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Biomedical subjects

O I Linet

Publications and source records attributed to O I Linet.

At least 19 recordsLinked to original sources
PubMed1995

Evaluation of real-time RigiScan monitoring in pharmacological erection.

PURPOSE: The clinical assessment of pharmacologically induced erectile response was compared to the real-time RigiScan* monitoring response. MATERIALS AND METHODS: Erection was induced by 521 intracavernous injections of a new alprostadil formulation. The clinical end point was "full rigidity" and the RigiScan criterion was radial rigidity of 70% or more for 10 consecutive minutes or longer. RESULTS: For 752 prostaglandin E1 injections the sensitivity and specificity of the RigiScan device compared to clinical evaluation were 53.8% (133 of 247 cases) and 92.9% (469 of 505), respectively. For rigidity of 60% or greater the sensitivity increased to 70.8% (175 of 247 cases) and specificity decreased to 85.0% (429 of 505). CONCLUSIONS: The RigiScan device is useful to document objectively a pharmacologically induced erection yet it appears to be more conservative than clinical evaluation.

Adult↗
PubMed1991

Intravenous prostacyclin (PGI2) infusion to 108 patients with ischaemic peripheral vascular disease: phase II-open study.

We recently reported the results of a double-blind trial of PGI2 in 108 patients with ischaemic peripheral vascular disease Stage II according to Fontaine. They were randomly allocated to receive an intravenous infusion of either PGI2 (6 ng/kg/min over 8 hours daily for 5 consecutive days) or placebo and classified as treatment responders or non-responders on the basis of changes in absolute and relative walking times. Patients treated with placebo and those who did not improve in this double blind trial entered an open trial in which they all received infusion of PGI2 (6 ng/kg/min over 8 hours daily for 5 consecutive days). The results of this open trial are reported here. Patients who had been allocated to PGI2 in the blind trial had significantly (p less than 0.01) longer walking times as compared to placebo-treated patients prior to receiving the second (PGI2) infusion. PGI2-infusion caused significant (p less than 0.01) prolongation of walking times in both groups up to the 2nd follow-up month. One month after infusion 52% (23 patients) of the initially placebo-treated patients and 31% (14 patients) of the initially PGI2-treated patients were scored as positive treatment responders (p less than 0.01).

Aged↗
PubMed1990

Clinical safety of flurbiprofen.

Data from 58 premarketing studies of the nonsteroidal antiinflammatory drug flurbiprofen were pooled for analyses of adverse drug reactions (ADRs). These studies included 5602 patients treated with flurbiprofen (N = 4123), aspirin (N = 1033), or placebo (N = 446) for varying durations. Diagnoses included rheumatoid arthritis, osteoarthritis, and other painful musculoskeletal conditions. In these studies serious upper gastrointestinal ADRs occurred in flurbiprofen-treated patients at less than one half the rate seen in aspirin-treated patients. The incidence of serious urinary tract ADRs was lower with flurbiprofen than with aspirin. The flurbiprofen group had no serious clinical ADRs related to the hemic/lymphatic system. The most common laboratory abnormality was a decrease in hematocrit, which occurred less often than in the aspirin group. We also evaluated serious flurbiprofen-related ADRs in 4370 patients in a variety of other studies and reviewed published reports of flurbiprofen clinical trials and case reports. These reviews showed no additional, unanticipated patterns of intolerance. These clinical safety data indicate that in the doses studied, flurbiprofen is a well tolerated agent for patients requiring nonsteroidal antiinflammatory drug therapy.

Adult↗
PubMed1990

A double blind placebo controlled trial of intravenous prostacyclin (PGI2) in 108 patients with ischaemic peripheral vascular disease.

108 patients with ischemic peripheral vascular disease were randomly allocated to receive infusion of either PGI2 (6 ng/kg/min over 8 hours daily for 5 consecutive days) or placebo in a double-blind manner. All patients had Stage II disease (Fontaine classification). One month after infusion the absolute and relative walking times were significantly (p less than 0.05) longer in the PGI2- than in the placebo-treated group. Patients were further classified as treatment responders or non-responders on the basis of increase of absolute and relative walking times. After one month 44% (24 out of 54) of the PGI2- and 15% (8 out of 54) of the placebo-treated patients were positive treatment-responders (p less than 0.01).

