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PubMed2005

Effect of the proton pump inhibitor omeprazole on the pharmacokinetics of extended-release formulations of oxybutynin and tolterodine.

This study assessed the effect of the proton pump inhibitor omeprazole on the bioavailability of the extended-release formulations of oxybutynin and tolterodine. Forty-four healthy volunteers received each of 4 treatments in a 4-period crossover design. The treatments consisted of osmotically controlled extended-release oxybutynin chloride tablets at 10 mg/d or extended-release tolterodine tartrate capsules at 4 mg/d, with and without preceding treatment with 20 mg omeprazole daily for 4 days. Blood samples collected predose and at scheduled time points for 36 hours postdose were analyzed for oxybutynin and its active metabolite, N-desethyloxybutynin, or tolterodine and its active 5-hydroxymethyl metabolite, as appropriate. The AUCinfinity ratios for oxybutynin and its metabolite with and without prior omeprazole fell within the 80% to 125% range (accepted as the criterion for bioequivalence), as did those for tolterodine and its active moiety. The peak concentration ratios for oxybutynin and metabolite also conformed to this range; those for tolterodine did not. Increasing gastric pH with omeprazole does not substantially alter the pharmacokinetic properties of extended-release oxybutynin but may alter those of extended-release tolterodine.

Adolescent↗

PubMed1993

The effects of group therapy on bereaved extended family of children with cancer.

The impact of the death of a child from cancer and subsequent grief on the extended family members has not been documented. Additionally, the effect of a support group for these individuals has not been explored. Therefore, this one group pretest/post-test study sought to determine the effects of participation in a support group for bereaved extended family members whose child died from cancer. Extended family members completed the Emotions Profile Index before and after the group sessions. Descriptive data were collected from the cotherapists' process log and the participants' evaluation. No significant differences were found between pretest and post-test scores for any emotional state. However, the group process log showed significant clinical data related to the intensity of the grief experienced and ways of coping with the loss. The Bereaved Extended Family Group Evaluation demonstrated the usefulness of the group experience. Tentative conclusions support the value of such a group in providing a forum for the bereaved extended family to ventilate feelings of anger and sadness and find ways to cope with the future.

Adaptation, Psychological↗

PubMed1996

Multiple delayed peak lithium concentrations following acute intoxication with an extended-release product.

OBJECTIVE: To describe delayed peak lithium concentrations after an overdose of extended-release lithium tablets. CASE SUMMARY: A patient with borderline personality disorder and depression ingested extended-release lithium approximately 20.25 g along with other agents. At presentation, the lithium concentration was 1.4 mEq/L. Significant enteral intake was initiated 27 hours after presentation and the lithium concentration 5 hours later increased to 3.2 mEq/L. A second lithium peak concentration of 5.0 mEq/L was noted 40 hours after presentation. Two hemodialysis sessions lasting 4 hours each were performed along with administration of sodium polystyrene sulfonate in sorbitol 20% to enhance lithium elimination and decrease absorption. Eighty-eight hours after presentation, the lithium concentration had decreased to 1.5 mEq/L. DISCUSSION: Delayed and secondary peak lithium concentrations have been reported following an overdose with an extended-release product. Extended-release lithium may form an aggregate in the gastrointestinal tract and/or have delayed absorption secondary to coingested drugs. Toxicity may result if the patient begins enteral intake of drugs, fluids, or nutrition. CONCLUSIONS: Continued monitoring of lithium concentrations after an acute ingestion with an extended-release product are recommended until lithium concentrations are less than 1.5 mEq/L and there are no signs of toxicity, particularly once the patient begins significant enteral intake.

Adult↗

PubMed1997

Effect on dissolution from halving methylphenidate extended-release tablets.

