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PubMed1997

Comparison of utilization of Sinemet and Parkinson's disease mortality as surrogate indicators of Parkinson's disease in the United States.

OBJECTIVE: To compare two surrogate indicators of population disease burden for Parkinson's disease: utilization of Sinemet and Parkinson's disease mortality. DESIGN: National Center for Health Statistics data were used to tabulate Parkinson's disease mortality in the United States by state for 1987-1989. Sinemet sales data by state were obtained from Merck & Co., Inc. for 1988. Least squares regression analyses were used to assess the relationship between Sinemet utilization and Parkinson's disease mortality. SETTING: United States. RESULTS: Regression analyses showed extraordinarily strong associations between state-level Parkinson's disease mortality and Sinemet utilization (underlying-cause model r2 = 0.969, p = 0.0001; multiple-cause model r2 = 0.980, p = 0.0001). CONCLUSIONS: Sinemet utilization very closely parallels Parkinson's disease mortality, suggesting that Sinemet utilization and Parkinson's disease mortality are both useful indices of the population burden of Parkinson's disease for large-scale epidemiological studies.

Antiparkinson Agents↗
PubMed2001

Varicella vaccine exposure during pregnancy: data from the first 5 years of the pregnancy registry.

OBJECTIVE: To assess the risks of congenital varicella syndrome and other birth defects in offspring of women who inadvertently received varicella vaccine during pregnancy or within 3 months of conception. METHODS: Pregnant women inadvertently exposed to varicella vaccine, reported voluntarily, were enrolled in the Pregnancy Registry for VARIVAX (Merck & Co., Inc., West Point, PA). The pregnancies were monitored and the outcomes ascertained from questionnaires completed voluntarily by the health care providers. The rates of congenital varicella syndrome and congenital anomalies were calculated for seronegative women prospectively reported to the registry. RESULTS: From March 17, 1995 through March 16, 2000, 362 pregnancy outcomes were identified from prospective reports. Ninety-two women were known to be seronegative to varicella, of whom 58 received their first dose of vaccine during the first or second trimester. No cases of congenital varicella syndrome were identified among 56 live births (rate 0%, 95% confidence interval [CI] 0, 15.6). Among all the prospective reports of live births, five congenital anomalies were reported. No specific pattern was identified in either the susceptible cohort or the sample population as a whole. CONCLUSION: No abnormal features have been reported that suggested the occurrence of congenital varicella syndrome or other birth defects related to vaccine exposure during pregnancy. Because of the small numbers, this study has limited precision, so continued surveillance is warranted. However, these results should provide some assurance to health care providers and women with inadvertent exposure before or during pregnancy.

Adolescent↗
PubMed2006

Control of onchocerciasis.

Onchocerciasis is a filarial infection which causes blindness and debilitating skin lesions. The disease occurs in 37 countries, of which 30 are found in Africa (the most affected in terms of the distribution and the severity of the clinical manifestations of the disease), six in the Americas and one in the Arabian Peninsula. The latest WHO Expert Committee on Onchocerciasis estimated that in 1995 around 17.7 million persons were infected, about 270,000 of whom were blind and another 500,000 severely visually impaired. The disease is responsible for 1 million DALYs. Eye disease from onchocerciasis accounts for 40% of DALYs annually although severe skin disease is also recognized as of public health significance. Great progress has been made in the last thirty years in the control of onchocerciasis, both in Africa and the Americas, and this progress has been due largely to international public-private partnerships, sustained funding regional programmes, and new tools and technology. Landmarks in the global control of river blindness include the significant success of the Onchocerciasis Control Programme of West Africa (1975-2002), and the donation of ivermectin (Mectizan) by Merck & Co. Inc., in 1988, a medicine that is distributed to millions free of charge each year. Future major technical challenges of onchocerciasis control include ivermectin mass administration in areas co-endemic for the parasite Loa loa in the light of possible severe adverse reactions, ivermectin treatment in hypoendemic areas hitherto excluded from African control programmes, sustainability of ivermectin distribution, post-control surveillance for recrudescence detection, surveillance for emergence of resistance, and decisions of when to stop mass ivermectin treatments. There is the need to develop the appropriate information systems and diagnostic tools to help in accomplishing many of these tasks. A search for a second-line treatment or as an additional drug to ivermectin as well as a search for a macrofilaricide are issues that need to be addressed in the future.

