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At least 73 records · Page 4Linked to original sources
PubMed1995

Observational versus randomized medical device testing before and after market approval--the atherectomy-versus-angioplasty controversy.

Percutaneous transluminal coronary angioplasty was developed in the late 1970s as a nonsurgical alternative for revascularization of atherosclerotic coronary arteries. It gained widespread acceptance without a controlled trial. Introduced in 1986, directional coronary atherectomy was the first of other recently developed coronary devices that sought to improve on the results of angioplasty. It was approved in 1990 by the Food and Drug Administration (FDA) on the basis of observational data. Its use expanded rapidly, reaching over 35,000 procedures in 1992, accounting for more than 10% of all interventions. After premarket approval, two major randomized trials tested the hypothesis that atherectomy would be superior to angioplasty. Their results raised a cautionary flag and stood in contrast to projections made from prior observational data. It is concluded that randomized controlled trials validate claims of relative efficacy and safety of competing medical technologies, a lesson reflected in recent changes in policy at the FDA.

Angioplasty, Balloon, Coronary↗
PubMed1995

Inhalational anesthetics: desflurane and sevoflurane.

This article reviews the physico-chemical properties and performance characteristics of the two new potent inhaled anesthetics, desflurane and sevoflurane. Both drugs provide a greater degree of control of anesthetic depth and a more rapid immediate recovery from anesthesia than is currently available with other inhaled agents because of their decreased solubility. Desflurane is currently in widespread clinical use in the United States and parts of Europe. Compared with sevoflurane, it has the additional advantage of being extremely resistant to degradation and biotransformation. However, its pungent odor and tendency to irritate the respiratory tract make it unsuitable for inhalational inductions, and it has been linked to CO production in CO2 absorbents. The sympathetic nervous system activation that occurs with desflurane limits its use in patients with cardiac disease. Otherwise, its hemodynamic and physiologic effects are similar to those seen with isoflurane. Studies of the economics of using desflurane are mixed, although it may offer the advantage of shorter postoperative recovery time. Sevoflurane is currently in widespread clinical use in Japan and parts of South America. The FDA Advisory Panel has recently recommended approval of sevoflurane in the United States, and we can expect the drug to be clinically available in the United States in the second quarter of 1995. Compared with desflurane, sevoflurane has the additional advantage of being nonirritating to the airway; inhalational induction of anesthesia with sevoflurane is achieved rapidly and easily. The instability of sevoflurane with CO2 absorbents and its in vivo biotransformation produce potentially toxic byproducts. These byproducts, including Compound A and fluoride, have been extensively studied, and although the possibility for iatrogenic sequelae from sevoflurane exists, the likelihood of long-term toxicity appears quite low. Phase IV studies are indicated to determine the safety of administering sevoflurane (1) to renally impaired patients and (2) to any patient with fresh gas flows less than 2 L/min. Sevoflurane is otherwise very well tolerated and appears to offer the advantage of rapid and smooth induction and emergence from general anesthesia.

Adult↗
PubMedDate not supplied

The potential impact of palivizumab on pediatric airway reconstruction.

PURPOSE: To examine the role of palivizumab, a monoclonal antibody vaccine designed to prevent respiratory syncytial virus (RSV) infection, in the surgical setting, and to explore the feasibility, in terms of medical benefit and cost, of its use in pediatric airway reconstruction patients. MATERIALS AND METHODS: Literature review of MEDLINE database using the following indexing terms ("respiratory syncytial virus," "palivizumab," "laryngotracheal reconstruction," and "cricotracheal reconstruction") and limited to following subcategories (English language, postoperative complication, and morbidity and mortality). All phase IV clinical trials reporting data regarding safety, efficacy, and application of palivizumab in the general pediatric population were selected, as well as all studies from any surgical specialty with data on postoperative outcome complicated by RSV infection. RESULTS: The literature demonstrates significant postoperative morbidity and mortality attributable to RSV infection within several surgical specialties including otolaryngology. Meta-analysis of the data from phase IV clinical trials suggests potential benefit from the perioperative use of palivizumab. The cost of vaccination is the principal limiting factor preventing its more widespread application. CONCLUSION: Otolaryngologists need to be aware of the potential significant morbidity caused by perioperative RSV infection and should consider the prophylactic use of palivizumab in their pediatric airway reconstruction patients in high-risk seasons. A large multicenter study would be required to adequately perform a cost-benefit analysis of palivizumab use for this specific indication.

