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PubMed2000

A comparison of ibuprofen and indomethacin for closure of patent ductus arteriosus.

BACKGROUND: Indomethacin is the conventional treatment for hemodynamically important patent ductus arteriosus in preterm infants. However, its use is associated with various side effects. In a prospective study, we compared ibuprofen and indomethacin with regard to efficacy and safety for the early treatment of patent ductus arteriosus in preterm infants. METHODS: We studied 148 infants (gestational age, 24 to 32 weeks) who had the respiratory distress syndrome and an echocardiographically confirmed, hemodynamically important patent ductus arteriosus. The infants were randomly assigned at five neonatal intensive care centers to receive three intravenous doses of either indomethacin (0.2 mg per kilogram of body weight, given at 12-hour intervals) or ibuprofen (a first dose of 10 mg per kilogram, followed at 24-hour intervals by two doses of 5 mq per kilogram each), starting on the third day of life. The rate of ductal closure, the need for additional treatment, side effects, complications, and the infants' clinical course were recorded. RESULTS: The rate of ductal closure was similar with the two treatments: ductal closure occurred in 49 of 74 infants given indomethacin (66 percent), and in 52 of 74 given ibuprofen (70 percent) (relative risk, 0.94; 95 percent confidence interval, 0.76 to 1.17; P=0.41). The numbers of infants who needed a second pharmacologic treatment or surgical ductal ligation did not differ significantly between the two groups. Oliguria occurred in 5 infants treated with ibuprofen and in 14 treated with indomethacin (P=0.03). There were no significant differences with respect to other side effects or complications. CONCLUSIONS: Ibuprofen therapy on the third day of life is as efficacious as indomethacin for the treatment of patent ductus arteriosus in preterm infants with the respiratory distress syndrome and is significantly less likely to induce oliguria.

Cyclooxygenase Inhibitors↗
PubMed2001

Making dollars out of DNA. The first major patent in biotechnology and the commercialization of molecular biology, 1974-1980.

In 1973-1974 Stanley N. Cohen of Stanford and Herbert W. Boyer of the University of California, San Francisco, developed a laboratory process for joining and replicating DNA from different species. In 1974 Stanford and UC applied for a patent on the recombinant DNA process; the U.S. Patent Office granted it in 1980. This essay describes how the patenting procedure was shaped by the concurrent recombinant DNA controversy, tension over the commercialization of academic biology, governmental deliberations over the regulation of genetic engineering research, and national expectations for high technology as a boost to the American economy. The essay concludes with a discussion of the patent as a turning point in the commercialization of molecular biology and a harbinger of the social and ethical issues associated with biotechnology today.

Biotechnology↗
PubMed2002

Patents and innovation in cancer therapeutics: lessons from CellPro.

This article discusses the interaction between intellectual property and cancer treatment. CellPro developed a stem cell separation technology based on research at the Fred Hutchinson Cancer Center. A patent with broad claims to bone marrow stem cell antibodies had been awarded to Johns Hopkins University and licensed to Baxter Healthcare under the 1980 Bayh-Dole Act to promote commercial use of inventions from federally funded research. CellPro got FDA approval more than two years before Baxter but lost patent infringement litigation. NIH elected not to compel Hopkins to license its patents to CellPro. CellPro went out of business, selling its technology to its competitor. Decisions at both firms and university licensing offices, and policies at the Patent and Trademark Office, NIH, and the courts influenced the outcome.

Biomedical Research↗
PubMed1990

Gut blood flow velocities in the newborn: effects of patent ductus arteriosus and parenteral indomethacin.

The effects on gut blood flow velocities of parenteral indomethacin (0.2 mg/kg) given either quickly as a bolus or slowly as an infusion were compared in consecutive studies of two groups of infants with symptomatic patent ductus arteriosus. In the presence of patent ductus arteriosus the range of velocities in the superior mesenteric artery before indomethacin was given was characterised by pronounced abnormalities including absent--or in some cases even retrograde--diastolic flow. In eight subjects the first rapidly given bolus dose of indomethacin (duration 20 seconds or less) caused a pronounced and sustained fall in the velocity of the superior mesenteric artery blood flow (mean peak systolic velocity (cm/second): before 74; after 38; median time to maximum fall 7.4 minutes; median time to recovery 50 minutes). A further 10 subjects received their first dose of indomethacin by slow infusion (duration 30-35 min) and the percentage fall in peak systolic velocity was both substantially less (22% compared with 47%) and later (median time to maximum fall 37.3 minutes) than after rapid infusion. Qualitatively similar but smaller changes were seen in the coeliac axis. Return of antegrade end diastolic flow in the superior mesenteric artery within one hour of the first dose of indomethacin was a good predictor of subsequent closure of the ductus. These data suggest that there is a profound disturbance in mid gut perfusion in infants with patent ductus, which is exacerbated by indomethacin given rapidly by intravenous bolus. They may also provide a rational explanation for the well recognised association between necrotising enterocolitis and both patent ductus arteriosus and indomethacin administration. The unwanted effects of the indomethacin are abrogated by slow infusion, without loss of efficacy in closure of the ductus.

