US 2024/0006084 A1 · METHODS FOR TREATMENT OF HYPERTENSION WITH AN ANGIOTENSIN II RECEPTOR BLOCKER PHARMACEUTICAL COMPOSITION

Abstract

A method is provided for lowering blood pressure in a subject in need thereof by administering an angiotensin II receptor blocker pharmaceutical composition to a subject qualified for over-the-counter access to the angiotensin II receptor blocker pharmaceutical composition. In some embodiments, the angiotensin II receptor blocker pharmaceutical composition includes azilsartan medoxomil, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, or valsartan. In some embodiments, the angiotensin II receptor blocker pharmaceutical composition comprises an active ingredient that is (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2′-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate or a pharmaceutically acceptable salt thereof.

Claims61

Dependent claims

1-70. (canceled)

A non-transitory computer readable storage medium, wherein the non-transitory computer readable storage medium stores instructions, which when executed by a computer system, cause a computer system to perform a method of qualifying a human subject for over-the-counter delivery of an angiotensin II receptor blocker pharmaceutical composition for lowering blood pressure, the method comprising:

a) obtaining a plurality of assessment survey results, wherein the plurality of assessment survey results comprises:
whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant,
whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
a systolic blood pressure of the subject,
a diastolic blood pressure of the subject,
an age of the subject,
information required to calculate a risk of atherosclerotic cardiovascular disease for the subject,
whether the subject has ever had an abnormal electrolyte blood level, and
whether the subject has ever had a kidney problem;
and
b) applying an algorithm to the plurality of assessment survey results, wherein the algorithm:
i) runs all or a portion of the plurality of assessment survey results against a plurality of filters, wherein, when a respective filter in a first subset of the plurality of filters is fired, the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective filter in a second subset of the plurality of filters is fired the subject is provided with a warning corresponding to the respective filter, wherein the plurality of assessment filters comprises:
a pregnancy assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject is pregnant or the subject is breastfeeding,
a drug interaction assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
a blood pressure assessment filter that is fired at least when the plurality of assessment survey results indicates the subject is not hypertensive or the subject has severe hypertension,
an age assessment filter that is fired at least when the plurality of assessment survey results indicate the subject is too young to receive the angiotensin II receptor blocker pharmaceutical composition,
a pooled cohort equation assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject has a risk for atherosclerotic cardiovascular disease that is below a floor threshold of risk or the subject has an incalculable risk for atherosclerotic cardiovascular disease,
an electrolyte blood level assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had an abnormal electrolyte blood level, and
a kidney problem assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had a kidney problem;
ii) obtains, when no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of filters;
and
iii) proceeds with a fulfillment process when (1) no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of filters that was fired and that is associated with a warning, wherein the fulfillment process comprises:
storing an indication in a subject profile of an initial order for the angiotensin II receptor blocker pharmaceutical composition,
communicating an over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and
authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure.

22 more elements

A non-transitory computer readable storage medium, wherein the non-transitory computer readable storage medium stores instructions, which when executed by a computer system, cause a computer system to perform a re-fulfillment method comprising, responsive to receiving a re-order request from the subject for the angiotensin II receptor blocker pharmaceutical composition:

(a) obtaining a plurality of reassessment survey results, wherein the plurality of reassessment survey results comprises:
a systolic blood pressure of the subject,
a diastolic blood pressure of the subject,
whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant,
whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
whether the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition,
whether the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and
whether the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition;
and
(b) applying an algorithm to the plurality of reassessment survey results, wherein the algorithm:
i) runs all or a portion of the plurality of reassessment survey results against a plurality of reassessment filters, wherein, when a respective reassessment filter in a first subset of the plurality of reassessment filters is fired, the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective reassessment filter in a second subset of the plurality of reassessment filters is fired the subject is provided with a warning corresponding to the respective filter, wherein the plurality of reassessment filters comprises:
a blood pressure reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject has hypertension,
a pregnancy reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is pregnant or the subject is breastfeeding,
a drug interaction reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
a hypotension reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition,
an electrolyte blood level reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and
a kidney problem reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition;
ii) obtains, when no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of reassessment filters;
and
iii) proceeds with a re-fulfillment process when (1) no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of reassessment filters that was fired and that is associated with a warning, wherein the re-fulfillment process comprises:
storing an indication in the subject profile of a re-order for the angiotensin II receptor blocker pharmaceutical composition,
communicating the over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and
authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, a re-order provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure.

