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Klinik Farmakoloji Derneği
Turkish Society of Clinical Pharmacology

Derneğimiz EACPT ve ISPOR üyesidir


DİKKAT: STATİNLER DİYABETE SEBEP OLUYOR

Çok geniş bir kadro ile 90.410 kişiyi kapsayan çalışmada statin kullanımının diyabete sebep olduğu ortaya çıktı.Bu hafta Lancette yayınlanan çalışmada en az 1000 hasta ihtiva eden ve en az bir sene statin kullanan çalışmalar meta analize dahil edildi. Yapılan analizler sonucunda statin kullanımı diyabet oluşumunu, kontrol grubuna nazaran %9 oranında artırıyor.

Daha once yapılan “Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER)” çalışmasında da rosuvastatin’in (CRESTOR, AstraZeneca; COLNAR, Sanovel;ROSUCOR, Salutis; ULTRAX, Nobel; ROSUFIX, Mentis) kullanıma başladıktan ortalama 1.9 sene sonra diyabete sebep olduğu gösterilmişti. Pravastatin (PRAVACHOL, BMS; PRAXAL, Sandoz) ile yapılan PROSPER çalışmasında da diyabet riski %32 artmış bulunmuştu.

The Lancet, Early Online Publication, 17 February 2010

Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials

Prof Naveed Sattar PhD a , Dr David Preiss MRCP a , Heather M Murray MSc b, Paul Welsh PhD a, Prof Brendan M Buckley FRCPI c, Anton JM de Craen PhD d, Sreenivasa Rao Kondapally Seshasai MD e, Prof John J McMurray MD a, Dilys J Freeman PhD f, Prof J Wouter Jukema MD g, Prof Peter W Macfarlane DSc h, Prof Chris J Packard DSc h, Prof David J Stott MD h, Prof Rudi G Westendorp MD i, Prof James Shepherd MD h, Prof Barry R Davis PhD j, Sara L Pressel MS j, Prof Roberto Marchioli MD k, Prof Rosa Maria Marfisi MS k, Prof Aldo P Maggioni MD l, Prof Luigi Tavazzi MD m, Prof Gianni Tognoni MD k, Prof John Kjekshus MD n, Prof Terje R Pedersen MD o, Thomas J Cook MS p, Prof Antonio M Gotto MD q, Prof Michael B Clearfield DO r, John R Downs MD s, Prof Haruo Nakamura MD t, Prof Yasuo Ohashi MD u, Prof Kyoichi Mizuno MD v, Kausik K Ray MD e, Prof Ian Ford PhD b

Background

Trials of statin therapy have had conflicting findings on the risk of development of diabetes mellitus in patients given statins. We aimed to establish by a meta-analysis of published and unpublished data whether any relation exists between statin use and development of diabetes.

Methods

We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from 1994 to 2009, for randomised controlled endpoint trials of statins. We included only trials with more than 1000 patients, with identical follow-up in both groups and duration of more than 1 year. We excluded trials of patients with organ transplants or who needed haemodialysis. We used the I2 statistic to measure heterogeneity between trials and calculated risk estimates for incident diabetes with random-effect meta-analysis.

Findings

We identified 13 statin trials with 91 140 participants, of whom 4278 (2226 assigned statins and 2052 assigned control treatment) developed diabetes during a mean of 4 years. Statin therapy was associated with a 9% increased risk for incident diabetes (odds ratio [OR] 1•09; 95% CI 1•02—1•17), with little heterogeneity (I2=11%) between trials. Meta-regression showed that risk of development of diabetes with statins was highest in trials with older participants, but neither baseline body-mass index nor change in LDL-cholesterol concentrations accounted for residual variation in risk. Treatment of 255 (95% CI 150—852) patients with statins for 4 years resulted in one extra case of diabetes.

a British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK
b Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK
c Department of Pharmacology and Therapeutics, Cork University Hospital, Cork, Ireland
d Department of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, Netherlands
e Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
f Department of Reproductive and Maternal Medicine, University of Glasgow, Glasgow, UK
g Department of Cardiology, Leiden University Medical Centre, Leiden, Netherlands
h Cardiovascular and Medical Sciences Division, University of Glasgow, Glasgow, UK
i Netherlands Consortium for Healthy Aging, Leiden, Netherlands
j University of Texas School of Public Health, TX, USA
k Consorzio Mario Negri Stud, S Maria Imbaro, Italy
l ANMCO Research Centre, Florence, Italy
m GVM Hospitals of Care and Research, Cotignola, Italy
n Department of Cardiology, Rikshospitalet University Hospital, Oslo, Norway
o Centre for Preventative Medicine, Ulleval University Hospital, Oslo, Norway
p Agile 1, Paramus, NJ, USA
q Weill Medical College, Cornell University, NY, USA
r College of Osteopathic Medicine, Touro University, CA, USA
s Department of Medicine, University of Texas Health Science Centre, San Antonio, TX, USA
t Mitsukoshi Health and Welfare Foundation, Tokyo, Japan
u Department of Biostatistics/Epidemiology and Preventive Health Sciences, University of Tokyo, Tokyo, Japan