Africa↗
PubMed2001

Mecamylamine: new therapeutic uses and toxicity/risk profile.

BACKGROUND: Mecamylamine hydrochloride was initially developed for its ganglion-blocking activity and has been marketed as an antihypertensive agent in the United States for >40 years. Several other potential therapeutic applications are being investigated, most of them focusing on the drug's ability to cross the blood-brain barrier and selectively antagonize neuronal nicotinic acetylcholine receptors. This central activity of mecamylamine is demonstrable at much lower doses than the effective antihypertensive dose, thus avoiding many of the bothersome side effects associated with the drug's inhibition of parasympathetic activity. OBJECTIVE: Because investigations are being conducted in new patient populations, including pediatric patients, an update of the toxicity/risk profile of mecamylamine is timely. This review describes nonclinical and clinical data pertaining to the pharmacology, toxicity, and tolerability of mecamylamine, including some previously unpublished toxicology and clinical pharmacokinetics data. Potential new therapeutic applications are discussed, including the use of mecamylamine in treating autonomic dysreflexia; dependencies on nicotine, cocaine, and other substances of abuse; Tourette's syndrome; and other neuropsychiatric disorders. METHODS: Information for this review of mecamylamine was identified through a search of MEDLINE from 1966 to the present, as well as from the master files of Merck & Co, Inc, the drug's original manufacturer, and Layton BioScience, Inc, its present manufacturer. CONCLUSIONS: The available data concerning potential new applications of mecamylamine, although sparse, suggest that the drug's toxicity/risk profile may be much improved at lower doses.

Animals↗
PubMed2001

A randomized study of a flexible booster dosing regimen of VAQTA in adults: safety, tolerability, and immunogenicity.

BACKGROUND: VAQTA (hepatitis A vaccine inactivated, Merck & Co., Inc., West Point, PA) is licensed for use in healthy adults in a two-dose schedule at 0 and 6 months. OBJECTIVE: to determine whether the responses to a booster dose of VAQTA administered to adults 12 or 18 months after the first dose were similar to the response when the booster dose was administered 6 months after the first dose. METHODS: healthy adults were randomized to receive 50-U of VAQTA at 6 (Group I), 12 (Group II), or 18 months (Group III) following receipt of Dose 1 on Day 0. Blood samples were collected immediately prior to Doses 1 and 2 and then, 4 weeks following Dose 2. Seropositivity rates (SPRs), geometric mean titers (GMTs) in milli-international units per milliliter (mIU/ml) and booster response rates (BRRs) were compared among treatment groups. Safety data were collected on Vaccination Report Cards. RESULTS: no serious adverse experiences were reported, and the vaccine was well-tolerated by subjects in the three treatment groups. One month following the booster dose, SPRs and GMTs for Groups I, II, and III, respectively, were, 100% (102/102) and 6726.4 mIU/ml; 97.9% (93/95) and 4863.8 mIU/ml; 100% (86/86) and 6068.3 mIU/ml. The BRRs were 88.2% (Group I), 90.2% (Group II) and 94.2% (Group III). CONCLUSION: responses to the booster dose were comparable regardless of the timing (i.e. 6, 12, or 18 months following Dose 1). Flexibility in the timing of the booster dose of VAQTA in adults would allow the vaccination schedule to be the same for adults, adolescents, and children and may increase the likelihood that adults receive the booster dose.

Adult↗
PubMed2002

Comparative in vitro activities of ertapenem against aerobic and facultative bacterial pathogens from patients with complicated skin and skin structure infections.