OBJECTIVE: To determine the effect on in vitro dissolution from cutting methylphenidate extended-release tablets in half. DESIGN: Ritalin-SR (Ciba Pharmaceutical Co.) and generic methylphenidate extended-release (MD Pharmaceutical Inc.) tablets were dissolved in water according to the method prescribed by the US Pharmacopeia under two conditions: whole and halved. Samples were collected at 15, 30, and 45 minutes and at 1, 2, 3, 3.5, 4, 5, 6, and 7 hours. Methylphenidate content was determined by HPLC. RESULTS: Halving the tablets caused a statistically significant increase in cumulative dissolution as early as 15 minutes. The difference in cumulative dissolution reached its maximum for both Ritalin-SR and generic methylphenidate extended-release tablets at 2 hours. At this time point, the percent dissolution of the whole versus halved tablets was 57% versus 74% (Ritalin-SR), respectively, and 49% versus 67% (generic), respectively. The dissolution profiles of halved and whole extended-release methylphenidate tablets were parallel from this point through the 7-hour collection period. At 7 hours, however, there was no difference in the cumulative dissolution of halved versus whole tablets. CONCLUSIONS: While statistical differences during in vitro dissolution do exist and pharmacokinetic ramifications have not yet been determined, the absolute differences in dissolution between halved and whole tablets are not great. Halving methylphenidate extended-release tablets may be a clinically acceptable means of achieving a small increment/decrement in dose without converting to a regular-release tablet.

Chromatography, High Pressure Liquid↗

PubMed2002

Unrelated donor bone marrow transplantation for thalassemia: the effect of extended haplotypes.

Allogeneic bone marrow transplantation (BMT) from a genotypically identical family donor is an accepted therapeutic option for homozygous beta-thalassemia. However, only a minority of patients have access to this curative procedure. The aim of this study is to explore the feasibility of matched unrelated transplants in thalassemia and the possibility of reducing the risk of immunologic complications through careful selection of donor/recipient pairs. Since November 1992, 32 patients (age range, 2-28 years) have been enrolled. There were 4 patients assigned to risk-class I, 11 to risk-class II, and 17 to risk-class III of the Pesaro classification. Extended haplotype analysis and family segregation studies were employed for identification of suitable donors. Of the 32 donor/recipient pairs, 24 were identical for HLA-A, B, C, DRB1, DRB3, DRB4, DRB5, DQA1, and DQB1 loci; 7 pairs were identical for 2 extended haplotypes, and 15 pairs shared one extended haplotype. Grade II-IV acute graft-versus-host disease (GVHD) developed in 11 cases (41%) and chronic GVHD in 6 (25%) out of 24 patients at risk. There are 22 patients (69%) who are alive and transfusion-independent after a median follow-up of 30 months (range, 7-109 months). There were 6 patients (19%) who engrafted and subsequently died from transplant-related complications. In 4 cases (12.5%) graft rejection was observed within 30 days and it was followed by autologous reconstitution. Out of 22 patients with a donor identical for at least one extended haplotype, there are 19 who survived, 17 of them being transfusion-independent. Among the 10 recipients who did not share any extended haplotype with the donor, only 5 are alive without thalassemia and 3 patients died. Of the 6 patients who died, 5 belonged to risk-class III and only 1 to risk-class II. BMT from well-selected unrelated donors may offer results comparable to those obtained in transplantations using HLA-identical family donors, especially for patients with lesser iron overload.

Adolescent↗

PubMed2005

Time to symptom relief for uncomplicated urinary tract infection treated with extended-release ciprofloxacin: a prospective, open-label, uncontrolled primary care study.