Antibodies, Monoclonal↗
PubMed2006

Clinical and bacteriologic efficacy of telithromycin in patients with bacteremic community-acquired pneumonia.

This retrospective analysis was performed to determine the clinical and bacteriologic efficacy of the ketolide antibacterial telithromycin in patients with community-acquired pneumonia (CAP) with pneumococcal bacteremia. Patients 13 years old with radiologically confirmed CAP and a positive blood culture for Streptococcus pneumoniae at screening were analyzed from eight multicenter Phase III/IV clinical trials. In four open-label, non-comparative studies, patients received telithromycin 800 mg once daily for 7-10 days. In four randomized, controlled, double-blind, comparative studies, patients received telithromycin 800 mg once daily for 5-10 days or a comparator antimicrobial (amoxicillin 1000 mg three times daily, clarithromycin 500 mg twice daily, or trovafloxacin 200 mg once daily) for 7-10 days. In total, 118 patients (telithromycin, 94/1061 [8.9%]; comparator, 24/244 [9.8%]) had documented pneumococcal bacteremia. Those who were treated with telithromycin achieved a clinical cure rate of 90.2% (74/82, per-protocol population); S. pneumoniae was eradicated in 77/82 (93.9%) bacteremic patients who received telithromycin and 15/19 (78.9%) comparator-treated patients. Clinical cure was also observed among telithromycin-treated bacteremic patients who were infected with penicillin- or erythromycin-resistant strains of S. pneumoniae (5/7 and 8/10, respectively). In conclusion, telithromycin achieves high clinical and bacteriologic cure rates in CAP patients with pneumococcal bacteremia.

Adolescent↗
PubMed1998

Research, introduction, and use: advancing from Norplant.

As the first real contraceptive innovation in over 20 years, and as a long-acting method requiring clinical intervention for insertion and removal, Norplant raised an especially wide range of issues. It also encountered a number of difficulties. In April 1997, an Institute of Medicine (IOM) workshop on implant contraceptives reviewed newly available data on Norplant's efficacy, safety, and use; considered lessons learned from the method's development, introduction, and market experience; and explored approaches based on those lessons that could improve the environment for contraceptive research and development and make market entry for new contraceptive technologies less troubled. In addition to presenting the IOM workshop findings, the present article calls attention to the rich scientific prospects available for development of the next generation of contraceptives, and notes signs of an evolving new paradigm, essential if those prospects are to be realized to any significant extent.

Clinical Trials, Phase IV as Topic↗
PubMed2006

Beyond registration--measuring the public-health potential of new treatments for malaria in Africa.

Malaria claims over one million lives a year in some of the poorest countries of the world. Affected populations and governments cannot afford to pay for expensive new therapies. Most antimalarial treatments are purchased from local shops and administered in the home. These factors make for a complex set of requirements for any new treatment for malaria if a substantial reduction in mortality is ever to be achieved. Thankfully there are several treatments being developed, mostly within public-private partnerships. Typically, the goal of public-private partnerships is the granting of a product license, so work plans end after phase III trials. As these drugs will ultimately be used unsupervised, malaria control programme managers will require further data on safety and whether the drug is as efficacious when used outside of controlled clinical trials before allowing widespread use of these new products. These data need to be collected in highly specific phase IV programmes. We explain why public-private partnerships should extend their development plans well beyond drug registration, and set out the requirements of such a programme. We aim to generate debate and discussion so that guidelines that are internationally accepted and adhered to can be developed not only for antimalarials but for all drugs that are being developed specifically for use in resource-poor settings.

Africa↗
PubMed2003

[Treatment of acute stroke -- an overview].

