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Biomedical subjects

David Gordon

Publications and source records attributed to David Gordon.

47 records · Page 3Linked to original sources
PubMed2003

Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial.

BACKGROUND: The goal of the current study was to compare the long-term (25-month) safety and efficacy of zoledronic acid with pamidronate in patients with bone lesions secondary to advanced breast carcinoma or multiple myeloma. METHODS: Patients (n = 1648) were randomized to receive 4 mg or 8 mg (reduced to 4 mg) zoledronic acid as a 15-minute infusion or to receive 90 mg pamidronate as a 2-hour infusion every 3-4 weeks for 24 months. The primary endpoint was the proportion of patients with at least 1 skeletal-related event (SRE), defined as pathologic fracture, spinal cord compression, radiation therapy, or surgery to bone. Secondary analyses included time to first SRE, skeletal morbidity rate, and multiple-event analysis. Hypercalcemia of malignancy (HCM) was included as an SRE in some secondary analyses. RESULTS: After 25 months of follow-up, zoledronic acid reduced the overall proportion of patients with an SRE and reduced the skeletal morbidity rate similar to pamidronate. Compared with pamidronate, zoledronic acid (4 mg) reduced the overall risk of developing skeletal complications (including HCM) by an additional 16% (P = 0.030). In patients with breast carcinoma, zoledronic acid (4 mg) was significantly more effective than pamidronate, reducing the risk of SREs by an additional 20% (P = 0.025) compared with pamidronate and by an additional 30% in patients receiving hormonal therapy (P = 0.009). Zoledronic acid (4 mg) and pamidronate were tolerated equally well. The most common adverse events included bone pain, nausea, and fatigue. CONCLUSIONS: Long-term follow-up data confirm that zoledronic acid was more effective than pamidronate in reducing the risk of skeletal complications in patients with bone metastases from breast carcinoma and was of similar efficacy in patients with multiple myeloma.

Bone Diseases↗
PubMed2003

Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial--the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group.

PURPOSE: To assess the efficacy and safety of zoledronic acid in patients with bone metastases secondary to solid tumors other than breast or prostate cancer. PATIENTS AND METHODS: Patients were randomly assigned to receive zoledronic acid (4 or 8 mg) or placebo every 3 weeks for 9 months, with concomitant antineoplastic therapy. The 8-mg dose was reduced to 4 mg (8/4-mg group). The primary efficacy analysis was proportion of patients with at least one skeletal-related event (SRE), defined as pathologic fracture, spinal cord compression, radiation therapy to bone, and surgery to bone. Secondary analyses (time to first SRE, skeletal morbidity rate, and multiple event analysis) counted hypercalcemia as an SRE. RESULTS: Among 773 patients with bone metastases from lung cancer or other solid tumors, the proportion with an SRE was reduced in both zoledronic acid groups compared with the placebo group (38% for 4 mg and 35% for 8/4 mg zoledronic acid v 44% for the placebo group; P =.127 and P =.023 for 4-mg and 8/4-mg groups, respectively). Additionally, 4 mg zoledronic acid significantly increased time to first event (median, 230 v 163 days for placebo; P =.023), an important end point in this poor-prognosis population, and significantly reduced the risk of developing skeletal events by multiple event analysis (hazard ratio = 0.732; P =.017). Zoledronic acid was well tolerated; the most common adverse events in all treatment groups included bone pain, nausea, anemia, and vomiting. CONCLUSION: Zoledronic acid (4 mg infused over 15 minutes) is the first bisphosphonate to reduce skeletal complications in patients with bone metastases from solid tumors other than breast and prostate cancer.

Bone Neoplasms↗
PubMed2003

Health policy in relation to improving equity in child health.

A major independent inquiry into inequalities in health-and policies that would reduce them-was published in December 1998.(1) It identified >40 recommendations designed to reduce inequalities in health. Lifting children out of poverty is among the most important strategies to improve child health. If we want to change policies on health and poverty, then we have to consider the broad political context within which our health systems work. In the United Kingdom, we have a welfare state that sends checks and cash income to 85% of households every month. Many people pay into the welfare state, many people get money back, and everybody receives services.(2) In the United States, the situation is different. There, many people pay into the state, but only the poor and corporations actually receive a check. I leave you to decide who gets the most out of these respective systems. We also have fundamental differences in our health systems. In the United Kingdom, 97% of expenditures on health are made by the state; there is virtually no private spending. In the United States, only 44% of health expenditures are made by the state. The limited amount of private health expenditures in the United Kingdom will be reduced further as the National Health Service provides more dentistry in the future. In terms of the amount of resources, the United States spends 14% of its gross domestic product on health, compared with 6% in the United Kingdom. The United States spent 3700 dollars per person on health care in 1997. In the United Kingdom, we spent less than one third of that.