OBJECTIVE: Few studies have investigated symptom relief in urinary tract infections. This innovative exploratory trial aimed to measure the time to improvement of the signs and symptoms of uncomplicated urinary tract infection (UTI) in women receiving extended-release ciprofloxacin. Time to return to normal daily activities was also evaluated. RESEARCH DESIGN AND METHODS: An open-label, multicenter US study in adult female outpatients with uncomplicated UTI. Patients completed serial questionnaires: the Urinary tract infection Symptom Assessment [USA], tracking time to symptom improvement, and the Activity Impairment Assessment [AIA], measuring the time to return to normal daily activities, using hand-held electronic diaries. Severity on the USA questionnaire was categorized using a 4-point Likert-type scale, with improvement defined as a reduction of at least one degree of symptom severity. All patients received once-daily extended-release ciprofloxacin 500 mg tablets for 3 days. RESULTS: Of 276 female patients aged 18-78 years who enrolled at 28 sites, 273 (99%) were safety-valid, 264 (96%) completed at least 24 h of questionnaires and were valid for symptom relief analysis, and 170 (62%) had pre-therapy pathogen(s) > or = 10(3) CFU/mL and were valid for efficacy analysis. Six hours after the first dose of study drug, 50% of patients reported symptom improvement; 87% by 24 h and 91% by 48 h. At study entry, 54% of patients reported considerably decreased time at work or other activities; reduced to 23% by Day 2 and 10% by Day 3. At the test-of-cure visit (5-11 days post-therapy), 96% (163/170) of patients were clinical cures. Drug-related adverse events were reported by 18 (7%) patients and were consistent with previous extended-release ciprofloxacin studies (e.g., gastrointestinal disturbance, fungal superinfections). There were no serious adverse events or discontinuations due to adverse events. CONCLUSION: This open-label, non-comparative trial in adult women demonstrated a rapid improvement in uncomplicated UTI symptom severity (6-24 h) and the ability to return to work within 24 h following extended-release ciprofloxacin treatment. Clinical cure rate and tolerability profile were similar to results of previous extended-release ciprofloxacin studies.

Acute Disease↗

PubMed2003

Characterization of a circulating N-extended form of the thyrotropin-releasing hormone-like peptide pGlu-Glu-Pro amide in human plasma.

The TRH-like peptides pGlu-Glu-Pro amide, pGlu-Phe-Pro amide, and pGlu-Gln-Pro amide were isolated and identified some years ago, and these peptides have been proven to be present in many tissues and fluids. The presence of TRH-like immunoreactivity distinct from TRH in blood has been observed previously. In the present study, the presence of N-extended forms of TRH-like peptides in plasma has been investigated. Peripheral blood samples of human, rat, and rabbit were obtained and plasma was extracted. The peptides were separated in several steps of chromatography, including gel filtration, cation and anion exchange, and HPLC. The concentrations of the TRH-like peptides in the column fractions were measured by RIA with TRH antibody. The N-extended forms of TRH-like peptides were determined by RIA after trypsin digestion. In human plasma it was observed an N-extended form of TRH-like peptides in substantial concentration. After trypsin and heating, the N-extended forms of TRH-like peptides were rechromatographed on Sephadex G-50. This showed that the TRH-like peptides released have a similar size to TRH. The peptides were then separated by cation exchange chromatography, and the major fraction was unretained, indicating a neutral or acidic nature. Part of the unretained fraction was then chromatographed on anion exchange column in which the major fraction was retained, demonstrating the acidic nature of the peptides. Similar results have been observed in rat and rabbit. The other part of the unretained fraction from cation exchange chromatography of human plasma was purified on HPLC. The results demonstrated that the major component observed by HPLC cochromatographed with synthetic pGlu-Glu-Pro amide. This study represents the first demonstration of a circulating N-extended form of any TRH-like peptide.

Animals↗

PubMedDate not supplied

Extended-release nifedipine bezoar identified one year after discontinuation.

