Effect of the addition of rosiglitazone to metformin or sulfonylureas versus metformin/sulfonylurea combination therapy on ambulatory blood pressure in people with type 2 diabetes: A randomized controlled trial (the RECORD study)

Background: Hypertension and type 2 diabetes are common co-morbidities. Preliminary studies suggest that thiazolidinediones reduce blood pressure ( BP). We therefore used ambulatory BP to quantify BP lowering at 6 - 12 months with rosiglitazone used in combination with metformin or sulfonylureas compared to metformin and sulfonylureas in people with type 2 diabetes. Methods: Participants (n = 759) in the multicentre RECORD study were studied. Those taking metformin were randomized (open label) to add-on rosiglitazone or sulfonylureas, and those on sulfonylurea to add- on rosiglitazone or metformin. Results: 24-Hour ambulatory BP was measured at baseline, 6 months and 12 months. At 6 and 12 months, reductions in 24-hour ambulatory systolic BP (sBP) were greater with rosiglitazone versus metformin ( difference at 6 months 2.7 [95% CI 0.5-4.9] mmHg, p = 0.015; 12 months 2.5 [ 95% CI 0.2-4.8] mmHg, p = 0.031). Corresponding changes for ambulatory diastolic BP (dBP) were comparable ( 6 months 2.7 [95% CI 1.4-4.0] mmHg, p < 0.001; 12 months 3.1 [ 95% CI 1.8-4.5] mmHg, p < 0.001). Similar differences were observed for rosiglitazone versus sulfonylureas at 12 months (sBP 2.7 [ 95% CI 0.5-4.9] mmHg, p = 0.016; dBP 2.1 [ 95% CI 0.7-3.4] mmHg, p = 0.003), but differences were smaller and/or not statistically significant at 6 months ( sBP 1.5 [ 95% CI -0.6 to 3.6] mmHg, p = NS; dBP 1.3 [95% CI 0.0-2.5] mmHg, p = 0.049). Changes in BP were not accompanied by compensatory increases in heart rate, did not correlate with basal insulin sensitivity estimates and were not explained by changes in antihypertensive therapy between the various strata. Conclusion: When added to metformin or a sulfonylurea, 12-month treatment with rosiglitazone reduces ambulatory BP to a greater extent than when metformin and a sulfonylurea are combined. Trial registration: NCT00379769 http://clinicaltrials.gov/.