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A Randomized Trial of Distal Diuretics versus Dietary Sodium Restriction for Hypertension in Chronic Kidney Disease.
Bovée, DM, Visser, WJ, Middel, I, De Mik-van Egmond, A, Greupink, R, Masereeuw, R, Russel, FGM, Danser, AHJ, Zietse, R, Hoorn, EJ
Journal of the American Society of Nephrology : JASN. 2020;(3):650-662
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Abstract
BACKGROUND Distal diuretics are considered less effective than loop diuretics in CKD. However, data to support this perception are limited. METHODS To investigate whether distal diuretics are noninferior to dietary sodium restriction in reducing BP in patients with CKD stage G3 or G4 and hypertension, we conducted a 6-week, randomized, open-label crossover trial comparing amiloride/hydrochlorothiazide (5 mg/50 mg daily) with dietary sodium restriction (60 mmol per day). Antihypertension medication was discontinued for a 2-week period before randomization. We analyzed effects on BP, kidney function, and fluid balance and related this to renal clearance of diuretics. RESULTS A total of 26 patients (with a mean eGFR of 39 ml/min per 1.73 m2) completed both treatments. Dietary sodium restriction reduced sodium excretion from 160 to 64 mmol per day. Diuretics produced a greater reduction in 24-hour systolic BP (SBP; from 138 to 124 mm Hg) compared with sodium restriction (from 134 to 129 mm Hg), as well as a significantly greater effect on extracellular water, eGFR, plasma renin, and aldosterone. Both interventions resulted in a similar decrease in body weight and NT-proBNP. Neither approaches decreased albuminuria significantly, whereas diuretics did significantly reduce urinary angiotensinogen and β2-microglobulin excretion. Although lower eGFR and higher plasma indoxyl sulfate correlated with lower diuretic clearance, the diuretic effects on body weight and BP at lower eGFR were maintained. During diuretic treatment, higher PGE2 excretion correlated with lower free water clearance, and four patients developed mild hyponatremia. CONCLUSIONS Distal diuretics are noninferior to dietary sodium restriction in reducing BP and extracellular volume in CKD. Diuretic sensitivity in CKD is maintained despite lower diuretic clearance. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease (DD), NCT02875886.
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Effects of the DASH Diet and Sodium Intake on Bloating: Results From the DASH-Sodium Trial.
Peng, AW, Juraschek, SP, Appel, LJ, Miller, ER, Mueller, NT
The American journal of gastroenterology. 2019;(7):1109-1115
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INTRODUCTION Bloating is one of the most common gastrointestinal complaints. Evidence has linked fiber and sodium to bloating; however, randomized trials examining these diet components are lacking. Here, we used a randomized trial to examine the effects of the high-fiber DASH diet and dietary sodium intake on abdominal bloating. We hypothesized that both the high-fiber DASH diet and higher sodium intake would increase bloating. METHODS The DASH-Sodium trial (1998-1999) randomized healthy adults to a high-fiber (32 g/d) DASH or low-fiber (11 g/d) Western diet (control). On their assigned diet, participants ate 3 sodium levels (50, 100, and 150 mmol/d at 2100 kcal) in 30-day periods in random order, with 5-day breaks between each period. The participants reported the presence of bloating at baseline and after each feeding period. Statistical analyses included log-binomial models to evaluate the risk of bloating. RESULTS Of 412 participants (mean age 48 years; 57% women; 57% black), 36.7% reported bloating at baseline. Regardless of the diet, high sodium intake increased the risk of bloating (risk ratio = 1.27; 95% confidence interval: 1.06-1.52; P = 0.01). The high-fiber DASH diet also increased the risk of bloating over all sodium levels (risk ratio = 1.41; 95% confidence interval: 1.22-1.64; P < 0.001). The effect of high-fiber DASH on bloating was greater in men than in women (P for interaction = 0.001). DISCUSSION Higher dietary sodium increased bloating, as did the high-fiber DASH diet. Although healthful high-fiber diets may increase bloating, these effects may be partially mitigated by decreasing dietary sodium intake. Future research is needed to explore mechanisms by which sodium intake and diet can influence bloating.
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Relationship of Sodium Intake and Blood Pressure Varies With Energy Intake: Secondary Analysis of the DASH (Dietary Approaches to Stop Hypertension)-Sodium Trial.