OBJECTIVE: To report a case of tablet impaction of nifedipine extended-release tablets (Procardia XL) discovered one year after discontinuation of the drug in a patient with peptic stricture. DATA SOURCES: English-language references identified via a MEDLINE search from 1966 through September 1998 and bibliographic review of pertinent articles. DATA SYNTHESIS: Extended-release nifedipine has been associated with the formation of medication bezoars in case reports. Bezoars are concretions of undigested material within the gastrointestinal (GI) tract. Although they can occur throughout the GI tract, bezoars are most frequently located in the stomach and, rarely, in the duodenum. We report an unusual case of tablet impaction with a gastric outlet obstruction in the duodenal area discovered one year after the patient stopped taking extended-release nifedipine. CONCLUSIONS: Extended-release nifedipine is associated with tablet impaction, even long after discontinuing administration. Although rare, clinicians should be aware of this potential problem when prescribing extended-release medications to patients at risk, and should consider this possible etiology when refractory epigastric pain and weight loss occur.

Aged↗

PubMed2006

Extended bidirectional reflectance distribution function for polarized light scattering from subsurface defects under a smooth surface.

By introducing the scattering probability of a subsurface defect (SSD) and statistical distribution functions of SSD radius, refractive index, and position, we derive an extended bidirectional reflectance distribution function (BRDF) from the Jones scattering matrix. This function is applicable to the calculation for comparison with measurement of polarized light-scattering resulting from a SSD. A numerical calculation of the extended BRDF for the case of p-polarized incident light was performed by means of the Monte Carlo method. Our numerical results indicate that the extended BRDF strongly depends on the light incidence angle, the light scattering angle, and the out-of-plane azimuth angle. We observe a 180 degrees symmetry with respect to the azimuth angle. We further investigate the influence of the SSD density, the substrate refractive index, and the statistical distributions of the SSD radius and refractive index on the extended BRDF. For transparent substrates, we also find the dependence of the extended BRDF on the SSD positions.

Journal Article↗

PubMed1998

A randomized clinical trial comparing an extended-use hygroscopic condenser humidifier with heated-water humidification in mechanically ventilated patients.

STUDY OBJECTIVE: To determine the safety and cost-effectiveness of mechanical ventilation with an extended-use hygroscopic condenser humidifier (Duration; Nellcor Puritan-Bennett; Eden Prairie, Minn) compared with mechanical ventilation with heated-water humidification. DESIGN: Prospective randomized clinical trial. SETTING: Medical and surgical ICUs of Barnes-Jewish Hospital, St. Louis, a university-affiliated teaching hospital. PATIENTS: Three hundred ten consecutive qualified patients undergoing mechanical ventilation. INTERVENTIONS: Patients requiring mechanical ventilation were randomly assigned to receive humidification with either an extended-use hygroscopic condenser humidifier (for up to the first 7 days of mechanical ventilation) or heated-water humidification. MEASUREMENTS: Occurrence of ventilator-associated pneumonia, endotracheal tube occlusion, duration of mechanical ventilation, lengths of intensive care and hospitalization, acquired multiorgan dysfunction, and hospital mortality. RESULTS: One hundred sixty-three patients were randomly assigned to receive humidification with an extended-use hygroscopic condenser humidifier, and 147 patients were randomly assigned to receive heated-water humidification. The two groups were similar at the time of randomization with regard to demographic characteristics, ICU admission diagnoses, and severity of illness. Risk factors for the development of ventilator-associated pneumonia were also similar during the study period for both treatment groups. Ventilator-associated pneumonia was seen in 15 (9.2%) patients receiving humidification with an extended-use hygroscopic condenser humidifier and in 15 (10.2%) patients receiving heated-water humidification (relative risk, 0.90; 95% confidence interval=0.46 to 1.78; p=0.766). No statistically significant differences for hospital mortality, duration of mechanical ventilation, lengths of stay in the hospital ICU, or acquired organ system derangements were found between the two treatment groups. No episode of endotracheal tube occlusion occurred during the study period in either treatment group. The total cost of providing humidification was $2,605 for patients receiving a hygroscopic condenser humidifier compared with $5,625 for patients receiving heated-water humidification. CONCLUSION: Our findings suggest that the initial application of an extended-use hygroscopic condenser humidifier is a safe and more cost-effective method of providing humidification to patients requiring mechanical ventilation compared with heated-water humidification.

