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Biomedical subjects

K McCarroll

Publications and source records attributed to K McCarroll.

14 recordsLinked to original sources

Adverse effects of left ventricular hypertrophy in the reduction of endpoints in NIDDM with the angiotensin II antagonist losartan (RENAAL) study.

AIMS/HYPOTHESIS: We explored the impact of baseline left ventricular hypertrophy (LVH) and losartan treatment on renal and cardiovascular (CV) events in 1,513 patients from the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) trial, which studied the effects of losartan on the progression of renal disease and/or death in patients with type 2 diabetes and nephropathy. MATERIALS AND METHODS: LVH was assessed using ECG criteria (Cornell product and/or Sokolow-Lyon voltage). The risk of renal or CV events was determined by a proportional hazards model fit with treatment allocation and presence of LVH. Covariates at baseline included age, sex, systolic BP, mean arterial pressure, pulse, proteinuria, serum creatinine, albumin and haemoglobin. RESULTS: A total of 187 subjects (12%) had LVH at baseline. Treatment with losartan resulted in a significant decrease in the Cornell product (-6.2%) and Sokolow-Lyon voltage (-6.3%). LVH was shown to be significantly associated with the primary endpoint, which was a composite of doubling of serum creatinine (DSCR), endstage renal disease (ESRD) or death (hazard ratio [HR]=1.44, p=0.011), as well as with the composite renal endpoint of DSCR/ESRD (HR=1.42, p=0.031) and CV events (HR=1.68, p=0.001). Losartan treatment of patients with LVH decreased the CV as well as renal risk to a level similar to that of patients without LVH. CONCLUSIONS/INTERPRETATION: In patients with type 2 diabetes and nephropathy, LVH is associated with significantly increased risk of CV events and the progression of kidney disease. Importantly, in patients with LVH, losartan reduced the CV as well as the renal risk to a level similar to that seen in subjects without LVH.

Aged↗

Role of routine nonenhanced head computed tomography scan in excluding orbital, maxillary, or zygomatic fractures secondary to blunt head trauma.

The purpose of this paper is to determine the necessity of a dedicated facial bone/orbital computed tomography (CT) scan for fracture surveillance in patients who have suffered blunt head trauma and whose routine nonenhanced head CT scan is negative. It is based on a retrospective review of 115 patients presenting to the Emergency Department at a level I trauma center after blunt head trauma. Included patients underwent both a nonenhanced head CT scan and a dedicated facial bone or orbit CT. Standard nonenhanced head CT protocol was followed for each patient as per department protocol. A positive head CT scan is defined to include either an air-fluid level within the paranasal sinuses or fracture of the maxillary, orbital, or zygomatic osseous structures. A negative scan demonstrates none of these findings. Intracranial/parenchymal pathology was not evaluated in this study. Sixty-five of the 115 patients had a negative head CT scan as defined above. Of these 65 patients, none subsequently had a positive facial bone or orbit CT scan. The sensitivity and negative predictive values of a negative routine nonenhanced head CT scan for fracture surveillance are both 100%. In the setting of blunt trauma, a negative nonenhanced head CT scan precludes the need for a dedicated facial bone or orbital CT scan in the evaluation for orbital, maxillary, or zygomatic fractures. This saves the patient unnecessary radiation exposure, health care costs, and time spent in the emergency radiology department.

Adult↗

Sum of Pain Intensity Differences (SPID) in migraine trials. A comment based on four rizatriptan trials.

Sum of Pain Intensity Difference (SPID) is an outcome measure that summarizes treatment response over a clinically relevant period. SPID is widely reported in clinical trials of analgesics but has been little used in migraine trials. We compared SPID over 2 h with the standard migraine outcome measures of pain-free at 2 h and headache relief at 2 h using data from four published clinical trials of rizatriptan in migraine patients. In assessing treatment response (rizatriptan and sumatriptan versus placebo, rizatriptan versus sumatriptan, within-treatment dose effects), SPID usually yielded similar results to the more easily understood pain-free measure.

Humans↗

Accuracy of detecting screw penetration of the acetabulum with intraoperative fluoroscopy and computed tomography.

BACKGROUND: The purpose of this study was to determine the accuracy of computed tomography and fluoroscopy in assessing joint penetration by periacetabular screws. METHODS: A 3.5-mm acetabular periarticular screw was inserted in each of thirty-nine cadaveric hemipelves. Twenty screws were intentionally directed to violate the articular surface, whereas nineteen screws were positioned to avoid the articular surface. Using two fluoroscopic views (tangential and axial) in a manner simulating the clinical setting, an examiner blinded to the actual screw location determined whether each screw was violating the articular surface. In addition, each hemipelvis was examined with computed tomography with use of two different techniques: (1) a 1-mm slice thickness at 1-mm intervals, and (2) a 4-mm slice thickness at 3-mm intervals. Each scan was evaluated by another examiner who was blinded to the actual screw location. Sensitivity, specificity, and percent correct interpretations were then calculated for each method. RESULTS: The sensitivity, specificity, and percent correct interpretations were 95%, 84%, and 90%, respectively, for axial fluoroscopy; 85%, 89%, and 87% for tangential fluoroscopy; 100%, 84%, and 92% for the computed tomography scans with a 1-mm slice thickness at 1-mm intervals; and 100%, 58%, and 79% for the computed tomography scans with a 4-mm slice thickness at 3-mm intervals. Tangential fluoroscopy was found to be more specific than the computed tomography scans with a 4-mm slice thickness at 3-mm intervals (p = 0.02). No other significant differences were found. CONCLUSIONS: Fluoroscopy and computed tomography are equally accurate for determining intra-articular screw penetration. Computed tomography scans with thick slices (4 mm at 3-mm intervals) have a low specificity. Their use postoperatively may lead to a false-positive interpretation of the scan and unnecessary exploration of a hip for screw penetration.

