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SUPPLEMENTARY FILE Dose Doubling, Relative Potency, and Dose Equivalence of Potassium Sparing Diuretics Affecting Blood Pressure

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SUPPLEMENTARY FILE Dose Doubling, Relative Potency, and Dose Equivalence of Potassium Sparing Diuretics Affecting Blood Pressure SUPPLEMENTARY FILE Dose Doubling, Relative Potency, and Dose Equivalence of Potassium Sparing Diuretics Affecting Blood Pressure and Serum Potassium: Systematic Review and Meta-Analyses George C. Roush,1,2 Michael E. Ernst3, John B. Kostis4, Shamima Yeasmin,2 and Domenic A. Sica5 1Corresponding author 2UCONN School of Medicine and St. Vincent’s Medical Center, Department of Medicine, Bridgeport, CT, USA 3University of Iowa Hospital and Clinics, Department of Family Medicine, Iowa City, IA, USA 4Cardiovascular Institute, UMDNJ-Robert Wood Johnson Medical School, Chairman, Department of Medicine, New Brunswick, NJ, USA 5Department of Medicine and Pharmacology, Virginia Commonwealth University, Richmond, VA, USA METHOD FOR OBTAINING DOSE EQUIVALENCIES To obtain dose equivalency, a generalized method assumes that (1) changes in SBP caused by the log doses of the two drugs, A & B, are linear and fail to “bottom out” at higher doses and (2) dose-response effects for the two drugs are parallel. These assumptions were supported by the data. The general model is: SBP change = I – D*ln(Dose) – E*(1 if drug=A) – E*(0 if drug is B), where I, D, and E are constants. For drug B to compensate for its lesser potency: I – D*ln(Dose of A) – E*1 must equal I –D*ln(Dose of B) – E*0. This comes out to Dose of A = Dose of B*Exp(E/D). REFERENCES FOR META-ANALYSES TRIAMTERENE Kohvakka A, Salo H, Gordin A, Eisalo A. Antihypertensive and biochemical effects of different doses of hydrochlorothiazide alone or in combination with triamterene. Acta Med Scand. 1986;219(4):381-6. Webb EL, Godfrey JC, Gertel A, Costello RJ, Applin WJ, Zisblatt M, Vukovich RA, Neiss ES. The efficacy of a potassium-sparing combination of chlorthalidone and triamterene in the control of mild and moderate hypertension. I. J Int Med Res. 1984;12(3):133-9. Webb EL, Godfrey JC, Gertel A, Costello RJ, Cooper WH et al. The efficacy of a potassium-sparing combination of chlorthalidone and triamterene in the control of mild and moderate hypertension. II. J Int Med Res 1984;12:140-146. AMILORIDE Chrysant SG, Brown JL, Hagstrom D. J Clin Pharmacol. 1983 Apr;23(4):147-54. Hood SJ, Taylor KP, Ashby MJ, Brown MJ. The spironolactone, amiloride, losartan, and thiazide (SALT) double-blind crossover trial in patients with low-renin hypertension and elevated aldosterone-renin ratio. Circulation. 2007 Jul 17;116(3):268-75. Epub 2007 Jul 2. Koskelainen J, Turpeinen T, Lehto H, Lammintausta R. Metabolic effects of hydrochlorothiazide and hydrochlorothiazide-amiloride and trichlormethiazide- triamterene combinations. Current Therapeutic Research 1985;17:554-564. Laffer CL, Elijovich F, Eckert GJ, Tu W, Pratt JH, Brown NJ. Genetic variation in CYP4A11 and blood pressure response to mineralocorticoid receptor antagonism or ENaC inhibition: an exploratory pilot study in African Americans. J Am Soc Hypertens. 2014 Jul;8(7):475-80. Matthesen SK, Larsen T, Vase H, Lauridsen TG, Jensen JM, Pedersen EB. Effect of amiloride and spironolactone on renal tubular function and central blood pressure in patients with arterial hypertension during baseline conditions and after furosemide: a double-blinded, randomized, placebo-controlled crossover trial. Clin Exp Hypertens. 