Section 3 The tolerance and acceptability of ibuprofen (‘Brufen’) in the elderly patient

Summary

Data on the treatment of patients over the age of 65 years were extracted from the computer records of a long-term multi-centre study of ibuprofen. Patients were suffering from rheumatoid disease, osteoarthrosis or an allied condition. Records from 231 patients were available for analysis. Duration of therapy with ibuprofen ranged from 3 months to over 5 years. Assessments of clinical progress, as judged by both patients and physicians, changes in biochemical and haematological parameters, and side-effects showed that ibuprofen is an effective form of therapy and is generally well tolerated in the elderly.     

Section 3 The use of ‘Brufen’ (ibuprofen) in the treatment of juvenile chronic polyarthritis

Summary

Ibuprofen has been used routinely as an alternative therapy to aspirin in patients with juvenile chronic polyarthritis when aspirin produced gastric intolerance, gastro-intestinal bleeding, deafness, or an irritating rash. Two typical case studies are reported. Ibuprofen has proved to be a safe and effective form of treatment.     

The use of povidone-iodine (‘Betadine’) pessaries in the treatment of candidal and trichomonal vaginitis

Summary

One hundred and thirty-five women suffering from trichomonal, candidal, or both infections simultaneously, were treated with povidone-iodine pessaries, 2 pessaries being inserted nightly.

Ninety-nine women were given a 7-day course of treatment, but the results obtained were disappointing, and the authors do not recommend such a regime for routine treatment. Better results were obtained with the recommended 14-day course.

A further 36 women suffering from chronic trichomonal andj or candidal infections which had previously resisted orthodox treatment were given a prolonged 28-day course of pessary treatment. The results obtained were very encouraging, 92 % of the trichomonal and 96 % of the candidal infections being cured. Furthermore, although povidone-iodine is slightly less effective in trichomoniasis, most patients suffering from a chronic infection (candidal, as well as trichomonal) were cured by the one preparation. Side-effects did occur, but were significant in only 3 patients. Subjective symptoms, especially any offensive odour, disappeared within 3 days of the start of the treatment.

The authors recommend that the 28-day course of povidone-iodine pessaries is used in those cases where trichomoniasis or candidosis has been a therapeutic problem in the past, particularly if the patient is currently on the oral contraceptive pill.     

The use of oxyphenbutazone (‘Tanderil’) in acute pelvic inflammatory disease

Summary

Ninety-two patients with acute pelvic inflammatory disease were part of a double-blind clinical trial of the anti-inflammatory drug, oxyphenbutazone.

The length of hospital stay was significantly reduced. Other parameters suggested improvement with the trial drug against a placebo. No side-effects were noted, ft is suggested that oxyphenbutazone is a valuable addition to antibiotic therapy in the treatment of acute pelvic inflammatory disease.     

An exploration of health professionals’ experiences of medicines management in elderly,hospitalised patients in Abu Dhabi

Background Given the multiplicity of issues relating to medicines in the elderly, the structures and processes of medicines management should be clearly defined and described to optimise patient outcomes. There is a paucity of research which provides an in-depth exploration of these elements of medicines management for elderly patients. Objectives This study explored health professionals’ experiences of medicines management for elderly, hospitalised patients in Abu Dhabi. Setting The research was conducted in five major hospitals in Abu Dhabi, the United Arab Emirates. Method Responses to an online sampling questionnaire were used to purposively select nurses, pharmacists and physicians for interview. A semi-structured interview schedule was developed with reference to normalization process theory (NPT) and the theoretical domains framework (TDF) to explore issues of medicines management structures, processes and outcomes. Face-to-face interviews of 20–30 min were audio-recorded, transcribed verbatim and analysed using the Framework Approach. Main outcome measures Health professionals’ in-depth experiences of structures, processes and outcomes relating to medicines management. Results Saturation of themes was deemed to occur at interview 27 (7 nurses, 13 pharmacists, 7 physicians). Six key themes and several subthemes emerged from the qualitative analysis, which pertained to the need for: appropriate polypharmacy; a systematic approach to medicines history taking; improved communication and documentation; improved patients’ adherence to medicines; guidelines and policies to support medicines selection, and an educated and trained multidisciplinary team. The most dominant TDF behavioural determinants were issues around: professional role and identity; beliefs about capabilities; beliefs about consequences; environmental context and resources; knowledge, and goals. NPT construct identified little evidence of coherence, cognitive participation, collective action and reflexive monitoring. Conclusion The key themes identified in this research indicate the need to develop a more structured approach to medicines management in elderly hospitalised patients in Abu Dhabi. The NPT constructs and the TDF behavioural determinants can be utilised as part of service development and implementing change.     

Double-blind trial of a long-acting bronchodilator preparation (‘ethaprin Dospan’) in bronchospastic disease

Summary

A double-blind, placebo-controlled, crossover study was carried out in 48 patients with bronchospastic disease to assess the efficacy of a long-acting bronchodilator preparation Nethaprin Dospan')containing etafedrine hydrochloride, bufylline, doxylamine succinate and phenylephrine. Patients received 1 tablet nightly, with an extra dose in the morning if necessary, of active drug or placebo for 1 week, and were then crossed over to the alternative medication for a further week. All patients had marked disability, apparent on initial clinical examination and on respiratory function tests. The results showed that FEV₁and VC were significantly improved with the active medication, and patients slept better, had improved appetite and suppression of cough.     

