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J Mason

Publications and source records attributed to J Mason.

At least 73 records · Page 4Linked to original sources
PubMed2000

The importance of achieving additional drug benefits at a reasonable cost. A review of the fluoxetine years.

Fluoxetine continues to be remarkably successful; greater volumes of this drug are sold than for any other antidepressant in the world. Prozac has also become a household name. In this article we examine the circumstances that surround this success, and the evidence base that supports it. Rather than being a major step forward in the treatment for depression, the evidence for fluoxetine and for the selective serotonin reuptake inhibitors in general suggest at best a modest improvement in tolerability, with no evidence of improved efficacy. We note that the road to success was not problem free for fluoxetine, and highlight the response of the sponsor in the development of subsequent drugs for CNS disorders.

Antidepressive Agents, Second-Generation↗
PubMed2000

Fatal toxicity associated with antidepressant use in primary care.

BACKGROUND: New selective serotonin reuptake inhibitors (SSRIs) are perceived to be much safer in use than older tricyclic antidepressants (TCAs). However, previous assessments of association with fatal toxicity were made too soon after the introduction of the new drugs to permit accurate estimation. AIM: To determine the level of association of antidepressant drugs with fatal poisoning in the treatment of depression. METHOD: National data for England and Wales for three years (1993 to 1995) for fatal poisonings associated with antidepressants were obtained and, together with national primary care data on prescribing, were used to calculate fatality association by antidepressant drug. RESULTS: There were substantial variations between drugs in the level of association with fatal poisoning. Assuming an average treatment episode lasted three months, one fatality is associated with 11,800 treatment episodes of antidepressant use (95% CI = 11,120 to 12,580) when only single substance fatalities are considered. For SSRIs as a group the association was one in 411,800 (95% CI = 243,300 to 1.34 million) and for TCAs one in 8130 (95% CI = 7650 to 8670). However, for one of the newer TCAs, lofepramine, the single substance fatality rate associated with its use was one in 233,700 (95% CI = 124,500 to 1.89 million), which is not statistically significantly different from the SSRIs (P = 0.35). CONCLUSIONS: Estimated death rates associated with specific antidepressants should be compared with caution because drugs may be used selectively in patients with differing severity of depression. The proportion of these fatalities that could be prevented by switching to safer antidepressants is unclear when so few deaths are recorded as accidental; when there is intent to do self-harm the potential for switching to other means is unknown. However, this approach to relative toxicity may remain the best available since it is unlikely that a randomised trial will ever be conducted with a large enough sample size to obtain experimental data. Fatalities from antidepressant poisoning are very rare but if safety is paramount then lofepramine or an SSRI are justifiable treatment choices.

Antidepressive Agents, Second-Generation↗
PubMed2000

The management of depression: the implications for managed care--roundtable discussion: Part 1.

Depression affects not only the patient and the provider, but the employer as well. Up to 25% of all women experience major depressive disorder, compared with perhaps as many as 12% of all men. It is highly prevalent in patients with other acute and chronic disease. On October 4, 1999, a panel of managed care medical directors, pharmacy directors, clinicians, researchers, and health economists was convened in San Diego to discuss the optimal treatment of the disorder. This roundtable discussion is presented in three parts. The first portion lays the clinical foundation for the management of this critical disorder.

Antidepressive Agents↗
PubMed2000

The management of depression: the implications for managed care--roundtable discussion: Part 3.

From the standpoint of managed care, the rising cost of depression can be addressed in multiple ways. In the final portion of the roundtable discussion, the faculty discuss not only disease management programs for depression, but other initiatives health plans (including at the pharmacy level) are undertaking to address the rising costs associated with depression. They also discuss the effect of mental health coverage "parity" laws, which can be expected to drive costs even higher.

Antidepressive Agents↗
PubMed1999

beta Blockade after myocardial infarction: systematic review and meta regression analysis.