Adolescent↗

PubMed2005

Modifications of bull spermatozoa induced by three extenders: Biociphos, low density lipoprotein and Triladyl, before, during and after freezing and thawing.

The success of artificial insemination with frozen semen implies the reduction of the deleterious effects on the cells induced by this technique. These effects can occur as early as during the first dilution in an extender, as well as at any step, during or after the freezing process. In this work, we have compared the modifications induced by Triladyl, low density lipoproteins (LDL) and Biociphos extenders, after dilution and cooling to 4 degrees C for 1, 4 and 24 h. Alterations in the cell structures were visualized by electron microscopy (EM). More than 80% of spermatozoa were injured after incubation for 4 h in Triladyl, while 3% and 47% were counted in LDL and Biociphos respectively. This latter extender was deleterious to cell membrane integrity after incubation for 4 h or longer. The ultrastructure of frozen spermatozoa was studied by EM of cryofixed-cryosubstituted samples obtained from regular 0.5 ml French straws frozen using our usual protocol. The main differences between samples concerned the size and appearance of the frozen extender veins, while very few cell defects were found to be added by the freezing process at any depth in the straws. After thawing, semen motility was twofold higher (P < 0.05) in Biociphos (64%) and LDL (61%) than in Triladyl (32%) and the cells were less altered in LDL. We concluded that the LDL extender offers a better protection for storage of frozen spermatozoa, and can probably also be used for the preservation of fresh semen for short periods.

Animals↗

PubMed2006

Relative benefits of stimulant therapy with OROS methylphenidate versus mixed amphetamine salts extended release in improving the driving performance of adolescent drivers with attention-deficit/hyperactivity disorder.

OBJECTIVE: Automobile accidents are the leading cause of death among adolescents, and collisions are 2 to 4 times more likely to occur among adolescents with attention-deficit/hyperactivity disorder. Studies have demonstrated that stimulants improve driving performance. This study compared 2 long-acting stimulant medications during daytime and evening driving evaluations. METHODS: Adolescent drivers with attention-deficit/hyperactivity disorder were compared on a driving simulator after taking 72 mg of OROS methylphenidate, 30 mg of mixed amphetamine salts extended release, or placebo in a randomized, double-blind, placebo-controlled, crossover study design. During laboratory testing, adolescents drove a driving simulator at 5:00 pm, 8:00 pm, and 11:00 pm. Driving performance was rated by adolescents and investigators. RESULTS: The study included 35 adolescent drivers with attention-deficit/hyperactivity disorder (19 boys/16 girls). The mean age was 17.8 years. The overall Impaired Driving Score demonstrated that OROS methylphenidate led to better driving performance compared with placebo and mixed amphetamine salts extended release, whereas mixed amphetamine salts extended release demonstrated no statistical improvement over placebo. Specifically, relative to placebo, OROS methylphenidate resulted in less time driving off the road, fewer instances of speeding, less erratic speed control, more time executing left turns, and less inappropriate use of brakes. OROS methylphenidate and mixed amphetamine salts extended release worked equally well for male and female adolescents and equally as well with teenagers who have combined and inattentive subtypes of attention-deficit/hyperactivity disorder. CONCLUSIONS: This study validates the use of stimulants to improve driving performance in adolescents with attention-deficit/hyperactivity disorder. In the study, OROS methylphenidate promoted significantly improved driving performance compared with placebo and mixed amphetamine salts extended release.

Accidents, Traffic↗

PubMed2005

Dexmethylphenidate extended-release capsules for attention deficit hyperactivity disorder.