This study compared the in vitro activities of ertapenem (Merck & Co., Inc.), ceftriaxone, amoxicillin-clavulanate, and piperacillin-tazobactam against 518 aerobic and facultative bacterial pathogens isolated from 340 patients with complicated skin and skin structure infections. Ciprofloxacin was also tested against Gram-negative isolates. Gram-positive cocci accounted for 68.1% of the aerobic bacteria; Staphylococcus aureus was the most common isolate (45.6%). The ertapenem MIC was < or = 2 microg/ml for 80.9% of isolates and > or = 8 microg/ml for 16.2% (including isolates of enterococci, methicillin-resistant S. aureus, Pseudomonas aeruginosa, and other nonfermentative Gram-negative bacteria). Against methicillin-susceptible S. aureus, ertapenem had the most potent activity. Ertapenem was the most active drug against Enterobacteriaceae (100% susceptible), whereas amoxicillin-clavulanate was least active (66% susceptible). Piperacillin-tazobactam was the most active drug against P. aeruginosa (100% susceptible), followed by ciprofloxacin (87% susceptible). In summary, ertapenem was highly active in vitro against many aerobic and facultative bacterial pathogens commonly recovered from patients with complicated skin and skin structure infections.

Aerobiosis↗
PubMed1998

Correlation of fermentation yield with yeast extract composition as characterized by near-infrared spectroscopy

Complex, ill-defined mixtures of natural origin are often used as nutrients in the production of biological products through microbial fermentation. Product yields are affected by variation in these natural products. It was desired to examine near-infrared spectroscopy as a rapid screening tool for qualifying raw material lots. Specifically, the characterization of yeast extract was investigated. The model system consisted of a Merck & Co., Inc., microbial fermentation process. Cell mass and specific product yields are dependent upon variations in the yeast extract used in the medium. Partial least-squares regression on the second-derivative spectral absorbances of various yeast extracts in the ranges 1150-1380, 1554-1826, and 2100-2300 nm resulted in the development of models with multiple correlation coefficients of 0.99 for cell mass yields and 0.96 for specific product yields in large-scale fermentations. These models could also be used to predict cell mass yields in 15 L batch fermentations and specific product yields in 2-L shake flasks.

Journal Article↗
PubMed2025

Biosynthesis of the 5-Isoxazolidinone-Containing Hexacyclic Structure of Parnafungin.

Parnafungins A-D (1-4) are fungal natural products that inhibit eukaryotic poly(A)-polymerase and were first discovered by Merck & Co., Inc., through a Candida albicans Fitness Test (CaFT) screening program. The biological activity of parnafungins is a result of the unique fused hexacyclic structure highlighted by a 5-isoxazolidinone (5ILD) N-heterocycle. In this work, we characterize the complete biosynthetic pathway of parnafungins through heterologous reconstitution and enzymatic assays. Nearly half of the 26-gene biosynthetic gene cluster of parnafungin is responsible for the production of a known polyketide natural product, blennolide C. Starting from the blennolide C fragment, a three-enzyme cascade involving CoA-ligase ParJ, P450 ParO, and DUF829 ParD catalyzes the formal biaryl cross-coupling between blennolide C and anthranilate. Subsequent oxidative cyclization generates a phenanthridine product that is then reduced by atypical short-chain reductase ParT. N-Hydroxylation by flavin-dependent monooxygenase ParB and subsequent lactonization catalyzed by a homologue of dienenolactone hydrolase ParF form the 5ILD ring and complete the biosynthesis of 1 and 2. Methylation of 1 forms parnafungin C (3), and lastly epoxidation forms parnafungin D (4). Together, our work revealed the chemical logic and enzymology in extending the biosynthetic pathway of a well-characterized natural product, blennolide C, to introduce considerable additional structural diversity that affords parnafungins with unique biological activity.

Molecular Structure↗
PubMed2006

Minimal-change nephrotic syndrome in a hematopoietic stem-cell transplant recipient.