Clinical Trials as Topic↗
PubMed1988

Epoprostenol (prostacyclin) in unstable angina.

The purpose of this randomized, double-blind multicenter trial was to investigate the potential therapeutic effect of epoprostenol (prostacyclin, PGI2) in patients with unstable angina, as compared with placebo, and to investigate the safety of this agent. Of the 184 patients enrolled, 28 did not fit the study criteria; of the remaining 156 patients, 30 received prostacyclin in an open-label fashion. In the double-blind portion of the study, 63 patients each received prostacyclin or placebo. The drug or its vehicle was infused intravenously up to 5 ng/kg/min dose for 72 hours with a tapering off period for the last 12 hours. Both treatment groups from the double-blind portion were comparable in regard to the demographic data, length of infusion, and total dose received. There were no significant differences between the placebo and prostacyclin group in the following clinical endpoints: levels of cardiac enzymes throughout hospitalization period (with the exception of lower SGOT level in the prostacyclin group at day 2), and severity of angina (throughout the study), and at the end of the study (day 30). The number of patients who had congestive heart failure, new myocardial infarction, balloon pump insertion, coronary artery bypass grafting, or percutaneous coronary angioplasty was similar in both groups. Similar results in regard to the efficacy endpoints were also apparent in the prostacyclin group that was treated under open-label fashion. There was also no difference in the New York Heart Association (NYHA) functional status at the end of the double-blind study.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1988

The effect of encapsulated, low-dose colestipol in patients with hyperlipidemia.

Colestipol is an effective cholesterol (C)-lowering agent, but it must be taken in large doses and the palatability is poor. In an open-label study, the effects of low doses (2-10 g) of encapsulated colestipol (size: 1 g or 0.65 g) were investigated. There were 16 men and 16 women with an average age of 59 +/- 11 years and with hyperlipidemias IIA, IIB, or IV. Patients were on AHA I diet and stayed in the study for up to 2 years with regular follow-up every 3 to 4 months. Colestipol was started after several months of dietary baseline; it was tolerated well with only two patients reporting mild constipation. A group mean for total cholesterol (T-C), LDL-C, HDL-C, VLDL-C and triglycerides (TG) was calculated at each of four daily dose intervals, i.e., 2 to 4 g, 4 to 6 g, 6 to 8 g and 8 to 10 g. Each patient usually received more than one of the four dosage intervals. A paired t test and a rank sum test were performed to test for significant (P less than or equal to .05) differences between baseline and drug treatment. With the exception of the lowest dose, total C was significantly decreased by all dosage ranges and LDL-C changes were similar. There was no significant effect on HDL-C and VLDL-C whereas TG levels increased at 4 to 6 g and 8 to 10 g dose. The use of diet and low colestipol doses may be considered in patients with moderate hypercholesterolemia who do not respond to diet alone.

Capsules↗
PubMed1988

Effects of a fish oil concentrate in patients with hypercholesterolemia.

The effects of a fish oil supplement on lipid and lipoprotein levels, platelet function, and vital signs were investigated in 31 hypercholesterolemic patients. Thirteen patients took 5 g of encapsulated fish oil per day and 18 patients took 5 g of encapsulated safflower oil "placebo" per day for 28 days. Diet and exercise patterns were kept as constant as possible during the study. The fish oil group had significant increases in several lipid/lipoprotein values at the end of the treatment, including an increase of total cholesterol of 14% (P = 0.0001), LDL of 16% (P = 0.003), HDL of 13% (P = 0.015) and HDL2 of 36% (P = 0.009). The triglyceride level fell 24%, a nonsignificant change (P = 0.217). The ratios of total cholesterol/HDL and LDL/HDL were increased at the end of fish oil treatment, and returned to baseline 30 days after fish oil was stopped. The placebo group had no significant changes in any of the lipid/lipoprotein values. Neither the fish oil nor the placebo group had significant changes in vital signs or platelet function tests (bleeding time, thromboxane B2, platelet factor 4 and beta-thromboglobulin) during the study. These results suggest that fish oil supplements may have an adverse effect on lipid/lipoprotein values in hypercholesterolemic patients.

