Novel Combination Containing a Stimulator of Soluble Guanylate Cyclase and a Lipid-Lowering Substance

1 . A combination product comprising as pharmaceutically active ingredients at least one active ingredient component A and at least one active ingredient component B, wherein active ingredient component A is a direct stimulator of soluble guanylate cyclase having the formula (I)

in which

R 1 is —NR 3 C(═O)OR 4 ,

R 2 is hydrogen or NH 2 ,

R 3 is hydrogen or (C 1 -C 4 )-alkyl,

R 4 is (C 1 -C 6 )-alkyl,

and active ingredient component B is a lipid-lowering agent.

2 . The combination product as claimed in claim 1 ,

wherein

R 1 is —NR 3 C(═O)OR 4 ,

R 2 is NH 2 ,

R 3 is methyl or ethyl, and

R 4 is methyl, ethyl or isopropyl.

3 . The combination product as claimed in claim 1 , wherein the direct stimulator of soluble guanylate cyclase of the formula (I) has the following structure:

4 . (canceled)

5 . (canceled)

6 . The combination product as claimed in any of claims 1 to 3 , wherein the active ingredient components A and B are in the form of a functional unit.

7 . The combination product as claimed in claim 1 , wherein the active ingredient components A and B are (spatially) separate from one another, in the form of a kit of parts.

8 . The combination product as claimed in claim 1 , wherein the lipid-lowering agent (active ingredient component B) is selected from the group consisting of (a) HMG-CoA-reductase inhibitors; (b) squalene synthase inhibitors; (c) bile acid absorption inhibitors (bile acid sequestrants); (d) fibric acid and its derivatives; (e) nicotinic acid and its analogs; and (f) ω3-fatty acids.

9 . The combination product as claimed in claim 8 , wherein the lipid-lowering agent (active ingredient component B) is an HMG-CoA reductase inhibitor and is selected from the group of statins.

10 . The combination product as claimed in claim 26 , wherein the lipid-lowering agent (active ingredient component B) is atorvastatin or its salt, hydrate, alcoholate, ester or tautomer.

11 . The combination product as claimed in claim 26 , wherein the lipid-lowering agent (active ingredient component B) is cerivastatin or its salt, hydrate, alcoholate, ester and or tautomer.

12 . A method for increasing the efficacy of direct soluble guanylate cyclase stimulators of the formula (I) as defined in claim 1 comprising administering a lipid-lowering agent in conjunction with said direct soluble guanylate cyclase stimulator of formula (I).

13 . A process for producing compositions as claimed in claim 1 , comprising converting at least one lipid-lowering agent and at least one direct soluble guanylate cyclase stimulator of the formula (I), where appropriate with conventional excipients and additives, into a suitable administration form.

14 . A method for the treatment of cardiovascular disorders comprising administering an effective amount of a combination of a direct stimulator of soluble guanylate cyclase of formula (I) and a lipid-lowering agent as defined in claim 1 , 2 , 3 , 6 , 7 , 8 , 9 , 10 , or 11 .

15 . A method for the treatment of hypertension comprising administering an effective amount of a combination of a direct stimulator of soluble guanylate cyclase of formula (I) and a lipid-lowering agent as defined in claim 1 , 2 , 3 , 6 , 7 , 8 , 9 , 10 , or 11 .

16 . A method for the treatment of thromboembolic disorders and ischemias comprising administering an effective amount of a combination of a direct stimulator of soluble guanylate cyclase of formula (I) and a lipid-lowering agent as defined in claim 1 , 2 , 3 , 6 , 7 , 8 , 9 , 10 , or 11 .

17 . A method for the treatment of sexual dysfunction comprising administering an effective amount of a combination of a direct stimulator of soluble guanylate cyclase of formula (I) and a lipid-lowering agent as defined in claim 1 , 2 , 3 , 6 , 7 , 8 , 9 , 10 , or 11 .

18 . A method for the treatment of arteriosclerosis comprising administering an effective amount of a combination of a direct stimulator of soluble guanylate cyclase of formula (I) and a lipid-lowering agent as defined in claim 1 , 2 , 3 , 6 , 7 , 8 , 9 , 10 , or 11 .

19 . A method for the treatment of osteoporosis comprising administering an effective amount of a combination of a direct stimulator of soluble guanylate cyclase of formula (I) and a lipid-lowering agent as defined in claim 1 , 2 , 3 , 6 , 7 , 8 , 9 , 10 , or 11 .

20 . A method for the treatment of inflammation comprising administering an effective amount of a combination of a direct stimulator of soluble guanylate cyclase of formula (I) and a lipid-lowering agent as defined in claim 1 , 2 , 3 , 6 , 7 , 8 , 9 , 10 , or 11 .

21 . A method for the treatment of central nervous system disorders comprising administering an effective amount of a combination of a direct stimulator of soluble guanylate cyclase of formula (I) and a lipid-lowering agent as defined in claim 1 , 2 , 3 , 6 , 7 , 8 , 9 , 10 , or 11 .

22 . The method as claimed in any of claims 14 to 21 , where the direct stimulator of soluble guanylate cyclase of formula (I) and the lipid-lowering agent are employed in combination with organic nitrates or NO donors or in combination with compounds which inhibit the breakdown of cyclic guanosine monophosphate (cGMP).

23 . The combination product as claimed in claim 6 wherein said functional unit is a mixture, mix, or blend.

24 . The combination product of claim 7 wherein the separation of active ingredient components A and B permits them to be separately administered either simultaneously or sequentially.

25 . The combination product of claim 24 wherein the separation of active ingredient components A and B permits them to be separately administered sequentially.

26 . The combination product as claimed in claim 8 , wherein the lipid-lowering agent is selected from the group of statins consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, pitavastatin, simvastatin and rosuvastatin, and their respective salts, hydrates, alcohols, esters and tautomers