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The American Journal of Managed Care October 2011
Does Telephone Care Management Help Medicaid Beneficiaries With Depression?
Sue E. Kim, PhD, MPH; Allen J. LeBlanc, PhD; Charles Michalopoulos, PhD; Francisca Azocar, PhD; Evette J. Ludman, PhD; David M. Butler, MA; and Greg E. Simon, MD, MPH
Absenteeism and Productivity Among Employees Being Treated for Hepatitis C
Richard A. Brook, MS, MBA; Nathan L. Kleinman, PhD; Jun Su, MD, MSc; Patricia K. Corey-Lisle, PhD; and Uchenna H. Iloeje, MD, MPH
Cost-Effectiveness of Intensive Tobacco Dependence Intervention Based on Self-Determination Theory
Irena Pesis-Katz, PhD; Geoffrey C. Williams, MD, PhD; Christopher P. Niemiec, PhD; and Kevin Fiscella, MD, MPH
Pharmacist-Provided Telephonic Medication Therapy Management in an MAPD Plan
Melea A. Ward, PharmD, MS; and Yihua Xu, PhD
High-Deductible Insurance: Two-Year Emergency Department and Hospital Use
J. Frank Wharam, MB, BCh, BAO, MPH; Bruce E. Landon, MD, MBA; Fang Zhang, PhD; Stephen B. Soumerai, ScD; and Dennis Ross-Degnan, ScD
Episode of Care Analysis Reveals Sources of Variations in Costs
Francois de Brantes, MS, MBA; Amita Rastogi, MD, MHA; and Christina M. Soerensen, MPH
Absenteeism and Productivity Among Employees Being Treated for Hepatitis C
Richard A. Brook, MS, MBA; Nathan L. Kleinman, PhD; Jun Su, MD, MSc; Patricia K. Corey-Lisle, PhD; and Uchenna H. Iloeje, MD, MPH
Routine Pre-cesarean Staphylococcus aureus Screening and Decolonization: A Cost-Effectiveness Analysis
Bruce Y. Lee, MD, MBA; Ann E. Wiringa, MPH; Elizabeth A. Mitgang; Sarah M. McGlone, MPH; Abena N. Afriyie, BS; Yeohan Song, BS; and Richard H. Beigi, MD, MSc
Evaluation of Value-Based Insurance Design With a Large Retail Employer
Yoona A. Kim, PharmD; Aimee Loucks, PharmD; Glenn Yokoyama, PharmD; James Lightwood, PhD; Karen Rascati, PhD; and Seth A. Serxner, PhD, MPH
The Incidence and Costs of Hypoglycemia in Type 2 Diabetes
Brian J. Quilliam, PhD; Jason C. Simeone, PhD; A. Burak Ozbay, PhD; and Stephen J. Kogut, PhD
Routine Pre-cesarean Staphylococcus aureus Screening and Decolonization: A Cost-Effectiveness Analysis
Bruce Y. Lee, MD, MBA; Ann E. Wiringa, MPH; Elizabeth A. Mitgang; Sarah M. McGlone, MPH; Abena N. Afriyie, BS; Yeohan Song, BS; and Richard H. Beigi, MD, MSc
Increasing Pharmaceutical Copayments: Impact on Asthma Medication Utilization and Outcomes
Jonathan D. Campbell, PhD; Felicia Allen-Ramey, PhD; Shiva G. Sajjan, PhD; Eric M. Maiese, PhD; and Sean D. Sullivan, PhD
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The Incidence and Costs of Hypoglycemia in Type 2 Diabetes
Brian J. Quilliam, PhD; Jason C. Simeone, PhD; A. Burak Ozbay, PhD; and Stephen J. Kogut, PhD
Evaluation of Value-Based Insurance Design With a Large Retail Employer
Yoona A. Kim, PharmD; Aimee Loucks, PharmD; Glenn Yokoyama, PharmD; James Lightwood, PhD; Karen Rascati, PhD; and Seth A. Serxner, PhD, MPH
Pharmacist-Provided Telephonic Medication Therapy Management in an MAPD Plan
Melea A. Ward, PharmD, MS; and Yihua Xu, PhD
High-Deductible Insurance: Two-Year Emergency Department and Hospital Use
J. Frank Wharam, MB, BCh, BAO, MPH; Bruce E. Landon, MD, MBA; Fang Zhang, PhD; Stephen B. Soumerai, ScD; and Dennis Ross-Degnan, ScD
Cost-Effectiveness of Intensive Tobacco Dependence Intervention Based on Self-Determination Theory
Irena Pesis-Katz, PhD; Geoffrey C. Williams, MD, PhD; Christopher P. Niemiec, PhD; and Kevin Fiscella, MD, MPH
Episode of Care Analysis Reveals Sources of Variations in Costs
Francois de Brantes, MS, MBA; Amita Rastogi, MD, MHA; and Christina M. Soerensen, MPH
Does Telephone Care Management Help Medicaid Beneficiaries With Depression?
Sue E. Kim, PhD, MPH; Allen J. LeBlanc, PhD; Charles Michalopoulos, PhD; Francisca Azocar, PhD; Evette J. Ludman, PhD; David M. Butler, MA; and Greg E. Simon, MD, MPH

