Physicians Call for Better Guidance on the use of Statins in
Patients at High Risk of Developing Diabetes
WOKINGHAM, England,
November 14, 2012 /PRNewswire/ --
On World Diabetes Day, outputs from a consultation with
physicians, including cardiologists and diabetologists, held during
the World Congress on Prevention of Diabetes and its Complications
(WCPD) in Madrid, has highlighted
a requirement for improved guidance on how to treat cardiovascular
disease risk in patients at risk of developing
diabetes.[1]
This call for guidance has come in response to further evidence
presented at the WCPD that demonstrates how statins differ in their
effect on developing
diabetes.[2],[3]
In addition, consulted physicians noted that recent warnings about
the potential for statins to cause diabetes in certain patients
were causing other treating physicians to be more cautious about
prescribing these lipid-lowering
drugs.[1]
"Although no-one doubts the huge benefit of statins in reducing
cardiovascular disease," said Prof Kausik
Ray, Professor of Cardiovascular Disease Prevention,
St George's, University of
London, "these insights
demonstrate how the medical community is taking the diabetogenic
risk of statins seriously and highlight the need for further
research and guidance in how to treat patients with high
cholesterol who are at risk of developing diabetes."
Although statins are considered safe and
well-tolerated,[4] conflicting
data exist regarding the effects of some statins on the risk of
developing diabetes. The largest meta-analysis of these data
included 13 trials with a total of 91,140 participants and
concluded that statin therapy is associated with a 9% increased
risk of new-onset diabetes.[5]
These studies resulted in a change made to the labels of some
statins to include a warning of this risk.
Mechanisms explaining the potentially higher incidence of
diabetes with statin therapy have not yet been identified and
studies looking at statins' effect on glucose metabolism suggest
that the effect may differ between statins. There are a number of
markers that can be used to measure impacts on glucose metabolism
such as increased fasting plasma glucose and HbA1c in the blood.
Some statins (e.g. atorvastatin) have been associated with
increased HbA1c levels in patients receiving intensive, but not
moderate,
therapy.[6],[7]
Other statins (e.g. pitavastatin) have demonstrated neutral or
favourable effects on glucose control in patients with and without
diabetes or metabolic
syndrome.[8]-[16]
New data presented during the WCPD demonstrated that both
pitavastatin and pravastatin have no effect on fasting plasma
glucose over 12 weeks in elderly
patients[2] and over 6 months in a
group of patients with carefully defined metabolic syndrome who
have multiple risk factors for
diabetes.[3] These data add to the
building body of evidence suggesting pitavastatin has a positive
effect on glucose metabolism and hence may not carry the same risk
of developing diabetes as other
statins.[8],[10]-[13]
The J-PREDICT trial, currently being undertaken in Japan, will aim to clarify these data by
evaluating the effect of pitavastatin on the risk for diabetes in
more than 1,200 people with impaired glucose
tolerance.[17] This study is due
to finish in 2015.
About the consultation
The consultation was conducted at the KOWA sponsored satellite
symposium held during the World Congress on Prevention of Diabetes
and its Complications (WCPD) from 11-14
November 2012 in Madrid,
Spain.
About LIVAZO®
LIVAZO® (pitavastatin) is a HMG-CoA reductase inhibitor
indicated for patients with primary hyperlipidemia and mixed
dyslipidemia as an adjunctive therapy to diet to reduce elevated
TC, LDL-C, Apo B, TG, and to increase HDL-C. LIVAZO® is
predominantly metabolized via glucuronidation and is only minimally
metabolised by CYP system, which may help reduce its potential for
CYP-mediated drug-drug interactions.
LIVAZO®, also known as LIVALO® and ALIPZA® in some markets, has
been available in Spain,
Portugal and Lebanon since 2011 and is available in the US
(2010), Mexico (2012),
Japan (2003), South Korea (2005), Thailand (2008), China (2009), Indonesia (2012) and Taiwan (2012).
In much of Europe, pitavastatin
will be marketed by Recordati as LIVAZO®. Pitavastatin is available
in three dosage strengths (1mg, 2mg and
4mg).[18] For more information
about the geographical availability of pitavastatin and marketing
companies please visit the Kowa Pharmaceutical Europe website
www.kowapharmaceuticals.eu
About Kowa
Kowa Company, Ltd. (KCL) is a privately held multinational
company headquartered in Nagoya,
Japan. Established in 1894, KCL is actively engaged in
various business fields with major focuses on the manufacturing and
sales of pharmaceutical products, LED lighting equipment and green
products, and the trading of textile goods, machinery, building
materials and chemical 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
€500 million (approximately 16% market share) in Japan during 2011 fiscal year.