Child↗
PubMed2002

Comparing the interpretations of CT pulmonary angiograms by attending and resident radiologists: can residents identify life-threatening pulmonary emboli in hospitalized patients?

OBJECTIVE: CT pulmonary angiography is now often the first-line investigation for pulmonary emboli. When these studies are performed after hours in teaching hospitals, they are often initially interpreted by trainees. It is of great significance whether the interpretations of trainees and certified radiologists with regard to the presence of pulmonary emboli on CT pulmonary angiograms correspond, because of the morbidity and mortality of both the condition and its treatment. MATERIAL AND METHODS: Twenty-five consecutive CT pulmonary angiograms (CTPAs) of hospitalized patients were viewed at lung and soft tissue windows both on a workstation and on hard copies, at the observers' discretion. Each CTPA was divided into 28 arterial zones based on pulmonary anatomy (including the subsegmental arteries), giving a total of 700 arterial zones, and analyzed retrospectively and independently by two cross-sectional imaging specialists and four residents. Each arterial segment was rated with regard to pulmonary embolus as either high, intermediate, or low probability or not visualized. The kappa (Kappa) test, which tests for interobserver agreement, was used for statistical analysis. RESULTS: At the time of the scan all patients were hospitalized for underlying conditions. Of the 25 patients studied, 9 were referred from the ICU, 7 experienced severe acute shortness of breath and respiratory failure, 5 were post-partum women, 2 had had a recent stroke, 1 patient had antithrombin III deficiency, and 1 had a diagnosis of breast cancer. The incidence of pulmonary emboli was 44%. For the main pulmonary arteries interobserver agreement was good (Kappa=0.61) and for the segmental pulmonary arteries it was fair (Kappa=0.26). For the subsegmental arteries interobserver agreement was poor (Kappa=0.16). The zones where interobserver agreement was greatest (Kappa>0.4) were the left main, left lower lobe, and the right main pulmonary arteries. Interobserver agreement was poorest (Kappa<0.05) in the left interlobar, left lower lobe lateral basal segment, right lower lobe superior segment, and left lower lobe superior segment branches. None of the patients expired due to pulmonary emboli. CONCLUSION: Most life-threatening pulmonary emboli requiring urgent treatment are the more central emboli. This study demonstrates that trainees and certified radiologists can make similar conclusions regarding these central pulmonary emboli in hospitalized patients and that preliminary interpretations by trainees should not therefore adversely affect patient care.

Journal Article↗
PubMed2002

Tension-free vaginal tape for stress urinary incontinence: Is there a learning curve?

AIM: To assess the learning curve characteristics of the first 30 tension-free vaginal tape (TVT) procedures carried out in our medical center and to evaluate its safety and short-term effectiveness. METHODS: A total of 30 incontinent women with urodynamically proven SUI were enrolled. None had undergone any previous anti-incontinence procedure. All were operated on by one surgeon, in accordance with the technique described by Ulmsten et al. in 1996. Mean follow-up was 11.4+/- 3.6 months (range, 5-17 months). RESULTS: Five (17%) bladder perforations occurred at the beginning of the study, due to inadvertent insertion of the applicator. All perforations were identified by intraoperative cystoscopy. Five other patients (17%) had increased intraoperative bleeding (>200 mL) necessitating vaginal tamponade. Blood transfusions were not required. Eight (27%) patients had immediate postoperative voiding difficulties, necessitating catheterization for 2-10 days, but none needed long-term catheterization. There was no local infection or rejection of the Prolene tape was found. All patients were subjectively cured of their stress incontinence; however, urodynamic evaluation revealed "asymptomatic genuine stress incontinence" in one patient. Sixteen of 21 patients (80%) with preoperative urge syndrome, had persistent postoperative symptoms. No patient developed de novo urge incontinence. CONCLUSION: The TVT operation is a new, minimally invasive surgical procedure with excellent short- and medium-term cure rates. However, there is a definite learning curve, and we believe that the operation should only be performed by experienced surgeons.

Aged↗
PubMed2002

The new bisphosphonate, Zometa (zoledronic acid), decreases skeletal complications in both osteolytic and osteoblastic lesions: a comparison to pamidronate.

