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United States Patent (19) [11] Patent Number: 4,855,289 Wester Et Al

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United States Patent (19) [11] Patent Number: 4,855,289 Wester Et Al United States Patent (19) [11] Patent Number: 4,855,289 Wester et al. 45 Date of Patent: Aug. 8, 1989 54 COMBINATION OF TWO ACTIVE SUBSTANCES OTHER PUBLICATIONS Physicians' Desk Reference 31st Ed., Medical Econom (76. Inventors: Per O. Wester, Kvarnvägen 1 E, 902 ics Co., Publisher (Oradell, N.J.) pp. 1090-1091 (1977). 49 Umeå; Thomas R. Dyckner, Classen et al, "Experimental Studies on the Intestinal Norevågen 7, 13300 Saltsjöbaden, Absorption of Magnesium and Its Protective Effects both of Sweden Against Cardiac Hypertrophy and Nonocclusive Ne croses', Magnesium in Health and Disease, SP Medical & Scientific Books, Publisher, pp. 521-535 (1980). 21) Appl. No.: 80,150 Chadda et al., “Magnesium and Cardiac Arrhythmia in Patients with Acute Infarction-Preliminary Observa 22 Filed: Jul. 30, 1987 tions', Magnesium in Health and Disease, SP Medical & Scientific Books, Publisher, pp. 545-549 (1980). Related U.S. Application Data Shanker et al., "Effects of Furosemide on Serum and Urinary Magnesium in Congestive Heart Failure', 63 Continuation of Ser. No. 617,050, Jun. 4, 1984, aban Magnesium in Health and Disease, SP Medical & Scien doned. tific Books, Publisher, pp. 597-604 (1980). 51) Int. Cl* ..................... A61K 31/19; A61K 31/41; Primary Examiner-Allen J. Robinson A61K 31/56; A61K 31/415 Attorney, Agent, or Firm-JoAnn Villamizar; Irving M. (52) U.S. C. .................................... 514/171; 514/155; Fishman 514/249; 514/255; 514/259; 514/326; 514/363; 57 ABSTRACT 514/391; 514/404; 514/425; 514/561; 514/568; 514/569; 514/571; 514/602; 514/604; The invention concerns the use of a compound with 514/223.5 diuretic properties and of a magnesium supplementation 58 Field of Search ............... 514/561, 171, 155, 225, in the form of magnesium monoaspartate hydrochlo 514/249, 259, 326,363, 391, 404, 568, 569, 571, ride, magnesium oxide, magnesium hydroxide or mag 602, 604, 255, 425 nesium carbonate, and optionally of a potassium supple mentation, and pharmaceutical preparations comprising a compound with diuretic properties and a magnesium (56) References Cited supplementation in the form of magnesium monoaspa U.S. PATENT DOCUMENTS rate hydrochloride, magnesium oxide, magnesium hy 4,137,326 1/1979 Fischer et al. ...................... 424/319 droxide, or magnesium carbonate and optionally a po tassium supplementation. FOREIGN PATENT DOCUMENTS 1809119 6/1970 Fed. Rep. of Germany ...... 424/319 9 Claims, No Drawings 4,855,289 1. 2 or congestive heart failure, or both, with compounds COMBINATION OF TWO ACTIVE SUBSTANCES having diuretic effects, tests have been carried out ac cording to the methods described below: This application is a continuation of application Ser. A total of 39 ambulatory patients, receiving long term No. 617,050 filed June 4, 1984, now abandoned. 5 treatment with diuretics for hypertension or congestive The invention concerns the use of a compound with heart failure, or both, who had been receiving such diuretic properties and of a magnesium supplementation treatment for over one year, were assigned to the test. in the form of magnesium monoaspartate hydrochlo Twenty patients (16 women and 4 men; mean age ride, magnesium oxide, magnesium hydroxide or mag 62.2-E4.2 years) were randomised to receive treatment nesium carbonate, and optionally of a potassium supple 10 with magnesium monoaspartate hydrochloride. Eigh mentation, and pharmaceutical preparations comprising teen of these patients had hypertension (six World a compound with diuretic properties and a magnesium Health Organisation grade I, 12 grade II) and four had supplementation in the form of magnesium monoaspa congestive heart failure (two New York Heart Associa rate hydrochloride, magnesium oxide, magnesium hy tion grade II). Two of the four latter patients had both, droxide, or magnesium carbonate and optionally a po 15 hypertension and congestive heart failure (World tassium supplementation. Health Association grade II and New York Heart Asso It has been found, that the long-term treatment of ciation grade II, respectively, in both cases). The dura patients with hypertension and/or congestive heart tion of hypertension was between 2 and 30 years (mean failure with compounds having diuretic properties, par 9.76.8 years), and the duration of diuretic treatment ticularly of the 1,2,4-benzothiadiazine-1,1-dioxide-type, 20 ranged from 1.5 years to 25 years (mean 8.3-5.5 years). may give rise to potassium and magnesium deficiencies, Thirteen of the hypertensive patients were receiving accompanied by an increased cellular sodium content, bendroflumethiazide (2.5 mg/day), four hydrochloro which in turn may result in an increased cellular