OBJECTIVES: To assess the effectiveness of beta blockers in short term treatment for acute myocardial infarction and in longer term secondary prevention; to examine predictive factors that may influence outcome and therefore choice of drug; and to examine the clinical importance of the results in the light of current treatment. DESIGN: Systematic review of randomised controlled trials. SETTING: Randomised controlled trials. SUBJECTS: Patients with acute or past myocardial infarction. INTERVENTION: beta Blockers compared with control. MAIN OUTCOME MEASURES: All cause mortality and non-fatal reinfarction. RESULTS: Overall, 5477 of 54 234 patients (10.1%) randomised to beta blockers or control died. We identified a 23% reduction in the odds of death in long term trials (95% confidence interval 15% to 31%), but only a 4% reduction in the odds of death in short term trials (-8% to 15%). Meta regression in long term trials did not identify a significant reduction in effectiveness in drugs with cardioselectivity but did identify a near significant trend towards decreased benefit in drugs with intrinsic sympathomimetic activity. Most evidence is available for propranolol, timolol, and metoprolol. In long term trials, the number needed to treat for 2 years to avoid a death is 42, which compares favourably with other treatments for patients with acute or past myocardial infarction. CONCLUSIONS: beta Blockers are effective in long term secondary prevention after myocardial infarction, but they are underused in such cases and lead to avoidable mortality and morbidity.

Adrenergic beta-Antagonists↗
PubMed1999

Cardiovascular safety of fexofenadine HCl.

Fexofenadine HCl is the acid metabolite of terfenadine (Seldane). The effect of this recently approved nonsedating antihistamine on the corrected QT interval (QTc) was evaluated in dose-tolerance, safety, and drug-interaction studies with healthy volunteers, and in clinical studies in patients with seasonal allergic rhinitis (SAR). Twelve-lead electrocardiographic data were collected once before and after dosing or serially throughout these studies. Outliers were defined as QTc > 440 ms with a > or = 10 ms increase from baseline. The recommended fexofenadine HCl dose is 60 mg twice daily. Fexofenadine HCl doses up to 800 mg once daily or 690 mg twice daily for 28 days resulted in no dose-related increases in QTc. Longer term studies indicated no statistically significant QTc increases compared with placebo in patients receiving fexofenadine HCl 80 mg twice daily for 3 months, 60 mg twice daily for 6 months, or 240 mg once daily for 12 months. Interaction studies showed no significant increases in QTc when fexofenadine HCl 120 mg twice daily was administered in combination with erythromycin (500 mg 3 times daily) or ketoconazole (400 mg once daily) after dosing to steady state (6.5 days). Clinical trials in patients with SAR (n = 1,160) treated with 40, 60, 120, or 240 mg twice-daily fexofenadine HCl or placebo indicated no dose-related increases in QTc and no statistically significant increases in mean QTc compared with placebo. In controlled trials with approximately 6,000 persons, no case of fexofenadine-associated torsades de pointes was observed. The frequency and magnitude of QTc outliers were similar between fexofenadine HCl and placebo in all studies. Based on a large clinical database, we conclude that fexofenadine HCl has no significant effect on QTc, even at doses > 10-fold higher than that is efficacious for SAR.

Double-Blind Method↗
PubMed1999

The efficacy and safety of fexofenadine HCl and pseudoephedrine, alone and in combination, in seasonal allergic rhinitis.

BACKGROUND: Antihistamines effectively treat seasonal allergic rhinitis (SAR), although the ability of this drug class to reduce nasal congestion is limited. Nasal decongestants effectively treat nasal congestion but not the histamine-related components of SAR. Therefore antihistamine/nasal decongestant combinations are commonly used to maximize the treatment of SAR. Fexofenadine HCl is a nonsedating, long-acting H1 receptor antagonist that provides fast and effective relief from SAR. It is well tolerated, with no sedative or cardiotoxic effects. OBJECTIVE: We sought to compare the efficacy and safety of a fexofenadine HCl/pseudoephedrine HCl combination with that of each individual component in the treatment of ragweed allergy. METHODS: In this Canadian multicenter, double-blind, parallel-group study, 651 patients allergic to ragweed were randomized to receive 60 mg of fexofenadine HCl twice daily, 120 mg of sustained-release pseudoephedrine HCl twice daily, or a combination of the 2 drugs (60 mg of fexofenadine HCl/120 mg of sustained-release pseudoephedrine HCl) twice daily for 2 weeks. Efficacy analyses were based on symptom severity. In addition, a health economic assessment was performed. RESULTS: Combination therapy was significantly more effective than pseudoephedrine alone in improving primarily histamine-mediated symptoms (sneezing; rhinorrhea; itchy nose, palate, and/or throat; and itchy, watery, red eyes) and significantly more effective than fexofenadine alone in reducing nasal congestion. Combination therapy also produced greater improvements in daily activities and work productivity compared with the individual components. No serious adverse events were reported in any of the treatment groups. In addition, no clinically significant changes in 12-lead electrocardiogram parameters, vital signs, or clinical laboratory values were observed. CONCLUSION: Combination therapy is more effective than fexofenadine alone or pseudoephedrine alone in relieving the full spectrum of SAR symptoms (ie, both the primarily histamine-related symptoms and nasal congestion).

