Effects of risperidone on behavioral and psychological symptoms associated with dementia in clinical practice

Background: Risperidone significantly improves behavioral and psychological symptoms of dementia (BPSD), including aggression, agitation and psychosis, as shown by randomized, placebo-controlled trials.MethodsAn 8-week, multicenter, naturalistic, open-label study was carried out to examine whether the benefits of risperidone apply to clinical practice. A total of 4499 patients were treated with risperidone at flexible doses chosen by physicians, and were included in the safety evaluation. Of these, 3909 patients met the intended study criteria (at least 65 years of age, dementia, and the presence of BPSD) and were included in the efficacy analyses.Results:At the end of the study (after 8 weeks of treatment), risperidone (average final dose 1.6 mg/day) significantly improved all symptoms studied (agitation, aggressiveness, disturbance of the sleep–wake rhythm, social withdrawal, suspiciousness and delusions) as rated by physicians on a five-point scale of severity. On a four-point scale of global efficacy, more than 90% of patients were rated improved by both physicians and caregivers after 8 weeks of treatment. A significant improvement in sleep-wake cycle disturbances was also noted. A total of 422 adverse events were documented in 346 of the 4499 patients (7.7%); these included insufficient efficacy (2.6%), extrapyramidal symptoms (0.89%), deterioration of psychiatric symptoms (0.73%), sedation (0.56%), gastrointestinal disturbances (0.49%), cardiovascular disorders (0.38%), and cerebrovascular adverse events (0.36%).Conclusions: Risperidone is an effective and well-tolerated treatment for BPSD in routine clinical practice.

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Impact of Donepezil and Memantine on Behavioral and Psychological Symptoms of Alzheimer Disease: Six-month Open-label Study

Cognitive and Behavioral Neurology ◽

10.1097/wnn.0000000000000285 ◽

2021 ◽

Vol 34 (4) ◽

pp. 288-294

Author(s):

Petra Bago Rožanković ◽

Marjan Rožanković ◽

Jasna Badžak ◽

Maristela Stojić ◽

Ivana Šušak Sporiš

Keyword(s):

Alzheimer Disease ◽

Psychological Symptoms ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Behavioral And Psychological Symptoms

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A Comparison of Lamotrigine or Sodium Valproate on the Efficacy in Alzheimer’s disease with Behavioral and Psychological Symptoms of Dementia: A Retrospective Open-Label Study Running Title: Efficacy of Anticonvulsants for BPSD

Journal of Gerontology & Geriatric Research ◽

10.4172/2167-7182.1000253 ◽

2015 ◽

Vol 04 (06) ◽

Author(s):

Hidenobu Suzuki ◽

Yuichi Inoue

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Sodium Valproate ◽

Psychological Symptoms ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Behavioral And Psychological Symptoms

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Evaluation of risperidone in the treatment of behavioral and psychological symptoms and sleep disturbances associated with dementia

International Psychogeriatrics ◽

10.1017/s104161020500219x ◽

2005 ◽

Vol 17 (4) ◽

pp. 591-604 ◽

Cited By ~ 12

Author(s):

J. C. Durán ◽

A. Greenspan ◽

J. I. Diago ◽

R. Gallego ◽

G. Martinez

Keyword(s):

