Abstract | STUDY OBJECTIVE: DESIGN: Nested case-control study. DATA SOURCE: Health Search IMS Health Longitudinal Patient Database. PATIENTS: A total of 36,754 adults with a diagnosis of osteoarthritis and an incident (first-time) prescription of nonsteroidal antiinflammatory drugs ( NSAIDs) between January 2002 and June 2012 were identified; of these patients, cases were defined as those who had a diagnosis of an ACCE during the follow-up period (index date was the date of ACCE diagnosis; 2182 cases). For each case, up to five controls were randomly selected who were matched based on age, sex, month and year of cohort entry, and duration of follow-up (10,301 controls). Matched controls were assigned the same index date as their respective cases. MEASUREMENTS AND MAIN RESULTS: For each case and matched controls, all prescriptions of acetaminophen-containing medicines filled during follow-up were identified. The risk of ACCEs was investigated with respect to the recency of use of acetaminophen and/or an acetaminophen-codeine combination. Patients were classified as current (0-90 days preceding index date), recent (91-180 days), or past (181-365 days) acetaminophen users, or nonusers (longer than 365 days), with nonusers representing the reference category. Conditional logistic regression was estimated to calculate odds ratios ( ORs) and 95% confidence intervals (CIs). Of the 36,754 patients with osteoarthritis and newly prescribed NSAIDs, the incidence rate of ACCEs was 117.6 per 10,000 person-years. No significant association between exposure to acetaminophen-containing medications and ACCEs was observed in current (OR 1.22, 95% CI 0.96-1.55), recent (OR 1.12, 95% CI 0.80-1.55), or past users (OR 1.13, 95% CI 0.86-1.48). A secondary analysis evaluating exposure to acetaminophen monotherapy or acetaminophen-codeine combination therapy showed similar results for current users. CONCLUSION: Our findings indicate that no association can be made between the use of acetaminophen and/or an acetaminophen-codeine combination and the occurrence of ACCEs. This information contributes to support clinicians in the choice of acetaminophen therapy for osteoarthritis-related pain, especially in those patients presenting with cerebrovascular and cardiovascular morbidities or related risk factors.
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Authors | Giuseppe Roberto, Monica Simonetti, Carlo Piccinni, Pier Lora Aprile, Iacopo Cricelli, Andrea Fanelli, Claudio Cricelli, Francesco Lapi |
Journal | Pharmacotherapy
(Pharmacotherapy)
Vol. 35
Issue 10
Pg. 899-909
(Oct 2015)
ISSN: 1875-9114 [Electronic] United States |
PMID | 26497476
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 Pharmacotherapy Publications, Inc. |
Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Drug Combinations
- acetaminophen, codeine drug combination
- Acetaminophen
- Codeine
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Topics |
- Acetaminophen
(administration & dosage, adverse effects, therapeutic use)
- Aged
- Aged, 80 and over
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects, therapeutic use)
- Cardiovascular Diseases
(epidemiology)
- Case-Control Studies
- Cerebrovascular Disorders
(epidemiology)
- Codeine
(administration & dosage, adverse effects, therapeutic use)
- Cohort Studies
- Drug Combinations
- Female
- Humans
- Logistic Models
- Male
- Middle Aged
- Odds Ratio
- Osteoarthritis
(drug therapy)
- Risk Factors
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