Abstract | BACKGROUND: OBJECTIVES: Primary: to determine the effect of spironolactone on patient mortality, morbidity, and to quantify the magnitude of blood pressure lowering effect of spironolactone monotherapy.Secondary: to determine the prevalence of adverse reactions observed with spironolactone monotherapy and to determine if there is a blood-pressure lowering dose response with spironolactone. SEARCH STRATEGY: We searched the following databases: Cochrane Central Register of Controlled Trials (3rd Quarter 2009), MEDLINE (2005 - Sept. 2009), and EMBASE (2007 - Sept. 2009). References from retrieved studies were reviewed to identify any studies missed in the initial search. No language restrictions were applied. SELECTION CRITERIA: DATA COLLECTION AND ANALYSIS: Two reviewers independently reviewed the search results for studies meeting our criteria. Three reviewers extracted data and assessed trial quality using a standardized data extraction form. Data synthesis and analysis was performed using RevMan 5. MAIN RESULTS: Meta-analysis of the 5 cross-over studies found a reduction in SBP of 20.09 mmHg (95%CI:16.58-23.06,p<0.00001) and a 6.75 mmHg (95%CI:4.8-8.69,p<0.00001) reduction in DBP. These results were statistically significant and there was no evidence of heterogeneity between the studies. There may be a dose response effect with spironolactone up to 50 mg/day, but the confidence intervals around the mean end-of-study blood pressure for doses ranging 25-500 mg/day all overlapped. In other words, it appears that doses >50mg/day do not produce further reductions in either SBP or DBP. One cross-over study found that spironolactone 25 mg/day did not statistically significantly change SBP or DBP compared to placebo, SBP: -9.9 (95%CI:-21.15,1.35); DBP -2.34 (95%CI:-7.92,3.06). AUTHORS' CONCLUSIONS: From the limited available evidence, spironolactone appears to lower blood pressure compared to placebo to a similar degree in patients with primary ( essential) hypertension when doses of 100-500 mg/day are given. A dose of 25 mg/day did not statistically significantly reduce systolic or diastolic blood pressure, compared to placebo. Given the lack of a dose-response, coupled with a possible increased risk in adverse events with higher doses, doses of 25 to 100 mg/day are reasonable. There is no evidence of the effect of spironolactone on clinical outcomes in hypertensive patients.
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Authors | Josh Batterink, Sarah N Stabler, Aaron M Tejani, Curt T Fowkes |
Journal | The Cochrane database of systematic reviews
(Cochrane Database Syst Rev)
Issue 8
Pg. CD008169
(Aug 04 2010)
ISSN: 1469-493X [Electronic] England |
PMID | 20687095
(Publication Type: Journal Article, Meta-Analysis, Review, Systematic Review)
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Chemical References |
- Antihypertensive Agents
- Spironolactone
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Topics |
- Antihypertensive Agents
(adverse effects, therapeutic use)
- Blood Pressure
(drug effects)
- Cross-Over Studies
- Humans
- Hypertension
(drug therapy)
- Randomized Controlled Trials as Topic
- Spironolactone
(adverse effects, therapeutic use)
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