Clinical therapeutics
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Clinical therapeutics · Jan 2015
ReviewImpact of prolonged-release oxycodone/naloxone on outcomes affecting patients' daily functioning in comparison with extended-release tapentadol: a systematic review.
The objective of this systematic review was to assess the clinical efficacy, safety, tolerability, and health-related quality of life outcomes associated with management of moderate-to-severe chronic pain with oxycodone/naloxone and tapentadol, focusing on the effect of these treatments on patients' daily functioning. ⋯ Oxycodone/naloxone offers significant improvements in Patient Assessment of Constipation Symptoms total score and dizziness and was directionally favored for fatigue and headache compared with extended-release tapentadol, which may translate to improved patient daily functioning and health-related quality of life.
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Clinical therapeutics · Jan 2015
ReviewPractical considerations for the use of tapentadol prolonged release for the management of severe chronic pain.
Chronic pain is often challenging to address appropriately. Although patients with severe chronic pain may respond to treatment with an opioid analgesic, opioids are often associated with adverse effects that may lead patients to disrupt or discontinue therapy. In addition, opioid analgesics alone may not be effective for all types of chronic pain, including neuropathic pain. Tapentadol prolonged release (PR), a centrally acting analgesic with 2 mechanisms of action (μ-opioid receptor agonism and noradrenaline reuptake inhibition), provides strong and reliable analgesia across a range of indications, including nociceptive, neuropathic, and mixed types of chronic pain, and is associated with an improved tolerability profile relative to classic opioid analgesics. The purpose of this article was to review the recent literature on different aspects related to the clinical use of tapentadol PR. ⋯ The broad analgesic efficacy of tapentadol PR may simplify chronic pain management by allowing for the treatment of different types of pain with a single analgesic. In addition, tapentadol is associated with a low risk of pharmacokinetic interactions, which permits its use in patients taking multiple medications. Furthermore, the favorable tolerability profile of tapentadol PR may result in improved patient compliance and allow for easy titration and rotation from previous strong opioids.
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Clinical therapeutics · Jan 2015
Randomized Controlled TrialPharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers.
Sufentanil is a μ-opioid agonist with a high therapeutic index in preclinical studies and no active metabolites, and it is highly lipophilic, thereby enabling a transmucosal route of administration. Rapid distribution from the plasma after IV sufentanil administration results in a short duration of action requiring excessive repeated dosing if used for postoperative analgesia. The sufentanil sublingual tablet system (SSTS) is a handheld, preprogrammed, patient-controlled analgesia system designed to allow patients to self-administer sufentanil 15-μg tablets under their tongue with a 20-minute lockout. The pharmacokinetic (PK) characteristics of sufentanil, administered by different routes of delivery and after single and repeated sublingual (SL) administration, were examined in 2 studies. ⋯ These study results support the viability of the SSTS for use in patient-controlled analgesia. The wide range of mean drug concentrations achieved after repeated dosing at 20-minute intervals compared with those with a single dose suggests the flexibility of patient-controlled dosing to meet individual analgesic requirements. The prolonged plasma half-time with SL administration is expected to provide a more appropriate duration of analgesia compared with that of IV administration, and the PK properties of repeated-dose administration support a 20-minute lockout interval.
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Clinical therapeutics · Jan 2015
Real-world analysis of tyrosine kinase inhibitor treatment patterns among patients with chronic myeloid leukemia in the United States.
The treatment of chronic myeloid leukemia (CML) has improved considerably since the introduction of the tyrosine kinase inhibitor (TKI) imatinib in 2001 and the approval of second-generation TKIs (dasatinib and nilotinib) beginning in 2006.The objective of this study was to explore treatment patterns of TKI therapy (adherence, duration, and switching) among patients with CML in the United States, following the availability of second-generation TKIs. ⋯ For the US patients studied, we found that imatinib was used more frequently than other TKIs in the first-line setting, but there was an increased use of second-generation TKIs in the first-line setting over time (9% in 2008 vs 43% in 2011 were nilotinib or dasatinib users). Only about one fifth of patients switched to a second-line TKI during the period of data collection.
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Clinical therapeutics · Dec 2014
Randomized Controlled TrialEffects of delayed-release dimethyl fumarate (DMF) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the phase 3 DEFINE and CONFIRM studies.
Delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) has been reported to have clinical and neuroradiologic efficacy in people with relapsing-remitting multiple sclerosis (RRMS) in the Phase 3 DEFINE and CONFIRM studies. An integrated analysis of data from DEFINE and CONFIRM was conducted to estimate more precisely the therapeutic effects of delayed-release DMF. Here we describe the impact of RRMS on health-related quality of life (HRQoL) at baseline and assess the effects of delayed-release DMF on prespecified HRQoL end points over 2 years. ⋯ These HRQoL benefits parallel the improvements in clinical and magnetic resonance imaging end points with delayed-release DMF, suggesting that delayed-release DMF treatment improves patient-perceived health status as well as neurologic and physical functioning. ClinicalTrials.gov identifiers: NCT0042012; NCT00451451.