Atorvastatin in the treatment of Lithium-induced nephrogenic diabetes insipidus: the protocol of a randomized controlled trial

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Standard

Atorvastatin in the treatment of Lithium-induced nephrogenic diabetes insipidus : the protocol of a randomized controlled trial. / Fotso Soh, Jocelyn; Torres-Platas, Susana G; Beaulieu, Serge; Mantere, Outi; Platt, Robert; Mucsi, Istvan; Saury, Sybille; Renaud, Suzane; Levinson, Andrea; Andreazza, Ana C; Mulsant, Benoit H; Müller, Daniel; Schaffer, Ayal; Dols, Annemiek; Cervantes, Pablo; Low, Nancy Cp; Herrmann, Nathan; Christensen, Birgitte M; Trepiccione, Francesco; Rajji, Tarek; Rej, Soham.

I: BMC Psychiatry, Bind 18, Nr. 1, 227, 16.07.2018.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

Harvard

Fotso Soh, J, Torres-Platas, SG, Beaulieu, S, Mantere, O, Platt, R, Mucsi, I, Saury, S, Renaud, S, Levinson, A, Andreazza, AC, Mulsant, BH, Müller, D, Schaffer, A, Dols, A, Cervantes, P, Low, NC, Herrmann, N, Christensen, BM, Trepiccione, F, Rajji, T & Rej, S 2018, 'Atorvastatin in the treatment of Lithium-induced nephrogenic diabetes insipidus: the protocol of a randomized controlled trial', BMC Psychiatry, bind 18, nr. 1, 227. https://doi.org/10.1186/s12888-018-1793-9

APA

Fotso Soh, J., Torres-Platas, S. G., Beaulieu, S., Mantere, O., Platt, R., Mucsi, I., Saury, S., Renaud, S., Levinson, A., Andreazza, A. C., Mulsant, B. H., Müller, D., Schaffer, A., Dols, A., Cervantes, P., Low, N. C., Herrmann, N., Christensen, B. M., Trepiccione, F., ... Rej, S. (2018). Atorvastatin in the treatment of Lithium-induced nephrogenic diabetes insipidus: the protocol of a randomized controlled trial. BMC Psychiatry, 18(1), [227]. https://doi.org/10.1186/s12888-018-1793-9

CBE

Fotso Soh J, Torres-Platas SG, Beaulieu S, Mantere O, Platt R, Mucsi I, Saury S, Renaud S, Levinson A, Andreazza AC, Mulsant BH, Müller D, Schaffer A, Dols A, Cervantes P, Low NC, Herrmann N, Christensen BM, Trepiccione F, Rajji T, Rej S. 2018. Atorvastatin in the treatment of Lithium-induced nephrogenic diabetes insipidus: the protocol of a randomized controlled trial. BMC Psychiatry. 18(1):Article 227. https://doi.org/10.1186/s12888-018-1793-9

MLA

Vancouver

Fotso Soh J, Torres-Platas SG, Beaulieu S, Mantere O, Platt R, Mucsi I o.a. Atorvastatin in the treatment of Lithium-induced nephrogenic diabetes insipidus: the protocol of a randomized controlled trial. BMC Psychiatry. 2018 jul 16;18(1). 227. https://doi.org/10.1186/s12888-018-1793-9

Author

Fotso Soh, Jocelyn ; Torres-Platas, Susana G ; Beaulieu, Serge ; Mantere, Outi ; Platt, Robert ; Mucsi, Istvan ; Saury, Sybille ; Renaud, Suzane ; Levinson, Andrea ; Andreazza, Ana C ; Mulsant, Benoit H ; Müller, Daniel ; Schaffer, Ayal ; Dols, Annemiek ; Cervantes, Pablo ; Low, Nancy Cp ; Herrmann, Nathan ; Christensen, Birgitte M ; Trepiccione, Francesco ; Rajji, Tarek ; Rej, Soham. / Atorvastatin in the treatment of Lithium-induced nephrogenic diabetes insipidus : the protocol of a randomized controlled trial. I: BMC Psychiatry. 2018 ; Bind 18, Nr. 1.

