KR102233673B1 - Pharmaceutical composition for preventing or treating diabetic nephropathy - Google Patents

Abstract

The pharmaceutical composition of the present invention can effectively prevent or treat diabetic kidney disease by blocking, inhibiting or delaying the onset of diabetic kidney disease, or improving or inhibiting the progression of diabetic kidney disease.

Description

Pharmaceutical composition for preventing or treating diabetic nephropathy}

The present invention relates to a pharmaceutical composition for preventing or treating diabetic kidney disease, including fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof. More specifically, the present invention relates to a pharmaceutical composition capable of preventing or inhibiting the progression of diabetic kidney disease and effectively improving various symptoms associated with diabetic kidney disease.

Diabetes is a type of metabolic disease such as insufficient insulin secretion or inability to function normally.It is characterized by high blood sugar, which increases the concentration of glucose in the blood, and causes various symptoms and signs due to high blood sugar, and glucose is discharged through urine.

Long-term exposure to high blood sugar in diabetic patients can lead to peripheral neurosis, autonomic neurosis, macrovascular complications, microvascular complications, and other chronic complications.

Diabetic kidney disease is one of the complications of diabetes and is the most important causative disease of chronic renal failure, and accounts for a large proportion of the causative diseases of all dialysis patients.

Diabetic kidney disease usually has no symptoms at the beginning, and as it progresses, there are no obvious symptoms other than proteinuria in the urine test. Therefore, the onset of diabetic kidney disease is diagnosed by the discovery of microalbuminuria (in the urine albumin secretion 30-299mg/24h).

However, as described above, it is not easy to diagnose diabetic kidney disease at an early stage because the time when the symptoms of microalbuminuria are detected is also after the diabetic kidney disease has progressed considerably, and most of the cases are detected after the kidney disease has already progressed considerably.

In addition, in the case of diabetic kidney disease, abnormal proliferation of renal intervascular cells results in enlarged intervascular tissue, resulting in thickening of the basement membrane of glomeruli and tubules, narrowing the inner diameter of glomerular vessels, increasing glomerular vascular interstitial, accumulation of extracellular lipids, As the symptoms of glomerulosclerosis and tubulointerstitial fibrosis progress, the function of the kidney gradually weakens, eventually leading to chronic renal failure.

Another clinical significance of diabetic kidney disease is a marked increase in mortality. The mortality rate of type 1 diabetic patients with overt proteinuria compared to normal subjects was significantly higher than that of type 1 diabetic patients with normal albuminuria and normal subjects. That is, in the case of diabetic patients with kidney disease due to diabetes, the mortality rate is remarkably increased.

Such diabetic kidney disease is a trend that is increasing more and more in kidney disease with the increase of diabetic patients, and in particular, the number of patients with kidney disease caused by type 2 diabetes continues to increase.

However, to date, there are still few drugs that have an effective preventive or therapeutic effect for diabetic kidney disease, and drugs that have been used in the past have many side effects, i.e., hyperkalemia, or even functional or bronchial renal artery stenosis due to long-term use. May cause acute kidney failure.

Therefore, it is very important to develop new drugs for safe and effective prevention and treatment of diabetic kidney disease.

Korean Patent Registration No. 0354654

Cardiovasc Diabetol. 2009 Jan 21;8:4, Gurney AM Metabolism. 1979 Nov;28(11):1075-7, Somani P et al.

It is an object of the present invention to provide a pharmaceutical composition for preventing or treating diabetic kidney disease, including fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

It is an object of the present invention to provide a use of fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof to prevent or treat diabetic kidney disease.

It is an object of the present invention to provide a method for preventing or treating diabetic kidney disease by administering to a subject a pharmaceutical composition comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

The present invention is to provide a pharmaceutical composition for preventing or treating diabetic kidney disease, comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

In the present invention, the diabetic nephropathy refers to a kidney disorder occurring in a patient with diabetes, and is a typical complication caused by diabetes. The disease occurs when the glomerulus inside the kidney is damaged due to high blood sugar caused by diabetes, and kidney function is deteriorated.