Adolescent↗
PubMed1988

Ciprostene in patients with peripheral vascular disease (PVD). An open-label, tolerance trial.

Epoprostenol (Prostacyclin) has been studied with various success in patients with peripheral vascular disease (PVD). We investigated the tolerance of a new, stable prostacyclin derivative ciprostene (9-beta-methyl carbacyclin) in 9 PVD patients. The drug was infused intravenously for 8 hours a day, once a week for 4 consecutive weeks, at a dose of 120 ng/kg/min. There were 6 men and 3 women with a mean age of 63 years (42-78). The PVD was verified by arteriography (9 patients) and by clinical findings. Patient #9 was lost to follow up after the first infusion and, consequently, was excluded from further evaluation. In patient #5 with a history of arrhythmias, the last ciprostene infusion had to be discontinued at 4.5 hours due to arrhythmias but his data were included into the evaluation. The cardiac disturbances were not judged to be ciprostene-related. Patients were followed monthly for 3 months after last infusion. Ciprostene was well tolerated although it produced adverse medical events (AMEs); most of them were rated as mild. The most frequent were those typical of prostacyclin: headache, facial flushing and warmth, body warmth, jaw pain and sleepiness. No consistent changes in blood pressure and heart rate were observed. One patient who initially had 9 ischemic ulcers underwent transmetatarsal amputation at month 4. The absolute and relative claudication time was measured by treadmill. As compared to baseline, the absolute claudication time increased significantly at week 2 and 4 of the infusion period and also at the end of month 3, but not at the end of month 4.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1987

A prospective, randomized study of the effects of prostacyclin on neuropsychologic dysfunction after coronary artery operation.

This randomized, double-blind study was designed to evaluate the effect of prostacyclin (epoprostenol) on the incidence and severity of postoperative neuropsychologic dysfunction in patients undergoing coronary artery operation. Four days before operation and 1 week after operation, 100 patients having coronary artery bypass grafting underwent detailed neurologic and psychologic examinations and computed tomographic scans of the brain. The psychologic examination was repeated 2 months after operation. During cardiopulmonary bypass, all patients received 300 U/kg of heparin and then either buffer-diluent or prostacyclin (12.5 ng/kg/min from the time of heparinization until onset of cardiopulmonary bypass and 25 ng/kg/min during cardiopulmonary bypass). No deaths or major neurologic complications occurred in this series. Ninety-six patients completed the psychologic and neurologic evaluations 1 week after operation; 74 of these patients were evaluated psychologically 2 months after operation. Psychologic testing demonstrated similar declines in postoperative performance in both the prostacyclin-treated and the control groups; these changes were no longer present in either group 2 months after operation. Results of neurologic examinations and computed tomographic scans of the brain were unchanged. We conclude that the administration of prostacyclin during cardiopulmonary bypass in patients undergoing routine coronary artery operation has no effect on perioperative cognitive changes.

Adult↗
PubMed1987

Holter monitor ST segment evaluation in hospitalized patients with unstable angina.

The correlation of angina attacks with ST segment changes detected during ambulatory Holter monitoring was evaluated in patients with unstable angina. Forty hospitalized patients had one to three 24-hour Holter recordings each. Twenty-three patients had a cardiac catheterization, confirming significant coronary artery disease. The Holter recordings, scanned blindly by computer, were evaluated for ST segment shifts (defined as +/- 1.5 mm from baseline, lasting 60 seconds or longer). Angina attacks were carefully logged. Over the total forty patient experience, only 15 of 74 (20.3%) angina attacks had corresponding ST segment shifts on the Holter recordings. Nine of 34 (26.5%) angina attacks in the 23 patients who had a cardiac catheterization had corresponding ST segment shifts. A total of 159 ST segment shifts were recorded on these forty patients, but only 15 (9.4%) ST shifts corresponded to a time when the patients were actually experiencing angina attacks. The performance of the test procedure was quantified by use of Youden's J statistic. The aggregate J, over all patients, was 0.203 (J = 1.0 is perfect, J = 0.0 is useless). When consideration was restricted to patients with cardiac catheterization, the aggregate experience J was 0.263. Dealing with only the patients who had angina attacks during the monitoring, and computing the J statistic for each individual patient, the resulting mean J statistic was 0.146, with SEM = 0.0731. The Holter monitoring worked reasonably well in only 2 of the 14 patients who gave clear tests of the procedure. In an attempt to improve the performance of the procedure, 21 Holter recordings in eight patients were reread for ST segment shifts of only +/- 1 mm from baseline, lasting 30 seconds or longer. In these eight patients with rescanned Holter recordings, only five of 17 (29.4%) angina attacks resulted in an ST segment shift. In conclusion, ambulatory Holter recordings proved not to be a suitable method of documenting ST segment shifts during angina attacks in this study.

