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

Soh, Jocelyn Fotso; Torres-Platas, Susana G.; Beaulieu, Serge; Mantere, Outi; Platt, Robert W.; Mucsi, István; Saury, Sybille; Renaud, Suzane; Levinson, Andrea; Andreazza, Ana Cristina; Mulsant, Benoit H.; Müller, Daniel J.; Schaffer, Ayal; Dols, Annemiek; Cervantes, Pablo; Low, Nancy; Herrmann, Nathan; Christensen, Birgitte Mønster; Trepiccione, Francesco; Rajji, Tarek K.; Rej, Soham

doi:10.1186/s12888-018-1793-9

Cited by 8 publications

(6 citation statements)

References 42 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Data will be used from a pre-existing large double blind RCT conducted on lithium users to assess the effect of atorvastatin (20 mg/day) vs placebo on lithium induced NDI in patients with BD ( n = 54) and MDD ( n = 6). This double-blind RCT (Clinicaltrials.gov ID: NCT02967653) was conducted over a 12-week period [ 26 – 28 ]. For this secondary analysis, the RCT data will be used to assess whether atorvastatin versus placebo can reduce calcium levels in lithium users with BD and MDD.…”

Section: Methodsmentioning

confidence: 99%

“…Participants not meeting this criteria were excluded from the study. A sample of n = 60 participants will allow an effect size of 0.34 at two-tailed alpha = 0.05 and Power (1-Beta) =0.8 [ 28 ]. For the detailed study methodology and Consort Diagram, refer to the study protocol and the original RCT [ 26 – 28 ].…”

Section: Methodsmentioning

confidence: 99%

“…This secondary analysis of a randomized controlled trial (RCT) will assess whether atorvastatin use in lithium users can have an effect on serum calcium and thyroid stimulating hormone (TSH) [ 26 – 28 ].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Atorvastatin lowers serum calcium levels in lithium-users: results from a randomized controlled trial

Soh

Bodenstein

et al. 2022

BMC Endocr Disord

Self Cite

View full text Add to dashboard Cite

Background Although lithium is considered the gold-standard treatment for bipolar disorder (BD), it is associated with a variety of major endocrine and metabolic side effects, including parathyroid hormone (PTH) dependent hypercalcemia. Aside from surgery and medication discontinuation, there are limited treatments for hypercalcemia. This paper will assess data from a randomized controlled trial (RCT). Methods This is a secondary analysis of an RCT that explored the effects of atorvastatin (n = 27) versus placebo (n = 33) on lithium-induced nephrogenic diabetes insipidus (NDI) in patients with BD and major depressive disorder (MDD) using lithium (n = 60), over a 12-week period. This secondary analysis will explore serum calcium levels and thyroid stimulating hormone (TSH) measured at baseline, week 4, and week 12. Results At 12-weeks follow-up while adjusting results for baseline, linear regression analyses found that corrected serum calcium levels were significantly lower in the treatment group (mean (M) = 2.30 mmol/L, standard deviation (SD) = 0.07) compared to the placebo group (M = 2.33 mmol/L, SD = 0.07) (β = − 0.03 (95% C.I.; − 0.0662, − 0.0035), p = 0.03) for lithium users. There were no significant changes in TSH. Conclusion In lithium users with relatively normal calcium levels, receiving atorvastatin was associated with a decrease in serum calcium levels. Although exciting, this is a preliminary finding that needs further investigation with hypercalcemic patients. Future RCTs could examine whether atorvastatin can treat PTH dependent hypercalcemia due to lithium and other causes.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Atorvastatin lowers serum calcium levels in lithium-users: results from a randomized controlled trial

Soh

Bodenstein

et al. 2022

BMC Endocr Disord

Self Cite

View full text Add to dashboard Cite

show abstract

“…We have provided individual descriptions of the methods of each study below. Specific inclusion or exclusion criteria of the studies have been previously reported [ 19 , 20 ].…”