Murtaugh, MA, Beasley, JM, Appel, LJ, Guenther, PM, McFadden, M, Greene, T, Tooze, JA
Hypertension (Dallas, Tex. : 1979). 2018;(5):858-865
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Abstract
Dietary Na recommendations are expressed as absolute amounts (mg/d) rather than as Na density (mg/kcal). Our objective was to determine whether the strength of the relationship of Na intake with blood pressure (BP) varied with energy intake. The DASH (Dietary Approaches to Stop Hypertension)-Sodium trial was a randomized feeding trial comparing 2 diets (DASH and control) and 3 levels of Na density. Participants with pre- or stage 1 hypertension consumed diets for 30 days in random order; energy intake was controlled to maintain body weight. This secondary analysis of 379 non-Hispanic black and white participants used mixed-effects models to assess the association of Na and energy intakes with BP. The relationships between absolute Na and both systolic and diastolic BP varied with energy intake. BP rose more steeply with increasing Na at lower energy intake than at higher energy intake (P interaction<0.001). On the control diet with 2300 mg Na, both systolic and diastolic BP were higher (3.0 mm Hg; 95% confidence interval, 0.2-5.8; and 2.7 mm Hg; 95% confidence interval, 1.0-4.5, respectively) among those with lower energy intake (higher Na density) than among those with higher energy intake (lower Na density). The association of Na with systolic BP was stronger at lower levels of energy intake in both blacks and whites (P<0.001). The association of Na and diastolic BP varied with energy intake only among blacks (P=0.001). Sodium density should be considered as a metric for expressing dietary Na recommendations.
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Modest Salt Reduction Lowers Blood Pressure and Albumin Excretion in Impaired Glucose Tolerance and Type 2 Diabetes Mellitus: A Randomized Double-Blind Trial.
Suckling, RJ, He, FJ, Markandu, ND, MacGregor, GA
Hypertension (Dallas, Tex. : 1979). 2016;(6):1189-95
Abstract
The role of salt restriction in patients with impaired glucose tolerance and diabetes mellitus is controversial, with a lack of well controlled, longer term, modest salt reduction trials in this group of patients, in spite of the marked increase in cardiovascular risk. We carried out a 12-week randomized double-blind, crossover trial of salt restriction with salt or placebo tablets, each for 6 weeks, in 46 individuals with diet-controlled type 2 diabetes mellitus or impaired glucose tolerance and untreated normal or high normal blood pressure (BP). From salt to placebo, 24-hour urinary sodium was reduced by 49±9 mmol (2.9 g salt). This reduction in salt intake led to fall in clinic BP from 136/81±2/1 mm Hg to 131/80±2/1 mm Hg, (systolic BP; P<0.01). Mean ambulatory 24-hour BP was reduced by 3/2±1/1 mm Hg (systolic BP, P<0.01 and diastolic BP, P<0.05), and albumin/creatinine ratio was reduced from 0.73 mg/mmol (0.5-1.5) to 0.64 mg/mmol (0.3-1.1; P<0.05). There was no significant change in fasting glucose, hemoglobin A1c, or insulin sensitivity. These results demonstrate that a modest reduction in salt intake, to approximately the amount recommended in public health guidelines, leads to significant and clinically relevant falls in BP in individuals who are early on in the progression of diabetes mellitus with normal or mildly raised BP. The reduction in urinary albumin excretion may carry additional benefits in reducing cardiovascular disease above the effects on BP.
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Effect of a behavioral intervention of the SALdável program to reduce salt intake among hypertensive women: A randomized controlled pilot study.
Cornélio, ME, Godin, G, Rodrigues, RC, de Freitas Agondi, R, Alexandre, NM, Gallani, MC
European journal of cardiovascular nursing. 2016;(3):e85-94
Abstract
BACKGROUND Excessive salt intake has been directly associated with cardiovascular diseases, especially hypertension, and non-cardiovascular diseases. Despite the current recommendations, salt intake remains high, indicating the need to develop theory-based interventions aimed at reducing this intake. AIM: The purpose of this study was to test the impact of a theory-based intervention - the SALdável Program - to promote the use of less than 4 g of salt/day during cooking. METHODS This was a two-arm parallel-group randomized study. A total of 92 hypertensive women were randomly assigned to an intervention or control group. The intervention was aimed at motivating participants to reduce salt addition by increasing self-efficacy and counteracting the negative influence of habit. Primary outcomes were the behavioral question of salt addition and total salt addition, secondary outcomes were overall salt intake, provided by 24-hour urinary sodium excretion, and psychosocial variables (intention, self-efficacy, and habit). RESULTS At three-month follow-up, the intervention group improved significantly more than the control group regarding salt addition measures (p-values between 0.05 and 0.001) and psychosocial variables (all p-values ⩽0.001). The reduction in 24-hour urinary sodium excretion was not significant. CONCLUSION The findings showed that this theory-based intervention was effective to motivate and change the behavior of hypertensive women regarding daily salt use in cooking meals. This was accomplished by means of improvements in intention and self-efficacy and reduction of the habit of using more than 4 g of salt/day during cooking.
