Spironolactone for people aged 70 or over with osteoarthritic knee pain: a proof-of-concept trial

Marion E. T. McMurdo (Lead / Corresponding author), Deepa Sumukadas, Peter T. Donnan, Vera Cvoro, Petra Rauchhaus, Ishbel Argo, Helen Waldie, Roberta Littleford, Allan D. Struthers, Miles D. Witham

Research output: Contribution to journalArticle

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Abstract

Objective: To determine whether spironolactone could benefit older people with osteoarthritis (OA), based on a previous study showing that spironolactone improved quality of life.
Methods: This parallel-group, randomized, placebo-controlled, double-blind trial randomized community-dwelling people ages ≥70 years with symptomatic knee OA to 12 weeks of 25 mg daily oral spironolactone or matching placebo. The primary outcome was between-group difference in change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. Secondary outcomes included WOMAC stiffness and physical function subscores, EuroQol 5-domain (EQ-5D) 3L score, and mechanistic markers. Analysis was by intent to treat, using mixed-model regression, adjusting for baseline values of test variables.

Results: A total of 421 people had eligibility assessed, and 86 were randomized. Mean ± SD age was 77 ± 5 years and 53 of 86 (62%) were women. Adherence to study medication was 99%, and all participants completed the 12-week assessment. No significant improvement was seen in the WOMAC pain score (adjusted treatment effect 0.5 points [95% confidence interval (95% CI) − 0.3, 1.3]; P = 0.19). No improvement was seen in WOMAC stiffness score (0.2 points [95% CI −0.6, 1.1]; P = 0.58), WOMAC physical function score (0.0 points [95% CI −0.7, 0.8]; P = 0.98), or EQ-5D 3L score (0.04 points [95% CI −0.04, 0.12]; P = 0.34). Cortisol, matrix metalloproteinase 3, and urinary C-telopeptide of type II collagen were not significantly different between groups. More minor adverse events were noted in the spironolactone group (47 versus 32), but no increase in death or hospitalization was evident.
Conclusion: Spironolactone did not improve symptoms, physical function, or health-related quality of life in older people with knee OA.
Original languageEnglish
Pages (from-to)716-721
Number of pages6
JournalArthritis Care & Research
Volume68
Issue number5
Early online date28 Sep 2015
DOIs
Publication statusPublished - May 2016

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Spironolactone
Knee
Pain
Confidence Intervals
Knee Osteoarthritis
Osteoarthritis
Placebos
Quality of Life
Independent Living
Matrix Metalloproteinase 3
Collagen Type II
Ontario
Hydrocortisone
Hospitalization

Cite this

@article{661927c4268c491e9221fc16c245a5cd,
title = "Spironolactone for people aged 70 or over with osteoarthritic knee pain: a proof-of-concept trial",
abstract = "Objective: To determine whether spironolactone could benefit older people with osteoarthritis (OA), based on a previous study showing that spironolactone improved quality of life.Methods: This parallel-group, randomized, placebo-controlled, double-blind trial randomized community-dwelling people ages ≥70 years with symptomatic knee OA to 12 weeks of 25 mg daily oral spironolactone or matching placebo. The primary outcome was between-group difference in change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. Secondary outcomes included WOMAC stiffness and physical function subscores, EuroQol 5-domain (EQ-5D) 3L score, and mechanistic markers. Analysis was by intent to treat, using mixed-model regression, adjusting for baseline values of test variables.Results: A total of 421 people had eligibility assessed, and 86 were randomized. Mean ± SD age was 77 ± 5 years and 53 of 86 (62{\%}) were women. Adherence to study medication was 99{\%}, and all participants completed the 12-week assessment. No significant improvement was seen in the WOMAC pain score (adjusted treatment effect 0.5 points [95{\%} confidence interval (95{\%} CI) − 0.3, 1.3]; P = 0.19). No improvement was seen in WOMAC stiffness score (0.2 points [95{\%} CI −0.6, 1.1]; P = 0.58), WOMAC physical function score (0.0 points [95{\%} CI −0.7, 0.8]; P = 0.98), or EQ-5D 3L score (0.04 points [95{\%} CI −0.04, 0.12]; P = 0.34). Cortisol, matrix metalloproteinase 3, and urinary C-telopeptide of type II collagen were not significantly different between groups. More minor adverse events were noted in the spironolactone group (47 versus 32), but no increase in death or hospitalization was evident.Conclusion: Spironolactone did not improve symptoms, physical function, or health-related quality of life in older people with knee OA.",
author = "McMurdo, {Marion E. T.} and Deepa Sumukadas and Donnan, {Peter T.} and Vera Cvoro and Petra Rauchhaus and Ishbel Argo and Helen Waldie and Roberta Littleford and Struthers, {Allan D.} and Witham, {Miles D.}",
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language = "English",
volume = "68",
pages = "716--721",
journal = "Arthritis Care & Research",
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Spironolactone for people aged 70 or over with osteoarthritic knee pain : a proof-of-concept trial. / McMurdo, Marion E. T. (Lead / Corresponding author); Sumukadas, Deepa; Donnan, Peter T.; Cvoro, Vera; Rauchhaus, Petra; Argo, Ishbel; Waldie, Helen; Littleford, Roberta; Struthers, Allan D.; Witham, Miles D.

