Study comparing the effect of pioglitazone in combination with either metformin or sulphonylureas on lipid profile and glycaemic control in patients with type 2 diabetes (ECLA)

Abstract

Objective:

To explore whether the improvement of lipid profile and glycaemic control observed in randomized control trials with pioglitazone (PIO) is replicated under conditions of general clinical practice.

Research design and methods:

We studied 2388 patients with type 2 diabetes (T2DM) not adequately controlled by monotherapy on either metformin (MET) or sulphonylurea (SU). Addition of a second drug, according to the treating physician’s choice, resulted in three groups, PIO + MET, PIO + SU and MET + SU, followed for twelve months, while efficacy and safety parameters were measured at baseline, at six and at twelve months.

Results:

A total of 2116 (88.6%) patients completed the study. Diabetic control and lipid profile improved in all three groups, but the improvement was always greater in the two PIO groups. At 12 months PIO + SU and PIO + MET groups compared to SU + MET showed greater increase in HDL cholesterol (8.3% and 9.2 versus 4.3% p < 0.001) and greater decrease in HbA1c (1.53% and 1.46% versus 0.97%, p < 0.001 for both), in triglycerides (20.7% and 21.5% versus 15.2%, p < 0.001) and in LDL cholesterol (15.2% and 14.6% versus 11.3%, p < 0.001 and p < 0.01, respectively). All changes were greater in patients already taking hypolipidaemic drugs. As ECLA was an observational study, the major limitation is the introduction of confounding bias which, however, was accounted for in the statistical analysis.

Conclusions:

Since improvement of both glycaemic control and lipid profile are considered main targets in the management of the diabetic patient, the results of the present study, conducted under conditions of everyday clinical practice, show that pioglitazone may be considered a potential choice for the treatment of type 2 diabetes, when lifestyle and metformin fail.

Key words::

• Everyday clinical practice
• Lipid profile
• Pioglitazone

Transparency

Declaration of funding

This study has been funded by PHARMASERVE-Lilly.

Declaration of financial/other relationships

V.D., E.C. and S.S. have disclosed that they are full-time employees of Lilly or any of its affiliates. A.A. has disclosed that he has received fees from Lilly as clinical investigator. B.K has disclosed that he has received fees from Lilly as a speaker-trainer. A.T. has no financial relationship with Lilly. S.A., C.I., V.D., E.C. and S.S. have disclosed that they contributed in the writing and reviewing of the article.

The peer reviewers of this paper have no relevant financial relationships.

Acknowledgements

The authors thank the Hellenic ECLA study investigators: Avraam G., Aggelopoulos V., Adamidis S., Adamopoulos D., Alexiadis S., Andronis C., Anthimidis G., Antonopoulos A., Afendakis K., Bavea-Krubholtz B., Ballis D., Beskou-Vlachaki Ε., Biblis Ι., Chiotis N., Chiotis S., Demislis C., Dimitriadis C., Dimitsikoglou N., Ekonomidou C., Falireas N., Floros G., Georgali A., Giamalis D., Giannakakis I., Giannakidis S., Gabriel P., Girtzis I., Goni M.-E., Groutsis T., Grigoriou A., Harilas E., Hasban Taisir, Hatzilia A., Ioannidis I., Kagas S., Kagelaris N., Kalpakis N., Karamanos V., Karaouzas A., Karapiperis A., Karassavidou L., Kassos D., Katinakis A., Katsaros A., Kirgiannis A., Kiriakopoulos C., Kiriazopoulos S., Kleftaki A., Komplionas C., Kontogiannis A., Kotis E., Kotsa C., Koulouri-Pinotsi A., Kourtoglou G., Krikaki A., Laina A., Lalos V., Lazaridis A., Likoudi A., Malafis P., Maleza A., Manes C., Manis I., Marinos Ε., Milionis Α., Misichronis G., Mitakos Ν., Mitsiou C., Mountzouris D., Nikiforou S., Noutsou M., Panopoulos G., Panos A., Papadima S., Papadimitrakis C., Papageorgiou G., Papaikonomou P., Papanastasiou S., Pappas Κ., Patatsi V., Perakakis G., Petridis S., Phenekos C., Plageras A., Politis V., Pourou Ε., Roumeliotis C., Routsakos D., Sailer N., Sambanidou-Nikolaou Ε., Satsoglou A., Schinochoritis P., Simelidis D., Skoutas D., Solomonidis I., Souris S., Souyioultzoglou F., Spanakis E., Spina G., Spiropoulou A., Stamatakopoulos A., Styliaras I., Thanasoulas C., Themeli E., Theodorou C., Thomopoulos A., Timosidis M., Troulakis G., Tsaniklidis D., Tsatsoulis A., Tsimbos S., Tsiolakis D., Tsoumbeli A., Τsoureka A., Tzounas K., Vamvaka P., Vlachogiannis A., Vlachogiannis N., Vlachos D., Vourloumi A., Zervakis D., Zervas A.

The data in this paper were previously presented as ‘Evaluation of the changes on the glycemic control and on the lipid parameters in patients with type 2 diabetes after treatment with pioglitazone in combination with metformin or sulfonylurea in a Greek observational study (ECLA study). 12 months follow-up results.’ Ginis A, Karamanos V, Charalampidou E, Saridaki A and the Hellenic ECLA Study Group at the 42nd Annual Meeting of the European Association for the Study of Diabetes, 14–17 September 2006, Copenhagen, Denmark.