Quality of Life & Functioning

Quality of Life & Functioning

Quality of Life & Functioning

Functional outcomes with LATUDA

SECONDARY ENDPOINT

Patient-reported: Change in functional impairment as monotherapy

Secondary endpoint: Change in SDS total score as monotherapy at Week 61

Latuda® (lurasidone HCl) Bipolar Depression - Secondary Endpoint - Change in SDS Total Score at Week 6: Monotherapy Chart

Statistical analyses were not adjusted for multiplicity and are for descriptive purposes only. There was no statistical procedure conducted for controlling of the overall Type 1 error rate (false positive).

Areas of functional impairment measured on the Sheehan Disability Scale (SDS):

SEE MORE

CTA Block > Modal Body:

Total score range: 0–30, with higher scores indicating greater impairment.

Last observation carried forward (LOCF) analysis.

SDS=Sheehan Disability Scale.

Mean baseline SDS scores: Placebo: 19.8, LATUDA 20–60 mg/day: 19.7, LATUDA 80–120 mg/day: 19.8. 

Functional outcomes with LATUDA

SECONDARY ENDPOINT

Patient reported: Change in functional impairment as adjunctive therapy with lithium or valproate

Secondary endpoint: Change in SDS total score as adjunctive therapy with lithium or valproate at Week 62,3

Latuda® (lurasidone HCl) Bipolar Depression - Secondary Endpoint - Change in SDS Total Score at Week 6: Adjunctive Therapy Chart

Statistical analyses were not adjusted for multiplicity and are for descriptive purposes only. There was no statistical procedure conducted for controlling of the overall Type 1 error rate (false positive).

Areas of functional impairment measured on the Sheehan Disability Scale (SDS):

SEE MORE

CTA Block > Modal Body:

Total score range: 0–30, with higher scores indicating greater impairment.

LOCF analysis.

SDS=Sheehan Disability Scale.

Mean baseline SDS scores: Placebo: 20.1,

LATUDA 20–120 mg/day: 19.5. 

Quality of life improvements with LATUDA

SECONDARY ENDPOINT

Patient-reported: Change in quality of life as monotherapy

Secondary endpoint: Change in Q-LES-Q-SF total score as monontherapy at Week 61,4

Latuda® (lurasidone HCl) Bipolar Depression - Secondary Endpoint - Change in Q-LES-Q-SF Total Score at Week 6: Monotherapy Chart

Statistical analyses were not adjusted for multiplicity and are for descriptive purposes only. There was no statistical procedure conducted for controlling of the overall Type 1 error rate (false positive).

Areas of patient satisfaction measured on the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF):

SEE MORE

CTA Block > Modal Body:

  • Physical health
  • Mood
  • Work
  • Household activities
  • Social relationships
  • Family relationships
  • Leisure-time activities
  • Ability to function in daily life
  • Sexual drive, interest, and/or performance
  • Economic status
  • Living/housing situation
  • Ability to get around physically without feeling dizzy or unsteady or falling
  • Vision in terms of ability to do work or hobbies
  • Overall sense of well-being

Total score range: 14-70, with higher scores indicating better quality of life.

LOCF analysis.

Q-LES-Q-SF=Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form.

Mean baseline Q-LES-Q-SF scores: Placebo: 34.2,

LATUDA 20–60 mg/day: 33.8, LATUDA 80–120 mg/day: 33.5.

Quality of life improvements with LATUDA

SECONDARY ENDPOINT

Patient-reported: Change in quality of life as adjunctive therapy with lithium or valproate

Secondary endpoint: Change in Q-LES-Q-SF total score as adjunctive therapy with lithium valproate at Week 62,3

Latuda® (lurasidone HCl) Bipolar Depression - Secondary Endpoint - Change in Q-LES-Q-SF Total Score at Week 6: Adjunctive Therapy Chart

Statistical analyses were not adjusted for multiplicity and are for descriptive purposes only. There was no statistical procedure conducted for controlling of the overall Type 1 error rate (false positive).

