Showing papers on "Tolerability published in 1990"
TL;DR: Ketorolac offers promise as an alternative to opioid and to other nonsteroidal analgesics in ameliorating moderate to severe postsurgical pain, and with wider clinical experience may find a place in the treatment of acute musculoskeletal and other pain states, and ocular inflammatory conditions.
Abstract: Ketorolac is a non-steroidal agent with potent analgesic and moderate anti-inflammatory activity. It is administered as the tromethamine salt orally, intramuscularly, intravenously, and as a topical ophthalmic solution. Clinical studies indicate single-dose efficacy greater than that of morphine, pethidine (meperidine) and pentazocine in moderate to severe postoperative pain, with some evidence of a more favourable adverse effect profile than morphine or pethidine. In single-dose studies ketorolac has also compared favourably with aspirin, paracetamol (acetaminophen) and a few other non-steroidal anti-inflammatory drugs. If further investigation confirms the initially favourable findings regarding efficacy and tolerability, ketorolac will be a useful alternative to opioid agents in postsurgical pain. It may well also find use in acute musculoskeletal pain, where it appears at least as effective as other agents with which it has been compared. From the limited clinical data available, ketorolac also seems promising in the treatment of ocular inflammatory conditions. Additional multiple-dose studies are required to evaluate fully the potential of ketorolac in the management of chronic pain states where it has shown superior efficacy to aspirin. In summary, ketorolac offers promise as an alternative to opioid and to other nonsteroidal analgesics in ameliorating moderate to severe postsurgical pain, and with wider clinical experience may find a place in the treatment of acute musculoskeletal and other pain states, and ocular inflammatory conditions.
361 citations
TL;DR: Fenofibrates offers an effective and well tolerated alternative to clofibrate or other fibric acid derivatives, but its relative efficacy and tolerability compared with other types of lipid-lowering drugs, and its effect on cardiovascular morbidity and mortality, remain to be clarified.
Abstract: Fenofibrate is a lipid-regulating drug which is structurally related to other fibric acid derivatives, such as clofibrate. At the recommended dosage of 200 to 400 mg daily, it produces substantial reductions in plasma triglyceride levels in hypertriglyceridaemic patients and in plasma total cholesterol levels in hypercholesterolaemic patients. High density lipoprotein (HDL)-cholesterol levels are generally increased in patients with low pretreatment values. Fenofibrate appears to be equally effective in diabetic patients with hyperlipoproteinaemia without adversely affecting glycaemic control. The influence of fenofibrate on the plasma lipid profile is sustained during long term (2 to 7 years) treatment. Comparative studies conducted to date have involved only small groups of patients--in overall terms fenofibrate was at least as effective as other fibrates, but larger comparative studies are needed before valid conclusions on its relative efficacy compared with nonfibrate lipid-lowering drugs can be drawn. The influence of fenofibrate on morbidity and mortality from cardiovascular disease has not been studied. Clinical adverse reactions to fenofibrate have mainly consisted of gastrointestinal disturbances, headache and muscle cramps. Transient elevations in transaminase and creatine phosphokinase levels commonly occur. Isolated cases of hepatitis with substantially elevated transaminase levels have been reported. Fenofibrate induces hepatomegaly, peroxisome proliferation and hepatic carcinomas in rodents, but this type of hepatotoxicity has not been observed in humans. The biliary lithogenic index is increased by fenofibrate, but this has not been shown to have increased the incidence of gallstones in treated patients. Thus, fenofibrate offers an effective and well tolerated alternative to clofibrate or other fibric acid derivatives, but its relative efficacy and tolerability compared with other types of lipid-lowering drugs, and its effect on cardiovascular morbidity and mortality, remain to be clarified.
194 citations
TL;DR: The efficacy and tolerability of naproxen have been clearly established over many years of clinical use, and it can therefore be considered as a first-line treatment for rheumatic diseases and various pain states.
Abstract: Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) advocated for use in painful and inflammatory rheumatic and certain nonrheumatic conditions. It may be administered orally or rectally using a convenient once or twice daily regimen. Dosage adjustments are not usually required in the elderly or those with mild renal or hepatic impairment although it is probably prudent to start treatment at a low dosage and titrate upwards in such groups of patients. Numerous clinical trials have confirmed that the analgesic and anti-inflammatory efficacy of naproxen is equivalent to that of the many newer and established NSAIDs with which it has been compared. The drug is effective in many rheumatic diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and nonarticular rheumatism, in acute traumatic injury, and in the treatment of and prophylaxis against acute pain such as migraine, tension headache, postoperative pain, postpartum pain and pain associated with a variety of gynaecological procedures. Naproxen is also effective in treating the pain and associated symptoms of primary or secondary dysmenorrhoea, and decreases excessive blood loss in patients with menorrhagia. The adverse effect profile of naproxen is well established, particularly compared with that of many newer NSAIDs, and the drug is well tolerated. Thus, the efficacy and tolerability of naproxen have been clearly established over many years of clinical use, and it can therefore be considered as a first-line treatment for rheumatic diseases and various pain states.
