Pharmacology

More than 50% of patients taking an anticholinergic drug for symptoms of overactive bladder (OAB) stop taking their medicine—and at least half of those stop within the first 6 months. Two-thirds of patients never start again. That’s according to a study by researchers from Beaumont Hospital in Royal Oak, Michigan; Xcenda, LLC in Palm Harbor, Florida; and Allergan, Inc. in Irvine, California, who analyzed medical, pharmacy, and other data from the IMS LifeLink Health Plan Claims Database of 103,250 patients with OAB.

Anticholinergic drugs included oxybutynin, tolterodine, trospium, fesoterodine, and solifenacin, but 42% of patients received tolterodine extended release (ER) as their index prescription. To be considered a discontinuation, the patient had to have a gap of at least 45 days in therapy, based on fill dates and days’ supply. The corresponding time to treatment failure (TTF) was estimated as the number of days between the index date and the date of the first medication switch or estimated discontinuation date. Treatment reinitiation was defined as the documentation of a filled prescription for any anticholinergic agent after a discontinuation period of at least 45 days. The researchers in this study used claims data to avoid the problem of self-reported adherence, since patients often overstate their adherence to medications.

Initial treatment with the index drug failed in nearly all (92%) patients. Of those, only 6% were associated with switching drugs. More than half had permanently stopped all anticholinergic drugs at 24 months. Moreover, 33% of patients filled only 1 prescription, suggesting early failure (within the first 30 days).

The proportion of treatment failures was high across all primary diagnoses, ranging from 89% to 97%. Failure was also high regardless of the therapy. For instance, 90% of 43,902 patients on tolterodine ER and 96% of 2,246 patients on oxybutynin transdermal did not meet treatment goals. The researchers then took those numbers and pooled outcomes across all drugs to estimate the overall impact of anticholinergic treatment for patients with OAB and found that the mean TTF was 159 days.

Many patients (81%) who switched treatment during the 24-month study period also had no luck with the second drug. Treatment also failed for 29% who tried a third drug. Treatment failure didn’t always stop them from trying, though: About one-third started treatment again after a gap of at least 45 days, and about one-fifth restarted after 1 year.

Empirical studies of medications to treat chronic conditions have found persistence to OAB medications to be very low, the researchers say. When compared with oral antidiabetic drugs, angiotensin receptor blockers, statins, bisphosphonates, and prostaglandins, OAB medications had the lowest persistence rates at 6 months: 32% compared with 72% for oral antidiabetes drugs.

In research of patients with OAB, achievement of treatment goals is a strong predictor of treatment satisfaction, and dissatisfaction with treatment outcomes is the most common reason for patients stopping their treatment. Poor adherence to OAB drugs can have a negative impact on quality of life and increase the risk of medical sequelae, such as urinary tract infections. Thus, when anticholinergics fail, the researchers say, it’s important to give patients options, such as botulinum toxin A, sacral neuromodulation, and percutaneous tibial nerve stimulation.

Despite the “potential for better adherence” with some anticholinergic drugs, their findings suggest that the benefits of anticholinergic use in OAB are not being realized, and many patients may end up without any drug therapy at all.

Source
Chancellor MB, Migliaccio-Walle K, Bramley TJ, Chaudhari SL, Corbell C, Globe D. Clin Ther. 2013;35(11):1744-1751.
doi: 10.1016/j.clinthera.2013.08.017.

More than 50% of patients taking an anticholinergic drug for symptoms of overactive bladder (OAB) stop taking their medicine—and at least half of those stop within the first 6 months. Two-thirds of patients never start again. That’s according to a study by researchers from Beaumont Hospital in Royal Oak, Michigan; Xcenda, LLC in Palm Harbor, Florida; and Allergan, Inc. in Irvine, California, who analyzed medical, pharmacy, and other data from the IMS LifeLink Health Plan Claims Database of 103,250 patients with OAB.

Anticholinergic drugs included oxybutynin, tolterodine, trospium, fesoterodine, and solifenacin, but 42% of patients received tolterodine extended release (ER) as their index prescription. To be considered a discontinuation, the patient had to have a gap of at least 45 days in therapy, based on fill dates and days’ supply. The corresponding time to treatment failure (TTF) was estimated as the number of days between the index date and the date of the first medication switch or estimated discontinuation date. Treatment reinitiation was defined as the documentation of a filled prescription for any anticholinergic agent after a discontinuation period of at least 45 days. The researchers in this study used claims data to avoid the problem of self-reported adherence, since patients often overstate their adherence to medications.

