department of Medicine, University of Valencia, stressed the importance of the continued use of statins, where appropriate, by physicians, “This paper helps to put into perspective the level of risk of T2D. It is important for physicians to be aware that the benefits of using statins far outweigh the risks of T2D and that patients should continue with their statin therapy in accordance with present guidelines (ESC/EAS). This is not a general issue but one associated with high doses of potent statins and certain profile of patient, namely the elderly or subjects with an elevated risk of developing T2D, such as those with metabolic syndrome.”
The following guidance is provided for physicians in the paper:
- All patients with high CV risk considered for statins should have their T2D risk assessed using a validated risk score. If their risk score shows low- to moderate-T2D risk (e.g. FINDRISC score <15 or equivalent using other T2D risk scores) then HbA1c and/or FPG levels need not be assessed (see Figure 1).
- In a patient with CVD and/or high CV risk and high- to very-high T2D risk score (e.g. FINDRISC score ≥15 or equivalent), HbA1c or FPG levels should be measured pre-statin and re-assessed 3 months after statin initiation (see Figure 1).
- In a patient with a high T2D risk score and/or FPG >100mg/dL / 5.5mmol/L or HbA1c 6.0-6.4%, appropriate measures should be taken to reduce the risk of conversion from pre-diabetes to T2D. We suggest this might include targeting weight loss and reductions in glycaemia through more intensive lifestyle changes with or without T2D treatment.
- Patients developing T2D should continue their statin therapy and have their diabetes managed according to national guidelines
Figure 1. Recommendations for glycaemia testing pre- and post- statin commencement in individuals without known diabetes
The three Spanish co-authors on this paper were:
- Xavier Garcia-Moll, Unitat Hospitalitzacio´, Servei de Cardiologia, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma, Barcelona
- afael Carmena, Department of Medicine, University of Valencia. Institute of Clinical Research (INCLIVA) Hospital Clínico Universitario Valencia
- Lluís Masana, Unitat de Recerca en Lipids i Arteriosclerosi, IISPV, CIBERDEM, Universitat Rovira i Virgili, Sant Llorenc¸, 21, 43201 Reus
The paper can be found at http://www.atherosclerosis-supplements.com/article/S1567-5688(14)00002-6/abstract
Kowa Company, Ltd. (KCL) is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, KCL is actively engaged in various manufacturing and commercial activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and various consumer products. KCL's pharmaceutical division was founded in 1947, and is focused on cardiovascular therapeutics, with sales of the company's flagship product, pitavastatin (known as LIVALO, LIVAZO and ALIPZA in different markets) totalling $530 million in Japan fiscal year ending March 2014.
Kowa Research Europe, Ltd. (KRE), established in 1999 in the United Kingdom, is responsible for European clinical trials for Kowa's strategic global pharmaceutical development.
Kowa Pharmaceutical Europe Co. Ltd. (KPE), established in 2000, is a specialty pharmaceutical company located in Wokingham, UK, focused primarily on cardiometabolic therapeutics as well as medical devices. Working in harmony with KRE, these European pharmaceutical divisions of Kowa Company, Ltd. are committed to ground-breaking research, development and marketing to ensure quality products are made available to people around the world, enabling them to enjoy a better standard of health and a more comfortable life.