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*It is only for medical professionals to read for reference.
Tardive dyskinesia is not just an adverse drug reaction, it needs attention.
Speaking of patients with schizophrenia, I believe that the first word that appears in everyone's mind is "madman".
Due to problems such as incomprehension and social discrimination, many schizophrenic patients and their family members are reluctant to go to the hospital for treatment because they are afraid of becoming others’ after-dinner talks.
This delays the best time for treatment and affects recovery.
However, for patients with schizophrenia treated with antipsychotics, life is not so satisfactory.
They will face a series of adverse reactions caused by drugs, among which tardive dyskinesia (TD) is the involuntary rhythmic repetitive movement of a group of muscles caused by long-term use of high-dose antipsychotics.
According to statistics, in China, among schizophrenia patients who have received long-term antipsychotic treatment, the prevalence of TD is 33.
7%, which means that up to one-third of schizophrenia patients may have TD[1].
So, how does it affect the quality of life of patients with schizophrenia? Let's find out! Worse, the quality of life is further impaired.
TD is mainly manifested by involuntary movements of the mouth, lips, tongue and other parts, as well as dance-like movements of the limbs and trunk, and dystonia, which is obvious when emotionally stressed, and disappears during sleep.
It is more common in the continuous use of antipsychotics for several years, and a very small number occurs after the use of antipsychotics for several months [2].
A cross-sectional, web-based research study included 416 patients diagnosed with bipolar disorder (BD), depression (MDD) or schizophrenia (SZ), of which 197 patients had TD and 219 patients The patient is not accompanied by TD.
The 12-item Health Survey (SF-12v2) and the Concise Happiness and Quality of Life Satisfaction Questionnaire (Q-LES-Q-SF) were used to assess the patient’s health-related quality of life (HRQoL); the mental illness stigma scale- The Social Withdrawal Subscale (SW-ISMI) assesses the degree of social withdrawal of patients [3].
The results showed that in the total population of BD, MDD, and SZ patients, compared with patients without TD, patients with TD had worse HRQoL and a higher degree of social withdrawal (P<0.
001).
In separate analyses of different populations, similar results were also observed, but TD has a relatively greater impact on SZ patients.
Figure 1: HRQoL and degree of social withdrawal in patients with or without TD.
In addition, the researchers also stratified according to the severity of TD patients.
The results showed that the scale scores of all dimensions of patients with mild TD were better than medium/ Patients with severe TD.
Figure 2: HRQoL and degree of social withdrawal in patients with mild, moderate/severe TD As can be seen from the above studies, TD can significantly affect the physical and mental health of patients with schizophrenia, which also reminds clinicians when prescribing antipsychotics , Don’t just treat TD as an adverse reaction of antipsychotics, but need to fully consider the potential TD risks of the drug and make the most suitable treatment decision for the patient.
The world’s first deuterated drug brings good news to TD patients.
In May 2020, the world’s first deuterated drug, deuterium tetrabenazine, officially "landed" in China through the priority review and approval process, improving the availability of no medicines for Chinese TD patients The predicament also makes more schizophrenics no longer afraid of TD caused by long-term use of antipsychotics, which will help patients with schizophrenia persist in treatment and return to society as soon as possible.
At present, a number of international studies have confirmed the efficacy and safety of deuterium tetrabenazine treatment.
The ARM-TD study is a 12-week, placebo-controlled, flexible-dose trial involving 117 moderate to severe adult TD patients.
The results of the study showed that at the 12th week of treatment, the abnormal involuntary movement scale (AIMS) score of the deuterium tetrabenazine treatment group was improved by 3.
0 compared with the baseline, which was significantly better than that of the placebo group (the AIMS score was improved by 1.
6, P = 0.
019) [4]. The AIM-TD study is a randomized, flexible dose titration study.
222 patients were randomly assigned to deuterium tetrabenazine 12mg/d group, 24mg/d group, 36mg/d group and placebo group.
At 12 weeks of treatment, the AIMS scores of the deuterated tetrabenazine 12 mg/d group, 24 mg/d group, 36 mg/d group and placebo group decreased by 2.
1 points, 3.
2 points, 3.
3 points and 1.
4 points, respectively (compared with placebo group The comparative P values were 0.
217, 0.
003 and 0.
001) [5].
Table 1.
In the ARM-TD and AIM-TD studies, the changes in the AIMS score and the treatment success rate of deuterated tetrabenazine are worth mentioning.
A pooled analysis study published in Movment Disorder showed that for patients with TD, The minimum clinically significant change in the AIMS score is 2 points [6].
In the two studies of ARM-TD and AIM-TD, all doses of deuterium tetrabenazine scores improved> 2 points after 12 weeks of treatment, which has important clinical significance [4,5].
In addition, the above two studies confirmed that deuterium tetrabenazine is safe and well tolerated.