Medications for attention deficit hyperactivity disorder (ADHD) currently represent the ninth largest segment of the CNS market by sales, with 2.4 billion USD spent annually on this condition and 40% annual growth. Stimulant medications remain the most effective ADHD therapies and provide robust improvement in ADHD symptoms in both youth and adults. Current prescribing practices favor extended release preparations due to increased convenience, compliance and tolerability with once-daily dosing. Dexmethylphenidate extended release is a long-acting preparation of the ADHD medication Focalin (dexmethylphenidate immediate release) and was approved for marketing by the US Food and Drug administration in June 2005. Dexmethylphenidate consists of the single dextro-isomer form of d,l-methylphenidate commonly marketed as Ritalin. Dexmethylphenidate extended release utilizes spheroidal oral drug absorption system technology to achieve a 50% immediate medication delivery and 50% delayed release of dexmethylphenidate approximately 4 h after ingestion. Placebo-controlled, clinical trials in children and adults with ADHD have demonstrated efficacy for behavioral and academic ratings, with an analog classroom study showing medication effects up to 12 h after dosing. Dexmethylphenidate extended release was generally well tolerated with a side-effect profile similar to other stimulants. The most common reported side effects include diminished appetite and insomnia. Given its duration of effect, favorable tolerability and flexibility in dosing, dexmethylphenidate extended release is likely to gain considerable use as an ADHD treatment.

Animals↗

PubMed2004

Extended-release divalproex sodium for mood stabilization.

STUDY OBJECTIVE: To evaluate the efficacy, safety, and tolerability of extended-release divalproex sodium. DESIGN: Prospective, open-label, 4-week study SETTING: Long-term care facility of the Missouri Department of Mental Health. PATIENTS: Ten hospitalized patients (mean age 39.4 yrs) with mood or thought disorders who were experiencing adverse effects from delayed-release divalproex sodium. INTERVENTION: All participants were switched from delayed-release to extended-release divalproex sodium. MEASUREMENTS AND MAIN RESULTS: Efficacy was monitored with the Brief Psychiatric Rating Scale (BPRS), and safety and tolerability were monitored with the Systematic Assessment for Treatment Emergent Events (SAFTEE). Frequently reported adverse effects before conversion were sedation, stomach upset, and tremor. At study conclusion, no differences were seen in total BPRS scores or individual BPRS items, although a trend pointed to decreased somatic complaints (p=0.057). The mean serum concentration of valproic acid among participants did not change significantly in the transition from the delayed-release formulation to an equivalent dose-adjusted extended-release formulation (90.5 mg/L vs 95.5 mg/L, p=0.493). At study conclusion, significant decreases in low-density lipoprotein cholesterol (p=0.010) and potassium (p=0.043) levels were identified. Three categories of adverse effects decreased significantly after patients switched to the extended-release form of divalproex sodium: sedation (p=0.022), stomach or abdominal discomfort (p=0.045), and tremor (p=0.004). CONCLUSION: This preliminary investigation suggests that patients receiving delayed-release divalproex sodium for mood lability can be converted successfully to extended-release divalproex sodium. Moreover, these findings imply that this transition is associated with a reduction in some of the adverse effects associated with divalproex sodium.

Adult↗

PubMed2003

Extended trochanteric osteotomy in complex primary total hip arthroplasty. A brief note.

BACKGROUND: The extended trochanteric osteotomy has been a useful approach for patients undergoing revision total hip arthroplasty; however, it has not been well described as an approach for those undergoing complex primary total hip arthroplasty. The purpose of the present report is to describe our experience with the use of an extended trochanteric osteotomy for patients undergoing complex primary total hip arthroplasty. METHODS: Six patients underwent primary total hip arthroplasty with use of an extended trochanteric osteotomy. The reasons for the use of this technique included severe femoral deformity, removal of intraosseous hardware, and high-riding developmental hip dysplasia. A fully porous-coated femoral component with diaphyseal fixation was used for all reconstructions. The mean age of the patients at the time of surgery was fifty-six years. Clinical and radiographic evaluation was performed at a minimum of two years. RESULTS: After a mean duration of follow-up of fifty months, all patients had an osseointegrated, stable femoral component. The site of the extended trochanteric osteotomy healed in five of the six patients. One patient had nonunion at the osteotomy site and a fracture at the base of the greater trochanter, with a subsequent fracture of the femoral component. The mean Merle D'Aubigné and Postel pain and walking scores improved from 2.2 and 2.3 preoperatively to 5.3 and 4.7 at the time of the final follow-up (p < 0.001). CONCLUSIONS: The extended trochanteric osteotomy is useful for the correction of femoral deformity and facilitates the removal of intraosseous hardware in carefully selected patients undergoing complex primary total hip arthroplasty.

