Capsaicin for treatment of post-traumatic amputation stump pain.
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Adult↗
Biomedical subjects
M Weintraub
Publications and source records attributed to M Weintraub.
P&T Committee review of nifedipine GITS: new modality for angina and hypertension.
The nifedipine gastrointestinal therapeutic system (GITS) was recently approved for use in the treatment of angina and hypertension. According to the experts in this roundtable discussion, the GITS formulation provides continuous delivery of nifedipine, ensuring relatively constant drug levels and 24-hour efficacy with a once-daily dosage regimen. Nifedipine GITS also has a favorable side-effects and drug-interaction profile. This formulation will be useful for both inpatients and outpatients and may benefit patients in whom therapeutic levels previously could not be reached due to side effects.
Angina Pectoris↗
Compliance in the elderly.
Noncompliance is not a unique phenomenon associated with aging. Many of the same problems concerning taking medications most appropriately apply to 40 year olds as well as to 80 year olds. What is unique about the elderly is their greater sensitivity to medications, their greater propensity for the development of adverse effects, and the greater complexity of their regimens as they develop chronic illnesses through the course of their lives. In addition, decreasing acuity of special senses, problems with memory, and the interposition of other caregivers are all unique phenomena that have to be dealt with through expansion of the standard methods but only rarely through specific methods. Utilization of modern technology such as video cassette recorders, large print reproductions, and improved communication modalities for people with hearing and sight disabilities may overcome some of the problems leading to decreased comprehension and communication ability in elderly patients. Similarly, for those with financial barriers to appropriate utilization of medications, programs such as the Elderly Pharmaceutical Insurance Coverage (EPIC) in New York State may be helpful. Medicaid and AARP programs for obtaining medications at lower prices can help financially strapped patients. The necessity for physicians to learn about cultural attitudes toward family and governmentally supplied caregivers may also facilitate optimal medication utilization in our polycultural society. Medications can serve the elderly to great benefit. Misapplication and misuse of medications may result in undesirable outcomes, ranging from lack of maximum efficacy, annoying nuisance side effects, diminishing quality-of-life, and even life-threatening adverse outcomes.(ABSTRACT TRUNCATED AT 250 WORDS)
Aged↗
Branched chain amino acids as the protein component of parenteral nutrition in cancer cachexia.
A prospective randomized trial was conducted to determine the effects of branched chain amino acids (BCAA) as the protein component of total parenteral nutrition (TPN) on protein kinetics in patients with intraabdominal adenocarcinoma. Nine malnourished patients were given both conventional TPN containing 19 per cent BCAA (AA) and isocaloric, isonitrogenous TPN containing 50 per cent BCAA (BCAA-TPN), in random order. Both [13C]leucine and [14C]tyrosine were employed as tracers to avoid the potential bias due to the different amino acid composition of the two TPN solutions. With BCAA-TPN, leucine and tyrosine flux increased significantly from (mean +/- s.d.) 158.0 +/- 37.2 to 243.5 +/- 75.8 mumol kg-1 h-1 (P less than 0.025) and from 35.0 +/- 8.4 to 42.6 +/- 11.0 mumol kg-1 h-1 (P less than 0.05) respectively. Leucine oxidation was significantly higher on BCAA-TPN (24.1 +/- 6.3 on AA versus 68.3 +/- 37.1 mumol kg-1 h-1, P less than 0.025) while tyrosine oxidation was significantly lower (3.7 +/- 1.8 mumol kg-1 h-1 on AA versus 2.5 +/- 2.0 mumol kg-1 h-1 on BCAA-TPN, P less than 0.05). Whole body protein synthesis and breakdown was significantly higher on BCAA-TPN by the tyrosine tracer (31.3 +/- 7.3 on AA versus 40.1 +/- 9.3 mumol kg-1 h-1, P less than 0.025 and 33.0 +/- 8.4 on AA versus 41.3 +/- 11.1 mumol kg-1 h-1, P less than 0.05) respectively. Using the leucine tracers both synthesis and breakdown were increased, but not significantly, from 133.8 +/- 40.0 to 175.3 +/- 65.1 mumol kg-1 h-1 and from 127.9 +/- 33.6 to 167.7 +/- 71.2 mumol kg-1 h-1 respectively. The fractional albumin synthetic rate increased significantly on BCAA-TPN from 4.3 +/- 2.9 on AA to 8.0 +/- 5.1 per cent per day (P less than 0.05). The reduction in tyrosine oxidation, suggesting improved protein utilization, coupled with an increase in protein and albumin synthesis, strongly support a positive benefit from BCAA-TPN in cancer cachexia.
Abdominal Neoplasms↗
Drug treatment of obesity.