191 citations
TL;DR: Ticlopidine reduces the incidence of further stroke, myocardial infarction or vascular death, and is superior to placebo and aspirin in studies of patients with recent stroke or transient ischaemic attacks, or intermittent claudication and has a promising role in other disorders mediated by platelet dysfunction.
Abstract: Ticlopidine inhibits platelet aggregation induced by adenosine diphosphate (ADP) and most other platelet agonists in ex vivo studies of human platelets. The drug also improves other abnormalities of platelet function seen in patients with cerebrovascular disease, peripheral arterial disease, ischaemic heart disease or other conditions involving platelet hyperaggregation. Abnormal platelet activity has been implicated in a variety of clinical conditions in which patients are at high risk of thromboembolic events, and thus the effectiveness of ticlopidine has been investigated in such patients. Since the initial review of the drug appeared in the Journal, data from several large multicentre studies have shown that ticlopidine has a substantial benefit to offer patients who have experienced transient ischaemic attacks or stroke, and in those with peripheral arterial disease or ischaemic heart disease. Ticlopidine reduces the incidence of further stroke, myocardial infarction or vascular death, and is superior to placebo and aspirin in this regard in studies of patients with recent stroke or transient ischaemic attacks, or intermittent claudication. Ticlopidine is equally effective in both men and women and also improves symptoms of claudication in patients with peripheral arterial disease, and appears to reduce anginal pain. Patients with subarachnoid haemorrhage and sickle cell disease have shown some improvement with ticlopidine administration. The drug reduces thromboembolic events and re-stenosis in patients undergoing haemodialysis and cardiac surgery, and appears to prevent the progression of nonproliferative diabetic retinopathy. Ticlopidine in large clinical trials is associated with a higher incidence of adverse effects than placebo and an overall incidence similar to aspirin. Most adverse effects do not require withdrawal of treatment. Gastrointestinal symptoms (particularly diarrhoea) are most common, occurring almost twice as frequently with ticlopidine as with aspirin. Other adverse effects associated with ticlopidine include skin rash, haemorrhagic disorders, and haematological effects; these latter effects require careful monitoring of patients during the initial weeks of therapy. In conclusion, ticlopidine is a valuable addition to the prophylactic treatments available for the management of patients with cerebrovascular disease, peripheral arterial disease or ischaemic heart disease, who present a high risk of thromboembolic events. Although tolerability may be a problem for some patients, the overall benefit conferred by the drug would appear to outweigh this potential disadvantage. Because of its antiplatelet activity, ticlopidine has a promising role in other disorders mediated by platelet dysfunction. However, the precise role of the drug in these additional therapeutic indications awaits clarification with wider clinical experience.
162 citations
TL;DR: In this paper, the efficacy of Naproxen sodium (Nxs) in the prophylaxis of Menstrual Migraine (MM) was tested, versus Placebo (PL).
Abstract: In this study, the efficacy of Naproxen sodium (Nxs) in the prophylaxis of Menstrual Migraine (MM) was tested, versus Placebo (PL). Forty women suffering from MM were admitted to a double-blind treatment protocol with Nxs 550 mg twice each day by mouth or Placebo (PL), for 3 months; in the next 3 months all the women were treated with the active drug in an open study. The headache intensity and duration, as well as the number of days of headache and the analgesic consumption, were significantly reduced with Nxs compared to PL. The efficacy of Nxs, shown also in improving premenstrual pain, and its good tolerability, support the use of this drug in the prophylactic therapy of MM.
133 citations
TL;DR: Remoxipride seems to have a clinical profile characterized by antipsychotic efficacy in acute schizophrenia, apparently equal to that of haloperidol, and good tolerability in being non‐sedative and with low incidences of extrapyramidal, autonomic, and endocrine symptoms.