Adult↗
PubMed1986

Tolerance and pharmacology of ciprostene, a stable epoprostenol (prostacyclin) analogue in humans.

Safety, tolerance, and pharmacology of 9-beta-methylcarbacyclin calcium (ciprostene calcium) was investigated in healthy male volunteers. This stable prostacyclin analogue was infused intravenously into groups of 12, 11, and three volunteers for three, six, and eight hours, respectively, in doses up to 480 ng/kg/min. Based on the tolerance data obtained, a single-blind, placebo-controlled study was conducted. Seven subjects were infused for 8 hr/d for three days with ciprostene at a maximum dose of 160 ng/kg/min and seven subjects received placebo. One subject from each group did not complete the infusion schedule, and they were not included in the final analysis. During infusion of ciprostene, consistent changes in blood pressure and heart rate did not occur. Most frequent adverse drug reactions consisted of headache, restlessness, nausea, perspiration, flushing, and jaw pain. As compared with placebo, ADP-induced platelet aggregation was inhibited during the infusion period (P = .048). Significant (P = .04) elevations of platelet cyclic AMP were observed in subjects during infusion of ciprostene. Pre- versus postinfusion routine laboratory evaluations, fibrinogen concentration, antiplasmin activity, and plasminogen and template bleeding times remained unchanged. Placebo- and drug-treated subjects had a daily postinfusion shortening of euglobulin clot lysis time (ECLT). The preinfusion minus postinfusion ECLT for ciprostene subjects on days 2 and 3 (133 and 118 min, respectively) compared with placebo (239 and 217 min) suggest a trend to increased fibrinolytic activity. Based on the outcome of this trial, it is estimated that ciprostene is about 15 times less potent than prostacyclin.(ABSTRACT TRUNCATED AT 250 WORDS)

Adenosine Diphosphate↗
PubMed1986

Thromboxane, prostacyclin, and leukotrienes in cerebral ischemia.

Our understanding of the biochemistry and biologic actions of AA metabolites has been greatly expanded in recent years. The discoveries of TXA2, PGI2, and LTs have fostered new concepts of the pathophysiology of cerebral ischemia. New approaches to treatment of ischemia include seeking an optimal dose of aspirin, developing drugs that selectively inhibit or antagonize TXA2 or LTs, and administering PGI2 or its analogues. Altering the dietary content of essential fatty acids for prophylaxis is also being studied. Though the results of this thrust are still preliminary, the exploration of these therapeutic strategies in cerebrovascular disorders based on further understanding of the pathophysiologic roles of TXA2, PGI2, LTs and probably other AA metabolites is anticipated with some optimism.

Blood Platelets↗
PubMed1986

A prospective, randomized study of the effects of prostacyclin on platelets and blood loss during coronary bypass operations.