In: Arthritis Care & Research, Vol. 68, No. 5, 05.2016, p. 716-721.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Spironolactone for people aged 70 or over with osteoarthritic knee pain

T2 - a proof-of-concept trial

AU - McMurdo, Marion E. T.

AU - Sumukadas, Deepa

AU - Donnan, Peter T.

AU - Cvoro, Vera

AU - Rauchhaus, Petra

AU - Argo, Ishbel

AU - Waldie, Helen

AU - Littleford, Roberta

AU - Struthers, Allan D.

AU - Witham, Miles D.

N1 - Arthritis Research UK. Grant Number: 20228

PY - 2016/5

Y1 - 2016/5

N2 - Objective: To determine whether spironolactone could benefit older people with osteoarthritis (OA), based on a previous study showing that spironolactone improved quality of life.Methods: This parallel-group, randomized, placebo-controlled, double-blind trial randomized community-dwelling people ages ≥70 years with symptomatic knee OA to 12 weeks of 25 mg daily oral spironolactone or matching placebo. The primary outcome was between-group difference in change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. Secondary outcomes included WOMAC stiffness and physical function subscores, EuroQol 5-domain (EQ-5D) 3L score, and mechanistic markers. Analysis was by intent to treat, using mixed-model regression, adjusting for baseline values of test variables.Results: A total of 421 people had eligibility assessed, and 86 were randomized. Mean ± SD age was 77 ± 5 years and 53 of 86 (62%) were women. Adherence to study medication was 99%, and all participants completed the 12-week assessment. No significant improvement was seen in the WOMAC pain score (adjusted treatment effect 0.5 points [95% confidence interval (95% CI) − 0.3, 1.3]; P = 0.19). No improvement was seen in WOMAC stiffness score (0.2 points [95% CI −0.6, 1.1]; P = 0.58), WOMAC physical function score (0.0 points [95% CI −0.7, 0.8]; P = 0.98), or EQ-5D 3L score (0.04 points [95% CI −0.04, 0.12]; P = 0.34). Cortisol, matrix metalloproteinase 3, and urinary C-telopeptide of type II collagen were not significantly different between groups. More minor adverse events were noted in the spironolactone group (47 versus 32), but no increase in death or hospitalization was evident.Conclusion: Spironolactone did not improve symptoms, physical function, or health-related quality of life in older people with knee OA.

AB - Objective: To determine whether spironolactone could benefit older people with osteoarthritis (OA), based on a previous study showing that spironolactone improved quality of life.Methods: This parallel-group, randomized, placebo-controlled, double-blind trial randomized community-dwelling people ages ≥70 years with symptomatic knee OA to 12 weeks of 25 mg daily oral spironolactone or matching placebo. The primary outcome was between-group difference in change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. Secondary outcomes included WOMAC stiffness and physical function subscores, EuroQol 5-domain (EQ-5D) 3L score, and mechanistic markers. Analysis was by intent to treat, using mixed-model regression, adjusting for baseline values of test variables.Results: A total of 421 people had eligibility assessed, and 86 were randomized. Mean ± SD age was 77 ± 5 years and 53 of 86 (62%) were women. Adherence to study medication was 99%, and all participants completed the 12-week assessment. No significant improvement was seen in the WOMAC pain score (adjusted treatment effect 0.5 points [95% confidence interval (95% CI) − 0.3, 1.3]; P = 0.19). No improvement was seen in WOMAC stiffness score (0.2 points [95% CI −0.6, 1.1]; P = 0.58), WOMAC physical function score (0.0 points [95% CI −0.7, 0.8]; P = 0.98), or EQ-5D 3L score (0.04 points [95% CI −0.04, 0.12]; P = 0.34). Cortisol, matrix metalloproteinase 3, and urinary C-telopeptide of type II collagen were not significantly different between groups. More minor adverse events were noted in the spironolactone group (47 versus 32), but no increase in death or hospitalization was evident.Conclusion: Spironolactone did not improve symptoms, physical function, or health-related quality of life in older people with knee OA.

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