Areas of patient satisfaction measured on the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF):

SEE MORE

CTA Block > Modal Body:

  • Physical health
  • Mood
  • Work
  • Household activities
  • Social relationships
  • Family relationships
  • Leisure-time activities
  • Ability to function in daily life
  • Sexual drive, interest, and/or performance
  • Economic status
  • Living/housing situation
  • Ability to get around physically without feeling dizzy or unsteady or falling
  • Vision in terms of ability to do work or hobbies
  • Overall sense of well-being

Total score range: 14-70, with higher scores indicating better quality of life.

LOCF analysis.

Q-LES-Q-SF=Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form

Mean baseline Q-LES-Q-SF scores: Placebo: 35.7,

LATUDA 20–120 mg/day: 36.1.

 


 

footer-cta-learn-about

Learn About LATUDA

Find out more about a medication to treat bipolar depression in your patients.

footer-cta-vec

Virtual Education Center

Take a deeper dive into bipolar depression, patient populations, and LATUDA, led by your peers.

footer-cta-patient-support

Support Your Patients

Savings, support, and tools are available for your patients. Get the support they need. 

References:

1. Loebel A, Cucchiaro J, Silva S, et al. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2013;171(2):160-168.

2. Loebel A, Cucchiaro J, Silva S, et al. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo- controlled study. Am J Psychiatry. 2013;171(2):169-177.

3. Cucchiaro J. A randomized, 6-week, double-blind, placebo-controlled, flexible-dose, parallel-group study of lurasidone adjunctive to lithium or divalproex for the treatment of bipolar I depression. Clinical Study Report D1050235. July 2012.

4. Cucchiaro J. A randomized, 6-week, double-blind, placebo-controlled, fixed flexible-dose, parallel-group study of lurasidone for the treatment of bipolar I depression. Clinical Study Report D1050236. February 2012.

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Suicidal Thoughts and Behaviors
Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.

 

CONTRAINDICATIONS: LATUDA is contraindicated in the following:

Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials, elderly subjects with dementia randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported with administration of antipsychotic drugs. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of antipsychotic drugs, including LATUDA, intensive symptomatic treatment and monitoring.

Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses or may even arise after discontinuation of treatment. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes Atypical antipsychotic drugs have caused metabolic changes including:

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for diabetes should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, LATUDA elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia has been reported with antipsychotics. Agranulocytosis (including fatal cases) has been reported with other agents in the class. Monitor complete blood count in patients with a pre-existing low white blood cell count (WBC)/absolute neutrophil count (ANC) or history of drug-induced leukopenia/neutropenia. Discontinue LATUDA at the first sign of a decline in WBC in the absence of other causative factors.

Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest at the beginning of treatment and when increasing the dose. Monitor patients vulnerable to hypotension and those with cardiovascular and cerebrovascular disease.

Falls: Antipsychotics may cause somnolence, postural hypotension, or motor and sensory instability, which may lead to falls, causing fractures or other injuries. For patients with disease, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy.

Seizures: LATUDA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.

Potential for Cognitive and Motor Impairment: Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with LATUDA does not affect them adversely.

Body Temperature Regulation: Use LATUDA with caution in patients who may experience conditions that increase body temperature (e.g., exercising strenuously, exposure to extreme heat, concomitant medication with anticholinergic activity, or being subject to dehydration).

Dysphagia: Antipsychotics, including LATUDA, have been associated with esophageal dysmotility and aspiration, and should be used with caution in patients at risk for aspiration pneumonia.

Most Commonly Observed Adverse Reactions: Commonly observed adverse reactions (≥5% incidence and at least twice the rate of placebo) for LATUDA:

To report SUSPECTED ADVERSE REACTIONS, contact Sunovion Pharmaceuticals Inc. at 877-737-7226 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Indications

LATUDA is indicated for:

Before prescribing LATUDA, please read the full Prescribing Information, including Boxed Warning.