Efficacy

For patients with OA seeking pain relief...
VIMOVO patients experienced significant pain relief and up to a 47% overall improvement in their OA at 12 weeks1,2*

Pain Efficacy Trials (Studies 3 and 4)1
  • Patients with OA of the knee
  • Patients with a 6-month history of symptomatic, clinically diagnosed OA (aged 50 and older)

  • VIMOVO significantly decreased OA pain and allowed patients to increase their physical function1
  • WOMAC pain subscale (-42.0 for VIMOVO vs -35.6 for placebo; P<0.05)1†
  • WOMAC function subscale (-36.4 for VIMOVO vs -30.6 for placebo; P<0.05)1†

  • VIMOVO significantly decreased OA pain and allowed patients to increase their physical function1
  • WOMAC pain subscale (-44.2 for VIMOVO vs -38.4 for placebo; P<0.05)1†
  • WOMAC function subscale (-38.9 for VIMOVO vs -32.3 for placebo; P<0.05)1†

Trial Design

Study 3 and Study 4

Results from two US phase IIIB, 12-week, randomized, double-blind, placebo-controlled, multicenter studies to demonstrate efficacy of VIMOVO vs placebo in treating the signs and symptoms of OA that were measured by Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain, WOMAC Function, and PGA (patient global assessment). Study population consisted of symptomatic patients aged ≥50 years with a 6-month history of osteoarthritis of the knee (meeting ACR criteria); ACR functional status of I, II, or III; and receiving stable therapy with an NSAID, COX-2 selective agent, or other oral analgesic. Following a washout of chronic analgesic therapy for 7-14 days, patients (N=740) who experienced a flare of OA were randomized. Patients were randomized to VIMOVO 500 mg/ 20 mg twice daily or placebo. The co-primary end points were the change at Week 12 from baseline in WOMAC (Pain and Function subscales) and PGA-VAS scores. The change from baseline in the WOMAC pain subscale was measured during follow-up visits at Week 1 (24-hour recall), Week 6 (48-Hour recall) and Week 12 (48-hour recall).1


Footnotes

*The Patient Global Assessment (PGA) questionnaire used in these studies assessed patients' perception of their OA pain. Patients were asked, "Considering all the ways your arthritis affects you, how well are you doing?" This was completed at baseline and Weeks 1, 6, and 12 via electronic diaries; responses ranged between "Very poor" and "Excellent" using a 100-mm visual analog scale (VAS).

†Negative values of change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) subscales indicate improvement in the signs and symptoms of OA of the knee.

VIMOVO patients had 67% fewer discontinuations due to upper GI issues versus EC-naproxen3

Study 1 and Study 2: Percentage of Premature Patient Discontinuations Due to Upper GI Adverse Events, Including Duodenal Ulcers, Over 6 Months3

Pivotal Trial (Studies 1 and 2)3,4

  • Having a medical condition expected to require daily NSAID therapy for at least 6 months
  • 50 and over (no prior history of gastric or duodenal ulcer)
  • 18-49 with a documented history of gastric or duodenal ulcer within past 5 years
  • Majority of patients were 50-69 years of age (83%)

VIMOVO significantly reduced the incidence of gastric ulcers vs EC-naproxen over 6 months3,4

LDA: ~25% of the overall study population was taking concurrent low-dose aspirin (n=201)3,4

VIMOVO significantly reduced the incidence of gastric ulcers vs EC-naproxen over 6 months3,4

LDA: ~25% of the overall study population was taking concurrent low-dose aspirin (n=201)3,4

Trial Design

Study 1 and Study 2

Results from two US pivotal phase III, 6-month, randomized, double-blind, parallel-group, controlled, multicenter studies to evaluate the incidence of gastric ulcers in patients taking either VIMOVO or enteric-coated (EC)-naproxen who were at risk of developing NSAID-related gastric ulcers (N=854). Subjects were defined as having a medical condition expected to require daily NSAID therapy for at least 6 months, and were ≥50 years old, or if 18-49 years of age had either a history of a documented uncomplicated gastric or duodenal ulcer (mucosal break ≥3 mm in diameter with unequivocal depth, without any concurrent bleeding, clot, or perforation) within the last 5 years. Patients were randomized to either VIMOVO 500 mg/20 mg twice daily or EC-naproxen 500 mg twice daily. Assessments were conducted by endoscopy at Month 1, Month 3, Month 6; if a gastric ulcer was detected, use of study drug was discontinued and the patient was considered to have completed the study. Randomized patients did not have any gastric ulcers detected at baseline.4

