Kidney Week

Abstract: TH-PO1166

Is High-Dose Telmisartan for Proteinuria Better and Safe?

Session Information

• Late-Breaking Clinical Trials Posters
  October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• No subcategory defined

Authors

• Roychowdhury, Arpita, IPGMER, Kolkata, India

Arpita Roychowdhury,

• Dubey, Umesh, Ipgmer and sskm hospital, Kolkata, India

Umesh Dubey,

• Divyaveer, Smita Subhash, IPGMER, Kolkata, India

Smita Subhash Divyaveer,

Background

Renal and CV outcomes correlate with proteinuria(PU) reduction with ARB therapy in diabetic(DN) and non diabetic(non DN) proteinuric diseases. Combining ACEI with ARB for maximal RAAS blockade and PU reduction failed to meet safety criteria.This trial aims to compare benefit [of PU reduction] vs risk (rising creatinine, declining eGFR or hyperkalemia)of using high dose Telmisartan(hT) 160 mg/d i.e. Gr. A versus conventional dose Telmisartan 80mg/d(cT) i.e. Gr. B in treatment of DN and non DN proteinuric patients(pts).

Methods

This is hospital based RCT. Pts with persistent PU ≥1 gram/day,due to DN and non DN disease, neither on any disease specific therapy nor on RAAS blockers for prior 6 wks were screened.Fig 1 shows protocol of study.Furosemide 20mg/day was given in both groups. End point: completion of 6 mo. of follow up or discontinuation of therapy (K>5.5, Sr. Cr rise >30%, eGFR <30). Primary outcome: % change in PU within and between groups. Secondary outcomes:change in Sr.Cr,eGFR by MDRD,BP and occurrence of adverse effects.Intention to treat analysis was done.

Results

No. of pts after randomization and subsequent incidence of adverse effects has been shown in table 1.Dose-related adverse events eg.K+ > 5.5 mEq/L were comparable in both groups but decline in eGFR to <30 ml/min/1.73 m² was more in Gr.A compared to Gr.B (6 vs 2).

Conclusion

Effectiveness of cT versus hT for PU reduction is comparable in proteinuric diseases. Adverse effects like hyperkalemia were similar, however higher events of dose related decline in eGFR occurred with hT.

Study protocol

RESULTS

Funding

• Government Support - Non-U.S.