Overall, the incidence of any, treatment-related, neurological/psychiatric or serious adverse events in the deuterium tetrabenazine group was similar to that in the placebo group [4,5].
In terms of long-term treatment, an open, one-arm extended study included 343 patients with TD who received deuterium tetrabenazine in the ARM-TD and AIM-TD studies.
At 106 weeks of treatment, 55% and 30% of patients achieved a ≥50% response rate and ≥70% response rate (AIMS scores were improved by ≥50% and ≥70% from baseline).
The corresponding data at 132 weeks of treatment were 61% and 40%, respectively.
At the same time, studies have shown that deuterium tetrabenazine is well tolerated [7].
Figure 3: Summary of changes in AIMS response rate over time after receiving deuterium tetrabenazine treatment.
In clinical practice, most clinicians only regard TD as an adverse reaction of antipsychotics, without paying enough attention. In fact, TD can seriously affect the quality of life of patients, aggravate the degree of social withdrawal of patients, and pose a great challenge to patients' social function and medication compliance.
Deuterated tetrabenazine is the world's first deuterated drug, and a number of international evidence-based data have proven its efficacy and safety.
It is gratifying that deuterium tetrabenazine has entered the 2020 National Drug List, and its accessibility has further increased.
Looking forward to the extensive application of deuterium tetrabenazine in China, we will accumulate more experience and let more patients return to "safe" and stable lives! References: [1]Frye MA, Altshuler LL, McElroy SL, et al.
[2]Lu Ying, Sun Yang, Zhu Liping.
The mechanism and treatment progress of tardive dyskinesia[J].
Journal of Psychiatry.
2017; 30 (3): 237-240.
[3]McEvoy J, Gandhi SK, Rizio AA, et al.
Effect of tardive dyskinesia on quality of life in patients with bipolar disorder, major depressive disorder, and schizophrenia[J].
Qual Life Res .
2019 Dec;28(12):3303-3312.
[4]Fernandez HH, Factor SA, Hauser RA, et al.
Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study[J].
Neurology, 2017, 88(21): 2003-2010.
[5]Anderson KE, Stamler D, Davis MD, et al.
Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo- controlled, phase 3 trial[J].
The Lancet Psychiatry, 2017, 4(8): 595-604.
[6]Stacy M, Sajatovic M, Kane JM, et al. Scan the QR code below or click on the bottom of the article to read the original text to participate.
Thank you for your participation.
Tardive dyskinesia is not just an adverse drug reaction, it needs attention.
Speaking of patients with schizophrenia, I believe that the first word that appears in everyone's mind is "madman".
Due to problems such as incomprehension and social discrimination, many schizophrenic patients and their family members are reluctant to go to the hospital for treatment because they are afraid of becoming others’ after-dinner talks.
This delays the best time for treatment and affects recovery.
However, for patients with schizophrenia treated with antipsychotics, life is not so satisfactory.
They will face a series of adverse reactions caused by drugs, among which tardive dyskinesia (TD) is the involuntary rhythmic repetitive movement of a group of muscles caused by long-term use of high-dose antipsychotics.
According to statistics, in China, among schizophrenia patients who have received long-term antipsychotic treatment, the prevalence of TD is 33.
7%, which means that up to one-third of schizophrenia patients may have TD[1].
So, how does it affect the quality of life of patients with schizophrenia? Let's find out! Worse, the quality of life is further impaired.
TD is mainly manifested by involuntary movements of the mouth, lips, tongue and other parts, as well as dance-like movements of the limbs and trunk, and dystonia, which is obvious when emotionally stressed, and disappears during sleep.
It is more common in the continuous use of antipsychotics for several years, and a very small number occurs after the use of antipsychotics for several months [2].
A cross-sectional, web-based research study included 416 patients diagnosed with bipolar disorder (BD), depression (MDD) or schizophrenia (SZ), of which 197 patients had TD and 219 patients The patient is not accompanied by TD.
The 12-item Health Survey (SF-12v2) and the Concise Happiness and Quality of Life Satisfaction Questionnaire (Q-LES-Q-SF) were used to assess the patient’s health-related quality of life (HRQoL); the mental illness stigma scale- The Social Withdrawal Subscale (SW-ISMI) assesses the degree of social withdrawal of patients [3].
The results showed that in the total population of BD, MDD, and SZ patients, compared with patients without TD, patients with TD had worse HRQoL and a higher degree of social withdrawal (P<0.
001).
In separate analyses of different populations, similar results were also observed, but TD has a relatively greater impact on SZ patients.
Figure 1: HRQoL and degree of social withdrawal in patients with or without TD.
In addition, the researchers also stratified according to the severity of TD patients.
The results showed that the scale scores of all dimensions of patients with mild TD were better than medium/ Patients with severe TD.