BACKGROUND: A 61-year-old woman received standard immunizations, including Haemophilus influenzae type B, diphtheria, tetanus toxoid, and unconjugated 23-valent pneumococcal vaccine (Pneumovax), Merck & Co., Inc., Whitehouse Station, NJ), 1 year after undergoing nonmyeloablative hematopoietic stem-cell transplantation for acute myelogenous leukemia. After 5 days, she developed fatigue with progressive weight gain and edema, and 14 days after immunization she presented with anasarca and was found to have acute renal failure and nephrotic proteinuria. INVESTIGATIONS: Physical examination, serum chemistry, examination of urine sediment, renal ultrasound using Doppler scanning, 24 h urine collection, and renal biopsy. DIAGNOSIS: Minimal-change nephrotic syndrome with acute tubular injury. MANAGEMENT: Aggressive diuresis and oral corticosteroid therapy.

Female↗
PubMed2002

Response to recombinant hepatitis B vaccine in children and adolescents with chronic renal failure.

BACKGROUND: Diminished antibody responses to the dosage of hepatitis B (HB) vaccine indicated for healthy adults has led to a greater dosage recommendation (40 microg of HB surface antigen [HBsAg]) for adults with chronic renal failure (CRF), but an appropriate dosage for children with CRF has not been established. METHODS: Seventy-eight children and adolescents with CRF (22 patients, predialysis; 42 patients, chronic dialysis therapy; 14 renal transplant recipients) aged 1 to 19 years (mean, 10.1 years) were enrolled onto a study to test a three 20-microg dose course of the HB vaccine Recombivax HB (Merck & Co, Inc, West Point, PA). RESULTS: The vaccine was well tolerated; no patient had a serious adverse event attributable to vaccine, and no patient withdrew from the study because of an adverse event. Overall, 91% of 66 patients administered three doses had a protective titer of 10 mIU/mL or greater for antibody against HBsAg (anti-HBs) and a geometric mean titer (GMT) of 733 mIU/mL, with seroprotection rates and GMTs among predialysis, dialysis, and renal transplant patients of 100% (4,140 mIU/mL), 94% (419 mIU/mL), and 64% (152 mIU/mL), respectively. All (100%) predialysis patients had a 10-mIU/mL or greater anti-HBs titer after only two doses of vaccine compared with 64% of dialysis patients and 50% of transplant recipients. Eighty-eight percent of 57 fully vaccinated patients tested 12 months after the first dose retained a 10-mIU/mL or greater anti-HBs titer. CONCLUSION: A regimen of three 20-microg doses of Recombivax HB is suitably immunogenic for children with CRF not administered immunosuppressive medication. When possible, at least two, and preferably all three, doses of vaccine should be administered before progression to end-stage renal disease.

Adolescent↗
PubMed2003

Undertreatment of hyperlipidemia in patients with coronary artery disease and heart failure.

BACKGROUND: Coronary artery disease patients with heart failure (CAD+HF) are at high risk for cardiovascular events. We examined the frequency of lipid assessment and prescription of lipid-lowering agents in outpatients with combined CAD+HF compared with patients with CAD alone. METHODS: We analyzed an administrative data set from the Quality Assurance Program II, a Merck & Co., Inc., sponsored national retrospective chart audit of 41,487 CAD patients seen at 296 ambulatory medical practices. About 34% of these patients had CAD+HF. RESULTS: Documentation of low-density lipoprotein (LDL) cholesterol was significantly lower in patients with CAD+HF (53%) compared with those with CAD alone (69%). Lipid-lowering drugs were prescribed in only 36% of patients with CAD+HF, compared with 52% of patients with CAD alone. Lipid levels alone did not justify this disparity. Patients with documented LDL cholesterol values were 4 times more likely to receive a prescription for a lipid-lowering medication than those without recorded values. Other predictors of lipid-lowering prescription included: younger age, history of myocardial infarction, revascularization, care by a cardiologist, and geographic region. CONCLUSIONS: Patients with CAD, HF, and advanced age simultaneously experience among the highest risk and the lowest lipid-lowering treatment rates. Strategies to increase LDL testing and aggressively treat patients with heart failure and CAD are warranted.

