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Biomedical subjects

E Whalen

Publications and source records attributed to E Whalen.

At least 19 recordsLinked to original sources
PubMed2001

A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease.

OBJECTIVE: To investigate the efficacy and safety of donepezil in patients with moderate to severe AD (standardized Mini-Mental State Examination [sMMSE] scores of 5 to 17; Functional Assessment Staging score < or =6 at baseline). METHODS: Two-hundred ninety patients were randomized to treatment in this 24-week, double-blind, placebo-controlled trial. Patients received either donepezil 5 mg/day for the first 28 days and 10 mg/day thereafter as per the clinician's judgment (n = 144) or placebo (n = 146). The primary outcome measure was the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC+). RESULTS: Patients' mean age was 73.6 years (range 48 to 92 years). Baseline demographics were similar between the treatment groups. Least squares (LS) mean +/- SE sMMSE scores at baseline were 11.7 +/- 0.35 for the donepezil group and 12.0 +/- 0.34 for the placebo group. Patients receiving donepezil showed benefits on the CIBIC+, compared with placebo, at all visits up to week 24 (p < 0.001) and at week 24 last observation carried forward (LOCF) (p < 0.0001). All other secondary measures (including sMMSE, Severe Impairment Battery, Disability Assessment for Dementia, Functional Rating Scale, and Neuropsychiatric Inventory) showed significant differences between the groups in favor of donepezil at week 24 LOCF. Eighty-four percent of donepezil- and 86% of placebo-treated patients completed the trial. Adverse events (AE) were experienced by 83% of donepezil- and 80% of placebo-treated patients, the majority of which were rated mild in severity; 8% of donepezil- and 6% of placebo-treated patients discontinued because of AE. Laboratory and vital sign abnormalities were similar between the treatment groups. CONCLUSION: These data suggest that donepezil's benefits extend into more advanced stages of AD than those previously investigated, with very good tolerability.

Activities of Daily Living↗
PubMed2001

A randomized, double-blind, placebo-controlled study of the efficacy and safety of donepezil in patients with Alzheimer's disease in the nursing home setting.

OBJECTIVES: To evaluate the safety and efficacy of donepezil in the management of patients with Alzheimer's disease (AD) residing in nursing home facilities. DESIGN: Twenty-four-week, randomized, multicenter, parallel-group, double-blind, placebo-controlled trial. SETTING: Twenty-seven nursing homes across the United States. PARTICIPANTS: Two hundred eight nursing home patients with a diagnosis of probable or possible AD, or AD with cerebrovascular disease; mean Mini-Mental State Examination (MMSE) score 14.4; mean age 85.7. MEASUREMENTS: The primary outcome measure was the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH). Secondary efficacy measures were the Clinical Dementia Rating (Nursing Home Version)-Sum of the Boxes (CDR-SB), MMSE, and the Physical Self-Maintenance Scale (PSMS). Safety was monitored by physical examinations, vital signs, clinical laboratory tests, electrocardiograms (ECGs), and treatment-emergent adverse events (AEs). RESULTS: Eighty-two percent of donepezil- and 74% of placebo-treated patients completed the trial. Eleven percent of donepezil- and 18% of placebo-treated patients withdrew because of AEs. Mean NPI-NH 12-item total scores improved relative to baseline for both groups, with no significant differences observed between the groups at any assessment. Mean change from baseline CDR-SB total score improved significantly with donepezil compared with placebo at Week 24 (P < .05). The change in CDR-SB total score was not influenced by age. Differences in mean change from baseline on the MMSE favored donepezil over placebo at Weeks 8, 16, and 20 (P < .05). No significant differences were observed between the groups on the PSMS. Overall rates of occurrence and severity of AEs were similar between the two groups (97% placebo, 96% donepezil). Gastrointestinal AEs occurred more frequently in donepezil-treated patients. In general, AEs were similar in older and younger donepezil-treated patients, with the majority of patients experiencing only AEs that were transient and mild or moderate in severity. Weight loss was reported as an AE more frequently in older patients, although a loss at last visit of >or=7% of screening weight occurred at the same rate in older and younger patients (9% of donepezil- and 6% of placebo-treated patients). No significant differences between groups in vital sign changes, bradycardia, or rates of clinically significant laboratory or ECG abnormalities were observed. CONCLUSION: Patients treated with donepezil maintained or improved in cognition and overall dementia severity in contrast to placebo-treated patients who declined during the 6-month treatment period. The safety and tolerability profile was comparable with that reported in outpatient studies of donepezil. These findings also suggest that advanced age, comorbid illnesses, and high concomitant medication usage should not be barriers to donepezil treatment. Given the apparent improvement in behavior in the placebo group, and the high use of concomitant medications in both groups, the impact of donepezil on behavior in the nursing home setting is unresolved and merits further investigation. In summary, effects on cognition, overall dementia severity, and safety and tolerability findings are consistent with previous findings in outpatients and support the use of donepezil in patients with AD who reside in nursing homes.