The Incidence and Costs of Hypoglycemia in Type 2 Diabetes

Brian J. Quilliam, PhD; Jason C. Simeone, PhD; A. Burak Ozbay, PhD; and Stephen J. Kogut, PhD
The overall incidence of hypoglycemia was considerable in this large working-age population and was associated with $52 million (2008 dollars) in direct medical costs.
As presented in Table 1, the largest percentage of the population was between the ages of 50 and 64 years (70.8%), with an additional 25.7% aged 35 to 49 years. Only 3.3% of the study population was between the ages of 18 and 34 years and 0.1% were >65 years of age. The population had a slightly greater percentage of men (53.9%) versus women (46.1%). Within 90 days of cohort entry, 51.3% of the population had only 1 class of antidiabetic medication filled (referred to as monotherapy) while 48.7% had prescription fills for more than 1 class of antidiabetic drug therapy in the same 90-day period (combination therapy). The most common classes of OADs were metformin (75.7%), sulfonylureas (42.3%), and thiazolidinediones (33.3%). Insulin use in addition to OAD use was relatively infrequent, such that only 6.0% of the study population had a prescription for insulin filled in the baseline 90-day period. Overall, 7.0% of the study population had at least 1 macrovascular complication and 4.3% had at least 1 microvascular complication of diabetes. The prevalence of individual micro- and macrovascular complications of diabetes was relatively rare in the study population at baseline (<1.0%), with the exception of coronary artery disease (4.9%) and retinopathy (2.1%).

Incidence of Hypoglycemia

Overall, 3.5% (n = 18,657) of the study sample had at least 1 inpatient, ED, or outpatient visit for hypoglycemia. In Table 2, the overall IR of a medical encounter for hypoglycemia was 153.8 per 10,000 p-yrs. The IR was highest in the youngest study members (18-34 years; 218.8 per 10,000 p-yrs) followed by the >65 year cohort members (193.2 per 10,000 p-yrs). The rate of hypoglycemia was higher for women (168.7 per 10,000 p-yrs) than for men (141.0 per 10,000 p-yrs; P <.001), a trend consistent across all age categories. Women 18 to 34 years of age had an IR of 267.0 per 10,000 p-yrs compared with an IR of 159.8 per 10,000 p-yrs in men of the same age (P <.001). Statistically significant differences in IR also occurred when comparing men and women in the 35 to 49 year age category (P <.001) and the 50 to 64 year age category (P <.001). Within the 65 year age category, the IR did not differ statistically between men and women (P = .833).

As presented in Table 3, the overall rate of inpatient admissions was relatively infrequent, with a rate of 13.5 per 10,000 p-yrs. ED visits were more frequent, with an IR of 32.8 per 10,000 p-yrs. Outpatient visits occurred at the greatest rate, with 118.9 outpatient hypoglycemic encounters occurring per 10,000 p-yrs. As with the composite measure, the incidence of hypoglycemia was typically higher in women than in men across all age groups and in all 3 settings.

Direct Medical Costs of Hypoglycemia

In Table 4, we present the results of the cost analyses. During the study period, costs associated with hypoglycemia visits were $52,223,675, or 0.6% of all inpatient, ED, or outpatient costs. Hypoglycemia visits accounted for 1.0% of all inpatient costs, 2.7% of ED costs, and 0.3% of outpatient costs during the study period. The mean cost for inpatient hypoglycemia admissions was $17,564.25, compared with $13,862.03 for other diabetes-related inpatient admissions (P <.001) and $19,146.25 for all other inpatient admissions (P = .026). The mean cost for an ED visit related to hypoglycemia was $1386.80 relative to $320.54 for other diabetes-related ED visits (P <.001) and $632.32 for all other ED visits (P <.001). Mean cost for an outpatient hypoglycemia-related episode ($393.64) was higher than the mean cost for other diabetes-related encounters ($112.22; P <.001) and for non–diabetes-related encounters ($380.15; P = .05) within the same setting. The sum of PMPM costs related to hypoglycemia and diabetes in all settings was $36.98; 9.7% of all diabetes costs ($3.58) were related to hypoglycemia treatment. PMPM costs for hypoglycemia were highest for inpatient admissions at $2.12, which was 40.7% of all inpatient PMPM costs for diabetes care and approximately 1% of all inpatient costs.

DISCUSSION

Our study is a large retrospective cohort study assessing the incidence and costs of hypoglycemia-related medical visits in persons with type 2 diabetes and taking at least 1 OAD. To our knowledge, our study is the first to assess the comprehensive incidence of hypoglycemia and direct medical costs in a large, real-world population of adults with type 2 diabetes. We found the risk of hypoglycemia requiring medical intervention to be 3.5%, with total costs in excess of $52 million (2008 dollars). Our comprehensive assessment of hypoglycemia-related medical visits highlights the continued need for vigilance regarding adverse events associated with OAD therapy.