Blood Flow Velocity↗
PubMed1992

Atrial natriuretic peptide in newborn piglets with a patent ductus arteriosus.

Atrial natriuretic peptide (ANP) is a hormone involved in fluid and blood pressure homeostasis. We studied the effects of left-to-right shunting through a patent ductus arteriosus on blood pressure changes and plasma ANP concentrations in newborn piglets. In five experimental piglets, the ductus arteriosus was bathed with PGE1 and infiltrated with formalin to maintain its patency. In four age-matched control piglets, the ductus arteriosus was ligated. Plasma ANP concentrations and blood pressure determinations were obtained prior to (base-line) and 25 +/- 1 h (day 1), and 48 +/- 1 h (day 2) after surgery. Radionuclide-microsphere determinations of left-to-right patent ductus arteriosus shunts were performed on days 1 and 2 in the 5 piglets with a patent ductus arteriosus. Plasma ANP concentrations were significantly elevated in the left atrium on day 1 and the right atrium on day 2 in the PDA piglets. No correlation was demonstrated between plasma ANP concentrations and right or left atrial pressures. We conclude that left and right plasma atrial ANP concentrations are significantly elevated in newborn piglets with left-to-right patent ductus arteriosus shunts.

Animals↗
PubMed2006

Outcome following patent ductus arteriosus ligation in premature infants: a retrospective cohort analysis.

BACKGROUND: The patent ductus arteriosus (PDA) is an important problem in premature infants. Surgical PDA ligation is usually only be considered when medical treatment has either failed or was contraindicated. The aims of our study were to determine the mortality and morbidity following patent ductus arteriosus ligation in premature infants, and whether prostaglandin synthetase inhibitor (PSI) use prior to ligation affects outcome. METHODS: A retrospective case note review study to determine the outcome of premature infants undergoing patent ductus arteriosus ligation in one tertiary neonatal intensive care unit and two paediatric cardiothoracic centres. RESULTS: We had follow-up data on 87 infants. Cumulative mortality rates at 7 days, 30 days and at hospital discharge were 2%, 8% and 20% respectively. The incidence of chronic lung disease, intraventricular haemorrhage, necrotising enterocolitis and retinopathy of prematurity were 77%, 39%, 26% and 28% respectively. There was no difference in mortality, incidence of chronic lung disease or duration of oxygen dependence between those who had and those who had not received a PSI prior to surgical ligation. In those who had received 2 or more courses of PSI prior to surgical ligation, there was a trend to increase in the duration of oxygen therapy and chronic lung disease, but no difference in mortality. CONCLUSION: This study shows that patent ductus arteriosus ligation is a relatively safe procedure (30 day survival 92%) but there is substantial late mortality and a high incidence of morbidity in the survivors. 2 or more courses of PSI prior to surgical ligation trends to increased oxygen dependence and chronic lung disease. This high risk population requires careful follow-up. A definitive prospective cohort study is lacking.

Cardiovascular Surgical Procedures↗
PubMed1987

How a patent ductus arteriosus effects the premature lamb's ability to handle additional volume loads.

A model of patent ductus arteriosus in premature lambs was created to examine the lamb's ability to handle the volume load imposed by a patent ductus arteriosus and to determine the lamb's ability to handle any additional volume load. Fifteen preterm lambs [133 +/- 2 (+/- SD) days gestation, term 145 days], whose ductal diameter could be regulated with a mechanical occluder, were studied to determine the independent effects of ductus patency and a saline volume load (50 ml/kg over 3 min) on left ventricular output and its distribution. During a saline infusion, preterm lambs with a closed ductus could only increase their stroke volume by 40% above baseline stroke volume. When challenged with a saline infusion, lambs with an open ductus still were able to increase their stroke volume significantly; the maximal increase in stroke volume during the saline load with the ductus open was 70% above baseline stroke volume. We hypothesize that the associated reduced left ventricular afterload plays a significant role in the preterm lamb's ability to increase its stroke volume when challenged with a patent ductus arteriosus. Even with a patent ductus arteriosus, the lamb still has the ability to handle additional volume loads.

Animals↗
PubMed2006

Attenuated cyclooxygenase-2 expression contributes to patent ductus arteriosus in preterm mice.