Acetabulum↗

Low dose famotidine in the prevention of sleep disturbance caused by heartburn after an evening meal.

AIM: To determine whether, in a susceptible population, dosing with 10 mg famotidine 1 h before an evening meal could decrease the interference with sleep caused by heartburn. METHODS: Patients with a history of frequent heartburn (n = 309) were randomized to receive 10 mg famotidine or placebo 1 h before an evening meal likely to induce symptoms. Patients assessed the efficacy of the treatment in preventing heartburn after the meal, at bedtime and during the night. The number of awakenings due to heartburn and the consumption of antacid tablets taken to alleviate symptoms were also recorded. RESULTS: Treatment groups were well matched and data from 302 patients were available for analysis. Compared to placebo, famotidine treated patients had: less heartburn after the meal (P < 0.0001 mean global scores), less interference with getting to sleep (P = 0.0156 mean global scores), fewer awakenings (P = 0.0001 difference in mean number) and better control of heartburn during the night (P < 0.0001 mean global scores). They were also almost three times less likely to need antacid treatment than the placebo group during the night (relative odds for no antacid 2.78 (95% CI: 1.29-5.96). Only four patients in each group suffered adverse events. CONCLUSION: Taking a 10 mg dose of famotidine 1 h before an evening meal appears to be a successful and well tolerated strategy for preventing post-prandial heartburn and avoiding the associated interference with sleep.

Adult↗

Correlative imaging of the liver and hepatobiliary system.

Many imaging techniques can be used to assess the liver and hepatobiliary system. Each modality has individual strengths and limitations, which usually vary depending on the specific clinical situation. This review discusses several specific common clinical situations where imaging of the liver and biliary system is necessary and describes the various imaging options. Space-occupying liver lesions are discussed, and particular attention is paid to the assessment of liver metastasis, hepatoma, and incidentally discovered liver lesions such as hemangioma, adenoma, and focal nodular hyperplasia. The value of ultrasound, computed tomography, magnetic resonance imaging, and scintigraphic techniques in this patient population is described. Isolated sulfur colloid hepatic scintigraphy is not of great value in the evaluation of these patients. Therefore, this review describes in some detail the value of physiological liver scintigraphy, including gallium and iminodiacetic acid (IDA) scanning as well as dynamic flow imaging of the liver such as hepatic artery perfusion scintigraphy and tagged red cell scintigraphy. Imaging of the biliary tree also is described. The roles of ultrasound and scintigraphy are compared and contrasted as related to the diagnosis of acute cholecystitis, common duct obstruction, and postoperative complications.

Biliary Tract Diseases↗

Phase I-II trial of high-dose melphalan in previously untreated stage III multiple myeloma: Cancer and Leukemia Group B study 8512.

To study the efficiency of high-dose melphalan in previously untreated patients with advanced myeloma, we performed a Phase I-II trial. Twenty-eight patients were treated at dose level of 60-140 mg/m2. Each patient was first treated with a priming dose of cyclophosphamide (300 mg) followed by high-dose melphalen 1 week later. One course of therapy was given. Patients were then followed without further therapy until relapse. Clinical and laboratory features of the 28 patients in this study included: median age 63, performance status 0-2, hypercalcemia 21%, bone pain 82%, paraprotein types: IgG 76%, Iga 20%, and paraproteinuria 71%. Because none of the patients achieved complete remission (CR) at 60 mg/m2, despite life-threatening toxicity in all patients, the dose level was rapidly increased to 140 mg/m2, a dose previously reported to induce a high percentage of CR. At this dose, CR was achieved in only 1 of 11 patients (9%). This patient had multiple plasmacytomas without generalized bone marrow involvement. One additional patient at 100 mg/m2 achieved CR. Of the whole group, 12 achieved PR. Durations of remissions were generally short: CR 6.3 and 18+ months and PR 2.3-18 month, median 6.9 months. Life-threatening myelosuppression was universal with prolonged pancytopenia. Treatment-related deaths from sepsis were observed in 29% of patients. The median survival of the entire group was 15.6 months. Older patients in this trial did not tolerate high-dose melphalen therapy well; this resulted in a high proportion of toxic deaths and poor overall survival.

Adult↗

Phase II trial of etoposide and cis-diaminodichloro-platinum in patients with refractory and relapsed Hodgkin's disease: Cancer and Leukemia Group B (CALGB) Study 8353.

