BMC endocrine disorders · 2026
Alternate-day alternating monotherapy (q48h) versus daily concomitant atorvastatin-fenofibrate in adults with type 2 diabetes and mixed dyslipidemia: a 12-week randomized non-inferiority trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Shahramirad Soheil, Rezvani Milad, Jahanbazi Roya, Vataniman Mohammadreza, Razavianzadeh Nasrin
Аннотация
PURPOSE: To test the non-inferiority of alternate-day alternating monotherapy (q48h) versus daily concomitant atorvastatin-fenofibrate for change in LDL-C in adults with T2DM and mixed dyslipidemia (margin δ = 13 mg/dL).
METHODS: Single-center, randomized, parallel-group non-inferiority trial (12 weeks). Patients (N = 94) were allocated 1:1 to Daily concomitant therapy (atorvastatin 10 mg plus fenofibrate 100 mg once daily) or Alternating monotherapy (q48h), with fixed doses maintained throughout the 12-week study and no dose titration.
PRIMARY OUTCOME: ΔLDL-C with 90% CIs versus δ. Analyses were intention-to-treat; Analyses followed intention-to-treat with LOCF; multiplicity for secondary endpoints was controlled (Holm/FDR).
RESULTS: Eighty-six completed follow-ups. Both regimens improved TG, total cholesterol, LDL-C, and HDL-C; between-group differences in change were not significant across lipid or metabolic/safety markers. For LDL-C, the 90% CI for (Alternating - Daily) lay entirely within δ, demonstrating non-inferiority. Renal function remained stable; no severe adverse events; ΔAST/ΔALT did not differ between groups.
CONCLUSIONS: Over 12 weeks, Alternating monotherapy (q48h) was non-inferior to Daily concomitant atorvastatin-fenofibrate for LDL-C lowering, with similar secondary outcomes and acceptable tolerability. Findings support clinical feasibility of a simplified alternate-day schedule; no formal economic analysis was performed. Longer studies with objective adherence assessment are warranted.
TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): IRCT20250718066536N1. Registered retrospectively on 18 July 2025. Patient enrolment occurred from August 2024 to June 2025. The protocol and the primary/secondary endpoints were finalized prior to data analysis.
METHODS: Single-center, randomized, parallel-group non-inferiority trial (12 weeks). Patients (N = 94) were allocated 1:1 to Daily concomitant therapy (atorvastatin 10 mg plus fenofibrate 100 mg once daily) or Alternating monotherapy (q48h), with fixed doses maintained throughout the 12-week study and no dose titration.
PRIMARY OUTCOME: ΔLDL-C with 90% CIs versus δ. Analyses were intention-to-treat; Analyses followed intention-to-treat with LOCF; multiplicity for secondary endpoints was controlled (Holm/FDR).
RESULTS: Eighty-six completed follow-ups. Both regimens improved TG, total cholesterol, LDL-C, and HDL-C; between-group differences in change were not significant across lipid or metabolic/safety markers. For LDL-C, the 90% CI for (Alternating - Daily) lay entirely within δ, demonstrating non-inferiority. Renal function remained stable; no severe adverse events; ΔAST/ΔALT did not differ between groups.
CONCLUSIONS: Over 12 weeks, Alternating monotherapy (q48h) was non-inferior to Daily concomitant atorvastatin-fenofibrate for LDL-C lowering, with similar secondary outcomes and acceptable tolerability. Findings support clinical feasibility of a simplified alternate-day schedule; no formal economic analysis was performed. Longer studies with objective adherence assessment are warranted.
TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): IRCT20250718066536N1. Registered retrospectively on 18 July 2025. Patient enrolment occurred from August 2024 to June 2025. The protocol and the primary/secondary endpoints were finalized prior to data analysis.