Aged↗
PubMed1999

Single-dose oral ciprofloxacin compared with cefotaxime and placebo for prophylaxis during transurethral surgery.

To determine the efficacy and safety of single-dose oral ciprofloxacin prophylaxis for the prevention of post-operative bacteriuria following transurethral resection of the prostate or bladder tumour, a prospective, randomized, double-blind, placebo-controlled trial was conducted. Five hundred and eighteen patients were randomized in a 2:2:1 ratio to receive ciprofloxacin 500 mg, cefotaxime 1 g or placebo 30-90 min before surgery. Of the 368 efficacy-evaluable patients, five (3.3%) ciprofloxacin, seven (4.8%) cefotaxime and five (7.0%) placebo recipients had post-operative bacteriuria (> or = 10(4) cfu/mL) during post-operative days 2-15. Five (3.4%) ciprofloxacin, five (3.4%) cefotaxime and one (2.4%) placebo recipients were considered clinical failures, of whom one, two and one patients, respectively, had concomitant bacteriuria. Drug-related adverse events were reported in six of 204 (3%) ciprofloxacin, 12 of 197 (6%) cefotaxime and one of 101 (1%) placebo patients. The observed rates of post-operative bacteriuria suggest that a single 500 mg dose of ciprofloxacin is suitable prophylaxis for transurethral surgery.

Administration, Oral↗
PubMed1998

Single-dose oral ciprofloxacin versus placebo for prophylaxis during transrectal prostate biopsy.

OBJECTIVES: To determine whether antimicrobial prophylaxis could prevent infections after transrectal needle biopsy of the prostate using automated biopsy devices. METHODS: We conducted a prospective, randomized, double-blind, multicenter trial in which a total of 537 patients received either oral ciprofloxacin 500 mg or placebo before transrectal needle biopsy of the prostate. Repeated urine cultures and urinalysis were obtained at 2 to 6 days after biopsy and 9 to 15 days after biopsy. The primary determinant of efficacy was bacteriologic response (bacteriuria [more than 10(4) colony-forming units (CFU)/mL] versus no bacteriuria) at the 9- to 15-day follow-up evaluation. RESULTS: Two hundred twenty-seven (84%) of 269 ciprofloxacin patients and 230 (86%) of 268 placebo patients were valid for efficacy analysis in which a mean of four biopsies was performed. Six ciprofloxacin-treated (3%) and 19 placebo-treated (8%) patients had bacteriuria (more than 10(4) CFU/mL) after the procedure (P = 0.009). Six ciprofloxacin recipients (3%) and 12 placebo recipients (5%) had clinical signs and symptoms of a urinary tract infection (UTI) (P = 0.15). In addition, no ciprofloxacin-treated patients compared with 4 placebo-treated patients (2%) were admitted to the hospital for febrile UTI after the procedure. Ciprofloxacin reduced the expected net costs of treating infectious complications after biopsy by $23 per patient for an overall annual savings of $68,195 in the five study groups when compared with placebo. CONCLUSIONS: Single-dose oral ciprofloxacin reduced bacteriuria after biopsy compared with placebo in patients undergoing transrectal prostatic biopsy and provided an economic advantage. In addition, this study establishes the actual rate of bacteriuria after transrectal needle biopsy of the prostate without antibiotic prophylaxis to be 8% with a clinical rate of UTI of 5% and a hospitalization rate of 2%.

Administration, Oral↗
PubMed1998

Ciprofloxacin versus cefuroxime axetil in the treatment of adult patients with acute bacterial sinusitis.

