Ebm taylor Wofford 4 September 2009



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Taylor Wofford

4 September 2009
Nishizaka MK, Zaman MA, and Calhoun DA. Efficacy of Low-Dose Spironolactone in Subjects with Resistant Hypertension. American Journal of Hypertension 2003; 16: 925-930.
Objective: In patients with resistant hypertension, does addition of aldosterone inhibition lead to decreased systolic and diastolic blood pressure?
Study Population:

-Inclusion criteria: 1) Prior enrollment in a study of prevalence of primary aldosteronism (PA) in subjects with resistant hypertension. 2) Uncontrolled HTN at 2+ clinic visits despite 3+ agents including a diuretic and either ACE or ARB. 3) Secondary HTN previously ruled out (other than PA). Southern US city, university center.

-All subjects were tested for presence of PA, defined as suppressed plasma renin activity (<1.0 ng/mL/h) in setting of 24-hour urine collection for aldosterone being high (>12 μg/24 h) and 24-hour urine collection for sodium being high (>200 mEq/24 h).
Methods:

-Randomization: None. Divided into presence or absence of primary aldosteronism.

-Intervention: Low-dose spironolactone 12.5 to 25 mg daily was added, with uptitration to 50 mg daily if BP uncontrolled. Reassessment for BP was done at 6 weeks, 3 months, and 6 months. Repeat lytes done at each f/u and 2 weeks post-uptitration as indicated.

-Primary outcome measure: Systolic and diastolic blood pressure.

-Statistical analysis: student’s t test, one-way ANOVA, linear regression.
Results:

-n=76; 34 with primary aldosteronism.

-Mean systolic blood pressure decrease was 25 +/- 20 mmHg. Mean diastolic blood pressure decrease was 12 +/- 12 mmHg.

-Multiple subgroup analyses

-Adverse events: 3/76 (4%) with breast tenderness, 5/76 (7%) with AKI, 2/76 (3%) with hyperkalemia.
Discussion:

-Validity: Questionable because this is not a randomized controlled trial.

-Importance: Yes, a good source of hypotheses for future research.

-Applicability to clinical practice: Yes.


Discussion:

What would be the ideal trial design for this clinical question?



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