Current medical research and opinion
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Randomized Controlled Trial Multicenter Study
A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain.
To evaluate the relative efficacy and tolerability of tapentadol immediate release (IR) and oxycodone IR for management of moderate to severe pain following orthopedic surgery (bunionectomy). ⋯ Clinically meaningful and statistically significant improvements were observed with tapentadol IR 50 mg and 75 mg compared with placebo for the relief of moderate-to-severe acute pain after orthopedic surgery. Tapentadol IR 50 mg and 75 mg were non-inferior to oxycodone HCl IR 10 mg for the treatment of acute pain based on the primary efficacy endpoint of SPID(48) and the pre-specified margin of 48 points. The incidence of nausea and/or vomiting was statistically significantly lower for tapentadol IR 50 mg and numerically lower for tapentadol IR 75 mg than for oxycodone HCl IR 10 mg.
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This article reviews the currently available antiplatelet therapies and emerging investigational drugs in the treatment of acutecoronary syndrome (ACS), and considerations for primary and secondary prevention in the long-term management of ACS patients undergoing percutaneous coronary intervention (PCI). ⋯ Current antiplatelet therapies have clinical benefits such as reducing immediate and long-term cardiovascular risk, but substantial residual risk remains indicating a need for new therapeutic agents. Additional large randomized trials are necessary to determine the most appropriate treatment regimens for ACS patients.
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Review published clinical trial studies on pharmacological treatment of stroke using both the Barthel Index (BI) and Modified Rankin Scale (MRS) as outcome measures, and to highlight the differences in psychometric properties and cut-off scores through a systematic review. ⋯ Despite the lack of uniformity in the cut-off points used in the trials, the follow-up time after administration of therapy, and the amount of time within which treatment is initiated after onset of stroke symptoms, the MRS seems to be more sensitive and responsive as compared to the BI in measuring stroke disability. However, more studies are required to differentiate the BI and the MRS that would help in selecting a scale that would appropriately capture outcomes among stroke patients.
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To assess the validity of the patient global assessment (PGA) of the method of pain control, a single-item patient-reported outcome measure of a method of pain control for patients experiencing postoperative pain. ⋯ Findings suggest that both the content and construct validity of the PGA of the method of pain control in clinical trial settings are supported. However, this conclusion is potentially limited by the use of a narrow range of therapeutic interventions and, in some cases, small sample sizes in the clinical trials used to assess construct validity. The PGA of the method of pain control is an informative and useful measure for assessing pain control provided by different drug delivery systems for patients experiencing postoperative pain.
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The semi-synthetic opioid, buprenorphine, has the general structure of morphine but differs from it in significant ways, both pharmacologically and clinically. A number of long-term studies have shown effective, long-lasting analgesia in moderate to severe cancer and non-cancer pain, including neuropathic pain, with a low incidence of constipation, nausea, dizziness and tiredness. The treatment of moderate to severe chronic pain has improved as a result of the development of new methods of administration of this substance, particularly the introduction of the transdermal drug delivery system, which offers a number of advantages over the usual oral and parenteral routes. ⋯ The consensus was that transdermal buprenorphine has a valuable role to play in the treatment of chronic cancer pain because of its efficacy and good safety and tolerability profile, including a low risk of respiratory depression, a lack of immunosuppression and a lack of accumulation in patients with impaired renal function.