Comparison of Statins Dose Intensity on HbA1c Control in Outpatients with Type 2 Diabetes: A Prospective Cohort Study
The effect of statins dose intensity (SDI) on glycemic control in patients with existing diabetes is unclear. Also, there are many contradictory findings were reported in the literature; thus, it is limiting the possibility to draw conclusions. This project was designed to compare the effect of SDI on glycated hemoglobin (HbA1c%) control in outpatients with Type 2 diabetes in the endocrine clinic at Hospital Pulau Pinang, Malaysia, between July 2015 and August 2016. A prospective cohort study was conducted, where records of 345 patients with Type 2 diabetes (Moderate-SDI group 289 patients and high-SDI cohort 56 patients) were reviewed to identify demographics and laboratory tests. The target of glycemic control (HbA1c < 7% for patient < 65 years, and < 8% for patient ≥ 65 years) was estimated, and the results were presented as descriptive statistics. From 289 moderate-SDI cohorts with a mean age of 57.3 ± 12.4 years, only 86 (29.8%) cases were shown to have controlled glycemia, while there were 203 (70.2%) cases with uncontrolled glycemia with confidence interval (CI) of 95% (6.2–10.8). On the other hand, the high-SDI group of 56 patients with Type 2 diabetes with a mean age 57.7±12.4 years is distributed among 11 (19.6%) patients with controlled diabetes, and 45 (80.4%) of them had uncontrolled glycemia, CI: 95% (7.1–11.9). The study has demonstrated that the relative risk (RR) of uncontrolled glycemia in patients with Type 2 diabetes that used high-SDI is 1.15, and the excessive relative risk (ERR) is 15%. The absolute risk (AR) is 10.2%, and the number needed to harm (NNH) is 10. Outpatients with Type 2 diabetes who use high-SDI of statin have a higher risk of uncontrolled glycemia than outpatients who had been treated with a moderate-SDI.
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 S. Lewington, G. Whitlock, R. Clarke, P. Sherliker, J. Emberson, J. Halsey, et al. "Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55,000 vascular deaths," Lancet, 370 (9602): 1829–39, Dec. 2007.
 Cholesterol Treatment Trialists (CTT) Collaboration, C. Baigent, L. Blackwell, J. Emberson, et al. “Efﬁcacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomized trials,” Lancet 2010;376: 1670–1681.
 F. Taylor, Huffman, A. F. Macedo, T. H. Moore, M. Burke, G. S. Davey, K. Ward, Ebrahim S. "Statins for the primary prevention of cardiovascular disease," Cochrane Database Syst Rev 1: CD004816, 2013.
 V. Kumar, N. Fausto, A. K.Abbas, R. S. Cotran, S. L. Robbins. “Robbins and Cotran Pathologic Basis of Disease,” (7th ed.). Philadelphia, Pa.: Saunders. 2005; 1194–1195, ISBN 0-7216-0187-1.
 (5) D. G. Gardner, “Shoback Dolores. Greenspan’s basic & clinical endocrinology,” (9th ed.). New York: McGraw-Hill Medical. 2011. Chapter 17. ISBN 0-07-162243-8.
 The global diabetes community “Guide to HbA1c”, available at http://www.diabetes.co.uk/what-is-hba1c.html, (accessed at 16 –Jul -2015).
 Total Health Institute. Total Health Life (2005)."High Blood Sugar". Retrieved May 4, 2011.
 American Diabetes Association “Glycemic Targets, Standards of medical care in diabetes—2016,” Diabetes Care 2016;39(1): S39–S46 | DOI: 10.2337/dc16-S008.
 M. A. Hammad, D. A. Mohamed Noor, S. A. Syed Sulaiman, N. A. Aziz, Y. Elsobky, “A prospective study of prevalence of uncontrolled glycaemia in Type 2 diabetes mellitus outpatients,” American College of Clinical Pharmacy 2016, ACCP Virtual Poster Symposium, Pharmacotherapy, May 18–19, 2016.