Adverse Events ◽

Sleep Disturbances ◽

Psychological Symptoms ◽

Neuropsychiatric Inventory ◽

Open Label ◽

Sleep Behavior ◽

The Mean ◽

Behavioral And Psychological Symptoms ◽

Progressive Cognitive Impairment ◽

Risperidone Treatment

Background: Dementia is associated with progressive cognitive impairment and behavioral and psychological symptoms. Sleep–wake cycle disturbances are common in patients with dementia. This study evaluated the efficacy and safety of risperidone in the treatment of the behavioral and psychological symptoms of dementia (BPSD) and associated sleep–wake cycle disturbances.Methods: In this open-label, 12-week, observational, prospective study, the effects of risperidone were assessed using the Neuropsychiatric Inventory (NPI) total and subscale scores. Sleep–wake cycle disturbances were rated by patients/caregivers using a newly developed sleep behavior questionnaire that included assessment of sleep duration, quality, awakenings, and effects on daily activities. Tolerability assessments included the Udvalg for Kliniske Undersogelser (UKU) subscale for extrapyramidal symptoms (EPS) and the recording of adverse events.Results:A total of 338 patients entered the study, with 321 patients completing. Following 12 weeks of risperidone treatment (mean dose 1.49 mg/day at end-point), the mean NPI score was reduced to 10.6 from a baseline score of 28.7. Compared with baseline, patients/caregivers reported significant improvements following 12 weeks of risperidone in total sleep hours at night (5.5 vs. 7.1 hours), hours awake in bed at night (2.3 vs. 1.2 hours), insomnia (40.1% vs. 8.4%), and other sleep-related variables. Six patients reported a total of 10 adverse events, including somnolence (n = 3) and sialorrhea (n = 2). Scores on the UKU subscale of EPS improved significantly (mean 4.0 at baseline vs. 1.7 at week 12).Conclusions: Risperidone is effective and well tolerated in the treatment of BPSD and associated sleep disturbances.

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Yokukansan Treatment of Chronic Renal Failure Patients Receiving Hemodialysis, with Behavioral and Psychological Symptoms of Dementia: An Open-Label Study

American Journal of Geriatric Psychiatry ◽

10.1016/j.jagp.2011.06.001 ◽

2013 ◽

Vol 21 (11) ◽

pp. 1082-1085 ◽

Cited By ~ 6

Author(s):

Hidenori Sumiyoshi ◽

Akio Mantani ◽

Satoshi Nishiyama ◽

Soh Fujiwaki ◽

Shoichiro Ohta ◽

...

Keyword(s):

Renal Failure ◽

Chronic Renal Failure ◽

Psychological Symptoms ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Behavioral And Psychological Symptoms

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192 HEMIN TREATMENT FOR ACUTE PORPHYRIA: IMPLICATIONS FOR CLINICAL PRACTICE OF AN OPEN-LABEL STUDY OF 130 PATIENTS.

Journal of Investigative Medicine ◽

10.2310/6650.2005.x0008.191 ◽

2006 ◽

Vol 54 (1) ◽

pp. S290.4-S290

Author(s):

K. E. Anderson ◽

S. D. Collins

Keyword(s):

Clinical Practice ◽

Acute Porphyria ◽

Open Label ◽

Open Label Study ◽

Label Study

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P129: A phase IV real world study on the use of low dose methoxyflurane (PENTHROX™) for the treatment of moderate to severe trauma pain in the Canadian emergency department (ADVANCE-ED): an interim report on secondary outcomes

CJEM ◽

10.1017/cem.2020.333 ◽

2020 ◽

Vol 22 (S1) ◽

pp. S111-S111

Author(s):

S. Campbell ◽

E. Simard ◽

A. Arcand ◽

L. Blagrove ◽

P. Piraino ◽

...

Keyword(s):