Adult↗

PubMed2005

Extended anticoagulation therapy for the primary and secondary prevention of venous thromboembolism.

Extending the period of anticoagulation is an active area of investigation in both primary and secondary prevention of venous thromboembolic disease. In orthopaedic surgery, particularly in patients undergoing hip surgery, there is a growing interest in using extended anticoagulation beyond that traditionally given in the postoperative period using low-molecular weight heparin, oral anticoagulants, or newer agents such as fondaparinux sodium. Most studies show a benefit to extending anticoagulation without a considerable increase in major bleeding. There have been several large clinical trials addressing the question of extending oral anticoagulation in secondary prevention of venous thromboembolism (VTE). Just how long anticoagulation should be given in the treatment of venous thromboembolic disease remains an open question, depending on the nature of the initial VTE, associated patient risk factors and the risks of major bleeding. Future directions include the use of newer agents for anticoagulation as well as methods of better defining who will benefit most from extended anticoagulation based on an identification of risk factors with the aid of markers such as D-dimer or residual vein thrombosis.

Anticoagulants↗

PubMed2006

Extended-release intramuscular naltrexone.

An extended-release intramuscular formulation of naltrexone that provides sustained release of the drug over a 28-day period has been developed with the aim of improving treatment adherence in patients treated with naltrexone for alcohol dependence. Biodegradable polylactide-co-glycolide polymer microspheres containing 34% w/w naltrexone are reconstituted in an aqueous suspension just prior to intramuscular administration. Extended-release intramuscular naltrexone 380 mg administered once every 4 weeks, in combination with psychosocial therapy, demonstrated superior efficacy to placebo plus psychosocial therapy in reducing the heavy drinking event rate (primary endpoint) in adult patients with alcohol dependence in a 6-month well controlled trial. Among the subset of patients who abstained completely from drinking during the 7 days prior to the first dose of medication (n = 53; 8% of the total study population), those treated with extended-release intramuscular naltrexone 380 mg had greater reductions in the number of drinking days and the number of heavy drinking days compared with placebo recipients. Treatment with extended-release intramuscular naltrexone 380 mg once every 4 weeks for up to 18 months was generally well tolerated, with infrequent treatment-related serious adverse events. The most common treatment-emergent adverse events leading to treatment discontinuation were nausea, injection site reaction and headache. The proportion of patients with clinically significant plasma transaminase elevations was not different between patients receiving extended-release intramuscular naltrexone and those receiving placebo.

Adult↗

PubMed1976

Results of involved field and extended field radiotherapy in patients with pathologic state I and II Hodgkin's disease.

A series of 44 previously untreated patients was found to have stage I or II Hodgkin's disease on the basis of a diagnostic workup which included laparotomy and splenectomy in 39 cases. The patients were randomized to either involved field or extended field radiotherapy. No difference was found in overall survival rates between the two groups. Regional recurrences were seen in four patients in the involved field group and in none of the extended field group. Regional recurrences were seen in four patients in the involved field group and in none of the extended field group. Radiotherapy to the extended field treatment port (generally an extended mantle) can be given with acceptable side effects. Staging laparotomy was of definite value, changing the classification and resulting therapy of two groups: (1) patients with clinical stage (CS) I or II, pathologic stage (PS) III involvement, who were treated with appropriately larger radiotherapy fields; and (2) patients with CS III, PS I or II, who were spared unnecessarily extensive radiotherapy.

Adolescent↗