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Details for Patent: 5,830,895

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Details for Patent: 5,830,895

Title: Methods for the determination and adjustment of prolactin daily rhythms
Abstract:Methods for detecting abnormalities in prolactin daily rhythms of a subject are provided. Prolactin levels of a subject are compared to levels of healthy subjects and based on the comparison a determination is made of the adjustments necessary to normalize the subject's daily prolactin rhythm. Also provided are methods for normalizing a subject's daily prolactin rhythm.
Inventor(s): Cincotta; Anthony H. (Andover, MA), Meier; Albert H. (Baton Rouge, LA)
Assignee: The Board of Supervisors of Louisiana State University and Agricultural and Mechanical College (Baton Rouge, LA) N/A (Wakefield, RI) Ergo Research Corporation (N/A)
Filing Date:Jun 01, 1995
Application Number:08/456,952
Claims:1. A method for normalizing the daily prolactin rhythm in a first subject having an abnormal prolactin daily rhythm which comprises the steps of:

comparing a prolactin profile obtained from predetermined prolactin levels of said first subject to a prolactin profile of healthy subjects of the same species; and

adjusting the prolactin profile of said first subject to generally conform to or approach the prolactin profile of healthy subjects, thereby normalizing said rhythm, wherein said adjusting step comprises at least one of:

administering to said first subject a first predetermined amount of a prolactin inhibitor at a first predetermined time during waking hours at which the subject's prolactin level is higher than said healthy subjects' prolactin level by more than 1 SEM; and

administering to said first subject a second predetermined amount of a prolactin stimulator at a second predetermined time prior to a time point in said prolactin profile of said first subject at which said subject's sleeptime prolactin level is lower than 1 SEM below said healthy subjects' prolactin level.

2. A method for determining adjustments that will cause an abnormal daily prolactin rhythm of a patient to conform to or approach a healthy subject's daily prolactin rhythm, which comprises:

a. comparing a prolactin profile obtained from predetermined prolactin levels of a patient to a predetermined standard prolactin profile for healthy human subjects of the same sex as said patient;

b. determining that said patient should be administered a prolactin inhibitor when at any time point during waking hours the patient's prolactin level exceeds the prolactin level of healthy subjects at the same time point by more than 1 SEM;

c. selecting at least one time for administration to said patient of said prolactin inhibitor that is no later than the time at which the prolactin level of said patient during waking hours reaches its highest waking hours level; and

d. selecting the amount of said prolactin inhibitor to be administered to said patient so that the prolactin profile of said patient during waking hours generally conforms to or approaches the prolactin profile of healthy subjects during waking hours, thereby causing the patient's abnormal daily prolactin rhythm to conform to or approach said healthy subject' daily prolactin rhythm.

3. The method of claim 2 wherein said prolactin inhibitor is bromocriptine and said subject is a human.

4. The method of claim 3 wherein said bromocriptine is administered at least once between 06:00 and 12:00 h.

5. The method of claim 4 wherein said bromocriptine is administered at a total daily amount within the range of 0.8-8.0 mg.

6. The method of claim 5 wherein at least a portion of said bromocriptine is administered at 6:00 AM.

7. A method for determining adjustments that will cause an abnormal daily prolactin rhythm of a first subject to conform to or approach the daily prolactin rhythm of healthy subjects, comprising:

a. comparing a prolactin profile obtained from predetermined prolactin levels of a first subject to a predetermined standard prolactin profile for healthy subjects;

b. determining that said first subject is in need of administration of a prolactin stimulator by ascertaining that the prolactin level of said first subject at any time point during sleeptime is at least 1 SEM lower than the prolactin level of said healthy subjects at the same time point;

c. selecting the timing of said administration to said first subject to be prior to the time at which the sleeptime prolactin level reaches its peak in healthy subjects; and

d. selecting an amount of said prolactin stimulator to be administered to said first subject such that the prolactin profile of said first subject during sleeptime generally conforms to or approaches the prolactin profile of said healthy subjects during sleeptime, thereby causing said first subject's abnormal daily prolactin rhythm to conform to or approach the daily prolactin rhythm of healthy subjects.

8. A method for normalizing the daily prolactin rhythm in a first subject having an abnormal prolactin daily rhythm which comprises the steps of:

comparing a set of key predetermined prolactin levels of said subject to a corresponding set of prolactin levels of healthy subjects of the same species at the same time points as said key levels; and

adjusting the prolactin rhythm of said first subject to generally conform to or approach the prolactin rhythm of said healthy subjects and thereby normalize said rhythm, wherein said adjusting step comprises at least one of:

administering to said first subject a prolactin inhibitor if at least one key predetermined prolactin level of said first subject during waking hours is higher than 1 SEM above the corresponding prolactin level of said healthy subjects; and

administering to said first subject a prolactin stimulator if at least one key prolactin level of said first subject during night time is lower than 1 SEM below the corresponding prolactin level of said healthy subjects.

9. The method of claim 8 wherein said prolactin inhibitor is bromocriptine and said subject is a human.

10. The method of claim 9 wherein said bromocriptine is administered at least once between 06:00 and 13:00 h.

11. The method of claim 10 wherein said bromocriptine is administered at a total daily amount within the range of 0.8-8.0 mg.

12. The method of claim 11 wherein at least a portion of said bromocriptine is administered at 6:00 AM.

13. A method for determining adjustments that will cause an abnormal daily prolactin rhythm of a patient to conform to or approach a healthy subject's daily prolactin rhythm, which comprises:

a. comparing a set of key predetermined prolactin levels of said patient to corresponding standard prolactin levels at the same time points for healthy human subjects of the same sex as said patient;

b. determining that said patient should be administered a prolactin inhibitor when at least one key prolactin level of said patient exceeds the corresponding prolactin level of healthy subjects at the same time point by more than 1 SEM;

c. selecting at least one time for administration to said patient of said prolactin inhibitor that is between 06:00 h and 12:00 h; and

d. selecting the amount or amounts of said prolactin inhibitor to be administered to said patient so that at least one key prolactin level of said patient during waking hours will conform to or approach the corresponding prolactin level of healthy subjects, thereby causing the patient's abnormal prolactin daily rhythm to conform to or approach a healthy subject's daily prolactin rhythm.

14. A method for determining adjustments that will cause an abnormal daily prolactin rhythm of a first subject to conform to or approach the daily prolactin rhythm of a healthy subject, comprising:

a. comparing a set of key predetermined prolactin levels of said first subject to a set of predetermined prolactin levels obtained from a standard prolactin profile for healthy subjects;

b. determining that said first subject is in need of administration of a prolactin stimulator by ascertaining that a least one key prolactin level of said first subject during sleeptime is at least 1 SEM lower than the prolactin level of said healthy subjects during sleeptime;

c. selecting the timing of said administration to said first subject to be prior to the time at which the sleeptime prolactin level reaches its peak in healthy subjects; and

d. selecting an amount of said prolactin stimulator to be administered to said first subject such that at least one key prolactin level of said first subject during sleeptime is no lower than 1 SEM below the corresponding prolactin level of said healthy subjects at the same time point, thereby causing the first subject's abnormal daily prolactin rhythm to conform to or approach the daily prolactin rhythm of a healthy subject.

15. A method for determining whether a vertebrate test subject having a daily prolactin rhythm is in need of administration of one or more prolactin modulators that will cause an abnormal daily prolactin rhythm to approach or conform to a healthy subject's daily prolactin rhythm, which comprises the steps of:

(a) measuring a blood prolactin level of the vertebrate test subject at least once at a predetermined time point during a day time interval selected from at least one of early morning and early evening;

(b) comparing the measured prolactin level of said test subject to a corresponding predetermined standard prolactin level for healthy subjects of the same species at the same day time point; and

(c) determining that the test subject should be administered a prolactin inhibitor to decrease daytime prolactin levels of the subject, and thereby cause the test subject's prolactin rhythm to conform to or approach a healthy subject's prolactin rhythm, in the event that:

(i) said prolactin level of said test subject obtained from a single measurement in one of said intervals exceeds the corresponding standard prolactin level of healthy subjects at the same day time point by more than 2 standard errors of the mean, or

(ii) each of at least two of said prolactin levels of said test subject measured in one of said intervals exceeds the corresponding prolactin level of healthy subjects at the same day time point by more than 1 standard error of the mean.