Adolescent↗
PubMed1999

A framework for incorporating cost-effectiveness in evidence-based clinical practice guidelines.

In England, recent health care reforms emphasise the role of clinical guidelines in promoting effective and efficient health care. Introducing economic data into guidelines raises some methodological issues: specifically, the provision of valid and generalisable cost estimates, the weight placed upon cost 'evidence', and the presentation of cost-effectiveness information in a manner accessible to clinicians. A series of primary care guidelines, explicitly including consideration of health economic information, have recently been published, intended to help clinicians to aggregate the attributes of treatment choices to derive treatment recommendations consistent with both the clinical decision-making process and social objectives. Clinicians involved in developing guidelines responded well to the process and consistently managed to agree treatment recommendations, often after considerable debate about the evidence for treatment. In none of the guideline areas, all of which addressed common diseases, was there adequate information to estimate a cost per quality-adjusted-life-year, and it is unclear how helpful this approach would have been had it been possible. The implications of this method are discussed, guidance offered for economists new to guideline development and future areas of work identified.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1999

A randomized trial of Evidence-based OutReach (EBOR): rationale and design.

There is increasing interest in evaluating the methods used to implement the findings from medical research. This paper describes the Evidence-based OutReach (EBOR) trial, which is the first large randomized study in the United Kingdom that will evaluate the effectiveness and efficiency of educational outreach visits by trained pharmacists who are delivering messages derived from four evidence-based clinical practice guidelines. General practices form the unit of allocation and analysis. The study design addresses important factors that may influence the effectiveness of the intervention, such as the pharmacist who delivers the messages, the health authority in which practices are located, and the size of a practice.

Family Practice↗
PubMed1999

Novel coloured flowers.

The floricultural industry has focused its attention primarily on the development of novel coloured and longer living cut flowers. The basis for this was laid down some years ago through the isolation of 'blue' genes and ethylene biosynthesis genes. Recently, a novel 'blue' gene has been discovered and yellow pigments were produced in petunias by addition of a new branch to the phenylpropanoid pathway. More insight was obtained into the sequestration of anthocyanin pigments into storage vacuoles. Significant progress has been achieved in the commercialisation of genetically modified flower varieties.

Anthocyanins↗
PubMed1999

Syngeneic bone marrow transplantation for small cell carcinoma of the esophagus.

Small cell carcinoma (SCC) of the esophagus is an aggressive tumor which behaves biologically like its pulmonary counterpart. Since standard chemotherapy produces few long-term survivors, high-dose chemotherapy regimens with autologous progenitor cell support have been investigated to improve outcomes. Although these strategies have demonstrated improved response rates, overall survival has not been significantly impacted. Here, we report a unique case of a patient with stage IV SCC of the esophagus who underwent high-dose chemotherapy followed by syngeneic bone marrow transplantation. He remains disease-free 38 months post transplant with minimal long-term sequelae.

Bone Marrow Transplantation↗
PubMed1999

The systemic safety of fexofenadine HCl.