Diabetic kidney disease, in addition to the detection of minute albuminuria in the urine, does not show any special symptoms, so treatment is generally easy to be delayed. As a result, it leads to chronic renal failure, necessitating a kidney transplant, or death.

Therefore, in the case of diabetic kidney disease, it is important to prevent a subject with diabetes from developing diabetic kidney disease in advance or delay the occurrence of diabetic kidney disease as much as possible. In addition, when diabetic kidney disease occurs, it is important to suppress the progression of diabetic kidney disease or delay the progression of the disease by improving the symptoms or preventing the symptoms from worsening.

A pharmaceutical composition comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof can effectively prevent or treat kidney disease caused by diabetes. As a result, the onset of kidney disease in a diabetic subject can be prevented or suppressed or the onset of the onset can be delayed, or in a subject with diabetic kidney disease, symptoms of diabetic kidney disease can be improved, and kidney disease It can prevent the worsening of the disease by inhibiting the progression of the disease or delaying the progression of the disease.

Therefore, the composition according to the present invention can prevent diabetic kidney disease from leading to chronic renal failure, thereby significantly lowering the mortality rate of the patient. In addition, when diabetic kidney disease leads to chronic renal failure, it eventually leads to dialysis. A pharmaceutical composition containing fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof, inhibits the progression of diabetic kidney disease or Delays can delay the start of dialysis.

In the present invention, the prophylaxis refers to any action that prevents or inhibits the occurrence of diabetic kidney disease or symptoms accordingly or delays the onset by administration of the pharmaceutical composition according to the present invention. For example, when the composition of the present invention is administered to a subject who has diabetes but does not develop diabetic kidney disease, it is possible to prevent or delay the occurrence of diabetic kidney disease or symptoms.

In the present invention, the treatment is to improve and ameliorate diabetic kidney disease or its symptoms or inhibit or delay the progression of diabetic kidney disease by administration of the pharmaceutical composition according to the present invention. It means any action that suppresses deterioration. For example, when the composition of the present invention is administered to a subject suffering from diabetic kidney disease, diabetic kidney disease or symptoms thereof may be alleviated or improved. Alternatively, when the composition of the present invention is administered to a subject suffering from diabetic kidney disease, it is possible to suppress or delay the progression of diabetic kidney disease or symptoms resulting from diabetic kidney disease to suppress exacerbation of diabetic kidney disease, and as a result, chronic renal failure. It can significantly lower the mortality rate from diabetic kidney disease by preventing it from reaching and delay the start of dialysis.

In the present invention, the treatment includes reducing the mortality rate due to diabetic kidney disease or delaying the start of dialysis.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, it may prevent the occurrence of albuminuria and proteinuria, or reduce or delay the amount of albuminuria and proteinuria.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, it is possible to prevent or reduce the level of creatine and blood urea nitrogen in the serum, or to prevent the level from being increased. It can be delayed.

When the composition of the present invention is administered to a subject with diabetes or diabetic kidney disease, damage to the nephron, sclerosis and fibrosis of the glomerulus, thickening of the basement membrane in the glomerulus, phobia and necrosis of the tubule, thickening of the basement membrane of the tubule, of the tubule. Injury, tubulointerstitial fibrosis, hydronephrosis, and kidney volume increase can be prevented, and the above symptoms can be improved, or symptoms can be suppressed or delayed to prevent worsening of symptoms.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, it can prevent local inflammation of kidney cells or improve inflammation of kidney cells, and inhibit or delay the progression of inflammation. Can prevent deterioration.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, it can prevent the accumulation of protein in the tubular cavity, or improve the symptoms of protein accumulation in the tubular cavity, or delay the accumulation of protein. have.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, it can prevent the increase of mesangial cells or the accumulation of extracellular matrix proteins, and improve the above symptoms or suppress the symptoms. Or you can delay it.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, it prevents the occurrence of edema, itchiness, and uremic symptoms caused by kidney disease, or reduces the symptoms of edema, itching, and uremia, or the edema. , Itching and urinary poisoning may delay worsening.