Adult↗
PubMed2003

The HEDIS performance NAVIGATOR for controlling high blood pressure: a resource to assist health plans improve patient adherence.

This article describes how the resources in the Health Plan Employer and Data Information Set (HEDIS; a registered trademark of the National Committee for Quality Assurance) Performance NAVIGATOR for Controlling High Blood Pressure (HEDIS NAVIGATOR) developed by Merck & Co., Inc. assist managed care organizations in understanding and encouraging the active involvement of their members in adhering to a treatment plan developed in partnership by physicians and patients. (HEDIS is a set of standardized performance measures that enable purchasers and consumers to make informed decisions regarding the quality of managed care organizations.) The discussion uses the Health Belief and Transtheoretical Models as a framework to better understand patient behavior change. Targeted strategies to facilitate adherence are also addressed. Examples of structured programs using nationally recommended guidelines and HEDIS NAVIGATOR resources are included to illustrate coordinated efforts to assist patients with high blood pressure adhere to their treatment plan and help managed care organizations improve patient outcomes and HEDIS scores.

Data Collection↗
PubMed2002

Evaluation of preoperative administration of the cyclooxygenase-2 inhibitor rofecoxib for the treatment of postoperative pain after lumbar disc surgery.

OBJECTIVE: A combination of analgesics with different mechanisms of action may improve postoperative pain control and reduce the incidence of side effects. This study was designed to assess the efficacy of preoperative administration of rofecoxib (Vioxx; Merck & Co., Inc., Somerset, NJ) in reducing pain and opioid requirements after single-level lumbar microdiscectomy. METHODS: A randomized, double-blind, placebo-controlled clinical trial was performed on 61 consenting patients who were considered American Society of Anesthesiologists Class I or II and who were scheduled for elective single-level lumbar microdiscectomy. Patients received either two doses of rofecoxib 50 mg or a placebo preoperatively. The outcome measures included morphine use in the postanesthesia care unit (PACU), discharge times, and side effect profile. Data were analyzed by use of independent sample t tests for continuous variables or chi(2) tests for categorical variables. A P value of <0.05 was considered significant. RESULTS: The two groups were comparable with respect to patient characteristics, intraoperative opioid and hypnotic consumption, and duration of surgery. Patients in the rofecoxib group required significantly less morphine postoperatively. Significantly more patients in the placebo group reported pain scores greater than 7 at admission to the PACU. Time to first request for analgesia was shorter in the placebo group, but the difference did not reach statistical significance. There were no significant differences between groups in the incidence of nausea, time to discharge from the PACU, or hospital stay. CONCLUSION: Preoperative rofecoxib is effective in reducing postoperative narcotic consumption in patients undergoing lumbar laminectomy. The use of rofecoxib does not shorten PACU length of stay or hospital discharge time. These outcome measures depend on multiple administrative factors.

Adult↗
PubMed2001

Managing migraine: strategies for successful patient outcomes.

This article highlights information from the 2000 National Conference for Nurse Practitioners symposium held in Washington, D.C., on November 9, 2000. It was sponsored by The Nursing Institute of Springhouse Corporation and funded by an unrestricted educational grant from Merck & Co., Inc. The firsttopic, "Overview of Migraine: Compelling Effects on Patients and Society," was presented for Dedie Downey Russell, CNP, ANP/GNP, MS. The second topic, "Understanding Pathophysiology: Evolving from Traditional to Current Therapeutic Options," was presented by Dara G. Jamieson, MD. Maureen Moriarty-Sheehan, MS, CRNP, who also served as chairperson, presented the third topic, "Developing a Management Plan for Optimal Patient Benefit."

