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Combination of spironolactone and sitagliptin improves clinical outcomes of outpatients with COVID-19: a prospective cohort study

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Abstract

Background

There are evidences showing that sitagliptin and spironolactone can potentially improve the clinical outcomes of COVID-19 cases. In this observational study on acutely symptomatic outpatient COVID-19 cases, we investigated the effects of spironolactone and sitagliptin on the outcomes of the disease.

Methods

This is a prospective, naturally randomized cohort study. We followed mild to moderate symptomatic COVID-19 patients, who were treated with either combination (spironolactone 100 mg daily and sitagliptin 100 mg daily) or standard (steroid, antiviral and/or supportive care) therapy up to 30 days. The primary outcome was hospitalization rate. The secondary outcomes included ER visit, duration of disease, and complications, such as hypoglycemia, low blood pressure or altered mental status.

Results

Of the 206 patients referred to clinics randomly, 103 received standard therapy and 103 treated with combination therapy. There were no significant differences in baseline characteristics, except for slightly higher clinical score in control group (6.92 ± 4.01 control, 4.87 ± 2.92 combination; P < 0.0001). Treatment with combination therapy was associated with lower admission rate (5.8% combination, 22.3% control; P = 0.0011), ER visits (7.8% combination, 23.3% control; P = 0.0021) and average duration of symptoms (6.67 ± 2.30 days combination, 18.71 ± 6.49 days control; P ≤ 0.0001).

Conclusions

The combination of sitagliptin and spironolactone reduced duration of COVID infection and hospital visits better than standard therapeutic approaches in outpatients with COVID-19. The effects of combination of sitagliptin and spironolactone in COVID-19 patients should be further verified in a double-blind, randomized, placebo-controlled trial.

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Data availability

Shiraz University (MAD, YM, HF, FSRR, AP and MH) generated the data. University of Kentucky (KA and RA) has de-identified data and analyzed (RA) the data. The de-identified data are available for further investigations.

Abbreviations

ACE2:

Angiotensin-converting enzyme 2

ADAM17:

Disintegrin and metalloproteinase domain-containing protein 17

COVID-19:

Coronavirus disease 2019

DPP4:

Dipeptidyl peptidase-4

ER:

Emergency room

SARS-CoV-2:

Severe acute respiratory syndrome coronavirus 2

SUMS:

Shiraz University of Medical Sciences

TMPRSS2:

Transmembrane protease serine 2

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Acknowledgements

The authors express their gratitude to the Shiraz University Clinics for helping with data collection.

Funding

Shiraz University of Medical Sciences supported this project (Grant IR.SUMS.MED.REC.1399.550). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Author information

Authors and Affiliations

  1. Shiraz HIV/AIDS Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

    M. A. Davarpanah

  2. Department of Biostatistics, University of Kentucky, Lexington, KY, USA

    R. Adatorwovor

  3. Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran

    Y. Mansoori, F. S. R. Ramsheh, A. Parsa & M. Hajiani

  4. Department of Community Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

    H. Faramarzi

  5. Division of Biomedical Informatics, Department of Internal Medicine, University of Kentucky, Lexington, KY, USA

    R. Kavuluru

  6. Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Barnstable Brown Diabetes and Obesity Center, University of Kentucky, 2195 Harrodsburg Rd, Suite 125, Lexington, KY, 40504, USA

    K. Asadipooya

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Contributions

KA proposed the idea and designed the study. KA, RA, YM and RK wrote the manuscript. MAD, YM, HF, FSRR, AP, and MH collected the data. RA provided statistical analysis and wrote statistical part. All authors approved the final version of the manuscript.

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Correspondence to K. Asadipooya.

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Iranian registry of clinical trial

IRCT registration number: IRCT20201003048904N2, Registration date: December 10, 2020.

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Davarpanah, M.A., Adatorwovor, R., Mansoori, Y. et al. Combination of spironolactone and sitagliptin improves clinical outcomes of outpatients with COVID-19: a prospective cohort study. J Endocrinol Invest 47, 235–243 (2024). https://doi.org/10.1007/s40618-023-02141-0

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