The use of iloprost in the treatment of ‘out of proportion’ pulmonary hypertension in chronic obstructive pulmonary disease

Case Pulmonary hypertension secondary to respiratory disease most often occurs as a complication of chronic obstructive pulmonary disease, which currently constitutes one of the leading causes of death. Some patients with hypoxaemia reveal “out of proportion” pulmonary hypertension with inappropriate increase of pulmonary artery pressure. Iloprost, analogue of prostacyclin, dilates systemic vessels and pulmonary vessels in particular if administered by inhalation. It appears to be important, life-saving, complementary therapy. However, there is no evidence for its routine use in out of proportion arterial pulmonary hypertension. This case study presents a 44-year old man with chronic obstructive pulmonary disease and “out of proportion” pulmonary hypertension. We present the results of his treatment with iloprost. Conclusion In a patient with “out of proportion” pulmonary hypertension due to chronic obstructive pulmonary disease, inhaled iloprost led to improvement in clinical status and echocardiographic parameters, including a reduction of right ventricular systolic pressure.     

A multi-centre general practice study on the use of a timolol/bendrofluazide combination (‘Prestim’) in the management of hypertension: preliminary report

Summary

A preliminary report is given on the first 500 patients entered in an on-going open study in general practice of a combination of 10?mg timolol maleate and 2.5?mg bendro-fluazide used to treat mild to moderate essential hypertension. After a 2-week placebo period, dose titration was conducted at weekly intervals, with a final assessment 8 weeks after the diastolic blood pressure was controlled. Data for 472 patients out of 492 commencing active therapy were evaluated. Four-hundred and thirty-seven (93%) became normotensive (≤95 mmHg diastolic) on a mean dose of 1.9 tablets taken as a single daily dose. Control was maintained over the follow-up period in all but 13 (2.6%) patients who required a dosage reduction and 2 (0.4%) who required a dosage increase. The incidence of side-effects was low, 22 (4.4%) patients stopping treatment due to adverse events. Biochemical parameters all stayed within normal values. The rapidity of dosage titration, patient acceptability, compliance with regard to the once daily dosage and the low incidence of side-effects suggest that the timolol/bendrofluazide combination approaches optimum therapy for mild to moderate hypertension.     

Artist® tablets (carvedilol) for hypertensive patients in Japan: results of a drug use survey

Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey.Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan.Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension.Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol.Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed.After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases.Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension.     

A clinical trial of glycosaminoglycan-peptide complex (‘Rumalon’) in patients with osteoarthritis of the knee

Summary

A clinical trial was undertaken in 50 patients with osteoarthritis of the knee to assess the therapeutic value of glycosaminoglycan-peptide complex in treatment. The first year consisted of a randomized, double-blind, placebo-controlled, parallel-group trial (25 patients in each group), after which all patients received active treatment for a further 2 years. Treatment consisted of three 8-week courses in the first year and 2 such courses per year in subsequent years, each consisting of 2 ml intramuscular injections given 3 times per week. Patients were permitted to continue taking anti-inflammatory drugs and to receive physiotherapy during the trial period. At the end of the first year of the trial (double-blind phase), there were no significant differences between the two treatment groups. However, after the second year, those patients who had received glycosaminoglycan-peptide complex for 2 years had significantly greater improvements in night pain andrestpain than did those who had received active treatment for only 1 year. At the end of 3 years (when half the patients had received active treatment for 2 years and half for 3 years), there were significant overall improvements in relation to rest pain, pain on walking and morning stiffness, but not in respect to night pain, pain on standing or climbing stairs. At the same time, improvements were seen in radiological severity of disease (assessed double-blind) in 16% of patients, with ‘no change’ in 74% and deterioration in lo%, these figures being considerably better than might be expected with conventional therapy. Glycosaminoglycan-peptide complex was extremely well tolerated.     

Comparison of nystatin (‘Nystan’) and hydrargaphen (‘Penotrane’) in the treatment of vaginal candidosis in pregnancy

Summary

A double-blind comparison of nystatin (‘Nystan’) pessaries and hydrargaphen (‘Strong Penotrane’) pessaries for the treatment of vaginal candidosis showed that the former is more effective on clinical and mycological assessment. Relief from symptoms was obtained in 95.9% and 84.6% of the patients treated with nystatin and hydrargaphen respectively. On stopping treatment, yeasts could no longer be isolated from 75.0% of the cases receiving 'Nystan' and from 23.1% receiving 'Strong Penotrane'. There was no evidence of resistance to either drug before, during or after therapy.     