While other studies reviewed here have assessed rates of serious hypoglycemic events, direct comparison to our estimates is difficult as the sampled populations, definitions of hypoglycemia, and settings studied vary widely. In our study of hypoglycemic events warranting a medical encounter, we found an overall rate of 153.8 per 10,000 p-yrs among patients with type 2 diabetes taking 1 or more OADs. First hypoglycemia-related outpatient encounters occurred approximately 10 times more frequently as first hypoglycemia-related inpatient encounters in this cohort. A recent cohort study in England found similar rates of hypoglycemia (as diagnosed and reported by study participant’s general practitioner) for nateglinide (15.71 per 1000 p-yrs) and repaglinide (20.32 per 1000 p-yrs) users, but somewhat lower rates for rosiglitazone (9.94 per 1000 p-yrs) and pioglitazone (9.64 per 1000 p-yrs) users.22 In a study of persons with type 2 diabetes, taking an oral agent with or without insulin using the General Practice Research Database (GPRD), the rate of mild/moderate (reported by general practitioner) or severe (requiring hospitalization) hypoglycemia was 60 per 100,000 p-yrs for sulfonylureas and 110 per 100,000 p-yrs for metformin with an overall risk for hypoglycemia in the study of 4.1%.23 In a 1-year prospective cohort study, 39% of sulfonylurea users reported at least 1 hypoglycemic event compared with 51% of new insulin users (<2 years) and 64% of persons using insulin for >5 years.24 Finally, 2 other studies assessed rates of hypoglycemia resulting in ED visits. In a 4-year (1997-2000) prospective study conducted in Germany, the highest rate of ED visits related to sulfonylurea use was in glibenclamide users (5.6 per 1000 p-yrs),25 a rate comparable to our estimated rate of first ED visit (32.8 per 10,000). However, the mean age of persons with hypoglycemic events in this study was 79 years,25 an age group not adequately represented in our cohort. A 12-year prospective study of ED visits in Switzerland in persons with type 2 diabetes using sulfonylureas found a lower rate of ED visits (0.92 per 1000 p-yrs).26 Our study presents a more comprehensive recent assessment of instances of hypoglycemia requiring medical intervention and therefore provides new insight into the considerable impact of hypoglycemia on the rate of utilization of medical visits in the United States.

Another study finding was the increased rate of hypoglycemia by younger (aged 18-34 years) and relatively older (aged 65 years) adults in our cohort, although the number of older adults and corresponding hypoglycemic events included in our cohort was small (n = 655 with 12 events). In a study by van Staa and colleagues using the GPRD, the overall rate of hypoglycemia in sulfonylurea users at least 65 years of age was 196.7 per 10,000 p-yrs,27 a rate comparable to cohort members aged at least 65 years in our study (193.2 per 10,000 p-yrs). An older study of Medicaid enrollees with type 2 diabetes estimated the rate of serious hypoglycemic events in sulfonylurea users at least 65 years of age to be 123.1 per 10,000 p-yrs.28 It should be noted, however, that these studies had a broader range of older adults, whereas our population was closer to 65 years of age. We are unaware of studies that assessed rates of hypoglycemia in young adults (18-29 years). Lastly, the van Staa study also demonstrated a higher rate of hypoglycemia in women as compared with men,27 a pattern that was found in our study across all age groups.

Our analyses indicate that while hypoglycemia is relatively infrequent in this large working-age population, the mean cost of medical encounters associated with hypoglycemia was up to 4 times higher than for other diabetes-related claims. Furthermore, the total costs of all hypoglycemia-related inpatient admissions exceeded the costs of all hypoglycemia-related ED and outpatient visits combined. Recently, Curkendall et al found that a diagnosis of hypoglycemia in the inpatient setting was associated with over 38% higher total charges than in patients without hypoglycemia.13 In the same study, mean total inpatient charges for patients with hypoglycemia were approximately $86,000, compared with approximately $54,000 for patients without the complication.13 A study by Pelletier and colleagues of more than 44,000 patients with type 2 diabetes, however, found that mean direct medical charges for hypoglycemia complications were approximately $454.15 This study reported that 12-month mean allowed amounts for hypoglycemia totaled $345, but this analysis did not distinguish costs by setting type.15 A 1999 to 2001 study using MarketScan data found that annualized hypoglycemia-related medical costs were $3241 for insulin users.29 The absolute direct cost of medical visits for hypoglycemia was $52 million within our sample, with potentially avoidable inpatient admissions for hypoglycemia accounting for nearly 60% of medical costs for hypoglycemia ($30,930,649 of $52,223,675). While per-episode costs were high, overall PMPM costs associated with hypoglycemia were relatively low. As hypoglycemic events are potentially avoidable, development of additional strategies to decrease rates of hypoglycemia that warrant medical intervention are necessary.

 
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