Initial treatment with the index drug failed in nearly all (92%) patients. Of those, only 6% were associated with switching drugs. More than half had permanently stopped all anticholinergic drugs at 24 months. Moreover, 33% of patients filled only 1 prescription, suggesting early failure (within the first 30 days).

The proportion of treatment failures was high across all primary diagnoses, ranging from 89% to 97%. Failure was also high regardless of the therapy. For instance, 90% of 43,902 patients on tolterodine ER and 96% of 2,246 patients on oxybutynin transdermal did not meet treatment goals. The researchers then took those numbers and pooled outcomes across all drugs to estimate the overall impact of anticholinergic treatment for patients with OAB and found that the mean TTF was 159 days.

Many patients (81%) who switched treatment during the 24-month study period also had no luck with the second drug. Treatment also failed for 29% who tried a third drug. Treatment failure didn’t always stop them from trying, though: About one-third started treatment again after a gap of at least 45 days, and about one-fifth restarted after 1 year.

Empirical studies of medications to treat chronic conditions have found persistence to OAB medications to be very low, the researchers say. When compared with oral antidiabetic drugs, angiotensin receptor blockers, statins, bisphosphonates, and prostaglandins, OAB medications had the lowest persistence rates at 6 months: 32% compared with 72% for oral antidiabetes drugs.

In research of patients with OAB, achievement of treatment goals is a strong predictor of treatment satisfaction, and dissatisfaction with treatment outcomes is the most common reason for patients stopping their treatment. Poor adherence to OAB drugs can have a negative impact on quality of life and increase the risk of medical sequelae, such as urinary tract infections. Thus, when anticholinergics fail, the researchers say, it’s important to give patients options, such as botulinum toxin A, sacral neuromodulation, and percutaneous tibial nerve stimulation.

Despite the “potential for better adherence” with some anticholinergic drugs, their findings suggest that the benefits of anticholinergic use in OAB are not being realized, and many patients may end up without any drug therapy at all.

Source
Chancellor MB, Migliaccio-Walle K, Bramley TJ, Chaudhari SL, Corbell C, Globe D. Clin Ther. 2013;35(11):1744-1751.
doi: 10.1016/j.clinthera.2013.08.017.

More than 50% of patients taking an anticholinergic drug for symptoms of overactive bladder (OAB) stop taking their medicine—and at least half of those stop within the first 6 months. Two-thirds of patients never start again. That’s according to a study by researchers from Beaumont Hospital in Royal Oak, Michigan; Xcenda, LLC in Palm Harbor, Florida; and Allergan, Inc. in Irvine, California, who analyzed medical, pharmacy, and other data from the IMS LifeLink Health Plan Claims Database of 103,250 patients with OAB.

Anticholinergic drugs included oxybutynin, tolterodine, trospium, fesoterodine, and solifenacin, but 42% of patients received tolterodine extended release (ER) as their index prescription. To be considered a discontinuation, the patient had to have a gap of at least 45 days in therapy, based on fill dates and days’ supply. The corresponding time to treatment failure (TTF) was estimated as the number of days between the index date and the date of the first medication switch or estimated discontinuation date. Treatment reinitiation was defined as the documentation of a filled prescription for any anticholinergic agent after a discontinuation period of at least 45 days. The researchers in this study used claims data to avoid the problem of self-reported adherence, since patients often overstate their adherence to medications.

Initial treatment with the index drug failed in nearly all (92%) patients. Of those, only 6% were associated with switching drugs. More than half had permanently stopped all anticholinergic drugs at 24 months. Moreover, 33% of patients filled only 1 prescription, suggesting early failure (within the first 30 days).

The proportion of treatment failures was high across all primary diagnoses, ranging from 89% to 97%. Failure was also high regardless of the therapy. For instance, 90% of 43,902 patients on tolterodine ER and 96% of 2,246 patients on oxybutynin transdermal did not meet treatment goals. The researchers then took those numbers and pooled outcomes across all drugs to estimate the overall impact of anticholinergic treatment for patients with OAB and found that the mean TTF was 159 days.

Many patients (81%) who switched treatment during the 24-month study period also had no luck with the second drug. Treatment also failed for 29% who tried a third drug. Treatment failure didn’t always stop them from trying, though: About one-third started treatment again after a gap of at least 45 days, and about one-fifth restarted after 1 year.

