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Subtherapeutic Acetazolamide Doses as a Noninvasive Method for Assessing Medication Adherence.

ABSTRACT: Adherence monitoring is a vital component of clinical efficacy trials, as the regularity of medication consumption affects both efficacy and adverse effect profiles. Pill-counts do not confirm consumption, and invasive plasma assessments can only assist post hoc assessments. We previously reported on the pharmacokinetics of a potential adherence marker to noninvasively monitor dosage consumption during a trial without breaking a blind. We reported that consumption cessation of subtherapeutic 15 mg acetazolamide (ACZ) doses showed a predictable urinary excretion decay that was quantifiable for an extended period. The current study describes the clinical implementation of 15 mg ACZ doses as an adherence marker excipient in distinct cohorts taking ACZ for different "adherence" durations. We confirm that ACZ output did not change (accumulate) during 18-20 days of adherence, and developed and assessed urinary cutoffs as nonadherence indicators. We demonstrate that whereas an absolute concentration cutoff (989 ng/mL) lacked sensitivity, a creatinine normalized equivalent (1,376 ng/mg ACZ) was highly accurate at detecting nonadherence. We also demonstrate that during nonadherent phases of three trials, creatinine-normalized urinary ACZ elimination was reproducible within and across trials with low variability. Excretion was first order, with a decay half-life averaging ~ 2.0 days. Further, excretion remained quantifiable for 14 days, providing a long period during which the date of last consumption might be determined. We conclude that inclusion of 15 mg ACZ as a dosage form adherence marker excipient, provides a reliable and sensitive mechanism to confirm medication consumption and detect nonadherence during clinical efficacy trials.

SUBMITTER: Hampson AJ

PROVIDER: S-EPMC7669583 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Subtherapeutic Acetazolamide Doses as a Noninvasive Method for Assessing Medication Adherence.

Hampson Aidan J AJ Schroeder Jennifer R JR Ellefsen Kayla N KN Yammine Luba L Epstein David H DH Preston Kenzie L KL Huestis Marilyn A MA Verrico Christopher D CD

Clinical pharmacology and therapeutics 20200711 6

Adherence monitoring is a vital component of clinical efficacy trials, as the regularity of medication consumption affects both efficacy and adverse effect profiles. Pill-counts do not confirm consumption, and invasive plasma assessments can only assist post hoc assessments. We previously reported on the pharmacokinetics of a potential adherence marker to noninvasively monitor dosage consumption during a trial without breaking a blind. We reported that consumption cessation of subtherapeutic 15 ...[more]

PMID: 32496573

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Project description:BackgroundNonadherence produces considerable health consequences and economic burden to patients and payers. One approach to improve medication nonadherence that has gained interest in recent years is the use of smartphone adherence apps. The development of smartphone adherence apps has increased rapidly since 2012; however, literature evaluating the clinical app and effectiveness of smartphone adherence apps to improve medication adherence is generally lacking.ObjectiveThe aims of this study were to (1) provide an updated evaluation and comparison of medication adherence apps in the marketplace by assessing the features, functionality, and health literacy (HL) of the highest-ranking adherence apps and (2) indirectly measure the validity of our rating methodology by determining the relationship between our app evaluations and Web-based consumer ratings.MethodsTwo independent reviewers assessed the features and functionality using a 4-domain rating tool of all adherence apps identified based on developer claims. The same reviewers downloaded and tested the 100 highest-ranking apps including an additional domain for assessment of HL. Pearson product correlations were estimated between the consumer ratings and our domain and total scores.ResultsA total of 824 adherence apps were identified; of these, 645 unique apps were evaluated after applying exclusion criteria. The median initial score based on descriptions was 14 (max of 68; range 0-60). As a result, 100 of the highest-scoring unique apps underwent user testing. The median overall user-tested score was 31.5 (max of 73; range 0-60). The majority of the user tested the adherence apps that underwent user testing reported a consumer rating score in their respective online marketplace. The mean consumer rating was 3.93 (SD 0.84). The total user-tested score was positively correlated with consumer ratings (r=.1969, P=.04).ConclusionsMore adherence apps are available in the Web-based marketplace, and the quality of these apps varies considerably. Consumer ratings are positively but weakly correlated with user-testing scores suggesting that our rating tool has some validity but that consumers and clinicians may assess adherence app quality differently.

Project description:BackgroundHospital-discharged patients with schizoaffective disorder have a high risk of re-hospitalization. However, limited data exist evaluating critical post-discharge periods during which the risk of re-hospitalization is significant.ObjectiveAmong hospital-discharged patients with schizoaffective disorder, we assessed pharmacotherapy adherence and healthcare utilization and costs during sequential 60-day clinical periods before schizoaffective disorder-related hospitalization and post-hospital discharge.MethodsFrom the MarketScan(®) Medicaid database (2004-2008), we identified patients (≥18 years) with a schizoaffective disorder-related inpatient admission. Study measures including medication adherence and healthcare utilization and costs were assessed during sequential preadmission and post-discharge periods. We conducted univariate and multivariable regression analyses to compare schizoaffective disorder-related and all-cause healthcare utilization and costs (in 2010 US dollars) between each adjacent 60-day post-discharge periods. No adjustment was made for multiplicity.ResultsWe identified 1,193 hospital-discharged patients with a mean age of 41 years. The mean medication adherence rate was 46% during the 60-day period prior to index inpatient admission, which improved to 80% during the 60-day post-discharge period. Following hospital discharge, schizoaffective disorder-related healthcare costs were significantly greater during the initial 60-day period compared with the 61- to 120-day post-discharge period (mean US$2,370 vs US$1,765; p < 0.001), with rehospitalization (36%) and pharmacy (40%) accounting for over three-fourths of the initial 60-day period costs. Compared with the initial 60-day post-discharge period, both all-cause and schizoaffective disorder-related costs declined during the 61- to 120-day post-discharge period and remained stable for the remaining post-discharge periods (days 121-365).ConclusionsWe observed considerably lower (46%) adherence during 60 days prior to the inpatient admission; in comparison, adherence for the overall 6-month period was 8% (54%) higher. Our study findings suggest that both short-term (e.g., 60 days) and long-term (e.g., 6-12 months) medication adherence likely are important characteristics to examine among patients with schizoaffective disorder and help provide a more holistic view of patients' adherence patterns. Furthermore, we observed a high rate of rehospitalization and greater healthcare costs during the initial 60-day period post-discharge among patients with schizoaffective disorder. Further research is required to better understand and manage transitional care after discharge (e.g., monitor adherence), which may help reduce the likelihood of rehospitalization and the associated downstream costs.

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Subtherapeutic Acetazolamide Doses as a Noninvasive Method for Assessing Medication Adherence.

Publications

Subtherapeutic Acetazolamide Doses as a Noninvasive Method for Assessing Medication Adherence.

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