More Diabetes Potpourri : Additional Current Issues Related to Diabetes

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1 Page 1 Scott K. Stolte, Pharm.D. Associate Dean for Academic Affairs Bernard J. Dunn School of Pharmacy Shenandoah University This program has been brought to you by PharmCon Accreditation: Pharmacists: L01-P Pharmacy Technicians: L01-T Nurses: N-639 CE Credits: 1 contact hour Target Audience: Pharmacists, Technicians & Nurses Program Overview: The number of American adults with diabetes could double or triple by 2050 if current trends continue, warns a recently released federal government study. The number of new diabetes cases a year will increase from 8 per 1,000 in 2008 to 15 per 1,000 in 2050, predicts the U.S. Centers for Disease Control and Prevention. By 2050,m between one-fifth and one-third of all adults could have diabetes -- with virtually all the increase attributed to type 2 diabetes, which is largely preventable. This webcast reviews current issues relevant in the management and care of diabetes. Objectives: Describe two current issues in the management of diabetes. Compare and contrast two different/opposing viewpoints for the issues you described Identify one potential change in the management or care of patients with diabetes based on the findings of current literature PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. This program has been brought to you by PharmCon Speaker: Dr. Scott Stolte joined the faculty of the Bernard J. Dunn School of Pharmacy at Shenandoah University in Scott served as a faculty member and as Chair of the Department of Pharmacy Practice prior to assuming his position as Associate Dean for Academic Affairs. Dr. Stolte earned his Doctor of Pharmacy degree from Purdue University in West Lafayette, IN in After graduation, Dr. Stolte was the initial community pharmacy resident at Family PharmaCare Center, Inc. and Purdue University. Speaker Disclosure: Dr. Stolte has no actual or potential conflicts of interest in relation to this program This program has been brought to you by PharmCon PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. Describe two currents issues in the management and/or care of diabetes. Compare and contrast two different/opposing viewpoints for the issues you described Predict one potential change in the management or care of patients with diabetes based on the findings of current literature.

2 Page 2 Can certain foods lower risk for the development of Type 2 Diabetes? High fruit and vegetable intake is associated with lower risk of CV disease and cancer What about Type 2 DM? Meta-analysis of six prospective studies Median length 13.4 years More than 220,000 people Age range First, the surprise Highest levels of intake for: Vegetables only Fruits only Fruits and vegetables only NOT associated with lower Type 2 DM risk! HOWEVER

3 Page 3 Intake of green leafy vegetables DID lower risk Highest intake = 1.4 servings daily 14% lower risk of Type 2 DM development compared with low intake Statistically significant Lettuce, kale, spinach Meta-analysis not completely controlled for variables However, results add to large body of evidence in support of diets based primarily on plants Green leafy vegetables seem to be especially protective Rich in vitamin C, β-carotene, polyphenols, α- linolenic acid, and magnesium Carter P et al. Fruit and vegetable intake and incidence of type 2 diabetes mellitus: Systematic review and meta-analysis. BMJ 2010 Aug 19; 341:c4229. A. The risk is not known. B. Statins have no effect on diabetes risk. C. Statins decrease diabetes risk by 20%. D. Statins increase diabetes risk slightly.

4 Page 4 Does statin therapy increase the risk of the development of diabetes? Data from 13 trials 90,000 patients Randomized to receive statin or placebo/usual care Follow-up: mean of 4 years Rate of diabetes higher in patients who took statins 4.5% vs 4.9% Statistically significant One additional diabetes case for every 255 patients who took statins for 4 years No differences in risk among different statins Association stronger in older patients Statins prevent 5 major coronary events in 255 patients over 4 years of therapy Thus, risk of diabetes with statins should not deter statin therapy in patients with cardiovascular risk. Older patients taking statins should have periodic blood glucose monitoring.