When the composition of the present invention is administered to a subject with diabetes or diabetic kidney disease, it can reduce and improve anorexia and fatigue caused by kidney disease, and delay deterioration of anorexia and fatigue caused by kidney disease.

When the composition of the present invention is administered to a subject with diabetic kidney disease, it can prevent or delay chronic renal failure by preventing or slowing the progression of diabetic kidney disease, and as a result, significantly lowering the mortality rate of the subject or starting dialysis. You can delay the timing.

The composition of the present invention can sufficiently effectively prevent or treat diabetic kidney disease even when only fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof is used as an active ingredient.

The composition of the present invention exhibits sufficient safety to be administered to a subject for a long period of time. For example, the composition of the present invention does not cause hyperkalemia and irregular heartbeat or cardiac arrest, etc., even when administered to a subject with diabetes or diabetic kidney disease for a long period of time, and does not cause functional or organ renal artery stenosis. It does not cause kidney disorders such as acute renal failure, and has little or no toxicity, including other side effects. Accordingly, fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof according to the present invention can be safely administered to a subject with diabetes or diabetic kidney disease for a long period of time.

In the present invention, the subject refers to an animal including humans, for example, mice, rats, other rodents, rabbits, dogs, pigs, cats, cattle, sheep, horses, primates and humans. It may be a mammal including, preferably a primate or a human, and more preferably a human.

In the present invention, the diabetes may be insulin-dependent type 1 diabetes or non-insulin-dependent type 2 diabetes.

In the present invention, the fimasartan may be a compound represented by the following formula (1).

[Formula 1]

In the present invention, the pharmaceutically acceptable salt generally refers to an inorganic acid salt, an organic acid salt, or a metal salt used by a pharmaceutical manufacturer to manufacture a pharmaceutical product, and as an inorganic acid, hydrochloric acid, bromic acid, sulfuric acid, or phosphoric acid can be used. As organic acids, citric acid, acetic acid, lactic acid, tartaric acid, fumaric acid, formic acid, propionic acid, oxalic acid, trifluoroacetic acid, methanesulfonic acid, benzenesulfonic acid, maleic acid, benzoic acid, gluconic acid, glycolic acid, succinic acid, 4-morpholineethanesulfonic acid , Camphorsulfonic acid, 4-nitrobenzenesulfonic acid, hydroxy-O-sulfonic acid, 4-toluenesulfonic acid, calucturonic acid, emboic acid, glutamic acid, aspartic acid, adipic acid or camsylic acid, and the like, and the metal is sodium, Potassium, calcium, or magnesium may be used.

In the present invention, the salt of fimasartan is preferably fimasartan potassium salt, hydrochloride, calcium salt, sulfate, adipate salt, camsylate salt or besylate salt, and more preferably potassium salt. These are commercially available and can be manufactured by a known method (for example, Korean Patent Registration No. 0354654).

In the present invention, the hydrate may contain a stoichiometric or non-stoichiometric amount of water bonded by a non-covalent intermolecular force.

In the present invention, the solvate may include a stoichiometric or non-stoichiometric amount of a solvent bonded by a non-covalent intermolecular force. The solvent refers to a conventional organic solvent used for preparing organic compounds, for example, methanol, ethanol, 1-propanol, 2-propanol, 1-butanol, 2-butanol, 1-acetate, acetone, acetic acid, or Sol, tetrahydrofuran, methyl acetate, ethyl acetate, propyl acetate, isopropyl acetate, isobutyl acetate, n-butyl acetate, dimethyl sulfoxide, pentane, heptane, etc. It is not.

In the present invention, the hydrate and solvate may be contained in a ratio of 0.25 to 10 moles of water or a solvent with respect to 1 mole of fimasartan potassium, for example, 0.5 moles, 1 moles, 1.5 moles, 2 moles, 2.5 moles , 3 mol, 5 mol, and the like, and more preferably, 1 mol or 3 mol of water may be contained with respect to 1 mol of fimasartan potassium. For example, the pharmaceutical composition may be prepared using fimasartan potassium salt monohydrate or fimasartan potassium salt trihydrate.