Use of drugs for the treatment of obesity is regarded more skeptically than drug use in other chronic disease; this view, however, may be inappropriate. Anorexiant drugs, the major class of drugs currently available for treating obesity, differ in several important ways, including whether they act on noradrenergic or serotonergic systems and in their potential for abuse. New approaches to drug treatment of obesity include thermogenic agents and drugs acting on the digestive system and hormones.
Humans↗
P & T committee review of misoprostol: prevention of NSAID side effects is key--roundtable discussion.
Misoprostol, a prostaglandin of the E series, was recently introduced for the prevention of NSAID-induced gastric ulcers. Misoprostol was classified as "1A" (denoting a new chemical entity that is a significant therapeutic advance) for purposes of review priority by the Food and Drug Administration in 1988. A dosage of 200 micrograms qid is recommended for prophylaxis, for the duration of NSAID therapy. Misoprostol is generally well-tolerated, with some patients reporting diarrhea. Misoprostol should not be given to pregnant women because of its uterotonic effects. (Please see full prescribing information for a discussion of the safety profile of misoprostol.) Because of the magnitude of the problem of NSAID-induced gastric ulceration and the expense of treatments and hospitalizations, the use of misoprostol in preventing these ulcers should be clinically beneficial, and may contribute to significant cost savings in the hospital and other managed-care settings.
Alprostadil↗
Gentamicin blood levels: ordered too soon and too often.
Records of 100 consecutive patients in whom gentamicin blood levels (GBLs) had been measured were reviewed to assess the relation between GBL, disease course, and outcome. Thirty-two patients discontinued treatment, 16 within 72 hours because of negative cultures or improved clinical course, and 16 within 96 hours because susceptibility tests indicated that another antibiotic would be more appropriate. Of the remaining 68 patients who continued treatment, 21 recovered from their infection despite low peak or low peak and trough gentamicin levels, at least partially attributable to treatment with multiple antibiotics. Renal function deteriorated in only 1 of 10 patients with normal renal function and a high GBL. Our findings of early discontinuation of gentamicin, low concentrations with good outcome, and rare nephrotoxicity indicate wasteful overuse of GBLs. To decrease patient care costs without adversely affecting outcome, gentamicin measurements should be delayed for 72 to 96 hours--until culture results become available--except in patients with decreased renal function, documented gram-negative sepsis, leukopenia, or severe burns.
Adult↗
Red blood cell sorbitol lowering effects and tolerance of single doses of AL 1576 (HOE 843) in diabetic patients.
The safety and biochemical effects of AL 1576 (HOE 483), a recently developed aldose reductase inhibitor, were evaluated. In a double-blind, placebo-controlled, clinical trial, AL 1576 (HOE 483) was administered to diabetic patients for the first time. Four single, orally administered dose levels were tested, (2, 5, 10, and 20 mg). No clinically important adverse effects were seen in any of the patients. AL 1576 (HOE 483) suppressed red blood cell (RBC) sorbitol concentrations in a dose-related fashion. Also found were statistically significant inverse correlations between the plasma drug concentration and both RBC sorbitol concentrations as well as RBC sorbitol/serum glucose ratios. In single doses up to 20 mg, AL 1576 (HOE 483) is well tolerated and decreases RBC sorbitol, a biochemical marker of pharmacologic activity, in diabetic patients.
Adolescent↗
Parenteral nutrition in the surgical patient.
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Humans↗
Blinding, unblinding, and the placebo effect: an analysis of patients' guesses of treatment assignment in a double-blind clinical trial.
We administered a questionnaire to assess maintenance of patients' blindness at the end of a double-blind clinical trial of Osmotic Release Oral System phenylpropanolamine (PPA) vs. placebo in mild obesity. Seventy-four percent of placebo participants and 43% of PPA participants guessed their treatment correctly. Appetite control was the most frequently reported basis for guessing PPA, even by placebo participants. Lack of adverse drug reactions was the most frequently reported basis for guessing placebo, even by PPA participants. Participants receiving either PPA or placebo and guessing PPA lost more weight, had less diet difficulty, and had more adverse drug reactions than had participants receiving either PPA or placebo and guessing placebo. Although blindness was probably maintained in the PPA group, the placebo group seems to have been, at least at the study's end, unblinded. These results suggest that in double-blind studies, differences in outcome or incidence of adverse drug reactions may act as unblinding factors.
Body Weight↗
Editors' roundtable: current formulas for P & T Committee success. (Part 2).
In the second and final part of their recent roundtable discussion, the editors of Hospital Formulary express their views on numerous issues, including monitoring the use of approved drugs for unapproved indications, achieving and sustaining alterations in prescribing practices, and the establishment of guidelines for therapeutic substitution. All four editors--Arthur G. Lipman, PharmD, Harold C. Neu, MD, Bramah N. Singh, MD, PhD, and Michael Weintraub, MD--share the sentiment that most P & T Committees function as vital, effective bodies with responsibility for decision-making that has a significant impact on the day-to-day care of patients.