5 Page 5 Sattar N et al. Statins and risk of incident diabetes: A collaborative meta-analysis of randomized statin trials. Lancet 2010 Feb 27; 375:735. Does long-term metformin therapy raise risk for vitamin B12 deficiency? Metformin is the most commonly prescribed oral drug for patients with type 2 diabetes Metformin leads to vitamin B12 malabsorption Metformin is associated with lower vitamin B12 concentrations (Diabetes Care 2010; 33:156.) Investigators assessed risk for: B12 deficiency (<150 pmol/l) Low B12 concentration ( pmol/l) Elevated homocysteine concentrations 390 patients Metformin 850 mg po tid or placebo 4.3 years

6 Page 6 Metformin decreased vitamin B12 concentration by 19%, compared to placebo Risk for B12 deficiency and low B12 concentrations significantly higher in metformin group 14 patients would need to be treated for 4.3 years to experience deficiency 9 patients to experience low B12 concentrations Homocysteine concentrations significantly elevated Effect on B12 concentrations increased with duration of therapy Metformin raises risk for B12 deficiency, low B12 concentrations, and high homocysteine concentrations B12 deficiency can result in anemia, cognitive changes, and neuropathy Elevated homocysteine concentration is risk factor for CV disease Authors of study recommend routine B12 monitoring of metformin patients Not known if supplementation prevents deficiency De Jager J et al. Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B12 deficiency: Randomized placebo controlled trial. BMJ 2010 May 20; 340:c2181.

7 Page 7 A. TZDs do not increase fracture risk B. Fracture risk with rosiglitazone is greater than with pioglitazone C. Fracture risk is greater with pioglitazone than with rosiglitazone D. Fracture risk is equally high with both TZDs Do thiazolidinediones (TZDs) increase fracture risk? TZDs affect bone metabolism through activation of PPAR-γ receptors in bone Observational studies indicate an elevated risk for fractures Drawn from patients Multiple US sites Cases were 786 patients with fractures over three years 4 control patients for each case patient Matched for: Gender Age BMI

8 Page 8 TZD use associated with significantly higher risk for fractures in women aged 50 or older Odds ratio 1.7 Risk elevated but not significantly higher for men Odds ratio 1.4 Higher doses = higher risk Risk equal with pioglitazone and rosiglitazone Important: risk nearly identical for both TZDs Risk for CV adverse effects higher with rosiglitazone Both rosiglitazone and pioglitazone still available 9/23/2010 additional safety labeling and use restrictions added for rosiglitazone With alternative treatments available, use of TZDs for diabetes should be extremely limited. Bilik D et al. Thiazolidinediones and fractures: Evidence from Translating Research into Action for Diabetes. J Clin Endocrinol Metab 2010 Oct; 95:4560. Is increased waist circumference in patients with normal BMI harmful?

9 Page 9 Increased waist circumference is associated with: Insulin resistance Type 2 DM Dyslipidemia CHD Shortened life span 105,000 patients 50 yo 15,000 died between 1997 and 2006 Analyses adjusted for several demographic and lifestyle risk factors Age Smoking status BMI Risk for all-cause mortality was strongly associated with waist circumference 102% higher for men who had WCs > 47 inches compared with men who had WCs < 35 inches 136% higher for women who had WCs > 43 inches compared with women who had WCs < 29.5 inches Associated with higher all-cause mortality in each BMI category for men and women Esp for women with normal BMIs Central adiposity is a serious health risk Patients who are not obese or overweight still at risk with central adiposity Risks of abdominal obesity should be addressed with patients Pharmacists can measure waist circumferences for patients

10 Page 10 Jacobs EJ et al. Waist circumference and allcause mortality in a large US cohort. Arch Intern Med 2010 Aug 9/23; 170:1293. Are we any closer to curing Type 1 diabetes? Cell therapy approaches have been proposed to overcome extreme loss of insulin-producing pancreatic β cells Transplantation of donor islets of Langerhans being actively investigated Number of pts with Type 1 DM far greater than donor supply Embryonic stem cells or induced pluripotent stem cells could be converted into β cells Research is in very early stages Study in young mice Pancreatic β cells of young mice destroyed with a toxin Mice kept alive with regular insulin injections β cells began to replenish after several months Eventually, mice no longer needed insulin Glucagon-producing α cells were transforming into β cells via gene activation

11 Page 11 Nothing right now Do not know if humans have this capacity Would need to learn how to induce this gene expression and cellular transformation Offers another potential approach to cure Type 1 diabetes All potential cures are years, probably decades, away Thorel F et al. Conversion of adult pancreatic α- cells to β-cells after extreme β-cell loss. Nature 2010 Apr 22; 464:1149.