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Nogle J.M.,University of Florida | Forges B.,University of Florida | Chen P.C.,University of Miami | Sievers D.,Florida Hospital Diabetes Institute | And 2 more authors.
Journal of Occupational and Environmental Medicine | Year: 2014

Objective: A 12-month wellness program was provided for employees of a major employer in the Orlando area.Methods: The program involved screening and measurement of baseline indices, educational sessions, telephonic support, quarterly laboratory monitoring, and provision of glucometers and test strips.Results: For the 73 enrolled employees with prediabetes, serum hemoglobin A1c levels-mean (standard deviation)-decreased from 6.10% (0.53%) to 5.42% (0.51%) (P<0.0001). For the 151 enrolled employees with diabetes, mean serum hemoglobin A1c levels-mean (standard deviation)-decreased from 8.03% (1.91%) to 7.48% (1.52%) (P < 0.0001). In the 12 months before, during, and after the program, 27, 15, and 27 diabetic employees required hospitalization, respectively. Health insurance per member per month claims costs for employees with diabetes rose only 1.2% over the prior 12 months, and self-reported presenteeism increased (P < 0.0001).Conclusions: This employer-endorsed program achieved favorable outcomes for employees with prediabetes and diabetes. Copyright © 2014 by American College of Occupational and Environmental Medicine.


White W.B.,University of Connecticut | Pratley R.,Florida Hospital Diabetes Institute | Fleck P.,Takeda Global Research and Development Inc | Munsaka M.,Takeda Global Research and Development Inc | And 3 more authors.
Diabetes, Obesity and Metabolism | Year: 2013

Aim: As there have been concerns that some classes or agents for the treatment of type 2 diabetes may increase CV risk, we evaluated the cardiovascular profile of the dipeptidyl peptidase-4 inhibitor alogliptin. Methods: We evaluated the incidence of CV events in patients treated with alogliptin, placebo or comparator antihyperglycaemic drugs in the clinical trial database for alogliptin using the composite major adverse cardiovascular event (MACE) endpoints of CV death, non-fatal myocardial infarction and non-fatal stroke. Results: The pooled analysis included 4168 patients exposed to alogliptin 12.5 and 25 mg daily for 2023 patient-years compared to 691 patients treated with placebo for 263 patient-years and 1169 patients treated with other antidiabetic agents (metformin, sulfonylureas and thiazolidinediones) for 703 patient-years. CV events were adjudicated by an expert endpoint committee blinded to treatment allocation. The incidence rates of the combined MACE were not significantly different between patients treated with alogliptin and comparator therapies (hazard ratio=0.635, 95% confidence interval, 0.0, 1.41). Additionally, other types of serious CV events were not significantly different between patients treated with alogliptin and comparator therapies. Conclusion: These analyses have not shown a signal of increased CV risk with alogliptin in patients with type 2 diabetes. Future results from the adequately powered EXAMINE trial will definitively assess the CV safety profile of aloglipin in patients with type 2 diabetes mellitus. © 2013 Blackwell Publishing Ltd.


Pratley R.E.,Florida Hospital Diabetes Institute | Pratley R.E.,Translational Institute for Metabolism | Pratley R.E.,Sanford Burnham Institute for Medical Research
Endocrine Practice | Year: 2011

Elderly patients who are generally healthy should be managed according to the same goals and therapeutic approaches that are recommended for younger patients. However, many will need individualized regimens to address issues such as the potential need for relaxed glycemic targets, age-related changes, the presence of 1 or more comorbidities, and the increased impact of hypoglycemia. Some frst-line monotherapy, non-incretin- based treatment options may have characteristics that are better suited for the treatment of elderly patients than other agents (eg, low risk of hypoglycemia). However, clinical situations exist where incretin-based therapies can provide effective yet safe glycemic monotherapy in elderly patients. Benefts of DPP-4 inhibitors include once-daily oral dosing, availability as fxed-dose combination drugs (with metformin) to simplify the dosing regimen, weight neutrality, low risk of severe hypoglycemia, good tolerability, no gastrointestinal adverse effects, and no edema. However, their use in patients with renal insuffciency necessitates special attention, as dose adjustments are required for sitagliptin and saxagliptin. While GLP-1 RAs are not commonly prescribed for initial use in elderly T2DM patients, they exhibit favorable effects that make them attractive for use in some individuals, either as frst-line or add-on therapy. GLP-1 RAs promote weight loss, which may be benefcial in some elderly patients. They also have a low risk of hypoglycemia and provide greater improvements in A1C than DPP-4 inhibitors. GLP-1 RAs are injectables-exenatide BID is administered before meals, and liraglutide can be administered once daily at any time of the day. This lower dosing frequency may help limit polypharmacy and improve adherence. Gastrointestinal effects/nausea may affect adherence and could affect renal function; care should be taken when initiating or escalating the dose of GLP-1 RAs in elderly patients. However, for other comorbidities, GLP-1 RAs may provide benefts in liver insuffciency (NAFLD) and may improve CV risk factors, particularly blood pressure, total cholesterol, and triglyceride levels.


