Treatment of pain with sustained-release tramadol 100, 150, 200 mg: results of a post-marketing surveillance study.
In a post-marketing-surveillance study the use of a sustained-release tramadol preparation (Tramal long 100, 150, 200 mg) was investigated in 3153 patients. The intention was to comply with the legal obligation to carry out product surveillance and to collect data on prescribing behaviour. We focused our attention on drug safety and efficacy. Tramal long was used mainly for severe and very severe pain. The most frequently reported causes of pain were diseases of the locomotor system (49.9%), tumours (24.3%), traumas and fractures (10.1%), and neurogenic (9.3%). The mean daily dose was 235.7 mg, usually divided into two doses. The analgesic effect was described as very good or good by 82.5% of the patients. Adverse events occurred in 6.5% of the patients, mostly in the form of typical opioid side-effects such as nausea (3.4%), dizziness (1.5%) and vomiting (1.1%). Severe or unknown side-effects were not reported.
Nossol
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S
Medical Scientific Division, Grünenthal GmbH, Stolberg, Germany.
Schwarzbold
M
M
Stadler
T
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D011358:Product Surveillance, Postmarketing; D014147:Tramadol / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D014147:Tramadol