Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.

Summary

Phase IIIb, randomized, longitudinal, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia.

Timeline

Start

2022-02-15

Primary completion

2022-05

Completion

2022-05

Publications

• Background Escobedo-de la Pena J, de Jesus-Perez R, Schargrodsky H, Champagne B. [Prevalence of dyslipidemias in Mexico city and Its relation to other cardiovascular risk factors. Results from the CARMELA study]. Gac Med Mex. 2014 Mar-Apr;150(2):128-36. Spanish.
• Background Harivenkatesh N, David DC, Haribalaji N, Sudhakar MK. Efficacy and safety of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia: a randomized controlled trial. J Cardiovasc Pharmacol Ther. 2014 May;19(3):296-303. doi: 10.1177/1074248413518968. Epub 2014 Feb 10.
• Background Lella M, Indira K. A comparative study of efficacy of atorvastatin alone and its combination with fenofibrate on lipid profile in type 2 diabetes mellitus patients with hyperlipidemia. J Adv Pharm Technol Res. 2013 Jul;4(3):166-70. doi: 10.4103/2231-4040.116778.
• Background Athyros VG, Papageorgiou AA, Athyrou VV, Demitriadis DS, Kontopoulos AG. Atorvastatin and micronized fenofibrate alone and in combination in type 2 diabetes with combined hyperlipidemia. Diabetes Care. 2002 Jul;25(7):1198-202. doi: 10.2337/diacare.25.7.1198.
• Padilla-Padilla FG, Ruiz-Bernes LN, Roman-Pintos LM, Peraza-Zaldivar JA, Sander-Padilla JG, Lugo-Sanchez LA, Rios-Brito KF, Arguedas-Nunez MM, Flores-Huanosta D, Gonzalez-Canudas J. Efficacy and Safety of the Fixed-Dose Combination of Atorvastatin/Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients with Type 2 Diabetes and Dyslipidemia. Cardiol Ther. 2025 Jun;14(2):297-314. doi: 10.1007/s40119-025-00410-y. Epub 2025 May 5.

Drugs

Indications