Drug Utilization↗
Physician dispensing: P & T Committee implications.
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Drug Prescriptions↗
Editors' roundtable: Current formulas for P & T Committee success (Part 1).
In this roundtable discussion, the four editors of Hospital Formulary--Arthur G. Lipman, Pharm D, Harold C. Neu, MD, Bramah N. Singh, MD, PhD, and Michael Weintraub, MD--share their views on key issues that affect hospital P & T Committees. They agree that the P & T Committee is both highly visible and functions well, and they predict that its influence in the health care system wil heighten as prospective reimbursement continues. Challenges P & T Committees are confronted with today, such as therapeutic entities from new technologies, use of approved drugs for unapproved indications, and the need for educating and re-educating the medical staff are discussed. Cost containment continues to become a more and more important consideration with maintained patient care quality. Successful strategies for coping with and benefiting from these challenges are presented.
Conflict, Psychological↗
Phenylpropanolamine OROS (Acutrim) vs. placebo in combination with caloric restriction and physician-managed behavior modification.
We added phenylpropanolamine OROS (Acutrim; Ciba-Geigy Corp.) or placebo to a physician-managed behavior modification, mild caloric restriction, and exercise weight control program. One hundred six healthy, overweight (115% to 130% ideal body weight) women participated in this 14-week double-blind clinical trial. On average, the participants who took Acutrim lost significantly more weight (X +/- SE; 6.1 +/- 0.6 kg; 8.0% +/- 0.8%) than did those taking placebo (4.3 +/- 0.7 kg; 5.5% +/- 0.8%; P less than 0.05). Those taking Actrim continued to lose weight over the Christmas holiday, while the placebo group gained weight. Fifteen participants taking placebo withdrew, three because of adverse drug reactions (ADRs). Thirteen of 53 participants in the Acutrim group left the study, two because of ADRs. Dry mouth was the most frequent complaint from participants taking Acutrim. No serious cardiovascular effects occurred. Both complaints and the number of participants reporting ADRs decreased with continued dosing. We conclude that Acutrim is a safe, modestly effective adjunct to a physician-managed, integrated weight control program.
Adolescent↗
Taste preference for cough syrups: a comparative study of three codeine-containing medications.
Unpleasant taste is a common feature of cough syrups, particularly those containing codeine. An antitussive compound of codeine sulfate and chlorpheniramine maleate was formulated in a coated drug-resin complex, which prevents release of the active ingredients until they reach the stomach and small intestine. Thus patients do not taste the bitterness of the codeine. A three-way crossover taste test was conducted in 175 volunteers who tasted each of three cough syrups in random sequence, rated the taste of each, and ranked their preferences. The cough syrups used in the study were the aforementioned formulation (CM), promethazine hydrochloride with codeine (PH), and iodinated glycerol with codeine phosphate (IG). Tastes were rated on a scale from +2 (very good) to -2 (very poor). Mean rating scores for each product were 0.97 for CM, 0.14 for PH, and -1.5 for IG. Pairwise comparisons showed statistically significant differences between CM and PH (P less than 0.01) and CM and IG (P less than 0.001) but no significant difference between PH and IG. CM was ranked as most liked by 115 respondents and as least liked by 27 respondents. Reasons cited for this preference were its sweet rather than medicinal taste and its smooth, thick consistency. Bitterness was a common reason for the lack of preference for PH and IG. CM thus was shown to have greater user acceptability than either of the other two cough syrups tested.
Antitussive Agents↗
Acute myocardial infarction in a young woman taking oral contraceptives. A case report.
Acute myocardial infarction occurred in a 25-year-old woman. Coronary angiography performed one month after the acute illness was normal. An ergonovine test was negative. The patient's acute myocardial infarction most probably was induced by the use of oral contraceptives in combination with heavy smoking. Oral contraceptives, with their known influence on the blood coagulation system, must be considered a risk factor in precipitating coronary artery disease.
Adult↗
The French drug approval process II: The clinical basis for negative decisions by the commission for authorization of marketing a medication.
Between 1982 and 1983, the Commission on Approval for Marketing Medications of the French government made 76 negative decisions based on problems with clinical trials. In 21 instances, the reasons for a temporary negative decision could be resolved from data already on hand or readily available. More serious problems resulted in requests for new studies having better controls, better management of ancillary therapy, more participants, or lasting longer. Indications that denial of the application is likely or outright refusals to grant approval were based on failure to demonstrate efficacy and concerns about toxicity. Analysis of the reasons for negative decisions can ameliorate the clinical trials submitted in support of an application for marketing approval. Improving the design and conduct of clinical trials based on correcting the defects discussed here would benefit the sciences of drug development, regulation, and patient care.
Decision Making↗