Roflumilast (PDE4 Inhibitor)

Treatment for COPD

Typical Dosage: Roflumilast 500 mcg once daily

Effectiveness
60%
Safety Score
55%
Clinical Trials
4
Participants
15K

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
55
DangerousModerateSafe
Treatment Details
Dosage Range
Roflumilast 500 mcg once daily
Time to Effect
Weeks-months (exacerbation reduction)
Treatment Duration
Lifetime
Evidence Quality
HIGH
Number Needed to Treat (NNT)
10(Treat 10 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
7(Treat 7 patients to see 1 additional serious adverse event)
Confidence Score
85%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$5,400
Monitoring:$800
Side Effect Mgmt:$100
Total Annual:$6,300
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POOR
ICER
$200,000/QALY
QALYs Gained
0.02
Outcome-Based Costs
Cost per Responder
$12,600
Comparison vs Usual Care
Cost Difference
+$6,300/year
More expensive
QALY Difference
+0.02 QALYs
Better outcomes
Dominance
No dominance
Roflumilast (PDE4 Inhibitor) Outcomes

for COPD

Efficacy Outcomes
Overall Effectiveness
+60%
Response Rate
+50%
Common Side Effects
Diarrhea
+15%
Nausea
+8%
Headache
+7%
Weight loss
+5%
Insomnia
+4%

Sources:

nih.gov
dovepress.com
researchgate.net

WARNING: LIMITED TRIALS AVAILABLE

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Active Clinical Trials
No active trials currently recruiting for this treatment

No active trials found in ClinicalTrials.gov

Completed Clinical Trials
3 completed trials for Roflumilast (PDE4 Inhibitor) in COPD

Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization

NCT01973998COMPLETEDPHASE3
View Study
68 participants
INTERVENTIONAL
Philadelphia, United States
Started: Nov 1, 2013

Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

NCT00242294COMPLETEDPHASE2, PHASE3
View Study
570 participants
INTERVENTIONAL
Osaka, Japan
Started: Nov 1, 2004

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)

NCT00246935COMPLETEDPHASE3
View Study
150 participants
INTERVENTIONAL
Osaka, Japan
Started: May 1, 2005