Method of treating metabolic disorders and depression with dopamine receptor agonists
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Publication Number
US-11241429-B2
Publication Date
2022-02-08
Expiration Date
Abstract
This invention relates to methods and formulations for treating metabolic disorders and depression. In some embodiments, the methods comprise administering a dopamine receptor agonist and an anti-depressant.
Core Innovation
The invention relates to simultaneously treating a patient afflicted with a cardiovascular disease and depression by administering a therapeutically effective amount of a dopamine receptor agonist selected from lisuride, terguride, dihydroergotoxine (hydergine), and bromocriptine at a predetermined time of day. The predetermined time of day is in the morning in one aspect of the invention, and the simultaneous treatment is for both the cardiovascular disease and depression.
The invention further defines administration timing relative to sleep and circadian rhythm, including that the predetermined time of day is before bedtime and that the dopamine agonist is released substantially within 2 hours of waking. The cardiovascular disease is a member selected from arteriosclerosis, coronary artery disease, cerebrovascular disease, and peripheral vascular disease.
As described in the document, dopamine receptor agonists are used with attention to day/night timing, including morning dosing after waking and timing that corresponds to circadian rhythm. An Example described includes a 52-week double-blind randomized safety trial using morning Cycloset (bromocriptine mesylate quick-release) in a Type 2 diabetes population, with outcomes reported for cardiovascular composites and depression-related adverse event reporting versus placebo, alongside reported improvement in HbA1c in relevant subgroups.
Claims Coverage
The independent claims are directed to simultaneously treating a selected cardiovascular disease and depression using a dopamine receptor agonist administered at a predetermined time of day, with timing constraints relative to the morning and waking (Claim 1) and constraints requiring administration before bedtime with release substantially within 2 hours of waking (Claim 15).
Simultaneous treatment of cardiovascular disease and depression with morning dopamine receptor agonist
Administering to a patient in need of such treatment a therapeutically effective amount of a dopamine receptor agonist selected from lisuride, terguride, dihydroergotoxine (hydergine), and bromocriptine at a predetermined time of day, wherein the predetermined time of day is in the morning.
Simultaneous treatment with before-bedtime dopamine receptor agonist released within 2 hours of waking
Administering to a patient in need of such treatment a therapeutically effective amount of a dopamine receptor agonist selected from lisuride, terguride, dihydroergotoxine (hydergine), and bromocriptine at a predetermined time of day wherein the predetermined time of day is before bedtime and the dopamine agonist is released substantially within 2 hours of waking.
Overall, the claim coverage centers on giving a dopamine receptor agonist from the specified list as part of a simultaneous cardiovascular-disease-and-depression treatment regimen, with the key inventive distinction being morning timing in one independent claim versus pre-bedtime timing combined with release substantially within 2 hours of waking in the other independent claim.
Stated Advantages
Improved cardiovascular composite outcomes versus placebo in the described Example 1 safety trial.
Reduced depression-related adverse event reporting versus placebo in the described Example 1 safety trial.
Improved HbA1c in relevant subgroups in the described Example 1.
Documented Applications
A 52-week double-blind randomized safety trial using morning Cycloset (bromocriptine mesylate quick-release) in Type 2 diabetes, with reported cardiovascular composite outcomes and depression-related adverse event reporting versus placebo, and reported HbA1c improvement in relevant subgroups.
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