2013;35(5):313-24. Saha C, Eckert GJ, Ambrosius WT, Chun TY, Wagner MA, Zhao Q, Pratt JH. Improvement in blood pressure with inhibition of the epithelial sodium channel in blacks with hypertension. Hypertension. 2005 Sep;46(3):481-7. Salmela PI, Juustila H, Kinnunen O, Koistinen P. Comparison of low doses of hydrochlorothiazide plus amiloride and hydrochlorothiazide alone in hypertension in elderly patients. Ann Clin Res. 1986;18(2):88-92. Stears AJ, Woods SH, Watts MM, Burton TJ, Graggaber J, Mir FA, Brown MJ. A double-blind, placebo-controlled, crossover trial comparing the effects of amiloride and hydrochlorothiazide on glucose tolerance in patients with essential hypertension. Hypertension. 2012 May;59(5):934-42. SPIRONOLACTONE Carey RM, Douglas JG, Schweikert JR, Liddle GW. The syndrome of essential hypertension and suppressed plasma renin activity. Normalization of blood pressure with spironolactone. Arch Intern Med. 1972 Dec;130(6):849-54. Clement DL. Effect of spironolactone on systemic blood pressure, limb blood flow and response to sympathetic stimulation in hypertensive patients. Eur J Clin Pharmacol. 1982;21(4):263-7. Cranston WI, Juel-Jensen BE. The effects of spironolactone and chlorthalidone on arterial pressure. Lancet. 1962 Jun 2;1(7240):1161-4. Davies J, Gavin A, Band M, Morris A, Struthers A. Spironolactone reduces brachial pulse wave velocity and PIIINP levels in hypertensive diabetic patients. Br J Clin Pharmacol. 2005 May;59(5):520-3. Hood SJ, Taylor KP, Ashby MJ, Brown MJ. The spironolactone, amiloride, losartan, and thiazide (SALT) double-blind crossover trial in patients with low-renin hypertension and elevated aldosterone-renin ratio. Circulation. 2007 Jul 17;116(3):268-75. Epub 2007 Jul 2. Johnston LC, Grieble HG. Treatment of arterial hypertensive disease with diuretics. V. Spironolactone, an aldosterone antagonist. Arch Intern Med. 1967 Mar;119(3):225-31. Laffer CL, Elijovich F, Eckert GJ, Tu W, Pratt JH, Brown NJ. Genetic variation in CYP4A11 and blood pressure response to mineralocorticoid receptor antagonism or ENaC inhibition: an exploratory pilot study in African Americans. J Am Soc Hypertens. 2014 Jul;8(7):475-80. Leary WP, Asmal AC, Williams PC, Marwick B. Aldactone and acebutolol in treatment of hypertension. J Int Med Res. 1979;7(1):29-32. Ramsay LE, Hettiarachchi J. Spironolactone in thiazide-induced hypokalaemia: variable response between patients. Br J Clin Pharmacol. 1981 Feb;11(2):153-8. Swaminathan K, Davies J, George J, Rajendra NS, Morris AD, Struthers AD. Spironolactone for poorly controlled hypertension in type 2 diabetes: conflicting effects on blood pressure, endothelial function, glycaemic control and hormonal profiles. Diabetologia. 2008 May;51(5):762-8. Toner JM, Brawn LA, Yeo WW, Ramsay LE. Adequacy of twice daily dosing with potassium chloride and spironolactone in thiazide treated hypertensive patients. Br J Clin Pharmacol. 1991 Apr;31(4):457-61. Vaclavik J, Sedlak R, Plachy M, Navratil K, Plasek J, Husar R, Kocianova E, Taborsky M. Addition of spironolactone in patients with resistant arterial hypertension (ASPIRANT)--study protocol. Hypertension 2011;57:1069-1075. Weinberger MH, Roniker B, Krause SL, Weiss RJ. Eplerenone, a selective aldosterone blocker, in mild-to-moderate hypertension. Am J Hypertens. 