Chemotherapy-induced Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain, Neuropathic Pain
Conditions
Keywords
Diabetic peripheral neuropathic pain, Chemotherapy-induced peripheral neuropathy, Neuropathic pain, Treatment pattern
Brief summary
The aim of this study is to investigate the pharmacological treatment pattern among patients with diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) in China.
Detailed description
Diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) are common subtypes of neuropathic pain. The treatment pattern, subsequent medication usage, and adherence information of medication among these patients are still not clear. There is also an unmet need for the use of relevant analgesic medications in this area. This real-world data study aims to understand patients' characteristics, clinical diagnosis and treatment patterns, medication adherence, real-world effectiveness among DPNP and CIPN patients in China and will explore the current unmet needs of DPNP and CIPN, in order to inform physicians' decision-making in clinical practice
Interventions
OTHERNo Drug
This is an non-interventional, observational study. No drug was administered during this study.
Sponsors
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants who meet all the following criteria will be included in the DPNP cohort. 1. Participants were diagnosed with diabetic neuropathy and presented with the pain symptom between 1st January 2018 and 31st December 2021; 2. Participants received at least one targeted medication between 1st January 2018 and 31st December 2021; 3. Participants were ≥18 years on the index date; 4. Participants had at least one medical visit record within 12 months after the index date Participants who meet any one of the following criteria will be excluded from the DPNP cohort. (1) Participants were diagnosed with epilepsy, schizophrenia, or bipolar disorder before or on the index date Participants who meet all the following criteria will be included in the CIPN cohort. 1. Participants had neuropathy that was induced by the chemotherapy between 1st January 2018 and 31st December 2021, regardless of the presence of pain symptoms; 2. Participants received at least one targeted medication between 1st January 2018 and 31st December 2021; 3. Participants were ≥18 years on the index date; 4. Participants had at least one medical visit record within12 months after the index date Participants who meet any one of the following criteria will be excluded from the CIPN cohort. 1. Participants were diagnosed with epilepsy, schizophrenia, or bipolar disorder before or on the index date; 2. Participants had neuralgia or neuropathy caused by tumor metastasis or non-chemotherapy-induced factors (e.g., radiotherapy, myasthenia gravis syndrome, paraneoplastic syndrome, direct tumor invasion, local tissue compression, postoperative traumatic pain, immune therapy-related pain, comorbidity-induced pain, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to treatment add-on in participants with DPNP or CIPN | From index date up to 31st December 2022 | Time to treatment add-on is defined as the time interval between the end date of the current treatment regimen (including days covered by take-away medications) and the start date of the add-on treatment. |
| Proportion of participants receiving different treatment regimens (targeted medications or combinations) and related medication categories in participants with DPNP or CIPN | From index date up to 31st December 2022 | The treatment regimen will be evaluated and confirmed as monotherapy or combination therapy based on prescription records at each visit. Monotherapy is defined as participants only received one targeted medication. Combination therapy is defined as participants received more than one targeted medication at the same time. |
| Proportion of participants who discontinue/switch/add-on treatment and related medication categories in participants with DPNP or CIPN | From index date up to 31st December 2022 | Treatment discontinuation is defined as the time interval between two adjacent treatment regimens, or the time interval between the end of the last treatment regimen and the study end date (31st December 2022), or the time interval between the end of the last treatment regimen and the date of death is ≥90 days. Treatment switch is defined as the change of treatment regimen, either in monotherapy or in combination (exclude treatment add-on). Treatment add-on is defined as the addition of one or more targeted medications to an existing treatment regimen (monotherapy or combination therapy). |
| Proportion of participants who restarted treatment after discontinuation in participants with DPNP or CIPN | From index date up to 31st December 2022 | Among those who had discontinued treatment, the proportion of patients who received at least one targeted medication at the next visit will be assessed, where the treatment regimen containing the targeted medication includes the same treatment medication prior to discontinuation or a different treatment medication after treatment switch/add-on. |
| Duration of the current treatment in participants with DPNP or CIPN | From index date up to 31st December 2022 | Duration of the current treatment is defined as the time interval from the start date of a treatment to its end date. The end date of the treatment refers to its discontinuation date; for participants who did not experience a treatment discontinuation, the end date of treatment prescription is used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum daily dose in participants with DPNP or CIPN | From index date up to 31st December 2022 | Maximum daily dose is defined as the maximum of the daily dose. |
| Time to the maximum daily dose in participants with DPNP or CIPN | From index date up to 31st December 2022 | Time to the maximum daily dose is defined as the time interval between the daily dose to the maximum daily dose. |
| Proportion of participants who underwent the daily dose change in participants with DPNP or CIPN | From index date up to 31st December 2022 | Proportion of participants who underwent the daily dose change is defined as the proportion of participants who underwent the dose changes from the initial daily dose to 2 weeks, 4 weeks and 6 weeks, respectively. |
| Initial daily dose in participants with DPNP or CIPN | From index date up to 31st December 2022 | Initial daily dose is defined as the first prescribed daily dose of the targeted medications. |
Countries
China
Outcome results
None listed