16. The method of claim 15 further comprising the steps of:

(d) measuring a blood prolactin level of the test subject at least once at a predetermined time point during the night to obtain a night prolactin level;

(e) comparing said night prolactin level of the test subject to a corresponding predetermined standard night prolactin level for healthy subjects of the same species at the same night time point; and

(f) determining that the test subject should be administered a prolactin stimulator to increase night time prolactin levels of the subject, and thereby cause the test subject's prolactin rhythm to further conform to or approach a healthy subject's prolactin rhythm, in the event that;

(i) said night prolactin level of said test subject obtained from a single measurement is lower than the corresponding standard night prolactin level of healthy subject is by more than 2 standard errors of the mean, or

(ii) each of at least two of said night prolactin levels of said test subject is lower than the corresponding standard night prolactin level of healthy subjects by more than 1 standard error of the mean.

17. The method of claim 16 wherein in steps (b) and (e), the healthy subjects are of the same sex as the test subject.

18. The method of claim 15 which comprises measuring said blood prolactin level twice in early morning.

19. The method of claim 15 which comprises measuring said blood prolactin level twice in early evening.

20. The method of claim 15 which comprises measuring said blood prolactin level twice in early morning and twice in early evening.

21. The method of claim 15 which comprises measuring said blood prolactin level once in early morning and once in early evening.

22. The method of claim 15 wherein said human subject suffers from Type II diabetes.

23. The method of claim 15 wherein said human subject suffers from obesity.

24. The method of claim 15 wherein said human subject suffers from hyperlipidemia.

25. A method for identifying in a group of human subjects being tested a test subject in need of administration of one or more prolactin modulators that will cause an abnormal daily prolactin rhythm of said test subject to approach or conform to a healthy subject's daily prolactin rhythm, which comprises the steps of:

(a) measuring the blood prolactin levels of said subjects being tested at least once at a predetermined time point during a day time interval selected from one or more of early morning and early evening;

(b) comparing a prolactin level of each subject being tested to a corresponding standard prolactin level for healthy subjects of the same species at the same day time point; and

(c) determining that a test subject should be administered a prolactin inhibitor to decrease daytime prolactin levels of the test subject, and thereby cause the test subject's abnormal daily prolactin rhythm to conform to or approach a healthy subject's daily prolactin rhythm, in the event that:

(i) a prolactin level of said test subject obtained from a single measurement in one of said intervals exceeds the corresponding standard prolactin level of healthy subjects at the same day time point by more than 2 standard errors of the mean, or

(ii) each of at least two prolactin levels of said test subject measured in one of said intervals exceeds the prolactin level of healthy subjects at the same day time point by more than 1 standard error of the mean.

26. The method of claim 25 further comprising the steps of:

(d) measuring a blood prolactin level of said test subject at least once at a predetermined time point during the night to obtain a night prolactin level;

(e) comparing said night prolactin level of said test subject to a corresponding predetermined standard night prolactin level for healthy subjects of the same species at the same night time point; and

(f) determining that the test subject should be administered a prolactin stimulator to increase night time prolactin levels of the subject, and thereby cause the test subject's abnormal daily prolactin rhythm to further conform to or approach a healthy subject's daily prolactin rhythm, in the event that:

(i) a night prolactin level of said test subject obtained from a single measurement is lower than the corresponding standard night prolactin level of healthy subjects by more than 2 standard errors of the mean, or

(ii) each of at least two night prolactin levels of said test subject is lower than the corresponding standard night prolactin level of healthy subjects by more than 1 standard error of the mean.

27. The method of claim 25 wherein in steps (b) and (e), the healthy subjects are of the same sex as the test subject.

28. The method of claim 25 which comprises measuring said blood prolactin level twice in early morning.

29. The method of claim 25 which comprises measuring said blood prolactin level twice in early evening.

30. The method of claim 25 which comprises measuring said blood prolactin level twice in early morning and twice in early evening.

31. The method of claim 25 which comprises measuring said blood prolactin level once in early morning and once in early evening.

32. The method of claim 25 wherein said subjects being tested suffer from Type II diabetes.

33. The method of claim 25 wherein said subjects being tested suffer from obesity.

34. The method of claim 25 wherein said subjects being tested suffer from hyperlipidemia.

35. A method for determining whether a human subject is in need of administration of one or more prolactin modulators that will cause an abnormal daily prolactin rhythm of said human subject to approach or conform to a healthy subject's daily prolactin rhythm, which comprises the steps of:

(a) collecting blood samples from a human subject at least once at a predetermined time point during a time interval selected from at least one of early morning and early evening;

(b) measuring the prolactin content of each of said samples;

(c) plotting the prolactin content of each of said samples against the time at which said sample was collected to generate a daytime key prolactin level data point;