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Impact of Dietary Sodium Restriction on Heart Failure Outcomes.
Doukky, R, Avery, E, Mangla, A, Collado, FM, Ibrahim, Z, Poulin, MF, Richardson, D, Powell, LH
JACC. Heart failure. 2016;(1):24-35
Abstract
OBJECTIVES This study sought to evaluate the impact of sodium restriction on heart failure (HF) outcomes. BACKGROUND Although sodium restriction is advised for patients with HF, data on sodium restriction and HF outcomes are inconsistent. METHODS We analyzed data from the multihospital HF Adherence and Retention Trial, which enrolled 902 New York Heart Association functional class II/III HF patients and followed them up for a median of 36 months. Sodium intake was serially assessed by a food frequency questionnaire. Based on the mean daily sodium intake prior to the first event of death or HF hospitalization, patients were classified into sodium restricted (<2,500 mg/d) and unrestricted (≥2,500 mg/d) groups. Study groups were propensity score matched according to plausible baseline confounders. The primary outcome was a composite of death or HF hospitalization. The secondary outcomes were cardiac death and HF hospitalization. RESULTS Sodium intake data were available for 833 subjects (145 sodium restricted, 688 sodium unrestricted), of whom 260 were propensity matched into sodium restricted (n = 130) and sodium unrestricted (n = 130) groups. Sodium restriction was associated with significantly higher risk of death or HF hospitalization (42.3% vs. 26.2%; hazard ratio [HR]: 1.85; 95% confidence interval [CI]: 1.21 to 2.84; p = 0.004), derived from an increase in the rate of HF hospitalization (32.3% vs. 20.0%; HR: 1.82; 95% CI: 1.11 to 2.96; p = 0.015) and a nonsignificant increase in the rate of cardiac death (HR: 1.62; 95% CI: 0.70 to 3.73; p = 0.257) and all-cause mortality (p = 0.074). Exploratory subgroup analyses suggested that sodium restriction was associated with increased risk of death or HF hospitalization in patients not receiving angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (HR: 5.78; 95% CI: 1.93 to 17.27; p = 0.002). CONCLUSIONS In symptomatic patients with chronic HF, sodium restriction may have a detrimental impact on outcome. A randomized clinical trial is needed to definitively address the role of sodium restriction in HF management. (A Self-management Intervention for Mild to Moderate Heart Failure [HART]; NCT00018005).
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Changes in dietary intake and nutritional status associated with a significant reduction in sodium intake in patients with heart failure. A sub-analysis of the SODIUM-HF pilot study.
Colin-Ramirez, E, McAlister, FA, Zheng, Y, Sharma, S, Ezekowitz, JA
Clinical nutrition ESPEN. 2016;:e26-e32
Abstract
BACKGROUND & AIMS Concerns have been raised about the impact of dietary sodium restriction on the overall dietary intake and nutritional status in patients with heart failure (HF). The objective of this study was to evaluate the association between a significant reduction in sodium intake and dietary changes and nutritional status in patients with chronic HF. METHODS This is a secondary analysis of 38 patients enrolled in a pilot study of dietary sodium reduction. Patients were classified into two groups according to a level of sodium reduction achieved (≥25% [n = 21 patients] and <25% [n = 14 patients]) at 6 months. Between group changes in energy, nutrient intake, weight loss, and hand grip strength from baseline to 6 months were compared. RESULTS Patients had a median age of 65 years, 51% were male, median body mass index was 30.7 kg/m2 and median ejection fraction was 39%. Over 6 months, the group with ≥25% sodium reduction exhibited a greater increase in folate intake [median change 50 mcg/day (25th-75th percentiles: -101, 167) vs. -31 mcg/day (25th-75th percentiles: -221, 51), p = 0.04 between groups] and a larger reduction in calcium intake [median change -262 (25th-75th percentiles: -585, -9) vs. 91 (25th-75th percentiles: -114, 210), p = 0.01 between groups], and were more likely to meet the parameters of the DASH diet compared to the <25% sodium reduction group. No significant differences between groups were seen for caloric intake and other relevant nutrients and no significant weight loss was found in either group. CONCLUSIONS Dietary sodium reduction may be achieved without compromising overall dietary intake and nutritional status in patients with HF when an individualized and comprehensive dietary approached is used. CLINICAL TRIAL IDENTIFIER Clinicaltrials.gov identifier: NCT01480401.
