PMID- 26679966 OWN - NLM STAT- MEDLINE DCOM- 20160927 LR - 20230805 IS - 2376-1032 (Electronic) IS - 2376-0540 (Print) IS - 2376-0540 (Linking) VI - 21 IP - 12 DP - 2015 Dec TI - Health Outcomes Associated with Initiation of Basal Insulin After 1, 2, or >/= 3 Oral Antidiabetes Drug(s) Among Managed Care Patients with Type 2 Diabetes. PG - 1172-81 LID - 10.18553/jmcp.2015.21.12.1172 AB - BACKGROUND: Type 2 diabetes mellitus (T2DM) is a progressive disease. Despite starting with single oral antidiabetes drug (OAD) therapy and then adding OAD(s), most patients eventually require insulin therapy to achieve and maintain glycemic control. The timely initiation of insulin therapy could help patients with T2DM whose glycemic control is not adequately maintained using OADs alone. OBJECTIVE: To describe and compare baseline characteristics and assess real-world health outcomes associated with initiating basal insulin after 1 OAD, 2 OADs, or >/= 3 OADs among T2DM patients. METHODS: Data were analyzed from adult T2DM patients in a U.S. managed care claims database (IMPACT) who initiated a basal insulin (from January 1, 2001, to December 31, 2011) with continuous health plan enrollment for 6 months before (baseline) and 12 months after (follow-up) insulin initiation and who had at least 1 OAD prescription. Outcome measures according to the number of OADs used were (a) treatment discontinuation, (b) glycated hemoglobin (A1c) levels, (c) proportion of patients experiencing hypoglycemia, (d) health care resource utilization, and (e) costs. RESULTS: Data from 71,988 patients were included (1 OAD: 19,168 patients [26.6%]; 2 OADs: 29,112 [40.4%]; and >/= 3 OADs: 23,708 [32.9%]). All baseline characteristics, except nephropathy, were significantly different across the 3 groups. At baseline, when compared with the 1 OAD or 2 OADs groups, the >/=3 OADs group was less likely to be female or have macrovascular disease and had experienced fewer hypoglycemic events and hospitalization as well as lower costs. At follow-up, treatment discontinuation rates were 36.0%, 27.6%, and 21.4% for the 1 OAD, 2 OADs, and >/= 3 OADs groups, respectively. A1c reduction was -1.33%, -1.05%, and -0.86%, respectively. The proportion of patients experiencing any hypoglycemia was 4.7%, 3.8%, and 3.3% at baseline; and 3.7%, 3.5%, and 3.1% at follow-up for the 1 OAD, 2 OADs, and >/=3 OADs groups, respectively. In all 3 groups, health care costs decreased compared with baseline, particularly in the 1 OAD and 2 OADs groups, with decreased inpatient costs offsetting increased drug costs. CONCLUSIONS: This real-world analysis shows that there are significant baseline differences in patients with T2DM on 1 OAD, 2 OADs, or >/=3 OADs when adding insulin therapy. All 3 groups had significant improvements in clinical and economic outcomes compared with baseline, yet at different magnitudes. These data contribute to a growing body of evidence supporting the timely initiation of insulin therapy for T2DM patients not maintaining glycemic control with OADs. FAU - Levin, Philip A AU - Levin PA AD - Clinical Research, Greater Baltimore Medical Center, 6563 N. Charles St., Ste. 400 N, Towson, MD 21204. pal3420@yahoo.com. FAU - Zhou, Steve AU - Zhou S FAU - Gill, Jasvinder AU - Gill J FAU - Wei, Wenhui AU - Wei W LA - eng PT - Comparative Study PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't PL - United States TA - J Manag Care Spec Pharm JT - Journal of managed care & specialty pharmacy JID - 101644425 RN - 0 (Biomarkers) RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (hemoglobin A1c protein, human) SB - IM MH - Administration, Oral MH - Administrative Claims, Healthcare MH - Adult MH - Aged MH - Biomarkers/blood MH - Blood Glucose/drug effects/metabolism MH - Cost Savings MH - Cost-Benefit Analysis MH - Databases, Factual MH - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy/economics MH - Drug Costs MH - Drug Therapy, Combination MH - Female MH - Glycated Hemoglobin/metabolism MH - Health Resources/economics/statistics & numerical data MH - Hospital Costs MH - Humans MH - Hypoglycemia/chemically induced MH - Hypoglycemic Agents/*administration & dosage/adverse effects/economics MH - Insulin/*administration & dosage/adverse effects/economics MH - Male MH - *Managed Care Programs MH - Middle Aged MH - Retrospective Studies MH - Time Factors MH - Treatment Outcome PMC - PMC10397988 COIS- This study was funded by Sanofi U.S. Levin serves on an advisory panel for Sanofi U.S. Zhou, Gill, and Wei are employees of Sanofi U.S. Zhou developed the study design and methodology, collected the data, provided statistical and analytic reflections of the data, and drafted the study reports. Wei codeveloped the study design, researched data, contributed to discussion, and reviewed the manuscript. Levin and Gill provided clinical insights for the study design and data interpretation, contributed to discussion, and reviewed the manuscript. All authors had full access to all the data in the study. Zhou is the guarantor of this work and, as such, takes responsibility for the integrity of the data and the accuracy of the data analysis. EDAT- 2015/12/19 06:00 MHDA- 2016/09/28 06:00 PMCR- 2015/12/01 CRDT- 2015/12/19 06:00 PHST- 2015/12/19 06:00 [entrez] PHST- 2015/12/19 06:00 [pubmed] PHST- 2016/09/28 06:00 [medline] PHST- 2015/12/01 00:00 [pmc-release] AID - 2015(21)12: 1172-1181 [pii] AID - 10.18553/jmcp.2015.21.12.1172 [doi] PST - ppublish SO - J Manag Care Spec Pharm. 2015 Dec;21(12):1172-81. doi: 10.18553/jmcp.2015.21.12.1172.