# US 2013/0158084 A1 · Pharmaceutical Composition Comprising Losartin For Treating or Preventing Statin BasedGrug-Induced Muscle Toxicity

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- Number: US 2013/0158084 A1
- Document ID: US20130158084A1
- Status: Published application
- Kind: A1
- Application number: 13/433,000
- Filed: 2012-03-28
- Published: 2013-06-20
- Earliest claimed: 2011-12-16
- Assignees: Hanall Biopharma Co., Ltd.
- Inventors: Sung Wuk KIM; Seong Choon CHOE; Chang Hee MIN; Soon Im LEE; Ja Seong KOO; Sang Ouk SUN; Na Young LEE
- Web page: https://patentgrep.com/patent/US20130158084A1

## CPC

- A61K 31/4178: not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61K 31/351: not condensed with another ring
- A61K 31/402: 1-aryl substituted, e.g. piretanide
- A61P 9/12: Antihypertensives
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A pharmaceutical composition comprising losartan or a pharmaceutically acceptable salt thereof, which is capable of treating or preventing side effects such as muscle toxicity caused by administering a statin-based lipid-lowering drug, and a pharmaceutical combination composition comprising a statin drug and a losartan drug as active ingredients are provided. The pharmaceutical composition comprising losartan or a pharmaceutically acceptable salt thereof provides an effect on treating or preventing muscle-related side effects caused by administration of a statin drug for treating hyperlipidemia, as well as an intrinsic pharmacological effect for treating or preventing hypertension. When administered along with a statin drug in sequence or co-administered at the same time with the statin drug, the pharmaceutical composition can exhibit an effect of effectively or significantly decreasing or preventing side effects such as muscle toxicity.

## Claims

### Claim 1

A pharmaceutical composition for treating or preventing muscular side effects caused by a statin-based lipid-lowering drug, comprising losartan or a pharmaceutically acceptable salt thereof as an active ingredient.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the losartan or pharmaceutically acceptable salt thereof is administered with the statin-based lipid-lowering drug at the same time or in sequence.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further provides a medicinal use for treating or preventing hypertension.

### Claim 4 (depends on 1)

The pharmaceutical composition of claim 1, wherein the muscular side effects caused by the statin-based lipid-lowering drug include at least one selected from the group consisting of myositis, myopathy, rhabdomyolysis and myalgia.

### Claim 5 (depends on 1)

The pharmaceutical composition of claim 1, wherein the statin-based lipid-lowering drug is at least one selected from the group consisting of simvastatin, lovastatin, atorvastatin, pitavastatin, rosuvastatin, fluvastatin, pravastatin, and pharmaceutically acceptable salts thereof.

### Claim 6 (depends on 1)

The pharmaceutical composition of claim 1, wherein the total dosage of the losartan or pharmaceutically acceptable salt thereof is 0.1 mg to 2,000 mg a day.

### Claim 7 (depends on 1)

The pharmaceutical composition of claim 1, wherein the total dosage of the losartan or pharmaceutically acceptable salt thereof is 0.5 mg to 1,000 mg a day.

### Claim 8 (depends on 1)

The pharmaceutical composition of claim 1, wherein the total dosage of the losartan or pharmaceutically acceptable salt thereof is 1.0 mg to 500 mg a day.

### Claim 9 (depends on 1)

The pharmaceutical composition of claim 1, wherein the losartan or a pharmaceutically acceptable salt thereof is losartan potassium salt.

### Claim 10

A pharmaceutical composition for treating or preventing muscular side effects caused by a statin-based lipid-lowering drug, and decreasing lipids, comprising losartan or a pharmaceutically acceptable salt thereof, and the statin-based lipid-lowering drug as active ingredients.

### Claim 11 (depends on 10)

The pharmaceutical composition of claim 10, wherein the pharmaceutical composition further provides a medicinal use for treating or preventing hypertension.

### Claim 12 (depends on 10)

The pharmaceutical composition of claim 10, wherein the pharmaceutical composition is formulated into a general combination formulation or a timed-release combination formulation.

### Claim 13 (depends on 10)

The pharmaceutical composition of claim 10, wherein the timed-release combination formulation first releases the statin-based lipid-lowering drug and then later releases the losartan.