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Purpose <p>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&#xa0;mg/dL).</p> Methods <p>Single-center, randomized, parallel-group non-inferiority trial (12 weeks). Patients (<i>N</i> = 94) were allocated 1:1 to Daily concomitant therapy (atorvastatin 10&#xa0;mg plus fenofibrate 100&#xa0;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).</p> Results <p>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.</p> Conclusions <p>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.</p> Trial registration <p>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.</p>

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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

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  • 发表日期：

    2026年1月6日

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  • Soheil Shahramirad,
  • Milad Rezvani,
  • Roya Jahanbazi,
  • Mohammadreza Vataniman,
  • Nasrin Razavianzadeh

摘要

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.