Fexofenadine is a highly specific, H1-receptor antagonist with a safety profile similar to placebo. In placebo-controlled trials of seasonal allergic rhinitis (SAR) and chronic idiopathic urticaria (CIU), the type and incidence of adverse events were comparable in fexofenadine and placebo recipients. Fexofenadine does not impair performance in tests of driving or psychomotor performance and has been shown to improve quality of life in patients with SAR. Fexofenadine has a high margin of safety and is also well tolerated in subjects with renal or hepatic impairment, in children and the elderly. No clinically significant drug interactions have been identified. Fexofenadine is not associated with cardiotoxicity. Unlike some other antihistamines, such as loratidine or cetirizine [1, 2], fexofenadine is truly non-sedating, showing no dose-related increase in sedation, even at high doses [3, 4]. Fexofenadine is formulated and marketed as the hydrochloride salt. The recommended dose of fexofenadine HC1 is 120 mg daily for SAR (either as 120 mg once daily or 60 mg twice daily) or 180 mg once daily for CIU.

Aged↗
PubMed1999

Cardiovascular safety of fexofenadine HCl.

BACKGROUND: Certain first- and second-generation H1-receptor antagonists are associated with prolongation of the corrected QT interval (QTc) and, in rare instances, with ventricular dysrhythmias, including torsades de pointes ventricular tachycardia. OBJECTIVE: To assess the effect of fexofenadine HCl, a new non-sedating antihistamine, on QTc. METHODS: Dose-tolerance, safety, and drug-interaction studies with healthy volunteers; and clinical efficacy studies with seasonal allergic rhinitis patients were conducted. Twelve-lead ECG data were collected pre- and postdosing or serially throughout these studies. Outliers were defined as QTc >440 msec with a >/=10 msec increase from baseline. RESULTS: Fexofenadine HCl at single doses up to 800 mg q.d. (once daily) and multiple doses up to 690 mg b.d. for 28 days in healthy volunteers resulted in no increases in QTc (recommended dose range is 120-180 mg daily); QTc changes were similar to placebo. Compared with placebo, there were no statistically significant QTc increases in patients receiving fexofenadine HCl 80 mg b.d. for 3 months, 60 mg b. d. for 6 months, or 240 mg q.d. for 12 months. No statistically significant increases in QTc were detected when fexofenadine HCl 120 mg b.d. was administered in combination with erythromycin (500 mg t. d.) or ketoconazole (400 mg q.d.) after dosing to steady-state (6.5 days). In seasonal allergic rhinitis patients (n = 1160) treated with 40, 60, 120, or 240 mg b.d. fexofenadine HCl for 2 weeks, there were no dose-related increases in QTc and no significant increases in mean QTc compared with placebo. Frequency and magnitude of QTc outliers with fexofenadine HCl and placebo were similar in all studies. No case of fexofenadine-associated torsades de pointes has been observed in controlled trial experience with more than 6000 patients. CONCLUSION: Fexofenadine HCl has been investigated more extensively for possible electrophysiological effects than any other antihistamine. Fexofenadine HCl has no significant effect on QTc, even at doses much higher than those used in clinical practice.

Dose-Response Relationship, Drug↗
PubMed1999

A systematic review of foot ulcer in patients with Type 2 diabetes mellitus. I: prevention.

AIM: To evaluate the role of preventative strategies in reducing foot ulcers in patients with Type 2 diabetes mellitus, both in the general population and those identified to be at a raised risk. METHOD: A systematic review of interventions to prevent diabetic foot ulcers. RESULTS: Available studies are generally unsatisfactory in their ability to answer the important questions relating to prevention. However, where people with diabetes receive well-organized and regular care with rapid referral to appropriate specialist multidisciplinary teams when problems (or their precursors) occur, ulcer morbidity can be substantially reduced. CONCLUSION: Foot ulcers are common in people with diabetes and are costly in terms of both patient morbidity and the use of healthcare resources. Although it is nearly a decade since the St Vincent Declaration called for a marked reduction in morbidity to be achieved through better patient management, available evidence suggests that the process of care in Britain is still very variable in quality. Foot care for people with diabetes must be organized to provide monitoring, education and referral in a manner acceptable to patients and realistic for local healthcare providers.

Diabetes Mellitus, Type 2↗