Section: Methodsmentioning

confidence: 99%

Obesity and metabolic comorbidity in bipolar disorder: do patients on lithium comprise a subgroup? A naturalistic study

et al. 2021

Self Cite

View full text Add to dashboard Cite

Background Bipolar disorders (BD) are associated with increased prevalence of obesity and metabolic syndrome (MetS). Nevertheless, there is a wide range in prevalence estimates, with little known about the contributions of pharmacotherapy. It has been suggested that lithium might have a more favorable metabolic profile. We hypothesized that lithium use is associated with less increased body mass index (BMI), MetS, and type II diabetes, when compared with non-lithium users (those on anticonvulsants, second-generation antipsychotics). Methods Cross-sectional study of 129 patients aged 18–85 with bipolar disorder, followed at tertiary care clinics in Montreal. Patients using lithium were compared with those not on lithium, for body mass index and metabolic syndrome. Results The prevalence of obesity and metabolic syndrome in the sample of lithium-using patients with BD was 42.4 and 35.7% respectively, with an average BMI of 29.10 (+/− 6.70). Lithium and non-lithium groups did not differ in BMI or prevalence of MetS. However, compared to the non-lithium group, lithium users had lower hemoglobin A1C (5.24 +/− 0.53 versus 6.01 +/− 1.83, U = 753.5, p = 0.006) and lower triglycerides (1.46 +/− 0.88 versus 2.01 +/− 1.25, U = 947, p = 0.020). Conclusions There is a high prevalence of obesity and metabolic syndrome among patients with bipolar disorder. However, this did not appear to be associated with lithium use, when compared to those not on lithium. The lithium subgroup was also associated with lower prevalence of type II diabetes. Future prospective and intervention studies with larger sample sizes are necessary to further explore the association between lithium and insulin resistance, as well as its underlying mechanisms.

show abstract

“…Diabetes is a public health issue of general concern around the world. It is a lifelong chronic disease that can affect multiple organs; it is the third most common, frequently-occurring, and chronic non-communicable disease after cerebrovascular disease and tumors; and it poses a serious threat to human health ( 2 ). Statistics show that there are about 347 million patients suffering from diabetes mellitus type 2 (T2DM) in the world so far, and its prevalence in low-income countries is more serious ( 3 ).…”

Section: Introductionmentioning

confidence: 99%

The Nursing Effect of Individualized Management on Patients With Diabetes Mellitus Type 2 and Hypertension

Yang

et al. 2022

Front. Endocrinol.

View full text Add to dashboard Cite

It focused on clinical effects of individualized nursing and health education (INHE) on patients with diabetes mellitus type 2 (T2DM) and hypertension. 68 patients were randomly rolled into two groups, 34 cases in the control group (group A) received routine nursing and remaining 34 cases in the experimental group (group B) received INHE. The disease knowledge mastery (DKM) and the effect of rehabilitation nursing of patients were compared. The results suggested that DKM of patients in group B was obviously greater (P < 0.05). The total effective rate (TER) in group B was 91.45%, which was observably greater than that (76.35%) in group A (P < 0.05). After nursing, the fasting plasma glucose (FPG), 2-hour postprandial glucose (2h PG), systolic blood pressure (SBP), and diastolic blood pressure (DBP) levels of all patients decreased, and those in group B were much lower (P < 0.05). Scores of the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) of the two groups were 56.34 ± 8.12 points and 56.33 ± 8.01 points in group A, respectively; and those in group B were 42.52 ± 6.77 points and 41.71 ± 7.23 points, respectively; and they were all decreased and those in the group B were obviously smaller (P < 0.05). In summary, INHE can effectively improve the psychological cognition of patients with T2DM and hypertension and strengthen the control of blood pressure and blood sugar.

show abstract

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

Cited by 8 publications

References 42 publications

Atorvastatin lowers serum calcium levels in lithium-users: results from a randomized controlled trial

Atorvastatin lowers serum calcium levels in lithium-users: results from a randomized controlled trial

Obesity and metabolic comorbidity in bipolar disorder: do patients on lithium comprise a subgroup? A naturalistic study

The Nursing Effect of Individualized Management on Patients With Diabetes Mellitus Type 2 and Hypertension

Contact Info

Product

Resources

About