Bisphosphonates are the treatment of choice for lytic bone lesions associated with breast cancer. In contrast, bone lesions associated with prostate cancer are predominately osteoblastic. Zoledonic acid (Zol) is a new-generation bisphosphonate that is approximately 2-3 orders of magnitude more potent than pamidronate (Pam) in preclinical models and has demonstrated clinical efficacy in patients with both lytic and blastic lesions. Zoledonic acid (4 mg via 15 min infusion) every 3-4 weeks was directly compared to Pam (90 mg via 2 hr infusion) in 767 patients with breast cancer and bone metastases. The primary endpoint was the proportion of patients experiencing a skeletal-related event (SRE) over 13 months. Zoledonic acid was as effective as Pam, and the proportion of Zol-treated patients with an SRE (42% in the hormonal therapy strata and 44% in the chemotherapy strata) was comparable to the original studies comparing Pam to placebo. Among 371 breast cancer patients receiving hormonal therapy, the proportion of patients with an SRE was 47% for Pam vs. 57% for placebo (P = 0.057), and among 380 patients treated with chemotherapy, the proportions with an SRE were 43% for Pam vs. 56% for placebo (P = 0.008) at 12 months. Zoledronic acid (4 mg) has been compared to placebo in a randomized Phase III trial involving 422 men with hormone-refractory prostate cancer metastatic to bone. Zoledonic acid demonstrated a significant advantage over placebo for median time to first SRE (median not reached for Zol vs. 321 days for placebo; P = 0.011), the proportion of patients with an SRE over 15 months (33 vs. 44% for placebo; P = 0.021), and mean skeletal morbidity rate (number of SREs/time, 0.08 vs. 1.49 for placebo; P = 0.006). In addition, the effects of Zol were apparent early. At 3 months, only 12% of Zol-treated patients had an SRE vs. 23% for placebo (P = 0.003), and at 6 months, the proportions were 21 vs. 31% for placebo (P = 0.025). In contrast, a previous study of Pam in 236 prostate cancer patients found that Pam was no more effective than placebo in reducing bone pain or SREs over 6 months. In these studies, Zol was well tolerated with a safety profile similar to other IV bisphosphonates. In conclusion, Zol is the first bisphosphonate to demonstrate efficacy in both lytic and blastic disease. The unique properties of this novel agent should be further explored in future clinical trials.

Adenocarcinoma↗
PubMed2002

In vitro activity of nystatin compared with those of liposomal nystatin, amphotericin B, and fluconazole against clinical Candida isolates.

We investigated the in vitro activity of nystatin and liposomal nystatin against 103 Candida isolates to determine the effect of both time and medium on MICs. We also compared the nystatin MICs with those of amphotericin B and fluconazole. Testing was performed in accordance with the National Committee for Clinical Laboratory Standards M27-A microdilution methodology with RPMI 1640, RPMI 1640 supplemented with glucose to 2% (RPMI-2), and antibiotic medium 3 supplemented with glucose to 2% (AM3). While nystatin MICs were similar to or slightly lower than liposomal nystatin MICs in RPMI 1640 and RPMI-2, they were markedly higher than liposomal nystatin MICs in AM3. Use of AM3 and determination of the MIC after 24 h of incubation provided a slightly wider range of liposomal nystatin MICs (0.06 to >16 microg/ml). Under these conditions, the MICs at which 90% of isolates were inhibited of nystatin and liposomal nystatin were 2 and 1 microg/ml, respectively. Nystatin and liposomal nystatin in general showed good activity against all Candida spp. tested. Although the MICs of nystatin and liposomal nystatin tended to rise in parallel with the amphotericin B MICs, nystatin and liposomal nystatin MICs of 1 to 2 and 0.5 to 1 microg/ml, respectively, were obtained for seven and six, respectively, of nine isolates for which amphotericin B MICs were >or=0.25 microg/ml. No correlation between fluconazole and nystatin or liposomal nystatin MICs was observed. As amphotericin B MICs of >or=0.25 microg/ml correlate with in vitro resistance, these results suggest that liposomal nystatin might have activity against some amphotericin B-resistant isolates. In vivo testing in animal models is required for clarification of this issue.