 M. A. Hammad, A. A. Khamis., K. M. Al- Akhali, T. M. Ali, A. M. Alasmri, E. M. Al-Ahmari, et al. “Evaluation of Drug Dosing in Renal Failure. IOSR Journal of Pharmacy and Biological Sciences,” IOSR-JPBS 2016:11(5): PP 39-50.
 S. A. Syed Sulaiman, D. A. Mohamed Noor, M. A. Hammad, K. M. Al- Akhali, A. M. Alasmri, E. M. Al-Ahmari, et al. “Prospective Study of Evaluation of Antibiotics Dosage Adjustment in Patients with Chronic Renal Failure at Aseer Hospital,” The 7th Asian Association of Schools of Pharmacy Conference, Taipei, Taiwan, JAASP 2015;1: 142.
 M. A. Hammad, K. M. Al Akhali, A. M. Alasmri, E. M. Al-Ahmari, E. M. Mossa, N. M. Algahtani, et al., “Prospective Study of Evaluation of Drug Dosage Adjustment in Patient with Chronic Renal Failure at Aseer Hospital,” The 10th Annual Scientific Research Day for Medical, Applied and Basic Sciences, King Khalid University, 5.05.2014, P92.
 K. Al Akhali, M. A. Hammad Ali, M. A. Ansari. “Evaluation of Prevalence and Pattern of Anemia – A Hospital Based Study in Aseer Province,” Kingdom of Saudi Arabia. Journal of Experimental Medical & Surgical Research. Nr. 2 / 2013; 32 -35.
 K. M. Alakhali, M. Selim, M. A. Hammad. “Evaluation of therapeutic drug monitoring of cyclosporine and tacrolimus in kidney transplant patients,” JPCS.2014;3(8).
 M. A. Khaled, M. Asif Ansari, M. A Hammad Ali. “Analysis of Prevalence Risk Factor and Pharmacotherapy of Hypertension in Outpatients,” Indian Journal of Pharmacy Practice. 6(4), 2013, p: 64-66. Available at: https://www.researchgate.net/publication/270337790_Analysis_of_Prevalence_Risk_Factor_and_Pharmacotherapy_of_Hypertension_in_Outpatients?ev=prf_pub.
 K. M. Alakhali, A. Ansari, A. HA, “Analysis of Prevalence, Risk Factor and Pharmacotherapy of Hypertension in Outpatients,” The 10th Annual Scientific Research Day for Medical, Applied and Basic Sciences, King Khalid University, 5.05.2014, P68.
 M. A. Hammad, B. Tangiisuran, N. Abd El Aziz, Y. Hassan. "A prospective study of uncontrolled glycemia secondary to drug-drug interactions in Type 2 diabetes mellitus patients at Penang General Hospital in Malaysia, "Pharmacotherapy, 2013; 33(5): E50-E50.
 E. A. Brinton, Statin Therapy: Risks vs. Benefit: Medscape Cardiology. 2004;8(1).
 National Medical Research Register, National Institute of Health NIH guideline. (updated 11-Nov-2014) Available at: https://www.nmrr.gov.my/fwbLoginPage.jsp?fwbPageId=NMRR_Home (Accessed: 7- Mar -2016).
 American Diabetes Association: “Older Adults, Standards of medical care in diabetes—2016,” Diabetes Care 2016;39(1): S81–S85. DOI: 10.2337/dc16-S013.
 N. J. Stone, J. G. Robinson, A. H. Lichtenstein, C. N. B. Merz, C. B. Blum, R. H. Eckel, et al. “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines,” J Am Coll Cardiol. 2014;63(25_PA): 2889-2934. doi: 10.1016/j.jacc.2013.11.002.
 M. R. Law, N. J. Wald, A. R. Rudnicka. “Quantifying effect of statins on low-density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis,” BMJ 2003;326: 1423.
 N. J. Stone, J. G. Robinson, A. H. Lichtenstein, C. N. B. Merz, C. B. Blum, R. H. Eckel, et al. “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults,” Circulation. 2014;129: S1-S45. Doi: http://dx.doi.org/10.1161/01.cir.0000437738.63853.7a.
