Urine Osmolality Estimated Using Urine Urea Nitrogen, Sodium and Creatinine Can Effectively Predict Response to Tolvaptan in Decompensated Heart Failure Patients

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Decompensated heart failure (n=66). Intervention: Estimated urine osmolality criteria vs. Non-responders. Primary outcome: Prediction of tolvaptan efficacy (increase in urine volume at day 1) (AUC 0.948, p=<0.05).

Teruhiko Imamura; Koichiro Kinugawa; Shun Minatsuki; Hironori Muraoka; Naoko Kato; Toshiro Inaba; Hisataka Maki; Taro Shiga; Masaru Hatano; Atsushi Yao; Shunei Kyo; Issei Komuro

doi:10.1253/circj.cj-12-1328

January 1, 2013Circulation JournalOpen Access

Urine Osmolality Estimated Using Urine Urea Nitrogen, Sodium and Creatinine Can Effectively Predict Response to Tolvaptan in Decompensated Heart Failure Patients

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Key result

Criteria based on estimated urine osmolality significantly discriminated responders from non-responders to tolvaptan with an AUC of 0.948.

Why the study?

Does estimated urine osmolality predict diuretic response to tolvaptan in hospitalized patients with decompensated heart failure?

Study Design

Type

Observational (n=66)

Multicenter

No

Structured PICO

Does estimated urine osmolality predict diuretic response to tolvaptan in hospitalized patients with decompensated heart failure?

P

Population

66 hospitalized patients (mean age 55.2 years, 28.8% female) with decompensated heart failure and fluid retention despite maximum medical therapy, evaluated for predictors of tolvaptan response.

E

Exposure

Tolvaptan 3.75-15 mg/day oral added to standard medical therapy (including diuretics, beta-blockers, ACEi/ARB, and inotropes if applicable) for more than 1 week.

O

Outcome

Response to tolvaptan, defined as an increase in urine volume during the first day (day 1) compared with 1 day before tolvaptan dose (day 0).surrogate

Main Result

Effect estimate: AUC 0.948

p-value: p=<0.05

Urine osmolality can be accurately estimated using urine urea nitrogen, sodium, and creatinine, providing a practical and non-invasive method to predict diuretic response to tolvaptan in patients with decompensated heart failure.

Limitations

Retrospective study in a single center with a limited number of patients and potential selection bias.
Long-term effects of tolvaptan among responders were not addressed.
Formula is limited for patients with severe diabetes mellitus or nephritis due to potential glycosuria or proteinuria.
Lack of invasive hemodynamic measurements to exclude severe low cardiac output as a cause of unresponsiveness.
Retrospective single-center study with a limited number of patients and potential selection bias
Formula requires prospective validation
Response defined only by 24-hour urine volume increase, without addressing long-term effects
Formula is limited in patients with severe diabetes mellitus (glycosuria) or nephritis (proteinuria)
Lack of invasive hemodynamic measurements to exclude severe low cardiac output as a cause of unresponsiveness

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Implication

May support urine osmolality-guided tolvaptan selection in decompensated HF; hypothesis-generating and requires prospective validation.

Abstract

BACKGROUND: Urine osmolality (U-OSM) is valuable to predict response to tolvaptan (TLV) in decompensated heart failure patients, but measurement of U-OSM is not always available on site. METHODS AND RESULTS: Data were collected from 66 hospitalized patients with decompensated heart failure who had received TLV at 3.75-15 mg/day. U-OSM, which was estimated using the following formula: 1.07×{2×[(urine sodium (mEq/L)]+[urine urea nitrogen (mg/dl)]/2.8+[urine creatinine (mg/dl)]×2/3}+16, was well correlated with the actual measurement (r=0.938, P<0.001). Criteria consisting of C1 (estimated baseline U-OSM>358 mOsm/L) and C2 (%decrease in estimated U-OSM>24% at 4-6 h after the first TLV dose) significantly discriminated responders from non-responders (P<0.05). CONCLUSIONS: Response to TLV can be predicted using U-OSM, which can be estimated using urine urea nitrogen, sodium, and creatinine concentration data.

Discussion

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Cite This Study

Imamura et al. (2013) conducted an observational in Decompensated heart failure (n=66). Estimated urine osmolality criteria vs. Non-responders was evaluated on Prediction of tolvaptan efficacy (increase in urine volume at day 1) (AUC 0.948, p=<0.05). Criteria based on estimated urine osmolality significantly discriminated responders from non-responders to tolvaptan with an AUC of 0.948.

synapsesocial.com/papers/6a91700b49be6cf6a84671a8 https://doi.org/10.1253/circj.cj-12-1328

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Urine Osmolality Estimated Using Urine Urea Nitrogen, Sodium and Creatinine Can Effectively Predict Response to Tolvaptan in Decompensated Heart Failure Patients

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Urine Osmolality Estimated Using Urine Urea Nitrogen, Sodium and Creatinine Can Effectively Predict Response to Tolvaptan in Decompensated Heart Failure Patients

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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