Epidemiological data, efficacy and safety of a paracetamol–tramadol fixed combination in the treatment of moderate-to-severe pain. SALZA: a post-marketing study in general practice

Serrié, Alain; Ganry, H.

doi:10.1185/03007995.2011.565045

Cited by 15 publications

(12 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…There is also a possibility that measures taken by medical staff to minimize the incidence of ADRs affect this decreased incidence in practice. The SALZA study conducted in France in 2009 (n ¼ 2663) 14 is a large post-marketing prospective survey conducted in real-world practice whose design is similar to that of this survey. In the SALZA study, the incidences of AEs associated with TA administration were much lower (overall incidence, 4.5%; nausea and/ or vomiting, 2.8%; constipation, 0.6%; dizziness, 1.2%; and somnolence, 0.6%) than ADRs in this survey, although differences in patient characteristics, average dose per day (3.8 tablets), tabulation and recording of ADRs or AEs in our survey, and other factors should be taken into consideration.…”

Section: Mean Change In Nrs Scores Mean (Sd)mentioning

confidence: 99%

Overall safety profile and effectiveness of tramadol hydrochloride/acetaminophen in patients with chronic noncancer pain in Japanese real-world practice

Yoshizawa¹,

Kawai

Fujie³

et al. 2015

Current Medical Research and Opinion

View full text Add to dashboard Cite

Objective: To evaluate the overall safety profile and clinical effectiveness of tramadol hydrochloride/acetaminophen (TA) combination tablets in Japanese patients with chronic noncancer pain unrelieved by non-opioid drugs for up to 12 weeks in real-world practice. Research design and methods:This survey was a multicenter, prospective, longitudinal registry on the use of TA as a newly initiated pain treatment for chronic noncancer pain incurable by non-opioid analgesics that was conducted under the Good Post Marketing Study Practice regulation controlled by the Japan Ministry of Health, Labor and Welfare. Collected data included socio-demographics, treatment information, incidence of adverse drug reactions (ADRs), numerical rating scale for intensity of pain, EuroQol-5D (EQ-5D) scale, and physician's global impression (PGI) during the 12 week observation period. Results:A total of 1316 patients were registered. ADRs were reported in 259 patients (20.5%); most events were nonserious (99.4%), including nausea (n ¼ 87 [6.9%]), constipation (n ¼ 63 [5.0%]), dizziness and somnolence (n ¼ 29 [2.3%] each), and vomiting (n ¼ 21 [1.7%]). No event related to drug dependence or respiratory depression was reported. In addition, 82.8% of patients showed acceptable effectiveness based on PGI at Week 4. Numerical rating scale for intensity of pain and EQ-5D utility scores were improved by À2.7 (SD 2.3) and 0.16 (SD 0.20) at Week 4, respectively, and the improvement was maintained until Week 12. Conclusion:This is a first report to evaluate the risk-benefit profile of TA in Japanese real-world practice using large size registry data. It is suggested that the favorable risk-benefit balance of TA was confirmed for patients with chronic noncancer pain unrelieved by non-opioid drugs in real-world practice. Limitations of this study were those inherent to open-label and non-interventional study designs.

show abstract

Section: Mean Change In Nrs Scores Mean (Sd)mentioning

confidence: 99%

Overall safety profile and effectiveness of tramadol hydrochloride/acetaminophen in patients with chronic noncancer pain in Japanese real-world practice

Yoshizawa¹,

Kawai

Fujie³

et al. 2015

Current Medical Research and Opinion

View full text Add to dashboard Cite

show abstract

“…Indications reviewed separately below are osteoarthritis, low back pain, and rheumatoid arthritis. Three studies assessed tramadol/paracetamol for musculoskeletal pain of different origins and are discussed here [85–87]. The two latter studies are of particular interest to the family physician because they observed pain management in the clinical practice setting.…”

Section: Pain Indications Frequently Encountered By the Family Pramentioning

confidence: 99%

Tramadol/Paracetamol Fixed-Dose Combination for Chronic Pain Management in Family Practice: A Clinical Review

Merchante¹,

Pergolizzi

Laar³

et al. 2013

ISRN Family Medicine

View full text Add to dashboard Cite

The family practitioner plays an important role in the prevention, diagnosis, and early management of chronic pain. He/she is generally the first to be consulted, the one most familiar with the patients and their medical history, and is likely the first to be alerted in case of inadequate pain control or safety and tolerability issues. The family practitioner should therefore be at the center of the multidisciplinary team involved in a patient's pain management. The most frequent indications associated with chronic pain in family practice are of musculoskeletal origin, and the pain is often multimechanistic. Fixed-dose combination analgesics combine compounds with different mechanisms of action; their broader analgesic spectrum and potentially synergistic analgesic efficacy and improved benefit/risk ratio might thus be useful. A pain specialist meeting held in November 2010 agreed that the fixed-dose combination tramadol/paracetamol might be a useful pharmacological option for chronic pain management in family practice. The combination is effective in a variety of pain conditions with generally good tolerability. Particularly in elderly patients, it might be considered as an alternative to conventional analgesics such as NSAIDs, which should be used rarely with caution in this population.

show abstract

“…Tramadol is an atypical opioid used primarily to treat moderate-severe pain, both acute and chronic. The most common adverse effects of tramadol include dizziness, dry mouth, nausea, indigestion, abdominal pain, vertigo, vomiting, constipation, drowsiness, and headache (Mejjad et al, 2011). Flurbiprofen axetil is a new non-steroidal anti-inflammatory and analgesic drug, which avoids topically stimulating the digestive tract through intravenous injection.…”

Section: Introductionmentioning

confidence: 99%

Effects of flurbiprofen axetil on postoperative serum IL-2 and IL-6 levels in patients with colorectal cancer

Wang

Peng

et al. 2015

Genet. Mol. Res.

View full text Add to dashboard Cite

Epidemiological data, efficacy and safety of a paracetamol–tramadol fixed combination in the treatment of moderate-to-severe pain. SALZA: a post-marketing study in general practice

Abstract: PTC, due to the complementary action of its two analgesics, is effective in treating the different types of pain in a GP's practice setting and is well-tolerated, even in an elderly population. Study limitations include all those inherent to non-interventional and open-label observations.

Cited by 15 publications

References 12 publications

Overall safety profile and effectiveness of tramadol hydrochloride/acetaminophen in patients with chronic noncancer pain in Japanese real-world practice

Overall safety profile and effectiveness of tramadol hydrochloride/acetaminophen in patients with chronic noncancer pain in Japanese real-world practice

Tramadol/Paracetamol Fixed-Dose Combination for Chronic Pain Management in Family Practice: A Clinical Review

Effects of flurbiprofen axetil on postoperative serum IL-2 and IL-6 levels in patients with colorectal cancer

Contact Info

Product

Resources

About