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 (KPE) Co. Ltd, established in 2000,
is a specialty pharmaceutical company located in Wokingham, UK,
focused primarily on cardiometabolic therapeutics. Working in
harmony with KRE, these European pharmaceutical divisions of
Japanese 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.
Visit our New Website: www.Kowapharmaceuticals.eu/
References
- Kowa data on file. Report from consultation at the KOWA
sponsored satellite symposium held during the World Congress on
Prevention of Diabetes and its Complications (WCPD) from
11-14 November 2012 in Madrid, Spain.
- Sponseller CA, Stender S, Zhu B, et al. Neutral effects of
pitavastatin and pravastatin on fasting plasma glucose over 12
weeks in elderly patients with primary hyperlipidemia or mixed
lipidemia. Abstract 2421526. Presented at the 7th World Congress on
Prevention of Diabetes and its Complications 2012. Madrid, Spain.
- Hounslow N, Robillard P, Suzuki M, et al. Pitavastatin is
without effect on glycaemic parameters in metabolic syndrome.
Abstract 7161542. Presented at the 7th World Congress on Prevention
of Diabetes and its Complications 2012. Madrid, Spain.
- Armitage J. The safety of statins in clinical practice.
Lancet. 2007;370:1781-90.
- Sattar N, Preiss D, Murray HM, et al. Statins and risk of
incident diabetes: a collaborative meta-analysis of randomised
statin trials. Lancet. 2010;375(9716):735-742.
- Koh KK, Quon MJ, Han SH, et al. Atorvastatin causes insulin
resistance and increases ambient glycemia in hypercholesterolemic
patients. J Am Coll Cardiol 2010;55:1209-1216.
- Sabatine MS, Wiviott SD, Morrow DA, et al. High-dose
atorvastatin associated with worse glycemic control: a PROVE-IT
TIMI 22 substudy. Circ. 2004;110(Suppl 3):834.
- Yamakawa T, Takano T, Tanaka S, et al. Influence of
pitavastatin on glucose tolerance in patients with type 2 diabetes
mellitus. J Atheroscler Thromb. 2008;15:269-275.
- Yokote K, Saito Y. Influence of statins on glucose tolerance in
patients with type 2 diabetes mellitus: subanalysis of the
collaborative study on hypercholesterolemia drug intervention and
their benefits for atherosclerosis prevention (CHIBA study). J Atheroscler Thromb.
2009;16:297-298.
- Teramoto T, Urashima M, Shimano H, et al. A large-scale study
on cardio-cerebrovascular events during pitavastatin (LIVALO
tablet) therapy in Japanese patients with hypercholesterolemia
LIVES 5-year extension study. Jpn Pharmacol Ther.
2011;39:789-803.
- Teramoto T, Shimano H, Yokote K, Urashima M. New evidence on
pitavastatin: efficacy and safety in clinical studies. Expert
Opin Pharmacother. 2010;11:817-828.
- Saku K, Zhang B, Noda K, et al. Randomized head-to-head
comparison of pitavastatin, atorvastatin and rosuvastatin for
safety and efficacy - The PATROL study. Circ J.
2011;75(6):1493-505.
- Kryzhanovski V, Morgan R, Sponseller C et al. Pitavastatin 4mg
provides significantly greater reduction in LDL-C compared to
pravastatin 40mg with neutral effects on glucose metabolism:
prespecified safety analysis from the short-term phase 4 prevail UK
trial in patients with primary hyperlipidemia or mixed
dyslipidemia. JACC. 2012;59:E1692
- Baker WL, Talati R, White CM, Coleman CI. Differing effect of
statins on insulin sensitivity in non-diabetics: a systematic
review and meta-analysis. Diabetes Res Clin Pract.
2010;87(1):98-107.
- Gumprecht J, Gosho M, Budinski D, Hounslow N. Comparative
long-term efficacy and tolerability of pitavastatin 4 mg and
atorvastatin 20-40 mg in patients with type 2 diabetes mellitus and
combined (mixed) dyslipidaemia. Diabetes Obes Metab.
2011;13(11):1047-55.
- Kryzhanovski V, Eriksson M, Hounslow N and Sponseller C.
Short-term and long-term effects of pitavastatin and simvastatin on
fasting plasma glucose in patients with primary hyperlipidemia or
mixed dyslipidemia and >2 risk factors for coronary heart
disease. J Am Coll Cardiol. 2012;59(13s1):E1659.
- Yamazaki T, Kishimoto J, Ito C et al. Japan Prevention Trial of
Diabetes by Pitavastatin in Patients With Impaired Glucose
Tolerance (the J-PREDICT study): rationale, study design, and
clinical characteristics of 1269 patients. Diabetol Int.
2011;2:134-40.
- Pitavastatin Summary of Product Characteristics. Available at
http://www.kowapharmaceuticals.eu/_client/pdfs/livazo_smpc.pdf Accessed
Sep 2012