Pain Relief ◽

Adverse Events ◽

Acute Pain ◽

Real World ◽

Rescue Medication ◽

Low Dose ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Phase Iv

Introduction: Inhaled low dose methoxyflurane (MEOF) was recently approved in Canada for the short-term relief of moderate to severe acute pain associated with trauma or interventional medical procedures in conscious adult patients. ADVANCE-ED is an ongoing phase IV, prospective open label study undertaken to generate real-world evidence to complement the global clinical development program through evaluation of the effectiveness of low dose MEOF in Canadian emergency departments (EDs). Methods: This multi-centre study is enrolling adult (≥18 yrs) patients with moderate to severe acute pain (NRS0-10 ≥ 4) associated with minor trauma. To address limitations from the pivotal study, this study allows patients who were excluded in the pivotal trials: namely, those with severe (≥7) pain, and those using OTC or stably dosed analgesics for other conditions, including chronic pain. Eligible patients receive a single treatment of up to 2 x 3 mL MEOF (2nd 3 mL to be provided only upon request), self-administered by the patient under medical supervision. Rescue medication is permitted at any time, if required. Results: Here we describe the patient demographics and treatment satisfaction (Global Medication Performance, GMP) at 50% enrolment (n = 49). Mean (SD) patient age is 48.0 (17.1) yrs and 55.1% are female. Mean pain (SD) reported at enrolment is 8.3 (1.5), with 73.4% of patients with NRS0-10 ≥ 8. Injuries are overwhelmingly limb trauma (87.8%). The most common type is sprain/strain (40.8%), followed by fracture (32.7%). At 5 minutes post-start of administration (STA) of MEOF, 80.4% of patients reported pain relief; this increased to 91.3% at 15 minutes, and 100% of patients reported pain relief by 30 minutes post-STA. GMP was assessed as “good”, “very good” or “excellent” by ≥80% of patients both 20 minutes post-start of administration (STA) of MEOF (83.3%) and at discharge (85.8%). When asked to what extent their expectation of pain relief had been met, 32.7% responded good, 26.5% responded “very good” and 22.4% responded “excellent”. Three quarters of enrolled patients (75.5%) did not require rescue medication. The most common (≥5%) treatment-related adverse events were dizziness (n = 14, 28.6%) and euphoric mood (n = 4, 8.2%). No serious adverse events have been reported. Conclusion: Based on 50% of the patients enrolled in this prospective, open label study, responses to inhaled low-dose MEOF are within expectation for both effectiveness and tolerability.

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Effect of Cotherapy Reduction on Tolerability of Epilepsy Add-On Therapy: A Randomized Controlled Trial

Annals of Pharmacotherapy ◽

10.1345/aph.1e403 ◽

2005 ◽

Vol 39 (3) ◽

pp. 418-423 ◽

Cited By ~ 15

Author(s):

Dean K Naritoku ◽

Joseph F Hulihan ◽

Lesley Kraut Schwarzman ◽

Marc Kamin ◽

William H Olson

Keyword(s):

Adverse Events ◽

Dose Group ◽

Controlled Trial ◽

Fixed Dose ◽

Primary Study ◽

Open Label ◽

Open Label Study ◽

Effective Doses ◽

Receive Treatment ◽

To Receive

BACKGROUND: Adverse effects are the most common cause for failure of an antiepileptic drug (AED), especially when an AED is added to existing therapy. With the increased drug load, it may not be possible to titrate the newly added AED to effective doses. Reducing the dosage of AED cotherapy as the new drug is introduced may improve tolerability. OBJECTIVE: To evaluate reduction of AED cotherapy as a strategy to improve tolerability and patient retention when a new AED is added to existing therapy. METHODS: In a 20-week, randomized, open-label study, topiramate was initiated as add-on therapy in adults and adolescents (⩾12 y of age) with inadequately controlled partial-onset seizures. Patients were randomized to receive treatment in which adverse events could be managed by adjustments in AED cotherapy (flex-dose group) or treatment in which AED cotherapy dosages remained fixed (fixed-dose group). Topiramate could be adjusted as needed in both groups. In the flex-dose group, patients exited randomized treatment when topiramate was discontinued. In the fixed-dose group, patients exited when AED cotherapy was reduced due to adverse events or when topiramate was discontinued. The primary study outcome was the percentage of patients exiting randomized treatment due to adverse events. RESULTS: The flex-dose group comprised 297 patients; 302 patients were in the fixed-dose group. Significantly fewer patients in the flex-dose group exited the study due to adverse events (16% vs 23% in the fixed-dose group; p = 0.02). In the flex-dose group, 10% (17 of 168) of patients discontinued topiramate due to adverse events after AED cotherapy was reduced versus 22% (29 of 129) when AED cotherapy was not reduced. CONCLUSIONS: Reduction of AED cotherapy is a useful strategy to improve tolerability and retention when topiramate is initiated as adjunctive therapy.

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