Beyond Metformin:When Are Doctors Intensifying DiabetesTreatment?

Type 2 Diabetes Treatment Intensification - by Ambro

If you were diagnosed with Type 2 diabetes in the last ten years or so, your doctor may have advised a change in diet, monitoring of blood glucose levels, an occasional HbA1c blood test, increased physical activity, prescribing an anti-hyperglycemic oral medication, metformin, and follow-up visits. Treatment methods, of course, vary for many reasons.

If your treatment plan was somewhere along these lines, you were probably relieved you were not going to have to start right away with insulin shots, at least, not just yet. But what if the metformin did not work? When would it be time to try something different? Time to step it up a bit?

There are many articles and books discussing "treatment intensification" for Type 2 diabetes which refers to the point at which a patient's treatment is cranked up to the next level when the current treatment is not working. Some recent research has looked at treatment intensification and common care practice.

In August 2011 issue of Diabetes, Obesity, and Metabolism, Fu et al will report the results of their recent study of trends in treatment intensification related to Type 2 diabetes patients, specifically, those who fail to hit their improvement targets using "metformin monotherapy" (monotherapy refers to using only metformin as the diabetes-specific medication in a treatment plan). The patients in their study may have been prescribed additional medications to reduce hypertension and/or cholesterol, but this review is focusing on the metformin-related results primarily.

Where Did They Get The Data?

The team of collaborators from the Cleveland Clinic and NJ-based Merck affiliates was provided access to electronic medical record data on over 12 million patients from the humongous "General Electric (GE) Centricity" database.

Fu et al write that the GE database contains anonymous HIPPA-compliant clinical data entered by over 9000 medical providers, i.e., doctors, and includes demographic information, vital signs, laboratory orders and results, medication list entries, prescription orders, diagnoses, and medical problems." That's one comprehensive database. During your next office visit, you may notice a GE Centricity logo on the screen as your doctor patiently asks you questions and enters your responses in his computer.

The beauty of having this kind of data is that it can be sliced and diced in amazing ways to support medical research. With modern data analytic techniques, researchers can pose seemingly infinite questions and see if the data can support any correlations or conclusions.

Who Was Selected?

To be considered for their study, your anonymous health records would have been in the GE database. Then you would have been at least 18 years old, diagnosed with Type 2 diabetes, on metformin as the only diabetes-specific medication for a given period of time, and had "at least one Hb1Ac resulting in 7.0% or greater or two fasting blood glucose measurements at or greater than 126 mg/dl," etc. They pinpointed patients who met their criteria between 1997 and 2008, which gave them over a decade of experience for their analysis. That period of time is referenced as the "index date" in their analytics.

Highlights Of Selection Criteria

Fu et al's report walks through their data slicing algorithms and highlights what they found. They looked at a population of over 12,000 patients in their study. The average age was 63 years old, and about half were women.

The average HbA1c in the group selected was 8.0% but included some over 9%.

Only 64% of patients who failed metformin monotherapy according to the study's criteria were progressed to more intensive treatment.

Reported Results

After crunching the numbers, the research team made several interesting observations, including:

• Physicians seemed less inclined to initiate or intensify therapy in patients nearer a lower target HbA1c;
• The average time patients followed their original metformin treatment plan was 14 months before "treatment intensification;"
• There appeared to be some variance in the metformin-only diabetes treatment time and the dosage levels, i.e., patients who never exceeded 1500 mg of metformin had an average wait of 20.0 months before treatment intensification while those on higher dosages (46% in this study were prescribed 1500 mg or more) intensified in an average of about 9 months;
• Overall, in U.S. clinical practices, treatment intensification has sped up in the more recent years of the past decade, e.g., doctors appear to be waiting less time to abandon metformin alone when test results are not satisfactory. The researchers suggest this indicates an improvement in diabetes care.

Reviewer notes that diabetics with uncontrolled or inconsistent test results, more than one medical condition (co-morbidity), or complications may not align with comparison to this review. In order to assess the effectiveness of any treatment and make decisions about intensification, the diabetic patient must be diligent in following doctor's orders, attending follow-up exams, monitoring progress, reporting any concerns, and asking questions.

This team suggests more studies can be done for further assessment of care. For more information, the American Diabetes Association publishes standards of medical care in diabetes.

Special Thanks to Dr. Alex Z. Fu, Associate Professor, Department of Quantitative Health Sciences, Cleveland Clinic, for sharing additional information to support this review.

Other research-related articles by Melanie Hundley include: Diabetes Testing: What Are You Waiting For?, 2011: ADHD Treatments Reviewed; New Research: Autism and Vaccines.

Disclaimer: The information and links contained in this article are for educational purposes only and should not be used for diagnosis or to guide treatment without the opinion of a health professional. Any reader who is concerned about his or her health should contact a licensed medical doctor for advice.

Sources

• American Diabetes Association. (2011, January). Standards of medical care in diabetes. Diabetes Care,Vol. 34, No. Supplement 1, S11-S61. Retrieved July 16, 2011, from organization website. DOI: 10.2337/dc11-S011.
• Fu, A. Z., Qiu, Y. Y., Davies, M. J., Radican, L. L., & Engel, S. S. (2011). Treatment intensification in patients with type 2 diabetes who failed metformin monotherapy. Diabetes, Obesity & Metabolism, 13(8), 765-769. Retrieved July 14, 2011 from EBSCOhost online database. DOI:10.1111/j.1463-1326.2011.01405.x.
• Jordan, J. (2010, November 5). The data analytics boom. Forbes.com. Retrieved July 16, 2011, from corporate website.
• Lab Tests Online. (2011, June 17). Glucose. Retrieved July 16, 2011, from corporate website.
• National Center for Biotechnology Information. (2011, May 16). Comparing newer drugs for diabetes including combination drugs. Retrieved July 16, 2011, from PubMed Health online database.
• National Center for Biotechnology Information. (2010, June). Comparison of ge centricity electronic medical record database and national ambulatory medical care survey findings on the prevalence of major conditions in the united states Popular Health Management, 13(30), 139-50. Retrieved July 16, 2011, from PubMed Health online database.
• National Center for Biotechnology Information. (2011, April 15). Metformin. Retrieved July 16, 2011, from PubMed Health online database.
• National Center for Biotechnology Information. (2010, May 10). Type 2 Diabetes. Retrieved July 16, 2011, from PubMed Health online database
• U.S. National Library of Medicine. (April 2011). HbA1c. Retrieved July 1, 2011, from Medline Plus online database.