Bibtex

@article{2258af79572347b8b70f4cd2acd65ca5,
title = "Atorvastatin in the treatment of Lithium-induced nephrogenic diabetes insipidus: the protocol of a randomized controlled trial",
abstract = "BACKGROUND: Lithium is the gold-standard treatment for bipolar disorder, is highly effective in treating major depressive disorder, and has anti-suicidal properties. However, clinicians are increasingly avoiding lithium largely due to fears of renal toxicity. Nephrogenic Diabetes Insipidus (NDI) occurs in 15-20% of lithium users and predicts a 2-3 times increased risk of chronic kidney disease (CKD). We recently found that use of statins is associated with lower NDI risk in a cross-sectional study. In this current paper, we describe the methodology of a randomized controlled trial (RCT) to treat lithium-induced NDI using atorvastatin.METHODS: We will conduct a 12-week, double-blind placebo-controlled RCT of atorvastatin for lithium-induced NDI at McGill University, Montreal, Canada. We will recruit 60 current lithium users, aged 18-85, who have indicators of NDI, which we defined as urine osmolality (UOsm) < 600 mOsm/kg after 10-h fluid restriction. We will randomize patients to atorvastatin (20 mg/day) or placebo for 12 weeks. We will examine whether this improves measures of NDI: UOsm and aquaporin (AQP2) excretion at 12-week follow-up, adjusted for baseline.RESULTS: Not applicable.CONCLUSION: The aim of this clinical trial is to provide preliminary data about the efficacy of atorvastatin in treating NDI. If successful, lithium could theoretically be used more safely in patients with a reduced subsequent risk of CKD, hypernatremia, and acute kidney injury (AKI). If future definitive trials confirm this, this could potentially allow more patients to benefit from lithium, while minimizing renal risk.TRIAL REGISTRATION: ClinicalTrials.gov NCT02967653 . Registered in February 2017.",
keywords = "Atorvastatin, Kidney function, Lithium, Nephrogenic diabetes insipidus, Placebo, Randomized clinical trial, Urinary osmolality",
author = "{Fotso Soh}, Jocelyn and Torres-Platas, {Susana G} and Serge Beaulieu and Outi Mantere and Robert Platt and Istvan Mucsi and Sybille Saury and Suzane Renaud and Andrea Levinson and Andreazza, {Ana C} and Mulsant, {Benoit H} and Daniel M{\"u}ller and Ayal Schaffer and Annemiek Dols and Pablo Cervantes and Low, {Nancy Cp} and Nathan Herrmann and Christensen, {Birgitte M} and Francesco Trepiccione and Tarek Rajji and Soham Rej",
year = "2018",
month = jul,
day = "16",
doi = "10.1186/s12888-018-1793-9",
language = "English",
volume = "18",
journal = "B M C Psychiatry",
issn = "1471-244X",
publisher = "BioMed Central Ltd.",
number = "1",

}

RIS

TY - JOUR

T1 - Atorvastatin in the treatment of Lithium-induced nephrogenic diabetes insipidus