OBJECTIVE: This study compared the use and efficacy of ciprofloxacin to cefuroxime axetil for adult patients with acute bacterial sinusitis. METHOD: We conducted a prospective, randomized, double-blind pilot study of oral ciprofloxacin (500 mg twice daily) versus cefuroxime axetil (250 mg twice daily) for 2 to 3 weeks in the treatment of adult patients with a clinical diagnosis of acute bacterial maxillary sinus infections or acute exacerbation of chronic bacterial sinusitis. Patients with microbiologically and radiologically confirmed sinusitis infection composed the efficacy population. RESULTS: Of the 83 patients enrolled, 13 of 42 (31%) ciprofloxacin- and 19 of 41 (46%) cefuroxime axetil-treated patients had a respiratory pathogen isolated from a sinus aspiration. The most frequent pretherapy isolated included Haemophilus influenzae (11), streptococcus species (20), staphylococcus species (7), Proteus mirabilis (3), and Neisseria sicca (3). At the end of therapy, clinical resolution or improvement in efficacy-valid patients was achieved in 12 (100%) ciprofloxacin-treated patients and in 14 (74%) cefuroxime axetil recipients. The five (26%) cefuroxime axetil clinical failures were due to development of superinfection. Bacteriologic eradication occurred in 12 (100%) and 14 (100%) ciprofloxacin and cefuroxime axetil patients, respectively. Similar clinical and bacteriologic response rates were observed at the 2- to 4-week follow-up. Among 83 intent-to-treat patients, 19 (45%) ciprofloxacin and 14 (34%) cefuroxime axetil patients had drug-related adverse events. The most common adverse event in both treatment groups was gastrointestinal. CONCLUSION: This pilot study suggests that ciprofloxacin is efficacious in the management of acute bacterial sinusitis.

Acute Disease↗
PubMed1997

Cerivastatin, a New Potent Synthetic HMG Co-A Reductase Inhibitor: Effect of 0.2 mg Daily in Subjects With Primary Hypercholesterolemia.

BACKGROUND: Reduction of serum cholesterol, most notably low-density lipoprotein cholesterol is associated with reductions in cardiovascular morbidity and mortality. Statins have been shown to effectively reduce low-density lipoprotein cholesterol via inhibition of the hydroxymethyl-coenzyme A (HMG-CoA) reductase. Cerivastatin is the most potent HMG-CoA reductase inhibitor currently under study in the United States. METHODS AND RESULTS: A parallel group, randomized, placebo-controlled, double-blind, multicenter study was conducted to compare the efficacy and safety of three different dosing regimens of 0.2 mg/day of cerivastatin, a new HMG-CoA reductase inhibitor, in patients with hypercholesterolemia. After a 10-week diet-placebo lead-in period, 319 patients with low-density lipoprotein cholesterol >160 mg/dL were randomized to 4 weeks of treatment with one of the following regimens: cervastatin 0.1 mg twice daily, cerivastatin 0.2 mg once daily with the evening meal, cerivastatin 0.2 mg once daily at bedtime or placebo. All three active treatment groups produced statistically significant (P <.05) changes compared to aseline and placebo in total cholesterol (0.1 mg twice daily \_18.9%; 0.2 mg once daily with the evening meal: \_21.9%; 0.2 mg once daily at bedtime: \_22.1%; placebo: 0.0%), low-density lipoprotein cholesterol (0.1 mg twice daily: \_25.7%; 0.2 mg once daily with the evening meal: \_29.4%; 0.2 mg once daily at bedtime: \_30.4%; placebo: 1.4%) and high-density lipoprotein cholesterol (0.1 mg twice daily: 5.3%; 0.2 mg once daily with the evening meal: baseline and placebo, were also reduced by all active treatments (0.1 mg twice daily: \_11.6% [P =.05]; 0.2 mg once daily with the evening meal: \_11.6% [P =.05]; and 0.2 mg at bedtime: \_10.9% [P =.07]). The percentage change in total cholesterol and low-density lipoprotein cholesterol after 4 weeks of therapy for the once-daily cerivastatin groups was statistically significantly greater (P <.05) than the cerivastatin twice daily regimen. A treatment responser was seen by 1 week of therapy and was maximal by 3 weeks. The drug was well tolerated in all three dosing regimens and resulted in no significant increase in biochemical or clinical side effects compared to placebo. CONCLUSION: Cerivastatin is a novel, highly potent, well-tolerated HMG-CoA reductase inhibitor that produces low-density lipoprotein cholesterol reductions of approximately 30% when administered at 0.2 mg once a day in the evenings.

Journal Article↗
PubMed1996

Sexually transmitted diseases in pregnancy: diagnosis, impact, and intervention.