A clinical trial of a new long-acting nitroglycerine preparation (‘Nitrocontin’) in angina pectoris

Summary

In a double-blind crossover study of 15 patients with angina pectoris, a long-acting nitroglycerine preparation (‘Nitrocontin’) was compared against placebo. Patients received 2 tablets per day of either placebo or ‘Nitrocontin’ (6.4?mg. glvceryl trinitrate per tablet) for 4 weeks and were then crossed to the alternative preparation for a further 4 weeks. The results, as assessed by the number of attacks, consumption of glyceryl trinitrate sublingual tablets and patients' impression of improvement, showed that the active drug produced a significant reduction (p < 0.001) in the frequency of attacks. In a bicycle ergometric study, the long-acting preparation showed a signiJicant improvement (p < 0.001) in exercise performance against placebo.     

The challenge of pain in the pharmacological management of Parkinson’s disease

ABSTRACT

Introduction: Pain is a common symptom in Parkinson’s disease (PD), impairing quality of life. The clinical appearance and the underlying etiologies are diverse. Different subtypes of pain may occur, with musculoskeletal pain considered to be the most frequent. Often there is also a combination of different causes of pain. There is a lack of controlled studies addressing pain therapy in PD.

Areas covered: In this review the authors analyzed the currently available data, taking into account the available publications in the databases, especially PubMed. The authors further provided their expert perspectives on the challenges of treating pain in PD patients.

Expert opinion: There is both nociceptive and neuropathic pain and in patients with PD, some PD-related pain and some unrelated. Diagnosis requires a thorough and differentiated history and examination, and targeted diagnostics. Therapeutically, many drugs are used, but the data is unfortunately limited and not specific. Medications used include Parkinson-related, mainly dopaminergic drugs, as well as opioids and non-opioid analgetics, anticonvulsives, antidepressants, and more recently cannabinoids. Currently, therapy is performed nonspecifically, without taking into account the special requirements of PD. Unfortunately, in many cases, pain is resistant to these therapies. In the future, both diagnostic and therapeutic efforts should be made to address this issue.     

The systemic effect of bromhexine (‘Bisolvon’) in normal subjects

Summary

The effects of bromhexine (‘Bisolvon’), which is an oral mucolytic expectorant used in treatment of chronic bronchitis, on the excretion of connective tissue products has been studied in normal volunteers. The drug was given at two dose levels, 24?mg. daily for four weeks followed by 48?mg. for two weeks. The effect on a number of other blood constituents commonly estimated in clinical chemistry was also assessed and these results are discussed.

The drug had no effect on excretion of the connective tissue products, calcium, total hydroxyproline and glycosaminoglycans which suggests that its effects are primarily on mucus secretions and unlikely to affect connective tissue and ground substance throughout the body. However, these observations are made on normal subjects and the possibility of using the drug in the treatment of the mucopolysaccharidoses is discussed.     

What’s the role of topiramate in the management of patients with hyperkinetic movement disorders?

Topiramate (TPM) is an O-alkyl sulfamate derivative of the naturally occurring monosaccharide D-fructose with an epileptic activity. However, it has been suggested that, in addition to its use in epilepsy, TPM could also be used in the treatment of neurological disorders, psychiatric conditions and hyperkinetic movement disorders. The clinical applications of TPM in hyperkinetic movement disorders is consistent with the multiple pharmacodynamic mechanisms e.g., the modulation of both γ-aminobutyric acidergic or glutamatergic neurotransmission and the modulation of voltage-gated ion channels or intracellular signalling pathways. The purpose of the present review is to describe the mechanisms of action of TPM and its clinical efficacy in patients with hyperkinetic movement disorders.     

Examination of Setarud (IMOD™) in the management of patients with severe sepsis

BACKGROUND AND THE PURPOSE OF THE STUDY: Analysis of current immunomodulating strategies indicates that monovalent approaches are unlikely to restore immunostasis or achieve complete therapy of sepsis. Setarud (IMOD) as a mixture of urtica, carotenoids, urea, and selenium has been recently patented for its potential in reduction of Tumor Necrosis Factor alpha (TNF-α) and Interferon-γ and Interleukin-2 levels. The aim of this study was to examine efficacy of IMOD in the management of patients with severe sepsis. METHODS: Twenty patients with severe sepsis and acute physiology and chronic health evaluation (APACHE) score of more than 20 were randomized to receive standard treatment of severe sepsis (control group) or standard treatment plus IMOD (IMOD group). The group treated with IMOD for 14 days was according to the pilot study and regarding the stability of patient's conditions in the ICU. Of course patients in both groups received standard treatment and all were monitored for 28 days. Blood samples were analyzed for interleukins (IL-1, IL-2, IL-6), plasminogen activator inhibitor (PAI-1), TNF-α, total thiol molecules (TTM), nitric oxide (NO), total antioxidant power (TAP), and lipid peroxidation (LPO). Daily APACHE, Sequential Organ Failure Assessment (SOFA), and Simplified Acute Physiology Score (SAPS) were calculated. RESULTS AND MAJOR CONCLUSION: Comparing with controls, IMOD was significantly effective in improving SAPS, SOFA, and APACHE scores, and reduction of mortality rate. Among tested inflammatory biomarkers, IMOD significantly improved TTM and TNF-α values. It is concluded that IMOD might be added as a safe adjutant to standard treatment of severe sepsis.