A phase II study was conducted by the Cancer and Leukemia Group B (CALGB) in patients with refractory and relapsed Hodgkin's disease (HD) to assess the activity of the combination of etoposide and cis-platin. Twenty-seven patients were entered; 22 were evaluated for this report. Treatment consisted of etoposide (VP-16), 80 mg/m2 IV over 1 hour and cis-platin, 20 mg/m2 IV over 1/2-1 hour; both agents were given daily for 5 days and repeated every 21 days. All patients had received at least 2 prior chemotherapy regimens, had measurable disease, and most (86%) had a performance status of 0-1. In the 22 evaluable patients, there were 4 complete responses (18%) and 4 partial responses, for an overall response rate of 36% (95% Cl: 17.2%, 59.3%). Response duration was from 2.1 to 31 months. Significant toxicity was observed with this regimen. Ten patients (45%) had leukopenia less than 1,000/microliters, and 11 patients (50%) had thrombocytopenia less than 25,000/microliters. Serum creatinine levels reached greater than 2.0 in 14% of patients. Seven patients (32%) had severe nausea and vomiting. VP-16, cis-platin appears to be an active combination in HD; however, their combined activity is only marginally better than reported single-agent activity for VP-16 in the doses and schedule used. Further studies of related combinations in HD are currently under evaluation by the CALGB.

Adolescent↗

Phase II study of MOPLACE chemotherapy for patients with previously treated Hodgkin's disease: a CALGB study.

To further evaluate possible non-cross-resistant regimens in Hodgkin's disease, a phase II trial utilizing antimetabolites and etoposide was initiated by the Cancer and Leukemia Group B (CALGB). Etoposide was included because of its known efficacy in relapsed Hodgkin's disease and to evaluate for synergy with an alkylating agent and vincristine. Cytosine arabinoside and methotrexate were included to evaluate their effectiveness in rapidly growing resistant disease. Forty-two patients with previously treated Hodgkin's disease were entered, of which 37 are evaluable for response and toxicity. All patients had at least 2 prior regimens of chemotherapy and 59% had additional radiation therapy. Complete and partial response was observed in 61%; there were 32% complete responders. Duration of complete response was a median of 8 months (range 2-28+ months). Duration of partial response was 7 months (range 1-17 months). Three patients remain in complete remission at 19, 19, and 28 months. Major toxicity was hematologic with severe or life-threatening toxicity in 54%. There was one patient with a fatal infection. Non-hematologic toxicity, save for nausea and vomiting, was mild and uncommon. There were two fatal and one severe pulmonary toxicities reported in patients who had previous exposure to bleomycin and mediastinal radiation. Three had interstitial pneumonitis and one pulmonary emboli. The interstitial pneumonitis was thought to be drug related. Survival of the entire group is estimated at 61% at 12 months. We conclude that MOPLACE is an effective regimen with an appreciable complete response rate in this heavily pretreated group of patients. Hematologic and pulmonary toxicities are severe and may necessitate dose modifications. The use of etoposide containing combinations requires further study as primary therapy in untreated patients.

Adolescent↗

Interferon therapy of relapsed and refractory Hodgkin's disease: Cancer and Leukemia Group B Study 8652.

A phase II trial of alpha 2b-interferon in patients with relapsed or refractory Hodgkin's disease was conducted by the Cancer and Leukemia Group B. Nineteen patients were eligible for study. These patients had received at least two (median of four) previous chemotherapeutic programs and 79% had received prior radiation therapy. Three patients had undergone intensive chemotherapy and autologous bone marrow transplantation. The treatment regimen consisted of interferon-alpha 2b 10 X 10(6) IU/m2 subcutaneously three times per week. Only limited antineoplastic activity was seen in this heavily pretreated group of patients. There was one partial response and four patients had reduction in measurable disease not meeting the criteria for partial response. The drug was well tolerated. Toxicity was predominantly myelosuppression. Thrombocytopenia was particularly severe in patients with bone marrow involvement. The observed antineoplastic activity, albeit limited, in this heavily pretreated group of patients suggests a potential role for this agent in combination regimens in patients with earlier disease.

Adult↗

Comparative study of ibuprofen lysine and acetaminophen in patients with postoperative dental pain.

This single-dose, double-blind, parallel-group, single-site study compared ibuprofen lysine 400 mg with acetaminophen 1000 mg and placebo in 240 patients with moderate-to-severe postoperative dental pain. The relative onset of analgesic response, overall analgesic efficacy, duration of effect, and safety were assessed over a 6-hour postdose period. Analgesic efficacy was assessed by patient self-rating of pain intensity, pain relief, time to meaningful pain relief, need for additional analgesic medication, and patient global evaluation. Both ibuprofen lysine 400 mg and acetaminophen 1000 mg were significantly (P < or = 0.05) more effective than placebo. Ibuprofen lysine had a significantly (P < or = 0.05) faster onset of action with greater peak and overall analgesic effect than did effect than did acetaminophen. All treatments were generally well tolerated.

Acetaminophen↗