Clinical therapeutics
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Clinical therapeutics · Jul 2005
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialAntihypertensive efficacy and tolerability of two fixed-dose combinations of valsartan and hydrochlorothiazide compared with valsartan monotherapy in patients with stage 2 or 3 systolic hypertension: an 8-week, randomized, double-blind, parallel-group trial.
Combination therapy with at least 2 antihypertensive agents is usually needed to achieve appropriate blood pressure (BP) control in patients with isolated or predominant systolic hypertension. A currently recommended combination is a diuretic added to an angiotensin-receptor blocker. ⋯ Monotherapy with V160 was effective in these patients with stage 2 or 3 systolic hypertension. Significant additional reductions in SBP and DBP and an increase in responder rates were achieved with the addition to V160 of HCTZ12.5 and HCTZ25, with no significant effect on tolerability.
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Clinical therapeutics · Jul 2005
Changes in the prescribed daily doses of transdermal fentanyl and transdermal buprenorphine during treatment of patients with cancer and noncancer pain in Germany: results of a retrospective cohort study.
During long-term therapy with strong opioids (step III opioids according to the World Health Organization [WHO] analgesic ladder), dose increases are often necessary because of deterioration of the primary disease or development of tolerance. ⋯ This retrospective analysis showed a significantly higher increase in the mean daily doses of TD fentanyl as compared with TD buprenorphine. The results must be verified in prospective, randomized clinical studies.
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Clinical therapeutics · Jun 2005
ReviewAnalgesia and local anesthesia during invasive procedures in the neonate.
Preterm and full-term neonates admitted to the neonatal intensive care unit or elsewhere in the hospital are routinely subjected to invasive procedures that can cause acute pain. Despite published data on the complex behavioral, physiologic, and biochemical responses of these neonates and the detrimental short- and long-term clinical outcomes of exposure to repetitive pain, clinical use of pain-control measures in neonates undergoing invasive procedures remains sporadic and suboptimal. As part of the Newborn Drug Development Initiative, the US Food and Drug Administration and the National Institute of Child Health and Human Development invited a group of international experts to form the Neonatal Pain Control Group to review the therapeutic options for pain management associated with the most commonly performed invasive procedures in neonates and to identify research priorities in this area. ⋯ The most commonly performed invasive procedures in neonates included heel lancing, venipuncture, IV or arterial cannulation, chest tube placement, tracheal intubation or suctioning, lumbar puncture, circumcision, and SC or IM injection. Various drug classes were examined critically, including opioid analgesics, sedative/hypnotic drugs, nonsteroidal anti-inflammatory drugs and acetaminophen, injectable and topical local anesthetics, and sucrose. Research considerations related to each drug category were identified, potential obstacles to the systematic study of these drugs were discussed, and current gaps in knowledge were enumerated to define future research needs. Discussions relating to the optimal design for and ethical constraints on the study of neonatal pain will be published separately. Well-designed clinical trials investigating currently available and new therapies for acute pain in neonates will provide the scientific framework for effective pain management in neonates undergoing invasive procedures.
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Clinical therapeutics · Jun 2005
ReviewAnalgesia and anesthesia for neonates: study design and ethical issues.
The purpose of this article is to summarize the clinical, methodologic, and ethical considerations for researchers interested in designing future trials in neonatal analgesia and anesthesia, hopefully stimulating additional research in this field. ⋯ Much more research is needed in this field to formulate a scientifically sound, evidence-based, and clinically useful framework for management of anesthesia and analgesia in neonates. Newer study designs and additional ethical dilemmas may be defined with accumulating data in this field.
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Clinical therapeutics · Jun 2005
ReviewAnesthesia and analgesia during and after surgery in neonates.
Historically, the use of anesthetics and analgesics in neonates and infants has been based on extrapolations from studies performed in adults and older children. Over the past 20 years, there has been a growing body of research on the clinical pharmacology and clinical outcomes of these agents in neonates and infants. ⋯ There is a growing body of information on analgesic and anesthetic pharmacokinetics, pharmacodynamics, and clinical outcomes in neonates and infants, permitting safe and effective use in some clinical settings. Major gaps in knowledge persist, however. Future research may involve a combination of clinical trials and preclinical studies in suitable infant animal surrogate models.