Patent ductus arteriosus (DA) is the second most common congenital heart defect, the incidence of which is increased in premature infants, although mechanisms responsible are not clear. Our previous studies with genetic or pharmacological inactivation of cyclooxygenase-2 (COX-2) in mice, emphasized the importance of this enzyme in normal DA closure. The current study was designed to determine whether reduced COX-2 expression contributes to patent DA in preterm mice. Real-time PCR analysis indicated that COX-2 expression in the fetal mouse DA significantly increased with advancing gestational age. Furthermore, we observed a significant induction in COX-2 expression in the DA at 3 h after birth at full-term gestation. In contrast, COX-2 expression was significantly attenuated in the DA of preterm neonatal mice. DA closure was incomplete in preterm mice at 3 h postpartum, a time-point when the DA of full-term neonates was completely remodeled. Additionally, COX-2 expression was significantly attenuated in the DA of mice deficient in the prostanoid receptor EP4, which also show a patent DA phenotype, suggesting the importance of this receptor for the induction of COX-2 required for DA closure. Overall, these studies suggest that attenuated expression of COX-2 may contribute to increased patent DA at preterm gestation.

Animals↗
PubMedDate not supplied

Transcatheter closure of patent ductus arteriosus using occluding spring coils.

The purpose of this study is to report our initial experience with the use of spring coils to close the patent ductus arteriosus in the dog. There are few large-patient series reported in the veterinary literature. Coil closure was attempted in 15 dogs (median weight, 6.5 kg; range, 1.2 to 38.7 kg) presenting with a patent ductus arteriosus between May 1997 and May 1999. Arterial catheterization followed by angiography was used to decide if coil placement was adequate. A 5- or 8-mm embolization coil, depending on the angiographic diameter of the ductus, was delivered, with 1 loop in the pulmonary arterial side and the remainder of the coil in the aortic side of the duct. Additional coils were used if a residual shunt was present, and closure was confirmed by aortography. Patients were discharged the day after the procedure. Successful coil closure, without residual shunt on angiography, was achieved in 11 of 13 dogs in which coils were released. In 6 dogs, a coil embolized to the pulmonary artery. Four of these dogs had successful closure with multiple coils, and 2 others had surgery. None of these dogs experienced adverse effects. In 2 dogs with conical patent ductus arteriosus >5 mm in minimal diameter, coil closure was not done. We conclude that the patent ductus arteriosus size and anatomical shape are crucial in deciding whether coil closure is the method of choice. In selected cases, coil closure represents an elegant alternative to surgical ligation. Although pulmonary embolism occurred commonly, it did not cause any obvious clinical problem.

Animals↗
PubMed1978

Chest film diagnosis of patent ductus arteriosus in infants with hyaline membrane disease.

Patent ductus arteriosus in an infant with hyaline membrane disease is usually a serious complication. To evaluate the diagnostic role of chest radiography in these infants, a double-blind study comparing patients with both hyaline membrane disease and patent ductus arteriosus and matched controls was undertaken. Three pediatric radiologists acted as observers. In no instance were they more reliable than chance in predicting the presence of a patent ductus arteriosus. Analysis according to various clinical criteria (e.g., severity of illness, PAO2) also failed to show any subgroup in which the observers were accurate. From these data it is concluded that chest radiography does not play a significant role in the diagnosis of patent ductus arteriosus in infants with hyaline membrane disease.

Clinical Trials as Topic↗
PubMed1980

Patent ductus arteriosus in hyaline membrane disease: chest radiography.

Sequential chest radiographs of 45 consecutive neonates with respiratory distress were reviewed prospectively. Nineteen had hyaline membrane disease, 16 had infiltrates of other etiology, three had transient tachypnea of the newborn, and seven had no pulmonary pathology on chest radiography. Ten of the 19 infants with hyaline membrane disease and one of the 16 with pulmonary infiltrates had clinical and radiologic evidence of a patient arteriosus; there was echocardiographic confirmation in seven. Radiologic evidence of the patent ductus arteriosus was detected in all cases with no false positives. The radiographic criterion of the patent ductus was the appearance in sequential frontal chest films of pulmonary plethora, that is, pulmonary vascular engorgement and perihilar edema "haze." The radiographic appearance of the patent ductus arteriosus was detected prior to the clinical signs in seven of 11 cases and simultaneously with the clinical picture in three cases. In one the radiographic abnormally occurred later. Chest radiography is a valuable adjunct in the early diagnosis of a patent ductus arteriosus in infants with hyaline membrane disease.

Ductus Arteriosus, Patent↗
PubMed1996

Targeting technologies--recent patent literature.

The patent literature is rich with information about ideas and approaches related to targeted drug delivery. Although there is a typically a delay in the release of this information compared to that published in journal articles, some of the subject matter of patent applications is never released through any other medium and the breadth of anticipated uses is described best in the patent literature. As with any form of information, the patent literature can only provide an historical perspective of what has already occurred. However, the trends of this literature clearly points to the possibilities for the future in drug targeting.