cal thiazide (12.5 mg/day), and one mefruside (25 mg/day). cium content. In a recent study on patients with mild to The patients with congestive heart failure alone were moderate hypertension, potassium supplementation 25 receiving bendroflumethiazide (2.6 mg/day; one pa without changes in salt, particularly sodium chloride tient) and furosemide (frusemide) (40 mg/day; one pa intake resulted in a mean reduction in blood pressure tient). The two patients with both, hypertension and (systolic/diastolic) by 6/4 mm Hg (MacGregor et al., congestive heart failure, were receiving bendroflume Lancet, Vol. 1982, p. 567.). thiazide (40 mg/day) and furosemide (40 mg twice Surprisingly it has now been found, that in the long 30 daily). All patients received additional potassium sup term treatment of patients with hypertension or conges plementation in the form of potassium chloride. None of tive heart failure, a magnesium supplementation in the the patients was receiving treatment with other agents form of the magnesium monoaspartate hydrochloride, known to influence the metabolism of magnesium. On causes a significant lowering of the blood pressure as administration to the test, the patients were seen twice compared with the control groups not receiving the 35 at an interval of two to three days. Blood pressure and magnesium supplementation. The mean value of the heart rate were recorded with the patient supine after 30 blood pressure lowering effect caused by the magne minutes rest and in the standing position. The blood sium supplementation has been found to be 12/8 mm pressure recordings were obtained with an ordinary Hg. A similar effect on blood pressure has also been sphygmomanometer, and diastolic pressure was re observed in patients with hypertension or congestive corded at the disappearance of the Korotkoff sound. heart failure with magnesium supplementation in the The blood pressure obtained at the second initial visit form of magnesium oxide, magnesium hydroxide and was used in the protocol. magnesium carbonate. The patients continued their diuretic treatment, but Thus, through the combined administration of a com received supplementation with magnesium monoaspar pound with diuretic properties and the particular mag 45 tate hydrochloride (15 mmol/day, i.e. 365 mg magne nesium supplementation, and optionally of a potassium sium or 3689 mg magnesium monoaspartate hydro supplementation, the probability of therapeutic success chloride/day). After one month, the blood pressure was can be substantially increased, since the effect of the taken as on admission. After six months of treatment the two or optionally three types of active ingredients sup procedure carried out on admission was repeated. plement each other in a surprising and unexpected man 50 The patients randomised to form the control group le. consisted of 10 women and 9 men (mean age 67.84 The invention, therefore, concerns a new method of years). Seventeen patients had hypertension (2 World treating hypertension and/or congestive heart failure Health Organisation grade 1, 15 grade II) and 5 had by using a compound having diuretic properties, mag congestive heart failure (4 New York Heart Association nesium monoaspartate hydrochloride, magnesium ox 55 grade II, 1 grade III). Three of the patients had both, ide, magnesium hydroxide or magnesium carbonate as a hypertension (World Health Organisation grade II) and magnesium supplementation and optionally a potassium congestive heart failure (2 grade II, 1 grade I). The salt as a potassium supplementation, as well as new duration of the diuretic treatment ranged from 1 to 20 antihypertensive preparations comprising of a combina years (mean 6.1-4.5 years). Eight patients were receiv tion of a compound having diuretic properties, a magne 60 ing bendroflumethiazide (2.5 mg/day), 3 hydrochloro sium compound selected from the group consisting of thiazide (12.5-25 mg/day), 3 chlorthalidone (25-50 magnesium monoaspartate hydrochloride, magnesium mg/day), and 5 furosemide (40-80 mg/day). All pa oxide, magnesium hydroxide and magnesium carbonate, tients received potassium supplements in the form of and optionally a potassium salt. potassium chloride, and none was taking any treatment In order to determine the effects of the magnesium 65 known to influence the metabolism of magnesium. Sam supplementation, particularly in the form of magnesium pling procedures were the same as for the treatment monoaspartate hydrochloride, on the blood pressure in group. The control group patients continued their treat patients receiving long term treatment for hypertension ment unchanged throughout the test. 4,855,289 3 4. In the treatment group, 19 of the 20 patients showed 6-chloro-7-sulfanoyl-1,2,4-benzothiadiazine-1,1-diox a significant decrease in blood pressure. In 3 patients, ide (chlorothiazide), the dosage of the magnesium
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