International journal of clinical practice
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Int. J. Clin. Pract. · Aug 2010
Randomized Controlled TrialA pilot double-blind randomised placebo-controlled trial of the effects of fixed-dose combination therapy ('polypill') on cardiovascular risk factors.
Our objective was to investigate the effects and tolerability of fixed-dose combination therapy on blood pressure and LDL in adults without elevated blood pressure or lipid levels. ⋯ The effects of the polypill on blood pressure and lipid levels were less than anticipated, raising questions about the reliability of the reported compliance. There is a case for a fully powered trial of a polypill for the prevention of cardiovascular disease.
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Is Institutional Review Board (IRB) approval and a rigorous informed consent process enough? It is our view that this is no longer the case. Conventional research ethics emphasise the importance of weighing the risks and benefits for prospective participants as one of the key determinants of deeming a clinical trial ethical. We support the notion that ethical obligations of research should include considerations not only at the individual level, but also at the community level (1,2).
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Int. J. Clin. Pract. · Aug 2010
Multicenter Study Clinical TrialA prospective, open-label, multicentre study of pregabalin in the treatment of neuropathic pain in Latin America.
The objective of this study was to evaluate the safety and efficacy of pregabalin at flexible doses of 150-600 mg/day in Latin American patients with neuropathic pain. ⋯ Flexible-dose pregabalin (150-600 mg/day) significantly reduced pain and anxiety and improved sleep and was generally well tolerated in Latin American patients with neuropathic pain.