T2 - the protocol of a randomized controlled trial

AU - Fotso Soh, Jocelyn

AU - Torres-Platas, Susana G

AU - Beaulieu, Serge

AU - Mantere, Outi

AU - Platt, Robert

AU - Mucsi, Istvan

AU - Saury, Sybille

AU - Renaud, Suzane

AU - Levinson, Andrea

AU - Andreazza, Ana C

AU - Mulsant, Benoit H

AU - Müller, Daniel

AU - Schaffer, Ayal

AU - Dols, Annemiek

AU - Cervantes, Pablo

AU - Low, Nancy Cp

AU - Herrmann, Nathan

AU - Christensen, Birgitte M

AU - Trepiccione, Francesco

AU - Rajji, Tarek

AU - Rej, Soham

PY - 2018/7/16

Y1 - 2018/7/16

N2 - BACKGROUND: Lithium is the gold-standard treatment for bipolar disorder, is highly effective in treating major depressive disorder, and has anti-suicidal properties. However, clinicians are increasingly avoiding lithium largely due to fears of renal toxicity. Nephrogenic Diabetes Insipidus (NDI) occurs in 15-20% of lithium users and predicts a 2-3 times increased risk of chronic kidney disease (CKD). We recently found that use of statins is associated with lower NDI risk in a cross-sectional study. In this current paper, we describe the methodology of a randomized controlled trial (RCT) to treat lithium-induced NDI using atorvastatin.METHODS: We will conduct a 12-week, double-blind placebo-controlled RCT of atorvastatin for lithium-induced NDI at McGill University, Montreal, Canada. We will recruit 60 current lithium users, aged 18-85, who have indicators of NDI, which we defined as urine osmolality (UOsm) < 600 mOsm/kg after 10-h fluid restriction. We will randomize patients to atorvastatin (20 mg/day) or placebo for 12 weeks. We will examine whether this improves measures of NDI: UOsm and aquaporin (AQP2) excretion at 12-week follow-up, adjusted for baseline.RESULTS: Not applicable.CONCLUSION: The aim of this clinical trial is to provide preliminary data about the efficacy of atorvastatin in treating NDI. If successful, lithium could theoretically be used more safely in patients with a reduced subsequent risk of CKD, hypernatremia, and acute kidney injury (AKI). If future definitive trials confirm this, this could potentially allow more patients to benefit from lithium, while minimizing renal risk.TRIAL REGISTRATION: ClinicalTrials.gov NCT02967653 . Registered in February 2017.

AB - BACKGROUND: Lithium is the gold-standard treatment for bipolar disorder, is highly effective in treating major depressive disorder, and has anti-suicidal properties. However, clinicians are increasingly avoiding lithium largely due to fears of renal toxicity. Nephrogenic Diabetes Insipidus (NDI) occurs in 15-20% of lithium users and predicts a 2-3 times increased risk of chronic kidney disease (CKD). We recently found that use of statins is associated with lower NDI risk in a cross-sectional study. In this current paper, we describe the methodology of a randomized controlled trial (RCT) to treat lithium-induced NDI using atorvastatin.METHODS: We will conduct a 12-week, double-blind placebo-controlled RCT of atorvastatin for lithium-induced NDI at McGill University, Montreal, Canada. We will recruit 60 current lithium users, aged 18-85, who have indicators of NDI, which we defined as urine osmolality (UOsm) < 600 mOsm/kg after 10-h fluid restriction. We will randomize patients to atorvastatin (20 mg/day) or placebo for 12 weeks. We will examine whether this improves measures of NDI: UOsm and aquaporin (AQP2) excretion at 12-week follow-up, adjusted for baseline.RESULTS: Not applicable.CONCLUSION: The aim of this clinical trial is to provide preliminary data about the efficacy of atorvastatin in treating NDI. If successful, lithium could theoretically be used more safely in patients with a reduced subsequent risk of CKD, hypernatremia, and acute kidney injury (AKI). If future definitive trials confirm this, this could potentially allow more patients to benefit from lithium, while minimizing renal risk.TRIAL REGISTRATION: ClinicalTrials.gov NCT02967653 . Registered in February 2017.

KW - Atorvastatin

KW - Kidney function

KW - Lithium

KW - Nephrogenic diabetes insipidus

KW - Placebo

KW - Randomized clinical trial

KW - Urinary osmolality

U2 - 10.1186/s12888-018-1793-9

DO - 10.1186/s12888-018-1793-9

M3 - Journal article

C2 - 30012135

VL - 18

JO - B M C Psychiatry

JF - B M C Psychiatry

SN - 1471-244X

IS - 1

M1 - 227

ER -