Mazza A.D.,Florida Hospital Diabetes Institute | Pratley R.E.,Florida Hospital Diabetes Institute | Pratley R.E.,Sanford Burnham Institute for Medical Research | Smith S.R.,Florida Hospital Diabetes Institute | Smith S.R.,Sanford Burnham Institute for Medical Research
Review of Diabetic Studies | Year: 2011

Obesity is associated with an increased risk of type 2 diabetes (T2D). Pancreatic beta-cell failure is an early event in the development of glucose dysregulation and diabetes. Interventions to halt beta-cell failure in T2D include diet modification, exercise, and use of pharmacologic agents. There is evidence that abdominal obesity may contribute to diabetes through insulin resistance and beta-cell impairment. Pivotal long-term studies into the prevention of T2D have shown the importance of weight loss beside diet, lifestyle, and medication. The Finnish Diabetes Prevention Program (DPP) showed that weight loss gradually reduces the risk of diabetes, and that even modest weight loss can significantly reduce the incidence of T2D. Similarly, in the US DPP, weight loss as part of intensive lifestyle modification was the major factor in reducing the incidence of T2D in high-risk subjects, being more effective than drug intervention. While understanding the relationship between obesity and diabetes is complex, we know that weight loss has positive effects on adipose tissue. It causes an increase in the beneficial fat cell hormone adiponectin, and a decrease in adipose tissue inflammation. Also, it is associated with reduced insulin resistance and a consequential reduction in glucolipotoxicity, which can improve beta-cell function. In summary, weight loss improves glycemic control and thereby mitigates diabetes symptoms and complications, possibly through the preservation of beta-cell function. Therefore, efforts to prevent diabetes and preserve beta-cell function in patients with T2D should more consequently emphasize and target weight loss. © by Lab & Life Press/SBDR.


Pratley R.E.,Florida Hospital Diabetes Institute | Pratley R.E.,Translational Research Institute for Metabolism and Diabetes | Pratley R.E.,Sanford Burnham Institute for Medical Research
Clinical Interventions in Aging | Year: 2014

Older people have the highest prevalence of type 2 diabetes mellitus (T2DM) of any age group and are thus frequent users of glucose-lowering agents. Because individuals 65 years or older are underrepresented in clinical studies, there is a lack of information regarding the efficacy and safety of available treatments in this population. Additionally, a high prevalence of comorbidities, polypharmacy, and frailty can make treatment of T2DM in this population challenging. Safety is an important consideration when choosing a treatment for older individuals. Renal impairment is quite common in older patients with T2DM and can contribute to hypoglycemia. Hypoglycemia can lead to serious consequences, such as falls and fractures, and cognitive changes. As such, hemoglobin A1c treatment targets, typically <7% in the general population, are less stringent in older people, with the goal being an individualized target that balances efficacy and safety. Many glucose-lowering agents can cause adverse events detrimental to older individuals, such as hypoglycemia (insulin, sulfonylureas), weight gain (sulfonylureas, thiazolidinediones), gastrointestinal events (metformin), and fractures (thiazolidinediones), and are contraindicated or require dose adjustments in those with renal impairment (most oral/injectable agents). Orally administered dipeptidyl peptidase (DPP)-4 inhibitors have a low risk of hypoglycemia and are generally well tolerated. Linagliptin is the only DPP-4 inhibitor excreted through nonrenal pathways and therefore does not require any dose adjustment in older patients with kidney disease. This paper reviews the findings of a recent study by Barnett et al assessing the efficacy and safety of the DPP-4 inhibitor linagliptin in patients with T2DM aged 70 years or older, which concluded that linagliptin may be a useful glucose-lowering option for older patients with T2DM. © 2014 Pratley.


PubMed | Florida Hospital Diabetes Institute
Type: Journal Article | Journal: The review of diabetic studies : RDS | Year: 2012

Obesity is associated with an increased risk of type 2 diabetes (T2D). Pancreatic beta-cell failure is an early event in the development of glucose dysregulation and diabetes. Interventions to halt beta-cell failure in T2D include diet modification, exercise, and use of pharmacologic agents. There is evidence that abdominal obesity may contribute to diabetes through insulin resistance and beta-cell impairment. Pivotal long-term studies into the prevention of T2D have shown the importance of weight loss beside diet, lifestyle, and medication. The Finnish Diabetes Prevention Program (DPP) showed that weight loss gradually reduces the risk of diabetes, and that even modest weight loss can significantly reduce the incidence of T2D. Similarly, in the US DPP, weight loss as part of intensive lifestyle modification was the major factor in reducing the incidence of T2D in high-risk subjects, being more effective than drug intervention. While understanding the relationship between obesity and diabetes is complex, we know that weight loss has positive effects on adipose tissue. It causes an increase in the beneficial fat cell hormone adiponectin, and a decrease in adipose tissue inflammation. Also, it is associated with reduced insulin resistance and a consequential reduction in glucolipotoxicity, which can improve beta-cell function. In summary, weight loss improves glycemic control and thereby mitigates diabetes symptoms and complications, possibly through the preservation of beta-cell function. Therefore, efforts to prevent diabetes and preserve beta-cell function in patients with T2D should more consequently emphasize and target weight loss.

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