 Food and Drug Administration. FDA drug safety communication: Important safety label changes to cholesterol-lowering statin drugs. 2012
 N. Sattar, D. Preiss, H. M. Murray, P. Welsh, B. M. Buckley, A. J. de Craen, et al. Statins and risk of diabetes: a collaborative meta-analysis of randomized statin trials. Lancet 2010; 375: 735-42.
 D. Preiss, S. R. Seshasai, P. Welsh, S. A. Murphy, J. E. Ho, D. D. Waters, et al. “Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a metaanalysis,” JAMA. 2011;305: 2556–2564.
 H. Cederberg, A. Stančáková, N. Yaluri, S. Modi, J. Kuusisto, M. Laakso. “Increased risk of diabetes with statin treatment is associated with impaired insulin sensitivity and insulin secretion: a 6-year follow-up study of the METSIM cohort,” 2015.
 K. C. Maki, P. M. Ridker, W. V. Brown, S. M. Grundy, N. Sattar. “An assessment by the Statin Diabetes Safety Task Force: 2014 update,” Journal of Clinical Lipidology 2014;8(3): S17–S29. DOI: http://dx.doi.org/10.1016/j.jacl.2014.02.012.
 S. M. Liew, et al. “Statins use is associated with poorer glycaemic control in a cohort of hypertensive patients with diabetes and without diabetes, ’Diabetology & Metabolic Syndrome 2014, 6:53.
 P. Y. Liu, L. Y. Lin, H. J. Lin, C. H. Hsia, Y. R. Hung, H. I. Yeh, et al. “Pitavastatin and atorvastatin double-blind randomized comparative study among high-risk patients, including those with Type 2 diabetes mellitus in Taiwan (PAPAGO-T study),” PLoS One. 2013;8:e76298. doi: 10.1371/journal.pone.0076298. (PMC free article) (PubMed) (Cross Ref).
 S. Erqou, C. C. Lee, A. I. Adler. “Statins and glycaemic control in individuals with diabetes: a systematic review and meta-analysis,” Diabetologia. 2014;57: 444–52. doi: 10.1007/s00125-014-3374-x. (PubMed) (Cross Ref).
 S. Simsek, C. G. Schalkwijk, B. H. Wolffenbuttel.” Effects of rosuvastatin and atorvastatin on glycaemic control in Type 2 diabetes – the CORALL study,” Diabet Med. 2012;29: 628–31. doi: 10.1111/j.1464-5491.2011.03553.x. (PubMed) (Cross Ref).
 J. Sasaki, Y. Ikeda, T. Kuribayashi, K. Kajiwara, S. Biro, K. Yamamoto, et al. “A 52-week, randomized, open-label, parallel-group comparison of the tolerability and effects of pitavastatin and atorvastatin on high-density lipoprotein cholesterol levels and glucose metabolism in Japanese patients with elevated levels of low-density lipoprotein cholesterol and glucose intolerance,” Clin Ther. 2008;30: 1089–101. doi: 10.1016/j.clinthera.2008.05.017. (PubMed) (Cross Ref).
 H. Ogawa, K. Matsui, Y. Saito, S. Sugiyama, H. Jinnouchi, M. Sugawara, et al. “Differences between rosuvastatin and atorvastatin in lipid-lowering action and effect on glucose metabolism in Japanese hypercholesterolemic patients with concurrent diabetes. Lipid-lowering with highly potent statins in hyperlipidemia with Type 2 diabetes patients (LISTEN) study,” Circ J. 2014;78: 2512–5. doi: 10.1253/circj.CJ-14-0810. (PubMed) (Cross Ref).
 Australian Government Department of Health and Ageing. “Australian Statistics on Medicines 2007,” (13th ed). Commonwealth of Australia 2009.
 Norwegian Institute of Public Health. “Drug Consumption in Norway 2003 – 2007,” Oslo 2008.
 A. Ramli, S. M. Aljunid, S. Sulong, M. F. A. Yusof. “National Drug Formulary review of statin therapeutic group using the multiattribute scoring tool,” Therapeutics and Clinical Risk Management. 2013;9: 491-504.