In the present invention, the pharmaceutical composition may contain fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof in an amount of 5% to 60% by weight based on the total weight of the composition, and preferably 10 It may be included in a weight% to 50 weight %.

In the present invention, the pharmaceutical composition may further include a pharmaceutically acceptable additive. The pharmaceutically acceptable means physiologically acceptable and when administered to a human, usually does not cause allergic reactions such as gastrointestinal disorders, dizziness, or similar reactions, and when preparing a pharmaceutical composition by a person having ordinary knowledge in the field, For use, reference may be made to the literature of Remington's Pharmaceutical Science (latest edition), Mack Publishing Company, Easton PA.

The additives may be carriers, excipients, extenders, antioxidants, buffers, fillers, anti-aggregating agents, lubricants, wetting agents, flavoring agents, emulsifying agents, suspending agents, surfactants, and preservatives. For example, the additives are lactose, dextrose, calcium silicate, corn starch, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, Methyl cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, stearic acid, magnesium stearate, calcium stearate, mineral oil, saline, glucose aqueous solution, pseudosugar solution, alcohol, glycol , Ether (eg, polyethylene glycol 400), oil, fatty acid, fatty acid ester, glyceride, or a mixture thereof. However, additives that may be included in the composition according to the present invention are not limited to the materials listed above, and these are only examples.

The pharmaceutical composition of the present invention may be formulated according to a conventional method, may be prepared as an oral or parenteral formulation, and preferably may be an oral formulation.

In the present invention, the formulation for oral administration may be a solid formulation such as a tablet, a pill, a powder, a granule, or a capsule, or a liquid formulation such as a suspension, a liquid solution, an emulsion, or a syrup, preferably a solid formulation. It may be the first, and more preferably, it may be a tablet.

When the pharmaceutical composition of the present invention is formulated as an oral solid preparation, examples of additives used include cellulose, calcium silicate, corn starch, lactose, sucrose, dextrose, calcium phosphate, stearic acid, magnesium stearate, and calcium stearate. , Gelatin, talc, and the like.

When the pharmaceutical composition is formulated as a liquid formulation for oral administration, various additives such as simple diluents, wetting agents, sweetening agents, fragrances, preservatives, preservatives, coloring agents, etc., are added to the pharmaceutical composition to formulate the pharmaceutical composition. I can.

When the pharmaceutical composition of the present invention is prepared in the form of an injection, the additives include water, saline, aqueous glucose solution, aqueous sugar-like solution, alcohol, glycol, ether (e.g., polyethylene glycol 400), oil, fatty acid, fatty acid ester, glycerol. Ride, etc. are mentioned.

In the present invention, the content of the additive included in the pharmaceutical composition is not particularly limited, and may be appropriately adjusted within the content range used for conventional formulation.

In the present invention, the pharmaceutical composition may contain fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof so that the content of fimasartan is about 1 mg to 240 mg, preferably about 30 It may contain to be 180mg.

In the present invention, the pharmaceutical composition may be administered orally or parenterally (for example, intravenous, subcutaneous, intraperitoneal or topically applied), and the dosage may be the weight, age, sex, and health of the patient. The range may vary depending on the condition, diet, administration time, administration method, administration period or interval, excretion rate, constitutional specificity, the nature of the formulation, the severity of the disease, and the like. For example, fimasartan may be administered orally so that the dosage of fimasartan is about 1 to 240 mg per day, preferably 30 to 180 mg, based on a general adult of about 60 kg, and the application may be applied once or several times a day. have.

