D125

Competitors

100

Name 2 common NSAIDS used to treat the pain associated with Osteoarthritis

Celebrex, Aleve

200

Commonly observed gastrointestinal adverse events in patients treated with NAPROSYN are heartburn, abdominal pain, nausea and ____________ . a. Blood in stool b. Constipation c. Flatulence d. Vomiting

b. Constipation

300

Serious adverse reactions which may be associated with OxyContin Tablet therapy in clinical use are those observed with other opioid analgesics, including respiratory depression, ____ respiratory arrest, and (to an even lesser degree) circulatory depression, hypotension, or shock. a. Apnea b. Vomiting c. Leg cramps d. Hyperglycemia

a. Apnea

400

Name at least 3 negative perceptions about Opiod pain agents

Scheduled classification (for some physicians) Risk of abuse Dependency Tolerance Requires special prescription form (in some states) Unfavorable adverse event profiles Overdose Symptoms associated with abrupt withdrawal Constipation

500

Name at least 3 warnings or precautions for the use of Celebrex

Cardiovascular Thrombotic Events Hypertension Congestive Heart Failure and Edema Gastrointestinal (GI) Effects Hepatic Effects Renal Effects Anaphylactoid Reactions Skin Reactions Pregnancy Corticosteroid Treatment Hematological Effects Disseminated Intravascular Coagulation (DIC) Preexisting Asthma Laboratory Tests GI Cancer in Familial Adenomatous Polyposis Inflammation Concomitant NSAID Use

Clinical Studies

100

What was the MEAN age of participants in the OA trials?

62

200

What were the dosages of Cymbalta used in studies HMFG and HMEP? a. 20 and 40 mg b. 30 and 60 mg c. 40 and 60 mg d. 60 and 120 mg

d. 60 and 120 mg

300

What percentage of the participants in the OA trials were classified as NSAID users?

45%

400

What were the inclusion criteria for the OA clinical trials?

1. experienced chronic pain due to OA for at least 3 months or longer and for 14 or more days a month. 2. Fulfilled ACR clinical AND radiographic criteria for ideopathic OA of the knee

500

Describe the Concomitant therapy procedure/protocol for the OA clinical trials

1. Washout of anticonvulsants, anti-depressants, and analgesics (except for NSAIDs and acetaminophen) prior to randomization. 2. Patients on NSAID could continue into trial--45% classified as such. 3. NSAID/APAP users defined as those who used meds at least 14 days a month for the 3 months prior to the studies.

Side Effects

100

A provider reports that a patient experienced nausea during titration from 30 mg. to 60 mg., but they've adjusted and now "doing well." Are you required to file an adverse event claim? Yes or No?

Yes

200

What was the duration of long-term, placebo-controlled studies that examined adverse events in patients taking Cymbalta for MDD?

34 weeks

300

What was the DC rate due to AE for Cymbalta and placebo during the OA clinical trials?

16.3 vs. 5.6

400

What were the three top AE during the OA clinical trials (rate was > or = 5%---double that of placebo)?

Nausea 8.4 fatigue 6.7 constipation 5

500

During the OA trials, which 2 adverse events reported as a reason for discontinuation and considered to be drug related?

Nausea Asthenia (muscle weakness)--which was lumped into the top AE mention of fatigue

PI

100

What is the half life of Cymbalta?

12 hours

200

What are the contraindications for Cymbalta?

uncontrolled narrow angle glaucoma conc. use of MAOI

300

In OA-1 trial, at what point were patients deemed to have "sub-optimal response" and how was that defined?

week 7, less than 30% pain reduction

400

What were the % of geriatric patients involved in the clinical trials for MDD, CLBP, and OA,

5.9% MDD 21.2% CLBP 40.5% OA

500

Name at least 4 warnings and precautions for Cymbalta...

suicidality, hepatotoxicity,orth hypotension/syncope,SS and NMS, Abnormal bleeding, severe skin reaction (st.johnson), D/c withdrawal sx, activation of mania/hypomania, seizures, BP, inhibit of cyp1a2, hyponatremia,hapatic insuff and severe renal imp.,controlled n.a.glaucoma, glucose control w/ diabetes, comorbid gastric emptying, urinary hesitation/retention

Osteo Arthritis Disease State

100

The American College of Rheumatology "clinical" classification criteria for knee OA include the following, EXCEPT: a. Synovial fluid signs b. Stiffness for less than 30 minutes c. Crepitus d. Bony tenderness

Synovial fluid signs

200

The parts of the body frequently affected by OA include: a. Hands, toes, spine, hips b. Elbows, hips, knees, toes c. Knees, ankles, elbows, spine d. Spine, hands, knees, hips

d. Spine hands knees hips

300

Which of the following is NOT one of the common risk factors for OA? a. Inflammation b. Ethnicity and race c. Muscle weakness d. Obesity

a. inflammation

400

What is the estimated number of adults in the U.S. who have OA? a. 200 thousand b. 2 million c. 2.7 million d. 27 million

d. 27 million

500

Which of the following statements about x-ray assessment of OA is false? a. When OA is asymptomatic, it is possible to conduct an assessment of the disease using x-rays. b. Characteristics seen on x-rays are thought to be better predictors of disability than patient-reported pain. c. Severity of joint damage as shown on x-rays is not directly correlated with the severity of pain. d. It is possible for patients who are not experiencing pain to have x-rays indicating the presence of OA.

b. Patient-reported pain is thought to be a better predictor of disability than x-ray evidence.