Empirical studies of medications to treat chronic conditions have found persistence to OAB medications to be very low, the researchers say. When compared with oral antidiabetic drugs, angiotensin receptor blockers, statins, bisphosphonates, and prostaglandins, OAB medications had the lowest persistence rates at 6 months: 32% compared with 72% for oral antidiabetes drugs.

In research of patients with OAB, achievement of treatment goals is a strong predictor of treatment satisfaction, and dissatisfaction with treatment outcomes is the most common reason for patients stopping their treatment. Poor adherence to OAB drugs can have a negative impact on quality of life and increase the risk of medical sequelae, such as urinary tract infections. Thus, when anticholinergics fail, the researchers say, it’s important to give patients options, such as botulinum toxin A, sacral neuromodulation, and percutaneous tibial nerve stimulation.

Despite the “potential for better adherence” with some anticholinergic drugs, their findings suggest that the benefits of anticholinergic use in OAB are not being realized, and many patients may end up without any drug therapy at all.

Source
Chancellor MB, Migliaccio-Walle K, Bramley TJ, Chaudhari SL, Corbell C, Globe D. Clin Ther. 2013;35(11):1744-1751.
doi: 10.1016/j.clinthera.2013.08.017.

More than one-third of the antiarrhythmic drugs used to treat some cardiac patients aren’t being used according to guideline recommendations, say researchers from Duke Clinical Research Institute in Durham, North Carolina.

The researchers used commercial health claims to identify and categorize patients into guideline-established groups based on their most serious concurrent heart disease: heart failure (HF), coronary artery disease (CAD), hypertension (HTN), and no heart disease.

Of 78,877 patients with a prescription for ≥ 1 antiarrhythmic drug (AAD), most received 1 AAD, 12% received 2 AADs, and 2% received ≥ 3 AADs. The median time from the first inpatient or outpatient encounter for the diagnosis of atrial fibrillation (AFib) to the first prescription claim for an AAD was 29 days (range, 9-89 days).

In the patients with HF and CAD, 45% and 31% of AADs were inconsistent with first- or second-line recommendations, respectively. Only 55% of AAD use (amiodarone and dofetilide) in patients with AFib and HF conformed to recommendations. The use of sotalol, dronedarone, propafenone, and flecainide did not conform. Among patients with AFib and CAD, only 40% of AAD use (sotalol, dronedarone and dofetilide) conformed to first-line recommendations. Propafenone and flecainide, which are not recommended for patients with CAD, accounted for 31% of AAD use, the researchers found.

Among patients with AFib and HTN, all the high-use AADs were consistent with guidelines. Of the 81,891 patients with AF who did not have HF, CAD, or HTN, 19% received AADs, usually flecainide, propafenone, and sotalol, which are all acceptable according to clinical practice guidelines.

This study raises several concerns, the researchers say, such as the high use of dronedarone. As the first study to address how dronedarone, introduced in 2009, is being used in the U.S., it provides an early picture of a drug that has since been reported to have safety issues. Although dronedarone was only available for less than one-third of the study period, it accounted for 9% of all AAD use in patients with HF or CAD, 8% in patients with HTN, and 6% in patients without the selected cardiac diseases.

Although the study provides only a “snapshot” of AAD use based on claims data, the high rate of nonconformity is concerning, the researchers say. They note that much of the recent focus has been on evaluating and comparing a rate- vs rhythm-control strategy, with relatively little attention given to evaluating or comparing the specific drugs used in those strategies. The “extensive use of potentially inappropriate AADs highlights the need for more detailed analyses of AAD drug selection,” they conclude, especially for patients with concomitant HF and CAD.

Source
LaPointe NMA, Lokhnygina Y, Sanders GD, Peterson ED, Al-Khatib SM. Am Heart J. 2013;166(5):871-878.
doi: 10.1016/j.ahj.2013.08.010.

More than one-third of the antiarrhythmic drugs used to treat some cardiac patients aren’t being used according to guideline recommendations, say researchers from Duke Clinical Research Institute in Durham, North Carolina.

The researchers used commercial health claims to identify and categorize patients into guideline-established groups based on their most serious concurrent heart disease: heart failure (HF), coronary artery disease (CAD), hypertension (HTN), and no heart disease.

Of 78,877 patients with a prescription for ≥ 1 antiarrhythmic drug (AAD), most received 1 AAD, 12% received 2 AADs, and 2% received ≥ 3 AADs. The median time from the first inpatient or outpatient encounter for the diagnosis of atrial fibrillation (AFib) to the first prescription claim for an AAD was 29 days (range, 9-89 days).