Drug Carriers↗
PubMed2000

Patenting inventions in combinatorial chemistry.

I have intended to provide an overview of some patent strategies for protecting intellectual property in the combinatorial chemistry arts, along with examples taken from recently issued patents. The opinions in this paper are those of the author, and are not intended to be relied upon as legal advice. Specific questions about any particular patent or invention should be discussed with competent counsel before action is taken. If you would like to look at the patents discussed in this article, they are available on-line at http:¿www.patents.ibm.com/boolquery and at other locations.

Combinatorial Chemistry Techniques↗
PubMedDate not supplied

[Pharmaceutical patents and the accessibility of drugs in Brazil].

Passage of Patent Law 9279/96, in effect since April 1997, has made relations between pharmaceutical patents and accessibility to medicine in Brazil complex. Under the new law, patents may extend to chemical inventions (products and process) and transgenic microorganisms. The issue is analyzed from two specific yet inter-related approaches: science and technology policy and health-care policy. The conclusion draws attention to the main future consequences of current international trends, both legal and regulatory. Brazil should ready its legal framework to respond to the negative consequences that genome patenting can be expected to have on the flow of scientific information and on access to pharmaceutical drugs.

Brazil↗
PubMed2002

[Patenting human genes].

The problem of patenting of human genes, which was discussed at the Workshop organized by OECD, has become very actual due to granted patents that concern testing of genetic disposition for breast cancer. Companies that had made large investments into this research clearly support patenting of their discoveries. But such patents can reduce general accessibility of genetic testing. Existing laws, and namely the Directive of the European Council unfortunately are not unambiguous and allow rather free explanation.

Communication↗
PubMed2002

Antibacterial agents: patent highlights January to June 2002.

A total of 48 patents dealing with disclosures on the different classes of antibacterial agents, including the beta-lactams, oxazolidinones, macrolides, quinolones, tetracyclines and miscellaneous antibacterial agents reported between January and June 2002 are selected for review. The miscellaneous agents section focused on the significant discovery of potential lead compounds as inhibitors of bacterial fatty acid synthase and peptide deformylase, and also included examples of novel peptidic antibiotics and pleuromutilin derivatives along with their antibacterial activities. Only a few patents disclosed novel agents in the quinolone and carbapenem areas. There are several patents disclosing improved formulation of old agents to increase their effectiveness and stability upon storage. Two patents disclosed effectiveness of antibiotic combinations with respect to the newer antibiotics linezolid and quinupristin/dalfopristin.

Animals↗
PubMed2003

The use of ibuprofen in neonates in the treatment of patent ductus arteriosus.

Indomethacin has long been used to treat patent ductus arteriosus but it is associated with a relatively high risk of adverse effects; recent evidence suggests that ibuprofen is effective and may be safer. In a randomised trial to compare the efficacy and safety of ibuprofen and indomethacin in the treatment of patent ductus arteriosus, 144 infants received three doses of ibuprofen lysine (10, 5 and 5 mg/kg) at 24-hour intervals or indomethacin 0.2 mg/kg at 12-hour intervals. Ductal closure occurred in 70% of children treated with ibuprofen and 66% of those given indomethacin on the first treatment (P = 0.41). Nineteen children underwent surgical ligation, equally distributed between the treatment groups (P = 0.81). Urine production was significantly greater than in children given indomethacin from day 3 to day 7 and the serum creatinine concentration was significantly lower from day 7. Ductal closure was associated with higher serum concentrations of ibuprofen and a concentration of 10-12 mg/l appears to be the minimum level for efficacy. In a randomised, placebo-controlled, double-blind trial of prophylaxis with ibuprofen, the rate of patent ductus arteriosus associated with ibuprofen was 19% compared with 42% with placebo. Urine output was comparable in the two groups except on day 1, when it was significantly lower among infants given ibuprofen. Ibuprofen is therefore as effective as indomethacin in the treatment of patent ductus arteriosus, and effective as prophylaxis, in premature infants.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2003

FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002).

In order to close the loophole in the generic drug approval process that allows a brand name drug patent holder to delay or defeat generic drug application merely by technicality, the FDA recently proposed to modify its regulations. Those proposals affect the patent listing requirements of a new drug application, and the duration of time that a generic drug application could be put on hold in the event of a patent infringement suit. With the modified rules, the FDA expects to see an increase in the availability of generic drugs, which eventually will lead to lower drug costs. Ms. Hui discusses the contents of the proposed regulations and provides an analysis of the proposed rule's legal authority, implications on patent rights, and impact on the pharmaceutical industry.

Drug Approval↗