Dataset Information

Effects of treatment interruption due to patient convenience on treatment of once a week teriparatide.

ABSTRACT:

Objectives

Once-weekly teriparatide (W-TPTD) is an effective drug for patients with osteoporosis; however, some patients discontinue W-TPTD owing to its adverse drug reactions (ADRs). Sequential treatment with W-TPTD and antiresorptive therapy may be effective in treating such patients. In this study, we evaluate the efficacy of this sequential treatment regimen.

Methods

This retrospective study was conducted at a single institution in Japan. The target subjects were patients with osteoporosis who started W-TPTD treatment. The subjects who received W-TPTD for 6 months or more were divided into 3 groups: TTT (W-TPTD for 18 months); TBT (sequential treatment of W-TPTD/bisphosphonates/W-TPTD; each for 6 months); and TET (sequential treatment of W-TPTD/elcatonin/W-TPTD, each for 6 months) groups. The efficacy endpoints were bone mineral densities (BMD) in the lumbar spine and femur.

Results

Lumbar spine BMD in group TBT increased significantly by 1.6% (P = 0.023), 2.9% (P = 0.001), and 4.4% (P < 0.001) after 6, 12, and 18 months, respectively, compared with baseline values. In group TET, it increased by 2.1%, (P = 0.001), 1.3% (P = 0.066), and 3.0% (P = 0.015) after 6, 12, and 18 months, respectively. A significant increase was observed only after 6 and 18 months. In group TTT, it increased significantly by 3.3% (P = 0.023), 5.1% (P = 0.019), and 7.1% (P = 0.010) after 6, 12, and 18 months, respectively. However, no significant difference in total hip BMD was observed among all three groups. No serious ADRs were reported.

Conclusion

In patients who discontinue treatment with W-TPTD due to ADRs, sequential treatment with W-TPTD and antiresorptive therapy would be beneficial.

SUBMITTER: Katahira G

PROVIDER: S-EPMC7093683 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of treatment interruption due to patient convenience on treatment of once a week teriparatide.

Katahira Genichiro G Akiba Kotaro K Takada Junichi J Iba Kousuke K Yamashita Toshihiko T

Osteoporosis and sarcopenia 20200214 1

<h4>Objectives</h4>Once-weekly teriparatide (W-TPTD) is an effective drug for patients with osteoporosis; however, some patients discontinue W-TPTD owing to its adverse drug reactions (ADRs). Sequential treatment with W-TPTD and antiresorptive therapy may be effective in treating such patients. In this study, we evaluate the efficacy of this sequential treatment regimen.<h4>Methods</h4>This retrospective study was conducted at a single institution in Japan. The target subjects were patients with ...[more]

PMID: 32226827

Similar Datasets

Project description:BACKGROUND:The long-acting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) was recently approved for maintenance treatment of bipolar I disorder (BP-I). The purpose of this study was to evaluate the safety, tolerability, and efficacy of AOM 400 as long-term maintenance treatment for BP-I. METHODS:This open-label multicenter study evaluated the effectiveness of AOM 400 as maintenance treatment for BP-I by assessing safety and tolerability (primary objective) and efficacy (secondary objective). The study enrolled AOM 400-naive ("de novo") patients as well as AOM 400-experienced ("rollover") patients with BP-I from a lead-in randomized, placebo-controlled clinical trial that demonstrated the efficacy of AOM 400 in the maintenance treatment of BP-I (Calabrese et al. in J Clin Psychiatry 78:324-331, 2017). Safety variables included frequency and severity of treatment-emergent adverse events (TEAEs) and TEAEs resulting in study discontinuation. Efficacy was assessed by the proportion of patients maintaining stability throughout the maintenance phase, as well as mean changes from baseline in Young Mania Rating Scale (YMRS), Montgomery-Asberg Depression Rating Scale, and Clinical Global Impressions for Bipolar Disorder-Severity of Illness Scale (CGI-BP-S) total scores. Patient acceptability and tolerability of treatment was assessed using the Patient Satisfaction with Medication Questionnaire-Modified. RESULTS:Of 464 patients entering the maintenance phase, 379 (82%) were de novo and 85 (18%) were rollover. TEAEs were more common in de novo than rollover patients. The overall discontinuation rate due to TEAEs was 10.3% (48/464). Improvements in YMRS and CGI-BP-S total scores were maintained during the study, and the vast majority of both de novo (87.0%) and rollover (97.6%) patients maintained stability through their last visit. Overall, the need for rescue medication during the maintenance phase was minimal (<?10% of patients). Patient satisfaction levels were high, with both de novo and rollover patients rating the side effect burden of AOM 400 as greatly improved relative to previous medications. CONCLUSION:AOM 400 was safe, effective, and well tolerated by both de novo and AOM 400-experienced patients with BP-I for long-term maintenance treatment. Trial registration ClinicalTrials.gov, NCT01710709.

Dataset Information

Effects of treatment interruption due to patient convenience on treatment of once a week teriparatide.

Objectives

Methods

Results

Conclusion

Publications

Effects of treatment interruption due to patient convenience on treatment of once a week teriparatide.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets