Peripheral Neuropathic Pain
Conditions
Keywords
Real-life, non-interventional, observational, peripheral neuropathic pain, Lyrica, pregabalin
Brief summary
Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.
Detailed description
General practitioners and specialists participate in the study. When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.
Interventions
OTHERNo intervention. Non-interventional study
No intervention. Non-interventional study
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects aged 18 years or over. * Subjects diagnosed with peripheral neuropathic pain. * Subjects that independently of the study and before consideration for observation in the study have been prescribed pregabalin for treatment of peripheral neuropathic pain either. 1. for the first time ('first prescription patients') or 2. that have not used pregabalin within the previous 6 months but are prescribed pregabalin again ('re-treatment patients') * Subjects that haven't taken the first dose of the prescribed pregabalin yet.
Exclusion criteria
* Subjects not consenting to participate. * Subjects that at study inclusion (baseline) are on treatment with pregabalin for generalized anxiety or epilepsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline In Average Pain Level At Month 3 Telephonic Interview | Baseline, Month 3 Telephonic Interview | Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. |
| Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview | Baseline, Month 3 Telephonic Interview | Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. |
| Change From Baseline In Least Pain Level At Month 3 Telephonic Interview | Baseline, Month 3 Telephonic Interview | Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Interference Scale Score | Baseline, Month 1, 2, 3, Month 3 telephonic interview | Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. |
| Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) | Month 3 telephonic interview | PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported. |
| Health-related Quality of Life Scale Score | Baseline, Month 1, 2, 3 | Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant's health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. |
| Work Productivity and Activity Impairment (WPAI) Questionnaire | Baseline, Month 1, 2, 3 | WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. |
| Pregabalin Dose | After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview | Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. |
| Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Baseline, Month 1, 2, 3 Visit | Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category. |
| Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline, Month 1, 2, 3 visit | Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months. | 128 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | Adverse Event and Lack of Efficacy | 1 |
| Overall Study | Deterioration of pains | 1 |
| Overall Study | Gall stone surgery | 1 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Move | 1 |
| Overall Study | Nervous about confidentiality | 1 |
| Overall Study | Switch to carbamazapine | 1 |
| Overall Study | The price | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Continuous | 58.2 Years STANDARD_DEVIATION 16.5 |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 128 |
| serious Total, serious adverse events | 0 / 128 |
Outcome results
Primary
Change From Baseline In Average Pain Level At Month 3 Telephonic Interview
Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.
Time frame: Baseline, Month 3 Telephonic Interview
Population: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline In Average Pain Level At Month 3 Telephonic Interview | Baseline | 6.7 Units on a scale | Standard Deviation 1.9 |
| Pregabalin | Change From Baseline In Average Pain Level At Month 3 Telephonic Interview | Change at Month 3 Telephonic Interview | -2.2 Units on a scale | Standard Deviation 2.5 |
p-value: <0.001paired Wilcoxon signed-rank test
Primary
Change From Baseline In Least Pain Level At Month 3 Telephonic Interview
Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.
Time frame: Baseline, Month 3 Telephonic Interview
Population: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline In Least Pain Level At Month 3 Telephonic Interview | Baseline | 4.1 Units on a scale | Standard Deviation 2.3 |
| Pregabalin | Change From Baseline In Least Pain Level At Month 3 Telephonic Interview | Change at Month 3 Telephonic Interview | -1.5 Units on a scale | Standard Deviation 2.5 |
p-value: <0.001Wilcoxon signed-rank test
Primary
Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview
Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.
Time frame: Baseline, Month 3 Telephonic Interview
Population: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview | Baseline | 8.4 Units on a scale | Standard Deviation 1.7 |
| Pregabalin | Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview | Change at Month 3 Telephonic Interview | -2.1 Units on a scale | Standard Deviation 2.7 |
p-value: <0.001Wilcoxon signed-rank test
Secondary
Health-related Quality of Life Scale Score
Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant's health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time frame: Baseline, Month 1, 2, 3
Population: Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed N signifies those participants who were evaluable for this measure. For Baseline, n=those participants who were evaluable for this outcome. For Month 1 to Month 3, n=number of observations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Health-related Quality of Life Scale Score | Baseline (n= 104) | 0.47 Units on a scale | Standard Deviation 0.26 |
| Pregabalin | Health-related Quality of Life Scale Score | Month 1 (n= 81) | 0.58 Units on a scale | Standard Deviation 0.22 |
| Pregabalin | Health-related Quality of Life Scale Score | Month 2 (n= 52) | 0.58 Units on a scale | Standard Deviation 0.27 |
| Pregabalin | Health-related Quality of Life Scale Score | Month 3 (n= 64) | 0.63 Units on a scale | Standard Deviation 0.26 |
Secondary
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.
Time frame: After Baseline, Month 1, 2, 3 visit
Population: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here n signifies pharmacological treatments received at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: No drug treatment (n= 112) | 25 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 1 Visit: SNRIs (n= 70) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 3 Visit: Strong Opioids (n= 58) | 13 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: TCA (n= 112) | 12 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: Gabapentin (n= 112) | 6 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: NSAIDs (n= 112) | 16 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: Weak Opioids (n= 112) | 24 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: Strong Opioids (n= 112) | 17 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: SNRIs (n= 112) | 5 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: L/C (n= 112) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: Other (n= 112) | 7 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 1 Visit: No drug treatment (n= 70) | 23 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 1 Visit: TCA (n= 70) | 14 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 1 Visit: Gabapentin (n= 70) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: NSAIDs (n= 70) | 1 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 1 Visit: Weak Opioids (n= 70) | 15 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 1 Visit: Strong Opioids (n= 70) | 15 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 1 Visit: L/C (n= 70) | 1 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 1 Visit: Other (n= 70) | 1 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 2 Visit: No drug treatment (n= 60) | 13 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 2 Visit: TCA (n= 60) | 15 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 2 Visit: Gabapentin (n= 60) | 1 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 2 Visit: NSAIDs (n= 60) | 4 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 2 Visit: Weak Opioids (n= 60) | 16 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 2 Visit: Strong Opioids (n= 60) | 9 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 2 Visit: SNRIs (n= 60) | 2 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 2 Visit: L/C (n= 60) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 2 Visit: Other (n= 60) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 3 Visit: No drug treatment (n= 58) | 13 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 3 Visit: TCA (n= 58) | 13 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 3 Visit: Gabapentin (n= 58) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Baseline Visit: NSAIDs (n= 58) | 3 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 3 Visit: Weak Opioids (n= 58) | 15 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 3 Visit: SNRIs (n= 58) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 3 Visit: L/C (n= 58) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) | After Month 3 Visit: Other (n= 58) | 1 Participants |
Secondary
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.
Time frame: Before Baseline, Month 1, 2, 3 Visit
Population: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here n signifies pharmacological treatments received at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 1 Visit: SNRIs (n= 71) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 1 Visit: L/C (n= 71) | 1 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 1 Visit: Other (n= 71) | 1 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 2 Visit: NSAIDs (n= 60) | 4 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 2 Visit: Weak Opioids (n= 60) | 14 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 2 Visit: Strong Opioids (n= 60) | 10 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 3 Visit: No drug treatment (n= 58) | 12 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 3 Visit: TCA (n= 58) | 13 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 3 Visit: Strong Opioids (n= 58) | 12 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 3 Visit: SNRIs (n= 58) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 3 Visit: Other (n= 58) | 1 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Baseline Visit: No drug treatment (n= 143) | 5 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Baseline Visit: TCA (n= 143) | 14 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Baseline Visit: Gabapentin (n= 143) | 33 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Baseline Visit: NSAIDs (n= 143) | 25 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Baseline Visit: Weak Opioids (n= 143) | 35 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Baseline Visit: Strong Opioids (n= 143) | 18 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Baseline Visit: SNRIs (n= 143) | 6 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Baseline Visit: L/C (n= 143) | 1 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Baseline Visit: Other (n= 143) | 6 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 1 Visit: No drug treatment (n= 71) | 23 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 1 Visit: TCA (n= 71) | 11 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 1 Visit: Gabapentin (n= 71) | 2 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 1 Visit: NSAIDs (n= 71) | 5 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 1 Visit: Weak Opioids (n= 71) | 17 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 1 Visit: Strong Opioids (n= 71) | 11 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 2 Visit: No drug treatment (n= 60) | 14 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 2 Visit: TCA (n= 60) | 13 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 2 Visit: Gabapentin (n= 60) | 2 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 2 Visit: SNRIs (n= 60) | 2 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 2 Visit: L/C (n= 60) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 2 Visit: Other (n= 60) | 1 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 3 Visit: Gabapentin (n= 58) | 0 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 3 Visit: NSAIDs (n= 58) | 4 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 3 Visit: Weak Opioids (n= 58) | 16 Participants |
| Pregabalin | Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit | Before Month 3 Visit: L/C (n= 58) | 0 Participants |
Secondary
Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Time frame: Month 3 telephonic interview
Population: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) | Very Much Improved | 18 Participants |
| Pregabalin | Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) | Much Improved | 35 Participants |
| Pregabalin | Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) | Minimally Improved | 26 Participants |
| Pregabalin | Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) | No Change | 4 Participants |
| Pregabalin | Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) | Minimally Worse | 3 Participants |
| Pregabalin | Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) | Much Worse | 0 Participants |
| Pregabalin | Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) | Very Much Worse | 0 Participants |
Secondary
Pregabalin Dose
Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time frame: After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview
Population: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, n signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, n signifies number of observations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Pregabalin Dose | Dose Prior To Visit: Month 1 (n= 64) | 107.4 Milligram (mg) per day | Standard Deviation 112.7 |
| Pregabalin | Pregabalin Dose | Dose Prior To Visit: Month 2 (n= 48) | 123.4 Milligram (mg) per day | Standard Deviation 102 |
| Pregabalin | Pregabalin Dose | Dose Prior To Visit: Month 3 (n= 48) | 164.6 Milligram (mg) per day | Standard Deviation 128.7 |
| Pregabalin | Pregabalin Dose | Dose Prior To Month 3 telephonic interview (n=86) | 240.7 Milligram (mg) per day | Standard Deviation 210.4 |
| Pregabalin | Pregabalin Dose | Dose After Visit: Baseline (n=84) | 81.5 Milligram (mg) per day | Standard Deviation 89.1 |
| Pregabalin | Pregabalin Dose | Dose After Visit: Month 1 (n= 64) | 148.4 Milligram (mg) per day | Standard Deviation 144.5 |
| Pregabalin | Pregabalin Dose | Dose After Visit: Month 2 (n= 48) | 145.3 Milligram (mg) per day | Standard Deviation 115.2 |
| Pregabalin | Pregabalin Dose | Dose After Visit: Month 3 (n= 48) | 169.3 Milligram (mg) per day | Standard Deviation 145.3 |
Secondary
Sleep Interference Scale Score
Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time frame: Baseline, Month 1, 2, 3, Month 3 telephonic interview
Population: Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, n signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, n signifies number of observations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Sleep Interference Scale Score | Baseline (n = 71) | 5.3 Units on a scale | Standard Deviation 3.2 |
| Pregabalin | Sleep Interference Scale Score | Month 1 (n= 58) | 4.2 Units on a scale | Standard Deviation 3.1 |
| Pregabalin | Sleep Interference Scale Score | Month 3 telephonic interview (n= 86) | 2.3 Units on a scale | Standard Deviation 2.4 |
| Pregabalin | Sleep Interference Scale Score | Month 2 (n= 37) | 4.0 Units on a scale | Standard Deviation 2.8 |
| Pregabalin | Sleep Interference Scale Score | Month 3 (n= 52) | 4.3 Units on a scale | Standard Deviation 2.9 |
Secondary
Work Productivity and Activity Impairment (WPAI) Questionnaire
WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time frame: Baseline, Month 1, 2, 3
Population: Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed N signifies those participants who were evaluable for this measure. For Baseline, n=those participants who were evaluable for this outcome. For Month 1 to Month 3, n=number of observations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWPI Month 3 (n=19) | 48.9 Units on a scale | Standard Deviation 23.1 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWP Baseline (n= 25) | 28.4 Units on a scale | Standard Deviation 32.9 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWP Month 1 (n= 25) | 28.7 Units on a scale | Standard Deviation 34.7 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWP Month 2 (n=12) | 17.8 Units on a scale | Standard Deviation 38.6 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWP Month 3 (n= 18) | 29.9 Units on a scale | Standard Deviation 41.6 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWI Baseline (n= 23) | 70.0 Units on a scale | Standard Deviation 22.2 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWI Month 1 (n= 24) | 58.2 Units on a scale | Standard Deviation 28.5 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWI Month 2 (n=11) | 48.1 Units on a scale | Standard Deviation 24 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWI Month 3 (n= 15) | 56.3 Units on a scale | Standard Deviation 28.9 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWPI Baseline (n= 25) | 63.2 Units on a scale | Standard Deviation 21.5 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWPI Month 1 (n= 25) | 52.0 Units on a scale | Standard Deviation 25.8 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PWPI Month 2 (n=12) | 45.8 Units on a scale | Standard Deviation 18.8 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PAI Baseline (n= 29) | 68.3 Units on a scale | Standard Deviation 18.3 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PAI Month 1 (n= 27) | 63.7 Units on a scale | Standard Deviation 22.2 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PAI Month 2 (n=13) | 55.4 Units on a scale | Standard Deviation 17.1 |
| Pregabalin | Work Productivity and Activity Impairment (WPAI) Questionnaire | PAI Month 3 (n= 23) | 53.0 Units on a scale | Standard Deviation 22.2 |