Figure 2: HRQoL and degree of social withdrawal in patients with mild, moderate/severe TD As can be seen from the above studies, TD can significantly affect the physical and mental health of patients with schizophrenia, which also reminds clinicians when prescribing antipsychotics , Don’t just treat TD as an adverse reaction of antipsychotics, but need to fully consider the potential TD risks of the drug and make the most suitable treatment decision for the patient.
The world’s first deuterated drug brings good news to TD patients.
In May 2020, the world’s first deuterated drug, deuterium tetrabenazine, officially "landed" in China through the priority review and approval process, improving the availability of no medicines for Chinese TD patients The predicament also makes more schizophrenics no longer afraid of TD caused by long-term use of antipsychotics, which will help patients with schizophrenia persist in treatment and return to society as soon as possible.
At present, a number of international studies have confirmed the efficacy and safety of deuterium tetrabenazine treatment.
The ARM-TD study is a 12-week, placebo-controlled, flexible-dose trial involving 117 moderate to severe adult TD patients.
The results of the study showed that at the 12th week of treatment, the abnormal involuntary movement scale (AIMS) score of the deuterium tetrabenazine treatment group was improved by 3.
0 compared with the baseline, which was significantly better than that of the placebo group (the AIMS score was improved by 1.
6, P = 0.
019) [4]. The AIM-TD study is a randomized, flexible dose titration study.
222 patients were randomly assigned to deuterium tetrabenazine 12mg/d group, 24mg/d group, 36mg/d group and placebo group.
At 12 weeks of treatment, the AIMS scores of the deuterated tetrabenazine 12 mg/d group, 24 mg/d group, 36 mg/d group and placebo group decreased by 2.
1 points, 3.
2 points, 3.
3 points and 1.
4 points, respectively (compared with placebo group The comparative P values were 0.
217, 0.
003 and 0.
001) [5].
Table 1.
In the ARM-TD and AIM-TD studies, the changes in the AIMS score and the treatment success rate of deuterated tetrabenazine are worth mentioning.
A pooled analysis study published in Movment Disorder showed that for patients with TD, The minimum clinically significant change in the AIMS score is 2 points [6].
In the two studies of ARM-TD and AIM-TD, all doses of deuterium tetrabenazine scores improved> 2 points after 12 weeks of treatment, which has important clinical significance [4,5].
In addition, the above two studies confirmed that deuterium tetrabenazine is safe and well tolerated.
Overall, the incidence of any, treatment-related, neurological/psychiatric or serious adverse events in the deuterium tetrabenazine group was similar to that in the placebo group [4,5].
In terms of long-term treatment, an open, one-arm extended study included 343 patients with TD who received deuterium tetrabenazine in the ARM-TD and AIM-TD studies.
At 106 weeks of treatment, 55% and 30% of patients achieved a ≥50% response rate and ≥70% response rate (AIMS scores were improved by ≥50% and ≥70% from baseline).
The corresponding data at 132 weeks of treatment were 61% and 40%, respectively.
At the same time, studies have shown that deuterium tetrabenazine is well tolerated [7].
Figure 3: Summary of changes in AIMS response rate over time after receiving deuterium tetrabenazine treatment.
In clinical practice, most clinicians only regard TD as an adverse reaction of antipsychotics, without paying enough attention. In fact, TD can seriously affect the quality of life of patients, aggravate the degree of social withdrawal of patients, and pose a great challenge to patients' social function and medication compliance.
Deuterated tetrabenazine is the world's first deuterated drug, and a number of international evidence-based data have proven its efficacy and safety.
It is gratifying that deuterium tetrabenazine has entered the 2020 National Drug List, and its accessibility has further increased.
Looking forward to the extensive application of deuterium tetrabenazine in China, we will accumulate more experience and let more patients return to "safe" and stable lives! References: [1]Frye MA, Altshuler LL, McElroy SL, et al.
[2]Lu Ying, Sun Yang, Zhu Liping.
The mechanism and treatment progress of tardive dyskinesia[J].
Journal of Psychiatry.
2017; 30 (3): 237-240.
[3]McEvoy J, Gandhi SK, Rizio AA, et al.
Effect of tardive dyskinesia on quality of life in patients with bipolar disorder, major depressive disorder, and schizophrenia[J].
Qual Life Res .
2019 Dec;28(12):3303-3312.
[4]Fernandez HH, Factor SA, Hauser RA, et al.
Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study[J].
Neurology, 2017, 88(21): 2003-2010.
[5]Anderson KE, Stamler D, Davis MD, et al.
Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo- controlled, phase 3 trial[J].
The Lancet Psychiatry, 2017, 4(8): 595-604.
[6]Stacy M, Sajatovic M, Kane JM, et al. Scan the QR code below or click on the bottom of the article to read the original text to participate.
Thank you for your participation.