Abstract: Nine double-blind studies comparing remoxipride to haloperidol in the treatment of acute schizophrenia formed the basis of this analysis. All studies followed a basic protocol with the main assessments performed regularly during the 4–6 week trial period according to the same methodology, thus allowing the data to be pooled. The results showed that remoxipride in a daily dose of 150–600 mg had a therapeutic effect comparable to that of haloperidol (5–45 mg/day), both on positive and negative symptoms. There was a clear advantage for remoxipride over haloperidol with regard to adverse events/symptoms, particularly extrapyramidal symptoms, but also drowsiness/somnolence and tiredness/fatigue. Anticholinergic drugs were used consistently less frequently as concomitant medication to alleviate extrapyramidal symptoms in the remoxipride group; the use of sedatives/hypnotics was approximately the same in both groups. Based on these and supportive clinical data, remoxipride seems to have a clinical profile characterized by antipsychotic efficacy in acute schizophrenia, apparently equal to that of haloperidol, and good tolerability in being non-sedative (in terms of drowsiness/somnolence) and with low incidences of extrapyramidal, autonomic, and endocrine symptoms.
127 citations
TL;DR: The preoperative use of effective regimens (eg, EAP) seems to improve prognosis of patients with LAD and such a multimodal approach may increase the number of long-term survivors among patients with resectable gastric cancer, especially those whose stage indicates a high risk of relapse.
124 citations
TL;DR: All the clinical parameters studied were significantly improved by treatment with 5-HTP and only mild and transient side-effects were reported.
Abstract: A double-blind, placebo-controlled study of the efficacy and tolerability of 5-hydroxytryptophan (5-HTP) was conducted in 50 patients with primary fibromyalgia syndrome. All the clinical parameters studied were significantly improved by treatment with 5-HTP and only mild and transient side-effects were reported. Further controlled studies are required to define properly the value of 5-HTP in patients with primary fibromyalgia syndrome.
106 citations
TL;DR: Mesalazine suppositories are safe, well tolerated, and very effective in patients with active distal proctosigmoiditis: 500 mg twice daily appears a suitable dose regimen.
Abstract: A multicentre double-blind study was conducted to evaluate the efficacy and tolerability of 1 g or 1.5 g mesalazine daily compared with placebo in 94 patients with mild to moderate distal proctosigmoiditis (less than 20 cm). The study end point was the determination of clinical, endoscopic, and histologic remission rates at 4 weeks. Eleven patients, nine receiving placebo and two receiving 1.5 g mesalazine, withdrew during trial, mostly because of worsening of symptoms. At 4 weeks clinical remission was achieved in 7 of 31 (39%) patients with placebo, in 22 of 32 (69%) patients in the 1 g mesalazine group, and 23 of 31 (74%) patients in the 1.5 g mesalazine group. No serious clinical or biochemical side effect of treatment was reported. Mesalazine suppositories are safe, well tolerated, and very effective in patients with active distal proctosigmoiditis: 500 mg twice daily appears a suitable dose regimen.
90 citations
TL;DR: It is suggested that a subgroup of patients with chemotherapy-related leukopenia and fever may benefit from GM-CSF treatment in view of the observed effects on neutrophil count.
83 citations
TL;DR: It is concluded that Serratia peptidase has anti-inflammatory, anti-oedemic and fibrinolytic activity and acts rapidly on localized inflammation.
Abstract: The efficacy and tolerability of Serratia peptidase were evaluated in a multicentre, double-blind, placebo-controlled study of 193 subjects suffering from acute or chronic ear, nose or throat disorders. Treatment lasted 7-8 days, with the drug or placebo being administered at a rate of two tablets three times a day. After 3-4 days' treatment, significant symptom regression was observed in peptidase-treated patients. There was also a significant reduction in symptoms after 7-8 days for patients in both treatment groups but the response was more marked in those patients receiving the active drug. Statistical comparison between the two groups confirmed the greater efficacy and rapid action of the peptidase against all the symptoms examined at both stages. Tolerance was found to be very good and similar for both groups. It is concluded that Serratia peptidase has anti-inflammatory, anti-oedemic and fibrinolytic activity and acts rapidly on localized inflammation.
TL;DR: New information on the tolerability of lovastatin has emerged from an ongoing study of long-term therapy; preliminary results from a large, 48-week clinical trial; and spontaneous reports of adverse events observed during prescription use of the drug in the United States.