In the present invention, the pharmaceutical composition may further include an active ingredient having other pharmacological activity in addition to the fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

In addition to the fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof, the composition of the present invention may further include an antihypertensive agent, a diuretic agent, a hyperlipidemia agent, an antiobesity agent, or a diabetes agent. For example, the composition of the present invention is an active ingredient, fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof, together with amlodipine, nifedipine, verapamil, diltiazem, nicardipine, lercardipine, atorvastatin. , Cerivastatin, fluvastatin, lovastatin, pitavastatin, simvastatin, rosuvastatin, nicotinic acid, theophylline, caffeine, theobromine, aminophylline, hydrochlorothiazide, bendroflumethiazide, allogliptin, saxagliptin , Sitagliptin, metformin, exenatide, rosiglitazone, pioglitazone, tolbutamide, troglitazone, leptin, ephedrine, fenfluramine, fluoxetine, and the like.

The pharmaceutical composition of the present invention may be used alone or in combination with surgery, hormone treatment, drug treatment, and methods of using a biological response modifier for improvement, alleviation, treatment or prevention of diabetic kidney disease.

The present invention provides a use of fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof to prevent or treat diabetic kidney disease.

The present invention provides a method for preventing or treating diabetic kidney disease by administering to a subject a pharmaceutical composition comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

The pharmaceutical composition according to the present invention includes fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof, and can effectively prevent or treat diabetic kidney disease. The pharmaceutical composition according to the present invention may block or inhibit the onset of diabetic kidney disease in advance, and also improve the diabetic kidney disease or suppress the progression or deterioration of diabetic kidney disease.

1 and 2 are diagrams showing a decrease in albumin content in urine according to administration of the pharmaceutical composition of the present invention in rats.

Hereinafter, examples will be described in detail to aid understanding of the present invention. However, the following examples are merely illustrative of the contents of the present invention, and the scope of the present invention is not limited to the following examples. The embodiments of the present invention are provided to more completely describe the present invention to those of ordinary skill in the art. The experimental results of each example were statistically processed using ANOVA (one way analysis of variance), and if significance was recognized, the level of p<0.05 (* or †) or p<0.01 (**) using Dunnett's multiple comparison test. The significance test was performed below.

1. Preparation of experimental animals

(1) Selection of experimental animals

245 to 260 g of 8-week-old spontaneously hypertensive rat (SHR) was supplied for 2 weeks, temperature 22±3℃, humidity 55±15%, ventilation frequency 10-20 times/hr, lighting time 12 hours (am It was raised at 8 o'clock to 8 o'clock off) and at 150-300 lux. During the breeding period, feed for experimental animals produced by Cargill Agripurina Co., Ltd. was supplied from Dream Bio and allowed to be consumed freely. As for water, purified water was freely ingested using a drinking water bottle made of polycarbonate. Thereafter, 19 healthy rats were selected for use in the experiment, and were divided into the first group (6 mice), the second group (6 mice), and the third group (7 mice).

(2) Induction of diabetic kidney disease

Streptozotocin (STZ) was used to induce diabetic kidney disease in rats (Gurney AM, Cardiovasc Diabetol. 2009 Jan 21;8:4; Somani P et al., Metabolism. 1979 Nov;28(11): 1075-7). When administered intraperitoneally or intravenously, streptozotocin destroys the beta cells of the pancreas, causing a diabetic condition.

Streptozotocin was administered to the second and third groups. The subject was fasted one day through a fasting plate a day before the streptozotocin administration. A composition containing streptozotocin dissolved in 0.1M sodium citrate buffer (pH 4.5) was administered to fasting subjects at a volume of 1 mL/kg so that the content of streptozotocin per head was 50 mg/kg immediately after fasting blood glucose measurement.

Fasting blood glucose was measured 48 hours after streptozotocin administration, and if the blood glucose level was 250 mg/dl or more, it was determined that diabetes was induced and used in the experiment.

2. Administration of drugs

After 48 hours of streptozotocin administration, diabetes induction was confirmed and the drug was administered.

A solution prepared by dissolving fimasartan potassium salt trihydrate in 0.5% (v/v) aqueous solution of carboxyl methyl cellulose (SAMCHUN PURE CHEMICAL CO., LTD.) in the third group of rats, the content of fimasartan is 10mg/ It was administered at 4 mL/kg once daily for 24 weeks to become Kg/day.

