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Rosiglitazone RECORD study: glucose control outcomes at 18 months.
P D Home1, N P Jones, S J Pocock
1Newcastle Diabetes Centre and Newcastle University, UK.
Summary
Rosiglitazone combination therapy showed non-inferior glucose control compared to metformin and sulfonylurea in Type 2 diabetes patients over 18 months. While improving insulin sensitivity and C-reactive protein, it was linked to greater weight gain.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Pharmacology
Background:
- Type 2 diabetes management often requires combination therapy to achieve glycemic targets.
- Metformin and sulfonylurea are standard first-line combination treatments.
- Evaluating alternative combination therapies is crucial for optimizing patient outcomes.
Purpose of the Study:
- To compare the efficacy of rosiglitazone combination therapy versus metformin and sulfonylurea combination therapy in managing Type 2 diabetes over 18 months.
- To assess the impact of these therapies on glycemic control, specifically HbA1c levels.
- To evaluate secondary outcomes including insulin sensitivity, C-reactive protein levels, and body weight changes.
Main Methods:
- A multicenter, parallel-group study (RECORD) enrolled 1122 participants with Type 2 diabetes and HbA1c between 7.1-9.0%.
- Participants were randomized to add-on rosiglitazone or sulfonylurea to metformin, or add-on rosiglitazone or metformin to sulfonylurea.
- Glycemic control was managed to HbA1c <= 7.0% via dose titration, with a primary outcome assessed against a 0.4% non-inferiority margin for HbA1c.
Main Results:
- Rosiglitazone combination therapy was non-inferior to metformin + sulfonylurea in reducing HbA1c at 18 months.
- Greater improvements in insulin sensitivity (Homeostasis Model Assessment) and reductions in C-reactive protein were observed with rosiglitazone.
- Significant weight gain was associated with rosiglitazone compared to both metformin and sulfonylurea.
Conclusions:
- Rosiglitazone in combination with metformin or sulfonylurea offers comparable glycemic control to standard metformin + sulfonylurea therapy in Type 2 diabetes.
- Rosiglitazone therapy demonstrates benefits in improving insulin sensitivity and reducing inflammation.
- Clinicians should consider the increased risk of weight gain when prescribing rosiglitazone-based combination therapy.
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