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Important Safety Information About VIMOVO

Cardiovascular Risk

  • Naproxen, a component of VIMOVO, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk
  • VIMOVO is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery

Gastrointestinal Risk

  • NSAIDs, including naproxen, a component of VIMOVO, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events

VIMOVO is contraindicated in patients with known hypersensitivity to any component of VIMOVO or substituted benzimidazoles; in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; in patients during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery; or in patients in the late stages of pregnancy.

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Treatment should be withdrawn when active and clinically significant bleeding from any source occurs.

As with all NSAIDs, VIMOVO can lead to the onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Blood pressure should be monitored closely. NSAIDs, including VIMOVO, may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors and angiotensin II antagonists, beta-blockers, and in some patients can reduce the natriuretic effect of furosemide and thiazides.

Fluid retention and edema have been observed in some patients taking NSAIDs, including VIMOVO. NSAIDs should be used with caution in patients with fluid retention or heart failure.

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. VIMOVO can be administered with low-dose aspirin (≤325 mg/day) therapy. The concurrent use of aspirin and VIMOVO may increase the risk of serious adverse events. As with all NSAIDs, concurrent administration of naproxen and aspirin is not generally recommended because of the potential of increased adverse events.

NSAIDs, including VIMOVO, can cause serious GI adverse events, which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at high risk for GI events, especially the elderly. VIMOVO should be used with caution in these patients.

Epidemiological studies have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. In two studies, concurrent use of an NSAID, COX-2 inhibitor, or aspirin potentiated the risk of bleeding. Although these studies focused on upper gastrointestinal bleeding, bleeding at other sites cannot be ruled out.

NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.

Symptomatic response to esomeprazole, a component of VIMOVO, does not preclude the presence of gastric malignancy.

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which VIMOVO contains an enantiomer.

Anaphylactoid reactions may occur in patients without known prior exposure to either component of VIMOVO. NSAIDs should not be given to patients with aspirin triad.

NSAIDs can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. These serious events may occur without warning. Discontinue VIMOVO at first appearance of skin rash or any other sign of hypersensitivity.

In late pregnancy, as with other NSAIDS, VIMOVO should be avoided because it may cause premature closure of the ductus arteriosus.

VIMOVO is not recommended in patients with moderate or severe renal insufficiency. In addition, NSAIDs may cause renal toxicity.

VIMOVO is not recommended in patients with severe hepatic insufficiency. Consider dose reduction in mild/moderate hepatic insufficiency. If abnormal liver enzymes persist or worsen discontinue use immediately.

Several studies and literature reports indicate that long-term proton pump inhibitor (PPI) therapy is associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.

Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.

Avoid concomitant use of VIMOVO with St John's Wort or rifampin due to the potential reduction in esomeprazole levels.

Esomeprazole, a component of VIMOVO, inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, and digoxin).

Concomitant use of VIMOVO and warfarin may result in increased risk of bleeding complications. Monitor for increases in INR and prothrombin time.

The most commonly observed adverse events in clinical trials (experienced by >5% patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea.

Indication

VIMOVO is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.

Please see Important Safety Information and Prescribing Information, including Boxed Warnings, for VIMOVO.

References

  1. Hochberg MC, Fort JG, Svensson O, Hwang C, Sostek M. Fixed Dose combination of enteric-coated naproxen and immediate–release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin. 2011;27(6):1243-1253.
  2. Data on File (1319810). AstraZeneca Pharmaceuticals, LP.
  3. VIMOVO® Prescribing Information. Wilmington DE: AstraZeneca; May 2011.
  4. Goldstein JL, Hochberg MC, Fort JG, Zhang Y, Hwang C, Sostek M. Clinical trial: the incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs enteric-coated naproxen alone. Aliment Pharmacol Ther. 2010;32(3):401-413.

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