Clinical drug investigation
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Multicenter Study
Effective achievement of hemoglobin stability with once-monthly C.E.R.A. in peritoneal dialysis patients: a prospective study.
Correction of low hemoglobin (Hb) levels is associated with improved survival and greater quality of life in dialysis patients, but frequent administration of erythropoiesis stimulating agent (ESA) therapy is unsatisfactory for peritoneal dialysis patients. ⋯ In this large population of maintenance peritoneal dialysis patients, once-monthly administration of C.E.R.A. achieved a high degree of Hb stability and was well-tolerated.
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Multicenter Study Comparative Study
Effectiveness and tolerability of tapentadol prolonged release compared with prior opioid therapy for the management of severe, chronic osteoarthritis pain.
Tapentadol prolonged release (PR; 100-250 mg twice daily) has been efficacious and well tolerated for managing moderate-to-severe, chronic osteoarthritis hip or knee pain in phase 3 studies with washout of previous analgesic treatment. ⋯ Significant improvements in effectiveness were observed for tapentadol PR (50-250 mg twice daily) versus WHO step III opioids in patients with severe, chronic osteoarthritis knee pain who previously responded to WHO step III therapy. Equianalgesic ratios were calculated for tapentadol to transdermal buprenorphine and oral oxycodone and were in line with observations from previous phase 3 studies.
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Multicenter Study Clinical Trial
Efficacy and safety of sublingual fentanyl orally disintegrating tablets in patients with breakthrough pain: multicentre prospective study.
The aim of this study was to evaluate the effectiveness and safety of sublingual fentanyl oral disintegrating tablets (sublingual fentanyl ODT) for the treatment of breakthrough pain (BTP), cancer or non-cancer related, in terms of relief of pain intensity, adverse events (AEs) and patient satisfaction, and to further examine the clinical and epidemiological profile of patients with BTP in a clinical setting. ⋯ Sublingual fentanyl ODT provided rapid and consistent relief from BTP, both in cancer and non-cancer patients. It was well-tolerated and well-accepted by patients in routine clinical practice.
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Patients from a previous study of neuropathic pain (NP) in the Spanish primary care setting still had symptoms despite treatment. Subsequently, patients were treated as prescribed by their physician and followed up for 3 months. Since pregabalin has been shown to be effective in NP, including refractory cases, the objective of this study was to assess the effectiveness of pregabalin therapy in patients with NP refractory to previous treatments. ⋯ Treatment with pregabalin (as monotherapy or combination therapy) provides benefits in pain and treatment satisfaction in patients with NP, including refractory cases. Shorter disease progression and neuralgia and PCS etiologies are favorable factors for pregabalin treatment response.
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Multicenter Study Clinical Trial
Treatment satisfaction after switching to another therapy in Spanish orthopaedic clinic outpatients with knee or hip osteoarthritis previously refractory to paracetamol.
Hip and knee osteoarthritis is highly prevalent in the elderly, and the incidence is estimated to increase in the coming decades. Prior to surgery, symptomatic treatment, starting with non-pharmacological therapies, should be prescribed. Paracetamol (acetaminophen) is the recommended first pharmacological treatment for osteoarthritis. If paracetamol is ineffective, non-steroidal anti-inflammatory drug (NSAID) treatment is indicated. The superiority of NSAIDs over paracetamol has been demonstrated in several studies. Furthermore, the assessment of patient satisfaction could be an adequate indicator of the quality of care given and is likely related to the evolution of the condition and the therapeutic regimen. The objective of this study was to assess the satisfaction of patients diagnosed with hip and/or knee osteoarthritis who had been previously treated with paracetamol and switched to NSAID treatment due to a lack of effectiveness by paracetamol. ⋯ NSAIDs relieve pain due to OA in paracetamol-resistant patients and improve treatment effectiveness and patient satisfaction with treatment. Furthermore, paracetamol-refractory subjects under conventional medical treatment with NSAIDs experienced the drug as more effective and also tended to be more satisfied with treatment than those treated with non-NSAIDs.