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)

Michel Komajda¹ , Paula Curtis² , Markolf Hanefeld³ , Henning Beck-Nielsen⁴ , Stuart J Pocock⁵ , Andrew Zambanini² , Nigel P Jones⁶ , Ramon Gomis⁷ and Philip D Home⁸ for The RECORD Study Group

¹Université Pierre et Marie Curie Paris 6; Assistance Publique Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Paris, France

²GlaxoSmithKline Pharmaceuticals, Greenford, UK

³Zentrum für Klinische Studien Forschungsbereich Endokrinologie und Stoffwechsel, Dresden, Germany

⁴Department of Endocrinology & Metabolism, Odense, Denmark

⁵London School of Hygiene and Tropical Medicine, UK

⁶GlaxoSmithKline Pharmaceuticals, Harlow, UK

⁷Hospital Clinic, Barcelona University, Spain

⁸Newcastle Diabetes Centre and Newcastle University, UK

author email corresponding author email

Cardiovascular Diabetology 2008, 7:10doi:10.1186/1475-2840-7-10


Published:	24 April 2008

Abstract

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/ webcite