• 14
    Jun
  • A Cohort Study of NSAID Use: RESULTS

RESULTS

Of the 467 patients identified by their physicians as meeting the study’s inclusion criteria, 447 (96%) agreed to participate. The most frequent reason given for not participating was “not enough time.” Of the patients who completed a baseline survey, 440 (98%) completed the two follow-up surveys according to the timeline in the study protocol. All analyses include only these 440 subjects.

Demographics

The patients ranged in age from 50 to 99 years (mean = 65.3 years, median = 63 years), and 78% were women (Table 1). The racial breakdown (55% African-American, 38% white) reflected the practices from which the patients were recruited. Most subjects (52%) described themselves either as high school graduates or as having attended some college; 19% had completed college or postgraduate work.
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Table 1    Demographics of Patients Taking Nonsteroidal Anti-inflammatory Drugs

New

Changed Renewal

Rx

Rx

Rx

(n = 83)

(n = 29) (n = 328)

Gender (% female)

75

82

78

Age, Years: Mean (SD)

66 (11)

69 (11)

65 (11)

Ethnicity (%)
African-American

55

48

55

White

39

41

39

Other

6

11

6

Current smoker? (% Yes)

20

21

17

Insurance pay for
medications? (%)
Full

33

45

34

Part

59

55

60

Nothing

9

6

Education (%)
Less than high school

39

31

25

High school graduate or
some college

42

55

53

College or postgraduate study 14

14

21

Rx = prescription; SD = standard deviation.

According to the study definitions, 83 patients were categorized as new NSAID users, 29 as changed NSAID users, and 328 as renewal NSAID users upon enrollment. Demographic profiles in the three user groups were similar.

Indications for NSAIDs

The most common reasons reported for needing an NSAID prescription were arthritis of any type (256, or 58% of all subjects) and musculoskeletal pain, including back pain (254, or 58% of all patients). Some patients chose more than one reason. Less commonly chosen indications were headache (4%), postsurgical pain (2%), and miscellaneous causes (13%).

Choice of NSAID

Two NSAIDs—ibuprofen (e.g., McNeil Consumer) and canadian naproxen sulfate (e.g., Naprosyn drug, Roche)— accounted for more than half (56%) of all the NSAIDs pre­scribed at the baseline evaluation. Two other unique classes of NSAIDs—the cyclooxygenase-selective (COX-2) formulations (rofecoxib [Vioxx®, Merck] and [Pfizer; Pharmacia & Upjohn]) (16%) and an NSAID combined with a gastroprotective agent, misoprostol (Anthrotec®, Searle) (4%)—were the next most commonly prescribed. COX-2 NSAIDs comprised 13% of the NSAIDs prescribed for renewal NSAID users, 19% of those for new NSAID users, and 38% of those for changed NSAID users.

Table 2 Reasons Reported by Patients for Discontinuing Prescribed Nonsteroidal Anti-inflammatory Drugs

User Group (No. of Patients Stopping/Total, %)

Symptoms Resolved Denial of InsuranceCoverage/

Cost

Medication Ineffective Side Effects

Other

No

Reason

Given

At Two Weeks
Renewal Rx

6/15

3/15

3/15

2/15

1/15 4/15
(15/328, 5%)
Changed Rx

0

4/7

4/7

1/7

0 0
(7/29, 24%)
New Rx

6/13

1/13

1/13

1/13

0 5/13
(13/83, 16%)
At Six Weeks
Renewal Rx

12/30

1/30

7/30

3/30

2/30 7/30
(30/328, 9%)
Changed Rx

1/3

1/3

1/3

0

0 0
(3/29, 10%)
New Rx

9/20

1/20

5/20

5/20

1/20 1/20
(20/83, 24%)
* In each column, the numerator represents the number of patients who chose the option; the denominator is the total number of patients in each user group who reported that they were no longer taking NSAIDs. Some patients chose more than one reason for discontinuing their NSAID prescriptions.Rx = treatment.

Reduction in Pain

On a scale from 0 (“no pain”) to 10 (“the worst pain you can imagine”), the total study population described their pain as 4.2 ± 3.0 (standard deviation) at baseline (Figure 1). All three groups reported an improvement in pain at the two-week and six-week follow-up visits.

Figure 1 Pain improvement

Figure 1 Pain improvement, as reported by patients taking nonsteroidal anti-inflammatory agents. Rx = prescription.

NSAID Discontinuation

Most of the patients in all three groups reported still taking NSAIDs at the two-week and six-week follow-up visits (Table 2). Patients who were no longer taking NSAIDs were asked to explain why they had discontinued the prescribed drug. At the two-week visit, only four patients reported that they had stopped the medication because of side effects. At the six-week visit, only eight patients cited side effects as the reason for discontinuing NSAIDs. canadian antibiotics

Figure 2 Percentage of all patients taking nonsteroidal

Figure 2 Percentage of all patients taking nonsteroidal anti-inflammatory agents who reported gastrointestinal symptoms. Rx = prescription.

Patients who continued taking NSAIDs were asked whether they had experienced GI symptoms and to consult a checklist. Symptoms were categorized as dyspeptic (heartburn, nausea, vomiting, abdominal pain) or non-dyspeptic (bloating, gassiness, constipation, diarrhea). The “changed” NSAID users reported the highest rates of GI symptoms (Figure 2). Overall, nearly two-thirds of all GI symptoms were dyspeptic in nature.

Table 3 Management of Dyspeptic Symptoms by Patients Taking Nonsteroidal Anti-inflammatory Drugs*

User Group(No. of Patients*/Total)

with Dyspeptic Symptoms

No. Managing      No. Taking Prescriptionwithout              Gastroprotective Involving Physicians          Medications No. Involving Physicians in Management
At Two Weeks
Renewal Rx

31/36

4/36 1/36
(33/328, 10%)
Changed Rx (n = 7)

6/7

1/7 0
(7/29, 21%)
New Rx (n = 14)

16/17

1/17 0
(14/83, 17%)
At Six Weeks
Renewal Rx

22/31

6/31 3/31
(29/328, 9%)
Changed Rx

3/4

1/4 0
(4/29, 14%)
New Rx

11/12

1/12 0
(11/83, 13%)
* In each column, the numerator represents the number of symptoms managed as described; the denominator is the total number of dyspeptic symptoms reported by patients in the user group. Some patients chose more than one reason for discontinuing their NSAID medications.

Management of Gastrointestinal Symptoms

Patients who experienced GI symptoms were asked to explain, after selecting from a list of options, which actions they took in response to these symptoms (Table 3). Overall, 54 (12%) patients reported dyspeptic symptoms (a total of 60 symptoms) at two weeks, and 44 patients (10%) reported dyspeptic symptoms (a total of 47 symptoms) at six weeks. These actions were then categorized as follows:

  • Patients managed without involving a physician (e.g., “did nothing,” “took with food,” “reduced dose on own,” and “took OTC meds”).
  • Patients managed by taking prescription gastroprotective medications.
  • Patients managed by involving a physician (e.g., “called doctor,” “visited doctor,” and “went to hospital or emergency room”).

Fewer patients (7% at two weeks and 3% at six weeks) reported lower GI symptoms (all diarrhea or constipation) while taking prescription NSAIDs. Nearly all (93%) of these symptoms were managed without physician involvement.

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