In the patients with HF and CAD, 45% and 31% of AADs were inconsistent with first- or second-line recommendations, respectively. Only 55% of AAD use (amiodarone and dofetilide) in patients with AFib and HF conformed to recommendations. The use of sotalol, dronedarone, propafenone, and flecainide did not conform. Among patients with AFib and CAD, only 40% of AAD use (sotalol, dronedarone and dofetilide) conformed to first-line recommendations. Propafenone and flecainide, which are not recommended for patients with CAD, accounted for 31% of AAD use, the researchers found.

Among patients with AFib and HTN, all the high-use AADs were consistent with guidelines. Of the 81,891 patients with AF who did not have HF, CAD, or HTN, 19% received AADs, usually flecainide, propafenone, and sotalol, which are all acceptable according to clinical practice guidelines.

This study raises several concerns, the researchers say, such as the high use of dronedarone. As the first study to address how dronedarone, introduced in 2009, is being used in the U.S., it provides an early picture of a drug that has since been reported to have safety issues. Although dronedarone was only available for less than one-third of the study period, it accounted for 9% of all AAD use in patients with HF or CAD, 8% in patients with HTN, and 6% in patients without the selected cardiac diseases.

Although the study provides only a “snapshot” of AAD use based on claims data, the high rate of nonconformity is concerning, the researchers say. They note that much of the recent focus has been on evaluating and comparing a rate- vs rhythm-control strategy, with relatively little attention given to evaluating or comparing the specific drugs used in those strategies. The “extensive use of potentially inappropriate AADs highlights the need for more detailed analyses of AAD drug selection,” they conclude, especially for patients with concomitant HF and CAD.

Source
LaPointe NMA, Lokhnygina Y, Sanders GD, Peterson ED, Al-Khatib SM. Am Heart J. 2013;166(5):871-878.
doi: 10.1016/j.ahj.2013.08.010.

More than one-third of the antiarrhythmic drugs used to treat some cardiac patients aren’t being used according to guideline recommendations, say researchers from Duke Clinical Research Institute in Durham, North Carolina.

The researchers used commercial health claims to identify and categorize patients into guideline-established groups based on their most serious concurrent heart disease: heart failure (HF), coronary artery disease (CAD), hypertension (HTN), and no heart disease.

Of 78,877 patients with a prescription for ≥ 1 antiarrhythmic drug (AAD), most received 1 AAD, 12% received 2 AADs, and 2% received ≥ 3 AADs. The median time from the first inpatient or outpatient encounter for the diagnosis of atrial fibrillation (AFib) to the first prescription claim for an AAD was 29 days (range, 9-89 days).

In the patients with HF and CAD, 45% and 31% of AADs were inconsistent with first- or second-line recommendations, respectively. Only 55% of AAD use (amiodarone and dofetilide) in patients with AFib and HF conformed to recommendations. The use of sotalol, dronedarone, propafenone, and flecainide did not conform. Among patients with AFib and CAD, only 40% of AAD use (sotalol, dronedarone and dofetilide) conformed to first-line recommendations. Propafenone and flecainide, which are not recommended for patients with CAD, accounted for 31% of AAD use, the researchers found.

Among patients with AFib and HTN, all the high-use AADs were consistent with guidelines. Of the 81,891 patients with AF who did not have HF, CAD, or HTN, 19% received AADs, usually flecainide, propafenone, and sotalol, which are all acceptable according to clinical practice guidelines.

This study raises several concerns, the researchers say, such as the high use of dronedarone. As the first study to address how dronedarone, introduced in 2009, is being used in the U.S., it provides an early picture of a drug that has since been reported to have safety issues. Although dronedarone was only available for less than one-third of the study period, it accounted for 9% of all AAD use in patients with HF or CAD, 8% in patients with HTN, and 6% in patients without the selected cardiac diseases.

Although the study provides only a “snapshot” of AAD use based on claims data, the high rate of nonconformity is concerning, the researchers say. They note that much of the recent focus has been on evaluating and comparing a rate- vs rhythm-control strategy, with relatively little attention given to evaluating or comparing the specific drugs used in those strategies. The “extensive use of potentially inappropriate AADs highlights the need for more detailed analyses of AAD drug selection,” they conclude, especially for patients with concomitant HF and CAD.

Source
LaPointe NMA, Lokhnygina Y, Sanders GD, Peterson ED, Al-Khatib SM. Am Heart J. 2013;166(5):871-878.
doi: 10.1016/j.ahj.2013.08.010.