This paper provides an overview on the actual state of acute therapy in patients with ischemic stroke. The discussion focusses on intravenous and intraarterial thrombolysis, antithrombotic therapy, and the treatment of medical and neurological complications, and therapy recommendations are presented. Finally ongoing studies, particularly those concerning thrombolysis with glycoprotein IIb/IIIa receptor blockers and ultrasound-assisted thrombolysis, are presented.

Abciximab↗
PubMed1998

Oxaliplatin in practice.

Oxaliplatin, a new third-generation platinum complex, is active in the treatment of colorectal and advanced ovarian cancers, both as monotherapy and in combination therapy. It has demonstrated a very good safety profile, characterized by low haematotoxicity, and moderate and manageable gastrointestinal toxicity. No significant renal or ototoxicities have been observed. Oxaliplatin induces a peripheral sensory neuropathy which is characterized by distal and perioral dysaesthesia, and is induced or exacerbated by the cold; in general, it is regressive between cycles of treatment. This dose-limiting toxicity is cumulative, but reversible within a few months of discontinuation of treatment in the majority of cases. In a cohort study of 490 patients with advanced colorectal cancer included in an extended access programme, more than 2700 cycles of oxaliplatin plus 5-fluorouracil (5-FU) were administered. The overall safety profile of oxaliplatin was shown to be very favourable. Oxaliplatin and cisplatin, each in combination with cyclophosphamide, have a similar efficacy in the treatment of advanced ovarian cancer, but oxaliplatin was better tolerated than cisplatin in terms of haematological, gastrointestinal, neurosensory and renal toxicities. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy.

Antineoplastic Agents↗
PubMed2001

Apomorphine to Uprima: the development of a practical erectogenic drug: a personal perspective.

The development process for apomorphine SL as an effective treatment for patients with erectile dysfunction has been somewhat unusual. As often is the case, much of the impetus for the basic research originated in academia. However, somewhat unusually, the impetus for early stage clinical research also lay in the hands of the academics. This article represents a historical perspective from one of those involved throughout.

Administration, Oral↗
PubMed1997

Mortality studies and the effectiveness of drugs in long-term treatment.

In scientific observations on the utilization of drugs under routine treatment conditions in patients with affective disorders, one of the main problems is the establishment of criteria for measuring treatment effectiveness. As the mortality risk of such patients is considerable, the mortality rate is an important outcome criterion for determining the long-term effectiveness of medication administered in routine treatment settings. Mortality studies are typical phase IV studies; the researcher does not interact with the treatment procedure, he only observes the results of treatment with respect to death rates. As lithium treatment is of increasing importance and interest as a major prophylactic agent in recurrent affective disorders and is by its nature a long-term treatment, such a therapy provides an excellent field for observations of effectiveness under long-term treatment conditions. Mortality studies can take into account various factors, such as type of treatment setting, treatment regimen, drop-out analysis, and comparison between times on and off treatment. Results from several mortality studies on lithium-treated patients are reported in order to demonstrate the methodology and outcome of long-term observation of drug treatment. Mortality studies conducted within the framework of phase IV studies and particularly within the concept of pharmacoeconomics can help to demonstrate the effectiveness of long-term treatment, and are an important methodological adjunct to controlled clinical trials.

Antimanic Agents↗
PubMed1997

Guidelines for the implementation of drug utilization observation (DUO) studies in psychopharmacological therapy. The "Phase IV Research" Task-Force of the Association for Neuropsychopharmacology and Pharmacopsychiatry (AGNP).

The task-force on Phase-IV-Research of the Association for Neuropharmacology and Pharmacopsychiatry (AGNP) has developed guidelines for the implementation of scientifically sound drug utilisation observation studies (DUO studies). These guidelines have been adopted by the executive committee as the position of the association. DUO studies are prospective pharmacoepidemiological studies, by which prescription, illness, and patient data of individual patients are collected without interference with the routine course of treatment. They can answer questions on the interaction of treatment modalities with positive and negative treatment outcome. Scientific standards require that there is a study protocol which describes the epidemiological, statistical, procedural, and quality assurance methodology and states who is responsible for what. As such studies can violate data protection regulations or can be used for sales instead of scientific purposes, consultation of an ethics committee is recommended.

Clinical Trials, Phase IV as Topic↗