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The effect of a dietary portfolio compared to a DASH-type diet on blood pressure.
Jenkins, DJ, Jones, PJ, Frohlich, J, Lamarche, B, Ireland, C, Nishi, SK, Srichaikul, K, Galange, P, Pellini, C, Faulkner, D, et al
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2015;(12):1132-9
Abstract
BACKGROUND AND AIM Compared to a DASH-type diet, an intensively applied dietary portfolio reduced diastolic blood pressure at 24 weeks as a secondary outcome in a previous study. Due to the importance of strategies to reduce blood pressure, we performed an exploratory analysis pooling data from intensively and routinely applied portfolio treatments from the same study to assess the effect over time on systolic, diastolic and mean arterial pressure (MAP), and the relation to sodium (Na(+)), potassium (K(+)), and portfolio components. METHODS AND RESULTS 241 participants with hyperlipidemia, from four academic centers across Canada were randomized and completed either a DASH-type diet (control n = 82) or a dietary portfolio that included, soy protein, viscous fibers and nuts (n = 159) for 24 weeks. Fasting measures and 7-day food records were obtained at weeks 0, 12 and 24, with 24-h urines at weeks 0 and 24. The dietary portfolio reduced systolic, diastolic and mean arterial blood pressure compared to the control by 2.1 mm Hg (95% CI, 4.2 to -0.1 mm Hg) (p = 0.056), 1.8 mm Hg (CI, 3.2 to 0.4 mm Hg) (p = 0.013) and 1.9 mm Hg (CI, 3.4 to 0.4 mm Hg) (p = 0.015), respectively. Blood pressure reductions were small at 12 weeks and only reached significance at 24 weeks. Nuts, soy and viscous fiber all related negatively to change in mean arterial pressure (ρ = -0.15 to -0.17, p ≤ 0.016) as did urinary potassium (ρ = -0.25, p = 0.001), while the Na(+)/K(+) ratio was positively associated (ρ = 0.20, p = 0.010). CONCLUSIONS Consumption of a cholesterol-lowering dietary portfolio also decreased blood pressure by comparison with a healthy DASH-type diet. CLINICAL TRIAL REG. NO.: NCT00438425, clinicaltrials.gov.
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Effect of contrasted sodium diets on the pharmacokinetics and pharmacodynamic effects of renin-angiotensin system blockers.
Azizi, M, Blanchard, A, Charbit, B, Wuerzner, G, Peyrard, S, Ezan, E, Funck-Brentano, C, Ménard, J
Hypertension (Dallas, Tex. : 1979). 2013;(6):1239-45
Abstract
Dietary sodium, the main determinant of the pharmacodynamic response to renin-angiotensin system blockade, influences the pharmacokinetics of various cardiovascular drugs. We compared the effect of contrasted sodium diets on the pharmacokinetics of single oral doses of 8 mg candesartan cilexetil, 160 mg valsartan, 10 mg ramipril, and 50 mg atenolol administered to 64 (16 per group) normotensive male subjects randomly assigned to sodium depletion (SD) or sodium repletion (SR) in a crossover study. Pharmacodynamic response was assessed as the increase in plasma renin concentration for renin-angiotensin system blockers and electrocardiographic changes in PR interval duration for atenolol. The area under the curve (AUC) for plasma candesartan and atenolol concentrations was significantly lower for SR than for SD (respective ratios of AUC0-∞: 0.74; [90% CI, 0.66-0.82] and 0.69 [90% CI, 0.54-0.88], respectively), indicating a lack of bioequivalence between SR and SD. SR did not affect the pharmacokinetics of valsartan or ramipril. The increase in plasma renin concentration with the 3 renin-angiotensin system blockers was 10 times lower during the SR than the SD period. In the multiple regression analysis, the AUC0-24 of plasma drug concentration explained <1% and 21% of the variance of the AUC0-24 of delta plasma renin concentration for candesartan (P=0.8882/P=0.0368) during the SR and SD periods, respectively. The atenolol-induced lengthening of PR interval was fully reversed by SR. Thus, sodium balance modulates the pharmacokinetics of candesartan cilexetil and atenolol, with measurable effects on the selected pharmacodynamic end points.