(d) comparing said daytime key prolactin level data point to a corresponding predetermined standard prolactin level for healthy subjects at the same day time point; and

(e) determining that the human subject should be administered a prolactin inhibitor to decrease daytime prolactin levels of the subject, and thereby cause an abnormal daily prolactin rhythm of the human subject to conform to or approach a healthy subject's daily prolactin rhythm, in the event that:

(i) said prolactin level of said human subject obtained from a single measurement in one of said intervals exceeds the standard prolactin level of healthy subjects at the same day time point by more than 2 standard errors of the mean, or

(ii) each of at least two prolactin levels of said human subject measured in one of said intervals exceeds the prolactin level of healthy subjects at the same time point by more than 1 standard error of the mean.

36. The method of claim 35 further comprising the steps of:

(f) collecting a blood sample from the human subject at least once at a predetermined time point during the night;

(g) measuring the prolactin content of each of said samples to obtain a night prolactin level;

(h) comparing each of said night prolactin levels of said human subject to a predetermined standard night prolactin level for healthy subjects at the same night time point; and

(i) determining that the human subject should be administered a prolactin stimulator to increase night time prolactin levels of the subject, and thereby cause the human subject's abnormal daily prolactin rhythm to further conform to or approach a healthy subject's daily prolactin rhythm, in the event that:

(i) said night prolactin level of said human subject obtained from a single measurement is lower than the corresponding standard night prolactin level of healthy subjects by more than 2 standard errors of the mean, or

(ii) each of at least two night prolactin levels of said human subject is lower than the corresponding standard night prolactin level of healthy subjects by more than 1 standard error of the mean.

37. The method of claim 35 wherein in steps (d) and (h), the healthy subjects are of the same sex as the human subject.

38. The method of claim 35 which comprises measuring said blood prolactin level twice in early morning.

39. The method of claim 35 which comprises measuring said blood prolactin level twice in early evening.

40. The method of claim 35 which comprises measuring said blood prolactin level twice in early morning and twice in early evening.

41. The method of claim 35 which comprises measuring said blood prolactin level once in early morning and once in early evening.

42. The method of claim 35 wherein said human subject suffers from Type II diabetes.

43. The method of claim 35 wherein said human subject suffers from obesity.

44. The method of claim 35 wherein said human subject suffers from hyperlipidemia.

45. A method for determining whether a vertebrate subject having a daily prolactin rhythm is in need of administration of one or more prolactin stimulators that will cause an abnormal daily prolactin rhythm to approach or conform to a healthy subject's daily prolactin rhythm, which comprises the steps of:

(a) measuring the blood prolactin level of a vertebrate subject at least once at a predetermined time point during the night to obtain a night prolactin level;

(b) comparing said night prolactin level of said vertebrate subject to a corresponding predetermined standard night prolactin level for healthy subjects of the same species at the same night time point; and

(c) determining that the vertebrate subject should be administered a prolactin stimulator to increase night time prolactin levels of the subject in the event that:

(i) said night prolactin level of the vertebrate subject obtained from single measurement is lower than the corresponding standard night prolactin level of healthy subjects by more than 2 standard errors of the mean, or

(ii) each of at least two of said night prolactin levels of said vertebrate subject is lower than the corresponding standard night prolactin level of healthy subjects by more than 1 standard error of the mean.

46. A method for normalizing the daily prolactin rhythm in a first subject having an abnormal prolactin daily rhythm in that the subject has at least one of the following:

(i) at least one key prolactin level at any time point during sleeptime that is at least 1 SEM lower than the prolactin level of healthy subjects at the same time point; and

(ii) at least one key prolactin level at any time point during waking hours that exceeds the corresponding prolactin level of healthy subjects at the same time point by more than 1 SEM;

the method comprising at least one of:

administering to said first subject a first predetermined amount of a prolactin inhibitor at least once between 06:00 and 12:00 h; and

administering to said first subject a second predetermined amount of a prolactin stimulator at about one hour before said subject's bedtime

thereby normalizing said daily prolactin rhythm in said first subject.

47. The method of claim 46 wherein said prolactin inhibitor is bromocriptine and said first subject is a human.

48. The method of claim 47 wherein said bromocriptine is administered at a total daily amount within the range of 0.8-8.0 mg.

49. The method of claim 48 wherein at least a portion of said bromocriptine is administered at 6:00 AM.
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