20 more elements

A computer system for qualifying a human subject for over-the-counter delivery of an angiotensin II receptor blocker pharmaceutical composition for lowering blood pressure, the computer system comprising one or more processors and a memory, the memory comprising non-transitory instructions which, when executed by the one or more processors, cause the computer system to perform a method comprising:

a) obtaining a plurality of assessment survey results, wherein the plurality of assessment survey results comprises:
whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant,
whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
a systolic blood pressure of the subject,
a diastolic blood pressure of the subject,
an age of the subject,
information required to calculate a risk of atherosclerotic cardiovascular disease for the subject,
whether the subject has ever had an abnormal electrolyte blood level, and
whether the subject has ever had a kidney problem;
and
b) applying an algorithm to the plurality of assessment survey results, wherein the algorithm:
i) runs all or a portion of the plurality of assessment survey results against a plurality of filters, wherein, when a respective filter in a first subset of the plurality of filters is fired, the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective filter in a second subset of the plurality of filters is fired the subject is provided with a warning corresponding to the respective filter, wherein the plurality of assessment filters comprises:
a pregnancy assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject is pregnant or the subject is breastfeeding,
a drug interaction assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
a blood pressure assessment filter that is fired at least when the plurality of assessment survey results indicates the subject is not hypertensive or the subject has severe hypertension,
an age assessment filter that is fired at least when the plurality of assessment survey results indicate the subject is too young to receive the angiotensin II receptor blocker pharmaceutical composition,
a pooled cohort equation assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject has a risk for atherosclerotic cardiovascular disease that is below a floor threshold of risk or the subject has an incalculable risk for atherosclerotic cardiovascular disease,
an electrolyte blood level assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had an abnormal electrolyte blood level, and
a kidney problem assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had a kidney problem;
ii) obtains, when no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of filters;
and
iii) proceeds with a fulfillment process when (1) no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of filters that was fired and that is associated with a warning, wherein the fulfillment process comprises:
storing an indication in a subject profile of an initial order for the angiotensin II receptor blocker pharmaceutical composition,
communicating an over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and
authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure.

22 more elements

A computer system for requalifying a human subject for over-the-counter delivery of an angiotensin II receptor blocker pharmaceutical composition for lowering blood pressure, the computer system comprising one or more processors and a memory, the memory comprising non-transitory instructions which, when executed by the one or more processor, perform a re-fulfillment method comprising, responsive to receiving a re-order request from the subject for the angiotensin II receptor blocker pharmaceutical composition:

(a) obtaining a plurality of reassessment survey results, wherein the plurality of reassessment survey results comprises:
a systolic blood pressure of the subject,
a diastolic blood pressure of the subject,
whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant,
whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
whether the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition,
whether the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and
whether the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition;
and
(b) applying an algorithm to the plurality of reassessment survey results, wherein the algorithm:
i) runs all or a portion of the plurality of reassessment survey results against a plurality of reassessment filters, wherein, when a respective filter in a first subset of the plurality of reassessment filters is fired the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective filter in a second subset of the plurality of reassessment filters is fired the subject is provided with a warning corresponding to the respective filter, wherein the plurality of reassessment filters comprises:
a blood pressure reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject has hypertension,
a pregnancy reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is pregnant or the subject is breastfeeding,
a drug interaction reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
a hypotension reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition,
an electrolyte blood level reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and
a kidney problem reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition;
ii) obtains, when no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of reassessment filters;
and
iii) proceeds with a re-fulfillment process when (1) no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of reassessment filters that was fired and that is associated with a warning, wherein the re-fulfillment process comprises:
storing an indication in the subject profile of a re-order for the angiotensin II receptor blocker pharmaceutical composition,
communicating the over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and
authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, a re-order provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure.