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Moderate dietary sodium restriction added to angiotensin converting enzyme inhibition compared with dual blockade in lowering proteinuria and blood pressure: randomised controlled trial.
Slagman, MC, Waanders, F, Hemmelder, MH, Woittiez, AJ, Janssen, WM, Lambers Heerspink, HJ, Navis, G, Laverman, GD, ,
BMJ (Clinical research ed.). 2011;:d4366
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OBJECTIVE To compare the effects on proteinuria and blood pressure of addition of dietary sodium restriction or angiotensin receptor blockade at maximum dose, or their combination, in patients with non-diabetic nephropathy receiving background treatment with angiotensin converting enzyme (ACE) inhibition at maximum dose. DESIGN Multicentre crossover randomised controlled trial. SETTING Outpatient clinics in the Netherlands. PARTICIPANTS 52 patients with non-diabetic nephropathy. INTERVENTIONS All patients were treated during four 6 week periods, in random order, with angiotensin receptor blockade (valsartan 320 mg/day) or placebo, each combined with, consecutively, a low sodium diet (target 50 mmol Na(+)/day) and a regular sodium diet (target 200 mmol Na(+)/day), with a background of ACE inhibition (lisinopril 40 mg/day) during the entire study. The drug interventions were double blind; the dietary interventions were open label. MAIN OUTCOME MEASURES The primary outcome measure was proteinuria; the secondary outcome measure was blood pressure. RESULTS Mean urinary sodium excretion, a measure of dietary sodium intake, was 106 (SE 5) mmol Na(+)/day during a low sodium diet and 184 (6) mmol Na(+)/day during a regular sodium diet (P<0.001). Geometric mean residual proteinuria was 1.68 (95% confidence interval 1.31 to 2.14) g/day during ACE inhibition plus a regular sodium diet. Addition of angiotensin receptor blockade to ACE inhibition reduced proteinuria to 1.44 (1.07 to 1.93) g/day (P=0.003), addition of a low sodium diet reduced it to 0.85 (0.66 to 1.10) g/day (P<0.001), and addition of angiotensin receptor blockade plus a low sodium diet reduced it to 0.67 (0.50 to 0.91) g/day (P<0.001). The reduction of proteinuria by the addition of a low sodium diet to ACE inhibition (51%, 95% confidence interval 43% to 58%) was significantly larger (P<0.001) than the reduction of proteinuria by the addition of angiotensin receptor blockade to ACE inhibition (21%, (8% to 32%) and was comparable (P=0.009, not significant after Bonferroni correction) to the reduction of proteinuria by the addition of both angiotensin receptor blockade and a low sodium diet to ACE inhibition (62%, 53% to 70%). Mean systolic blood pressure was 134 (3) mm Hg during ACE inhibition plus a regular sodium diet. Mean systolic blood pressure was not significantly altered by the addition of angiotensin receptor blockade (131 (3) mm Hg; P=0.12) but was reduced by the addition of a low sodium diet (123 (2) mm Hg; P<0.001) and angiotensin receptor blockade plus a low sodium diet (121 (3) mm Hg; P<0.001) to ACE inhibition. The reduction of systolic blood pressure by the addition of a low sodium diet (7% (SE 1%)) was significantly larger (P=0.003) than the reduction of systolic blood pressure by the addition of angiotensin receptor blockade (2% (1)) and was similar (P=0.14) to the reduction of systolic blood pressure by the addition of both angiotensin receptor blockade and low sodium diet (9% (1)), to ACE inhibition. CONCLUSIONS Dietary sodium restriction to a level recommended in guidelines was more effective than dual blockade for reduction of proteinuria and blood pressure in non-diabetic nephropathy. The findings support the combined endeavours of patients and health professionals to reduce sodium intake. Trial registration Netherlands Trial Register NTR675.