Acute Disease↗
PubMedDate not supplied

Streptococcus pneumoniae sepsis and meningitis during the penicillin prophylaxis era in children with sickle cell disease.

The purpose of this study was to determine the age-related risks, disease-specific risks, and characteristics of serious pneumococcal infections in children with sickle cell disease (SCD) while penicillin prophylaxis was standard. The clinical experiences of three pediatric sickle cell programs spanning January 1, 1992, to May 31, 1998, were combined. Data were collected regarding the patients followed up and the characteristics of bacteremia and meningitis cases. Forty-seven pneumococcal infections (44 bacteremia, 3 meningitis) among 40 patients with SCD were observed. Forty infections occurred in children with homozygous hemoglobin S (SS) during 4108 patient-years at a median age of 22 months; 7 occurred in double heterozygous hemoglobin SC (SC) children during 1777 patient-years at a median age of 23 months. Ten infections occurred among 9 SS children 5 years or older. Most children in whom infections developed were reportedly taking prophylactic penicillin and when older than 24 months old had received Pneumovax (Merck & Co., Inc., West Point, PA, U.S.A. The following pneumococcal serotypes were identified in 15 cases studied: 6A, 6B, 9V, 14, 15B, 18B, 18F, 19F, and 23F. Infections resulted in five deaths and two strokes. The observed severe pneumococcal infection rate in SS children younger than 5 years was less than that reported before penicillin prophylaxis, supporting routine penicillin prophylaxis in this specific population. The optimal duration of penicillin prophylaxis in older children with SCD remains unknown. The administration of 7-valent Prevnar (Wyeth Lederle Vaccines, Philadelphia, PA, U.S.A.) to children younger than 24 months old with SCD should be beneficial, based on the serotype data.

Adolescent↗
PubMed2004

Ten year follow-up of healthy children who received one or two injections of varicella vaccine.

BACKGROUND: The rate of varicella and persistence of varicella antibody after a one dose vs. a two dose regimen of varicella virus vaccine live Oka/Merck (VARIVAX; Merck & Co., Inc., West Point, PA) in approximately 2000 children were compared during a 9- to 10-year follow-up period. METHODS: Children 12 months to 12 years of age with a negative history of varicella were randomized in late 1991 to early 1993 to receive either one or two injections of varicella vaccine given 3 months apart. Subjects were actively followed for varicella, any varicella-like illness or zoster and any exposures to varicella or zoster on a yearly basis for 10 years after vaccination. Persistence of varicella antibody was measured yearly for 9 years. RESULTS: Most cases of varicella reported in recipients of one or two injections of vaccine were mild. The risk of developing varicella >42 days postvaccination during the 10-year observation period was 3.3-fold lower (P < 0.001) in children who received two injections than in those who received one injection (2.2% vs. 7.3%, respectively). The estimated vaccine efficacy for the 10-year observation period was 94.4% for one injection and 98.3% for two injections (P < 0.001). Measurable serum antibody persisted for 9 years in all subjects. CONCLUSIONS: Administration of either one or two injections of varicella vaccine to healthy children results in long term protection against most varicella disease. The two dose regimen was significantly more effective than a single injection.

Age Distribution↗
PubMed2005

Exposure to rizatriptan during pregnancy: post-marketing experience up to 30 June 2004.

Merck & Co., Inc. evaluates outcomes of the use of rizatriptan during pregnancy through a Pregnancy Registry in the United States (US) and spontaneous reports for pregnancies reported from sources outside the US. Review of the outcomes of 25 prospective pregnancy reports in the Pregnancy Registry and reports from other sources does not suggest that treatment with rizatriptan predisposes patients to spontaneous abortions or congenital anomalies. However, the number of reports is small. Healthcare providers in the United States are encouraged to report any prenatal exposure to rizatriptan by calling the Pregnancy Registry at +1 (800) 986 8999 or visiting the Registry's website at http://www.merckpregnancyregistries.com.

Abnormalities, Drug-Induced↗