20 more elements

A method for qualifying a human subject for over-the-counter delivery of an angiotensin II receptor blocker pharmaceutical composition for lowering blood pressure, the method comprising:

a) obtaining a plurality of assessment survey results, via a computer system having a processor programed to receive the assessment survey results, wherein the plurality of assessment survey results comprises:
whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant,
whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
a systolic blood pressure of the subject,
a diastolic blood pressure of the subject,
an age of the subject,
information required to calculate a risk of atherosclerotic cardiovascular disease for the subject,
whether the subject has ever had an abnormal electrolyte blood level, and
whether the subject has ever had a kidney problem;
and
b) applying an algorithm to the plurality of assessment survey results, via a computer system having a processor programmed to perform the algorithm, wherein the algorithm:
i) runs all or a portion of the plurality of assessment survey results against a plurality of filters, wherein, when a respective filter in a first subset of the plurality of filters is fired the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective filter in a second subset of the plurality of filters is fired the subject is provided with a warning corresponding to the respective filter, wherein the plurality of assessment filters comprises:
a pregnancy assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject is pregnant or the subject is breastfeeding,
a drug interaction assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
a blood pressure assessment filter that is fired at least when the plurality of assessment survey results indicates the subject is not hypertensive or the subject has severe hypertension,
an age assessment filter that is fired at least when the plurality of assessment survey results indicates the subject is too young to receive the angiotensin II receptor blocker pharmaceutical composition,
a pooled cohort equation assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject has a risk for atherosclerotic cardiovascular disease that is below a floor threshold of risk or the subject has an incalculable risk for atherosclerotic cardiovascular disease,
an electrolyte blood level assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had an abnormal electrolyte blood level, and
a kidney problem assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had a kidney problem;
ii) obtains, when no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of filters;
and
iii) proceeds with a fulfillment process when (1) no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of filters that was fired and that is associated with a warning, wherein the fulfillment process comprises:
storing an indication in a subject profile of an initial order for the angiotensin II receptor blocker pharmaceutical composition,
communicating an over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and
authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, wherein the authorization includes a destination associated with the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure.

22 more elements

A method for requalifying a human subject for over-the-counter delivery of an angiotensin II receptor blocker pharmaceutical composition for lowering blood pressure, the method comprising:

(a) obtaining a plurality of reassessment survey results, via a computer system having a processor programed to receive the reassessment survey results, wherein the plurality of reassessment survey results comprises:
a systolic blood pressure of the subject,
a diastolic blood pressure of the subject,
whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant,
whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition,
whether the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition,
whether the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and
whether the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition;
and
(b) applying an algorithm to the plurality of reassessment survey results, via a computer system having a processor programmed to perform the algorithm, wherein the algorithm:
i) runs all or a portion of the plurality of reassessment survey results against a plurality of reassessment filters, wherein, when a respective reassessment filter in a first subset of the plurality of reassessment filters is fired the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective reassessment filter in a second subset of the plurality of reassessment filters is fired the subject is provided with a warning corresponding to the respective reassessment filter, wherein the plurality of reassessment filters comprises:
a blood pressure reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject has hypertension,
a pregnancy reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is pregnant or the subject is breastfeeding,
a drug interaction reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition
a hypotension reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition,
an electrolyte blood level reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and
a kidney problem reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition;
ii) obtains, when no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of reassessment filters;
and
iii) proceeds with a re-fulfillment process when (1) no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of reassessment filters that was fired and that is associated with a warning, wherein the re-fulfillment process comprises:
storing an indication in the subject profile of a re-order for the angiotensin II receptor blocker pharmaceutical composition,
communicating the over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and
authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, a re-order provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure.

20 more elements

Dependencies are inferred from the claim text.

Methods for treatment of hypertension with an angiotensin ii receptor blocker pharmaceutical composition

Life of this patent

Methods for treatment of hypertension with an angiotensin ii receptor blocker pharmaceutical composition

Life of this patent

Abstract

Claims61