To the 1st and 2nd groups, 0.5% (v/v) carboxyl methyl cellulose (SAMCHUN PURE CHEMICAL CO., LTD.) was administered at a dose of 4 mL/Kg/day, respectively.

To each group, an aqueous carboxyl methyl cellulose solution and fimasartan were orally administered once a day before 4 pm. When administered orally, the animals were fixed using the cervical skin fixation method and administered directly into the stomach using a sonde for oral administration.

<Example 1> Confirmation of the preventive and therapeutic effects of fimasartan against diabetic kidney disease 1

Urinalysis was performed on rats of each group administered with aqueous carboxyl methyl cellulose or fimasartan for 24 weeks at intervals of 2 weeks. After the rats of each group were placed in a metabolic cage and urine was collected for 24 hours, urine creatinine amount (CRE) and urine albumin amount (UAE) were measured using a blood biochemical analyzer (7020 Hitachi, Japan). The urine albumin amount (UAE) is shown in FIG. 1, and the ratio of urine albumin amount to urine creatinine amount (UACR) is shown in FIG. 2.

As can be seen in FIGS. 1 and 2, in the case of the second and third groups to which streptozotocin was administered, compared to the first group to which streptozotocin was not administered, the content of albumin in urine was increased. It was found that kidney disease occurred due to. However, in the case of the third group administered fimasartan, the content of albumin in urine was significantly reduced compared to the second group in which diabetes was induced by streptozotocin.

In general, the most representative symptom of diabetic kidney disease is the detection of albumin in the urine. Fimasartan decreased the amount of albumin in the urine when administered to a subject with diabetic kidney disease. It can be seen that the disease can be prevented or significantly improved.

<Example 2> Confirmation of the preventive and therapeutic effect of fimasartan against diabetic kidney disease 2

After administration of the drug to the first to third groups for 24 weeks, histopathological examination was performed on the rats of each group.

Tissue samples for histopathological examination were prepared by dividing the left kidney and the right kidney. The right kidney was trimmed perpendicular to the auspicious axis, and the left kidney was trimmed parallel to the auspicious axis. The cut tissue was fixed in a 10% neutral formalin solution for 24 hours, and then cut to a thickness of 3 mm. The sample tissue cut to a thickness of 3 mm was embedded in paraffin, and a 4 μm tissue section was prepared using a microtom. After staining with Hematoxylin & Eosin (H&E), histopathological examination was performed using an optical microscope (Olympus, BX41, Japan).

After obtaining 6 tissue samples from the 1st group, 8 from the 2nd group, and 8 from the 3rd group, histopathological examination was performed to confirm the degree of vacuole degeneration and necrosis of the tubules.

In the evaluation of histopathological examination, the degree of lesion was divided into none (0), minimal (1), little (2), moderate (3) and distinct (4), and scores were given, and the results are shown in the following table. It is shown in 1 to 3.

Table 1: Group 1

Table 2: Group 2

Table 3: Group 3

As can be seen in Tables 1 to 3, when looking at the 2nd and 3rd groups to which streptozotocin (STZ) was administered, the 3rd group to which fimasartan was administered was due to public degeneration of the tubules, etc. It was found that the lesion was significantly reduced compared to the second group.

From this, it can be seen that fimasartan can significantly reduce the incidence of lesions in kidney cells that occur in kidney disease caused by diabetes, and fimasartan can significantly delay and improve the progression of diabetic kidney disease.

Claims (6)

As a pharmaceutical composition for preventing or treating diabetic kidney disease, comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof,
The composition reduces proteinuria in a patient,
The pharmaceutical composition that the patient is a diabetic patient with hypertension. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable salt is fimasartan potassium salt. The pharmaceutical composition of claim 1, wherein the hydrate is fimasartan potassium salt trihydrate. The pharmaceutical composition of claim 1, wherein the composition further comprises a pharmaceutically acceptable additive. The pharmaceutical composition of claim 1, wherein the composition is for oral administration. The pharmaceutical composition of claim 1, wherein the composition comprises fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof in an amount of 5% to 60% by weight based on the total weight of the composition.

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