Table 2.
Studies Involving Diuretics
| Source | Drugs Studieda | No. of Patients (Age Mean or Range, y)/ Duration | Study Design | Population (Setting) | Jadad or Newcastle-Ottawa Scoreb | Results | Source of Funding |
|---|---|---|---|---|---|---|---|
| Murray et al,34 1997 | Lasix vs 3 versions of furosemide vs intravenous Lasix | 17 (65)/1 wk of each product | Bioequivalency study: open-label RCT with crossover | Outpatients with CHF (US) | 3 | Statistically nonsignificant differences in urine electrolytes (P = .37–.45) but wide intraindividual variability | Brand-name manufacturer |
| Awad et al,35 1992 | Lasix vs furosemide | 20 (21–32)/1 dose of each with washout | Bioequivalency study: RCT with crossover | Healthy subjects (non-US) | 0 | Statistically nonsignificant differences in urine electrolytes, urine volume (P > .05) | Not listed |
| Kaojarern et al,36 1990 | Lasix vs 3 versions of furosemide | 8 (25–39)/1 dose of each with washout | Bioequivalency study: RCT with crossover | Healthy subjects (non-US) | 1 | Statistically nonsignificant differences in 6-h urine output, urine electrolytes (P > .05) | Medical center, brand-name manufacturer |
| Sharoky et al,37 1989 | Dyazide vs triamterene-hydrochlorothiazide | 30 (55)/3 wk of brand and 3 wk of generic | Bioequivalency study: RCT with crossover | Outpatients with hypertension taking brand-name Dyazide (US) | 4 | Statistically nonsignificant differences in electrolytes, CBC, BP, tolerability (P > .05) | Generic manufacturer |
| Singh et al,38 1987 | Intravenous Lasix vs intravenous furosemide | 5 (20–51)/1 dose of each with washout | Bioequivalency study: double-blind RCT | Inpatients with edema of renal origin (non-US) | 2 | Statistically nonsignificant differences in urine electrolytes, standing and recumbent BP, urine output, tolerability (P > .05) | Not listed |
| Meyer et al,39 1985 | Lasix vs 3 versions of furosemide | 12 (NA)/1 dose of each with washout | Bioequivalency study: double-blind RCT with crossover | Healthy subjects (non-US) | 2 | Statistically significant differences in 6-h urine output (P < .05) | Not listed |
| Grahnen et al,40 1984 | Lasix vs furosemide vs intravenous furosemide | 8 (26)/2 doses of each with washout | Bioequivalency study: double-blind RCT with crossover | Healthy subjects (non-US) | 2 | Statistically nonsignificant differences in urine output (P > .05) | Not listed |
| Garg et al,41 1984 | Lasix vs furosemide | 16 (NA)/1 dose of each with washout | Bioequivalency study: double-blind RCT with crossover | Healthy subjects (non-US) | 2 | Statistically nonsignificant differences in serum and urine electrolytes, HR, BP, urine output (P > .05) | Not listed |
| Pan et al42 1984 | Lasix vs furosemide | 5 (NA)/2 d of each | Bioequivalency study: double-blind RCT with crossover | Outpatients with CHF (non-US) | 1 | Statistically nonsignificant differences in electrolytes, urine output, weight, urine electrolytes (P > .2) | Not listed |
| Maitai et al,43 1984 | Lasix vs 6 versions of furosemide | 6 (NA)/1 dose of each with washout | Bioequivalency study: RCT with crossover | Healthy subjects (non-US) | 0 | “Acceptable level of diuresis” in self-reported urine output (no statistical tests done) | Government |
| Martin et al,44 1984 | Lasix vs furosemide | 12 (18–42)/1 dose of each with washout | Bioequivalency study: RCT with crossover | Healthy subjects (non-US) | 0 | Statistically nonsignificant trend of lower urine output (P = .07–.08), statistically nonsignificant differences in urine electrolytes | Medical center |
Abbreviations: BP, blood pressure; CBC, complete blood count; CHF, congestive heart failure; HR, heart rate; NA, not available; RCT, randomized controlled trial.
a
Lasix is manufactured by Sanofi-Aventis, Paris, France; Dyazide is manufactured by GlaxoSmithKline, London, England.
b
The Jadad score range is 1–5 for RCTs; the Newcastle-Ottawa score range, 1–9 stars for observational studies.