2002 Aug;15(8):709-16. Wolf RI, Mendlowitz M, Robos J, Styan GPH, Kornfeld P, Weigl A. Treatment of Hypertension with spironolactone: Double-blind study. JAMA 1966;198:121-127. EPLERENONE Calhoun DA, White WB, Krum H, Guo W, Bermann G, Trapani A, Lefkowitz MP, Ménard J. Effects of a novel aldosterone synthase inhibitor for treatment of primary hypertension: results of a randomized, double-blind, placebo- and active-controlled phase 2 trial. Circulation. 2011 Nov 1;124(18):1945-55. Karns AD, Bral JM, Hartman D, Peppard T, Schumacher C. Study of aldosterone synthase inhibition as an add-on therapy in resistant hypertension. J Clin Hypertens (Greenwich). 2013 Mar;15(3):186-92. Saruta T, Kageyama S, Ogihara T, Hiwada K, Ogawa M, Tawara K, Gatlin M, Garthwaite S, Bittman R, Patrick J. Efficacy and safety of the selective aldosterone blocker eplerenone in Japanese patients with hypertension: a randomized, double-blind, placebo-controlled, dose-ranging study. J Clin Hypert 2004; 6: 175-183. Sica DA. Eplerenone and serum potassium change-relation to renal function. Am J Hypert 2003;16 (5): 100A. Weinberger MH, Roniker B, Krause SL, Weiss RJ. Eplerenone, a selective aldosterone blocker, in mild-to-moderate hypertension. Am J Hypertens. 2002 Aug;15(8):709-16. White WB, Carr AA, Krause S, Jordan R, Roniker B, Oigman W. Assessment of the novel selective aldosterone blocker eplerenone using ambulatory and clinical blood pressure in patients with systemic hypertension. Am J Cardiol. 2003 Jul 1;92(1):38-42 Table S1. Baseline gender, age, co-morbidities and background antihypertensive medications. % men, Background Author mean age Baseline conditions or comorbidities when specified BP meds Adherence3 Triamterene Kohvakka 19, 55 Exclusions: CHF, CAD, insulin dependent DM, CKD, liver disease Yes1 1 excluded Webb I 50, 50 NR Yes NM Webb II 67, 50 NR Yes NM Amiloride Chrysant 100, 51 Exclusions: CHF, recent MI, or recent stroke. Yes1 NM Hood 54, 60 Renin < 0.65 ng/mL/hr. Exclusions: secondary hypertension Mixed NM Koskelainen 53, 43 None mentioned Yes NM Laffer 53, 472 Renin < 2 ng/ml/hr Yes NM Matthesen 61, 45-70 Exclusions: diseases of the heart, lungs, and kidneys No NM Saha 53, 462 Plasma renin < 2 ng/ml/hr Yes 94%+ Salmela 30, 67 Exclusions: significant CHF, renal or liver disease Yes1 NM Stears 46, 65 None described Mixed NM Spironolactone Carey 36, 46 Exclusions: CKD, CHF, secondary HTN No NM Clement NR, NR None described No NM Cranston 70, 53 None described No NM Davies 70, 66 Diabetes type 2. Exclusions: CHF or liver failure No NM Hood 54, 60 Renin < 0.65 ng/mL/hr. Exclusions: secondary hypertension Mixed NM Johnston 23, 46 No comorbidities excluded. 24% with CHF, 30% with CKD No NM Laffer 53, 472 Renin < 2 ng/ml/hr Yes NM Leary 10, 28-63 None described No NM Matthesen 61, 45-70 Exclusions: diseases of the heart, lungs, and kidneys No NM Ramsay NR, NR No CHF, CKD, or liver failure Yes 93% Saha 53, 462 Plasma renin < 2 ng/ml/hr Yes NM Swaminathan NR, 63 Diabetes type 2. Exclusions: CHF, liver failure, recent hospitalization Yes1 NM Toner 67, 57 NR Yes “satisfactory” Vaclavik 62, 61 Resistant hypertension. Exclusions: CKD Yes1 “adequate” Weinberger 68, NR Exclusions: liver or valve disease, CKD, DM on insulin, CHF. No 96% Wolf None described No NM Eplerenone Calhoun 65, 55 Exclusions: cardiovascular disease, DM, CKD Yes NM Karns 63, 57 Exclusions: valvular dis, CHF, DM-1 (or poor control of Type 2), CKD Yes1 NM Saruta 69, 53 Most with low renin HTN.
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