Amphotericin B↗
PubMedDate not supplied

Characteristics and lipid distribution of a large, high-risk, hypertensive population: the lipid-lowering component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) consisted of 42,418 participants randomized to one of four antihypertensive treatment groups: chlorthalidone, amlodipine, lisinopril, or doxazosin. A subset of these participants with fasting low-density lipoprotein cholesterol levels 100-189 mg/dL were randomized into a lipid-lowering component: 5170 to receive pravastatin (40 mg daily) and 5185 to receive usual care. This report describes the characteristics and lipid distribution of these participants. There were no important differences between the randomized treatment groups. Women had higher total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol than men. There was a similar finding for black participants compared with whites, except blacks had lower triglycerides. Diabetics had lower high-density lipoprotein cholesterol and higher triglycerides than nondiabetics, and patients with body mass index <25 kg/m(2) had higher high-density lipoprotein cholesterol but lower low-density lipoprotein cholesterol and triglycerides than patients with higher body mass index. The success of the randomization of this large, diverse population and the differences in the lipid distributions among its subgroups will allow further understanding of optimal lipid-lowering treatment.

Aged↗
PubMedDate not supplied

The evil twins of chronic pelvic pain syndrome: endometriosis and interstitial cystitis.

OBJECTIVE: To determine the value in the initial laparoscopic and cystoscopic evaluation of avoiding the unnecessary delay in diagnosing the "evil twins" of chronic pelvic pain syndrome, endometriosis and interstitial cystitis. METHODS: We performed a retrospective review of 60 women ranging in age from 19 to 62. They underwent concurrent laparoscopy, cystoscopy, and hydrodistentions from January 1999 to October 2000. A gynecology and urology team performed these procedures in these 60 patients at a regional pelvic pain center in Northwest Ohio. RESULTS: Fifty-eight patients (96.6%) were diagnosed with interstitial cystitis by the presence of glomerulation and terminal hematuria according to National Institutes of Health criteria. A diagnosis of (active and inactive) endometriosis was found in 56 patients (93.3%). Biopsy-confirmed active endometriosis was found in 48 patients (80%). In the interstitial cystitis patient group (58), 54 patients had a diagnosis of (active and inactive) endometriosis (93.1%), and 47 patients had biopsy-confirmed active endometriosis (81%). In the group of 56 patients with a diagnosis of (active and inactive) endometriosis, 54 patients were found to have interstitial cystitis (96.4%). In the group of 48 patients with active biopsy-confirmed endometriosis, 47 have interstitial cystitis (97.7%). CONCLUSION: Patients with chronic pelvic pain syndrome are very difficult to manage. Eighty percent were found to have endometriosis and had numerous previous operations. Many patients failed to respond to multiple therapies. In many cases, pain persists even after a hysterectomy. Through our study, we showed the high prevalence and association of interstitial cystitis and endometriosis, the evil twins of chronic pelvic pain syndrome. It is absolutely necessary to perform both laparoscopic and cystoscopic examinations concurrently with the patient anesthetized in the initial evaluation and treatment of chronic pelvic pain syndrome to avoid unnecessary delay in making the diagnosis of the evil twins, because chronic pelvic pain syndrome can be caused by either or both of these entities. It is very important to have the gynecologists and urologists working as a team in making an early diagnosis to resolve these chronic debilitating diseases.

Adult↗
PubMedDate not supplied

Interstitial cystitis and endometriosis in patients with chronic pelvic pain: The "Evil Twins" syndrome.

OBJECTIVE: To determine the prevalence of interstitial cystitis and endometriosis in patients with chronic pelvic pain. METHODS: A prospective analysis was conducted in 178 women with CPP who presented with bladder base/anterior vaginal wall and/or uterine tenderness, with or without irritative voiding symptoms. The Potassium Sensitivity Test was used to assess bladder epithelial dysfunction. Patients were evaluated with concurrent laparoscopy and cystoscopy with hydrodistention. RESULTS: Laparoscopic findings among the 178 patients with chronic pelvic pain supported a diagnosis of endometriosis in 134 (75%) patients, and cystoscopy confirmed a diagnosis of interstitial cystitis in 159 (89%) patients. Both interstitial cystitis and endometriosis were diagnosed in 115 patients (65%). The Potassium Sensitivity Test was positive in 146 (82%) patients, with 140 (96%) of these patients diagnosed with interstitial cystitis and 105 (72%) with endometriosis. CONCLUSIONS: Results of this prospective study show that interstitial cystitis and endometriosis may frequently coexist in patients with chronic pelvic pain. A positive Potassium Sensitivity Test accurately predicted the presence of interstitial cystitis in 96% of these patients with chronic pelvic pain, as confirmed by cystoscopic hydrodistention. It is necessary to consider the diagnosis of endometriosis and interstitial cystitis concurrently in the evaluation of patients with chronic pelvic pain to avoid unnecessary delay in identifying either condition.

Adolescent↗