A randomized, double-blind study was designed to evaluate the therapeutic effect and safety of prostacyclin (epoprostenol) in patients undergoing cardiopulmonary bypass. One hundred patients having isolated coronary bypass grafting received 300 units/kg of heparin and then either prostacyclin (12.5 ng/kg/min from heparinization until cardiopulmonary bypass, 25 ng/kg/min during bypass) or buffer/diluent in a similar manner. Standardized anesthetic, perfusion, and surgical techniques were used. Drug and placebo groups were similar in demographic data and bypass times, and there were no deaths. Activated coagulation time and platelet count were significantly higher during cardiopulmonary bypass in patients receiving prostacyclin. Platelet count remained significantly higher 24 hours after bypass in the active drug group. Immediately after operation, there was significantly less prolongation of bleeding time (1.3 versus 2.9 minutes; p = 0.009) in the patients receiving prostacyclin. Blood loss was significantly reduced during the first 4 hours postoperatively in the prostacyclin group (261 +/- 159 versus 347 +/- 197 ml; p = 0.02). There was no significant difference between the groups when total blood loss was compared (710 +/- 351 versus 869 +/- 498 ml; p = 0.07). Patients receiving prostacyclin required an average of 257 ml less blood transfused in the intensive care unit (p = 0.02). We conclude that the clinical impact of prostacyclin in patients undergoing coronary artery operations was demonstrable, but small. Prostacyclin may provide clinical benefits in patients undergoing cardiopulmonary bypass when there are contraindications to or other difficulties with blood transfusion. With prostacyclin, reduced heparin dose is possible and therefore reduced protamine requirement would offer a potential benefit of less cardiovascular depression immediately after bypass. However, the advantages offered by prostacyclin are not sufficient to recommend its routine use during cardiopulmonary bypass.

Adult↗
PubMed1983

Absence of cardiac arrhythmias during a very-low-calorie diet with high biological quality protein.

Fourteen women who were at least 50 lb (22.7 kg) overweight entered the 15 week study which included 4 weeks of 1200 cal (5028 J) balanced diet followed by 7 weeks on a very-low-calorie diet (VLCD) and 4 weeks of refeeding. During the VLCD high biological quality protein (poultry, fish) and recommended supplements of vitamins, minerals and water were used. With the exception of week 5 and 14, 25-h Holter monitorings were done weekly. During the initial 4 weeks, 2 patients showed disturbances of cardiac rhythm and were discharged from the study. Twelve patients completed the trial without any clinically significant changes in cardiac rhythm. The 12 lead ECGs remained normal in all patients throughout the study. The average weight loss was 46 lb (20.9 kg) and the whole program was well tolerated. It is concluded that seven weeks of VLCD with high biological quality protein and recommended supplements appears to be a safe method for weight reduction for severely obese patients.

Adult↗
PubMed1982

Long-term efficacy of medical treatments of obesity.

Obesity is a chronic, usually life-long condition. Therefore, the success of any treatment should be measured by the long-term weight loss. More patients lose weight than maintain the weight loss after the active phase of therapy has ended. Conservative approaches like dietary restrictions or behavior modification techniques have been only modestly successful in weight maintenance. Both are, therefore, suitable for patients with milder degrees of obesity. Anorexicants seem to have specific but limited use in the treatment of obesity. Fasting and protein sparing modified fast are indicated for patients with a high degree of obesity, i.e. for those who are at least 30% or 25 kg or more over their ideal body weight. Both these procedures have definite risks. Rapid weight loss is induced by fasting but long-term follow-ups showed gradual regain of weight loss. Combinations of various techniques such as behavior modification, exercise, proper nutritional instruction and protein-sparing modified fast seem to have the best chance for long-term success.

Appetite Depressants↗
PubMed1981

Double-blind comparison of alprazolam and diazepam for subchronic withdrawal from alcohol.

The efficacy and safety of a new triazolobenzodiazepine, alprazolam, was compared to diazepam in 46 alcoholics in a double-blind study. The drugs were administered for 21 days starting on the fifth day after the last drink. The mean optimal daily oral dose of alprazolam was 2.2 mg and of diazepam 20.2 mg given in a t.i.d. fashion. Alprazolam was as effective as diazepam in the relief of anxiety as measured by the Hamilton Anxiety Rating Scale, Physician's Global Impressions, Patient's Global Impressions, Hopkins Symptom Checklist and Target Symptoms Record. At the end of the trial 95% of patients in both groups experienced moderate to marked therapeutic effect and felt much or very much better as compared to the start of the study. The number of side effects was similar in both groups and they were mostly described by patients as "mild".

Adolescent↗