Aliskiren and losartan study in non-diabetic CKD: a comparison of patients in the clinical trial versus the usual care group

Authors

  • Keng Thye Woo Department of Renal Medicine, Singapore General Hospital
  • Choong Meng Chan Department of Renal Medicine, Singapore General Hospital
  • Stephanie Fook Chong Department of Statistics and Epidemiology, Singapore General Hospital
  • Cynthia Lim Department of Renal Medicine, Singapore General Hospital
  • Jason Choo Department of Renal Medicine, Singapore General Hospital
  • Lina Choong Department of Renal Medicine, Singapore General Hospital
  • Suhail Mohamad Department of Renal Medicine, Singapore General Hospital
  • Han Khim Tan Department of Renal Medicine, Singapore General Hospital
  • Kok Seng Wong Department of Renal Medicine, Singapore General Hospital
  • Marjorie Foo Department of Renal Medicine, Singapore General Hospital

DOI:

https://doi.org/10.18203/2349-3259.ijct20180126

Keywords:

Aliskiren, Chronic kidney disease, Comparison, Clinical trial versus usual care

Abstract

Background: This is a comparative study of a 6 year retrospective analysis of the therapeutic efficacy and safety of Combined Aliskiren (150 mg a day) and Losartan (100 mg a day) in a Clinical Trial setting versus a Usual Care group of patients on Losartan (100 mg a day), Telmisartan (80 mg a day) and Combined Enalapril (10 mg a day) plus Losartan (100mg a day) in non-Diabetic Chronic Kidney Disease (CKD) patients. The objective of this study was to ascertain if there were any differences in the renal outcome of patients treated within a Clinical Trial setting versus a Usual Care setting. The study seeks to establish the relevance of having a Usual Care group as a comparator and whether its inclusion in the study would help to validate the findings in the Clinical Trial group

Methods: This is a 2nd Phase follow up study three years after the initial 1st Phase study in the Clinical Trial Group. Patients in the 2nd Phase study were those who continued to have proteinuria and were treated with Losartan 100mg a day. The 2nd Phase study seeks to document the incidence of remission of proteinuria following their initial 1st Phase therapy for proteinuria compared to those in the Usual Care group where treatment remained unchanged from year 1 to end of year 6. The rates of remission of proteinuria and improvement of renal function as well as associated comorbidities between the 2 groups are compared.

Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p<0.001). There were more patients with hypertension and hyperkalaemia in the Clinical Trial group compared to the Usual Care group. Seven patients were in ESRF in the Usual Care group compared to only 3 in the Clinical Trial group but this difference was not significant. More patients in the Clinical Trial group compared to the Usual Care group had improvement in eGFR at the end of the 6 years (p<0.001).

Conclusions: This study shows that patients in a Clinical Trial setting do better than those in the Usual Care setting as they are more likely to have improvement in renal function with remission of proteinuria. 

Author Biography

Keng Thye Woo, Department of Renal Medicine, Singapore General Hospital

Senior Consultant

Dept of Renal Medicine

References

Early termination of aliskiren study due to adverse effects. ALTITUDE Study. HSA Adverse Drug Reaction News. 2012;14(1):3.

Data Monitoring Committee’s recommendation letter for ALTITUDE, dated 14th Dec 2011. Available at: http://hc-gc.caldhp-mps/medeeff/advisories-avis/prof/_2012/rasilez_hpc -cps-eng.php. Accessed on 3 July 2017.

Health Sciences Authority, Adverse Drug Reaction News, April 2012;14(1). Available at: http://www.hsa.gov.sg. Accessed on 3 July 2017.

European Medicines Agency. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/public_health_ alerts/2012/02/human_pha_detail_000055.jsp&mid=WC0b01ac058001d126&jsenabled=true. Accessed on 3 July 2017.

Woo KT, Choong HL, Wong KS, Tan HK, Marjorie Foo, Stephanie Fook Chong, Evan Lee JC, Vathsala Anantharaman, Grace Lee SL, Chan CM. A retrospective Aliskiren and Losartan study in non-diabetic chronic kidney disease. World J Nephrol. 2013;2(4):129-35.

Thompson BT, Schoenfeld D. Usual care as the Control Group in Clinical Truials of Nonpharmacologic Interventions. Proc Amer Thorac Soc. 2007;4(7):577-82.

Strippoli GF, Craig JC, Schena FP. The number, quality, and coverage of randomized controlled trials in nephrology. J Am Soc Nephrology. 2004;15:411-9.

National Kidney Foundation K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification and strategies. Amer J Kidney Disease. 2002;39:S1-266.

Levinsky NG. Specialist evaluation in chronic kidney disease: too little, too late (Editorial). Ann Intern Med 2002;137:542-3.

Young S, Bishop L, Twells L, Dillon C, Hawboldt J, O’Shea P. Comparison of pharmacist managed anticoagulation with usual care in a family medicine clinic. BMC Family Practice 2011;12:88.

Dawson L, Zarin DA, Emanuel EJ, Friedman LM, Chaudhari B, Goodman SN. Considering Usual Medical care in Clinical Trial Design. PLoS Med, 2009;6(9):e1000111.

World Medical association. Declaration of Helsinki: ethical principles for medical research involving human subjects. Paragraph 29. Available at: www.wma.net/e/policy/b3.htm. Accessed on 3 August 2017.

Downloads

Published

2018-01-23

Issue

Section

Original Research Articles