Sexually transmitted diseases are a major health problem for the 1990s. The etiology of gonorrhea, chlamydia, syphilis, trichomonas, and bacterial vaginitis are presented, along with their treatment, pregnancy-related factors, intrapartum and neonatal factors, and follow-up. The incidence of sexually transmitted diseases has increased, and health care professionals must teach not only about disease impact but also about lifestyle and behavioral changes.

Animals↗
PubMed1993

The impact of new imaging technology on worldwide health care, research, and teaching: fifth international symposium, August 1992.

At the end of the final session, one of the co-chairs, Ronald L. Arenson (University of California, San Francisco) summarized the main points made at the conference. He mentioned that the talks had shown both the differences and similarities among the world's nations and that computers have become vital tools for radiologic practice and research. Dr. Arenson discussed four major themes that the symposium had brought into focus: the importance of cost-effectiveness analyses; the need to provide radiologic equipment to developing countries; the significance of worldwide training programs in radiology; and the search for continuing support for research. The government, industry, and academia all have great interest in cost-effectiveness. Radiologists in the future will be required even more than in the past to justify expenditures on equipment and to explain the benefits of sophisticated examinations. As leaders in radiology, the participants were encouraged to take the "offensive" in showing how new, admittedly expensive, technology can save lives and money in the long run--especially in terms of early diagnosis. Dr. Arenson suggested a conference was needed to address the single issue of cost-effectiveness of radiologic medicine and to start a "think tank" that could develop approaches to the problems of rationally calculating cost-effectiveness. Research is needed to provide an inexpensive field radiology unit for use in developing countries. The fields of industry and research have made tremendous progress in providing sophisticated equipment appropriate for hospitals in industrialized nations, but doctors in developing countries need mobile units, which are especially useful when one radiologist must serve tens of thousands of people. Dr. Arenson suggested exploring the use of computed radiography, so that no film or processing supplies are necessary, and providing through that unit a link over telephone lines to hospitals with radiologic expertise for special cases. Worldwide training of radiologists must move toward the goals of both standardizing educational requirements and providing education that is relevant for each country's situation (e.g., life expectancy, GNP per capita, leading causes of death). Also, training must be provided for technologists and other health care workers--particularly in regions in which there are too few radiologists. Such training could be done in conjunction with the field unit described in the preceding paragraph, so that examinations could be performed by technologists in the field and then the images could be interpreted via computer hook-up by radiology experts in large hospitals that may be far away from the patient.(ABSTRACT TRUNCATED AT 400 WORDS)

Radiology↗
PubMed1991

Does tobacco advertising target young people to start smoking? Evidence from California.

OBJECTIVE: To evaluate whether tobacco advertising encourages teenagers younger than 18 years to start smoking. DESIGN: Comparison of 1990 California telephone survey data with data from a 1986 national telephone survey (both used a random-digit dialing system); 95% confidence intervals were calculated. To test our hypothesis, we considered whether the perception of advertising was related to age, whether the pattern of market share across age and sex groups followed the pattern of perceived advertising, and whether changes in market share paralleled changes in advertising as perceived by the youngest age group. PARTICIPANTS: There were 24,296 adults and 5040 teenagers. RESULTS: The most advertised brands of cigarettes were Marlboro, according to 33.6% of adults and 41.8% of teenagers, and Camel, according to 13.7% of adults and 28.5% of teenagers--named most often by 12- to 13-year-olds (34.2%). The brands that were purchased most often were Marlboro and Camel. Together these were the brands of choice of 79.9% of males and 85% of females aged 12 through 17 years. Marlboro's market share increased in youths and young adults up to age 24 years and then decreased gradually with age; Camel's market share decreased abruptly with age: it was the brand of choice of 24.5% +/- 5.8% of males aged 12 through 17 years but was chosen by only 12.7% +/- 3.6% of males aged 18 through 24 years; for females, 21.7% +/- 13.7% aged 12 through 17 years chose Camels, while only 5.5% +/- 3.2% aged 18 through 24 years preferred this brand. Both Marlboro and Camel brands had a higher market share in California in 1990 compared with that for the United States in 1986. Of interest is that the market share for Camel increased among the younger smokers but was more evenly distributed for Marlboro. CONCLUSIONS: Perception of advertising is higher among young smokers; market-share patterns across age and sex groups follow the perceived advertising patterns; and changes in market share resulting from advertising occur mainly in younger smokers. Cigarette advertising encourages youth to smoke and should be banned.

Adolescent↗