Abstract: New information on the tolerability of lovastatin has emerged from an ongoing study of long-term therapy; preliminary results from a large, 48-week clinical trial; and spontaneous reports of adverse events observed during prescription use of the drug in the United States. As of June 1989, 744 patients had received lovastatin for an average duration of 3.6 years in the long-term study. Drug-attributable adverse events necessitated withdrawal of 17 patients (2.3%) from the study. These adverse effects were asymptomatic elevations of transaminases (10), skin rash (3), gastrointestinal symptoms (2), myopathy (1) and insomnia (1). No effect of lovastatin on the human lens was observed. In the 48-week study, 8,245 patients were randomized into 5 equal groups to receive placebo or lovastatin 20 or 40 mg once or twice daily on a double-blind basis. Only 3 cases of myopathy were observed, all in patients taking lovastatin 40 mg twice daily. The incidence of withdrawal from the study because of raised transaminases was approximately 0.1% in the placebo group vs 0.1, 0.7, 0.6 and 1.5% in patients taking lovastatin in doses of 20 mg once daily, 40 mg once daily, 20 mg twice daily and 40 mg twice daily, respectively. Lovastatin has been available in the United States since September 1987. By June 1989, the drug had been prescribed for approximately 1 million patients. Drug-attributable adverse events not observed in clinical trials (such as hypersensitivity reactions and symptomatic hepatitis) have been reported, but the incidence of each appears to be extremely low.
TL;DR: In a randomised double-masked study of 27 patients with a severe chronic idiopathic uveitis, small cumulative doses of cyclosporin proved to be nephrotoxic, but subjective tolerability for cyclOSporin was good.
Abstract: In a randomised double-masked study of 27 patients with a severe chronic idiopathic uveitis we evaluated the efficacy, safety, and tolerability of cyclosporin. All received prednisone in a low dose (0.3 mg/kg/day). In 14 patients this was combined with cyclosporin in a single daily dose of 10 mg/kg/day, while 13 patients received a placebo. The dosages were tapered off in accordance with a protocol, and we compared the number of months of successful therapy before the uveitis relapsed. The efficacy results, as expressed in a Kaplan-Meier curve, were in favour of cyclosporin. Owing to the small sample size, however, this difference did not reach statistical significance. The immunosuppressive effect of cyclosporin was not permanent, and in all but one patient the intraocular inflammation relapsed on reduction of dosage. Rather small cumulative doses of cyclosporin proved to be nephrotoxic, but subjective tolerability for cyclosporin was good.
TL;DR: The effects of the addition of lamotrigine, a novel antiepileptic drug, to the therapy of 125 patients with severe refractory epilepsy showed a marked improvement in seizure frequency, but no patient was rendered seizure-free.
TL;DR: Lamid is a new antifungal drug which can be administered orrally and is effective against a broad range of dermatomycoses and was particularly, and uniquely, effective in the most chronic form...
Abstract: Lamid is a new antifungal drug which can be administered orrally and is effective against a broad range of dermatomycoses. This report summarizes its mycological and clinical cure rates in 32 clini...
TL;DR: Ibuprofen suspension is an effective nonsteroidal antiinflammatory drug and its tolerability in children is acceptable, and a dose-response relationship was observed with respect to adverse reactions of the upper gastrointestinal tract.
Journal Article•
TL;DR: At the end of the study the selegiline group showed improvements statistically significantly superior to those obtained in the phosphatidylserine group on most of the cognitive areas examined, and of particular interest was the discovery of an increased degree of autonomy in day-to-day activities.
TL;DR: This treatment regimen was associated with a low incidence of delayed neurological dysfunction with no significant difference between the two dosage groups: three patients remained severely disabled and two moderately disabled due to vasospasm with or without additional complications.
Abstract: A European, multicenter, prospective, randomized, double-blind, dose-comparison study on preventive therapy with intravenously administered nimodipine was performed to evaluate the efficacy and tolerability of two different doses: 2 and 3 mg/h. Two hundred four patients fulfilled the criteria for enrollment in the study: surgery within 72 hours after the last subarachnoid hemorrhage, and age between 16 and 72 years. All patients who had Hunt and Hess grades of I to III were operated upon; patients who had poor Hunt and Hess grades (IV-V) were operated on according to the surgeon's choice. This treatment regimen was associated with a low incidence of delayed neurological dysfunction with no significant difference between the two dosage groups: three patients (1.5%) remained severely disabled and two (1%) moderately disabled due to vasospasm with or without additional complications. Among the patients with Hunt and Hess grades of IV or V, the long-term outcome was favorable (good-fair) for 40% and unfavorable for 60%. Among the patients with grades of I to III, the long-term outcome was favorable for 89% and unfavorable for 11%.
TL;DR: The proposed regimen is well tolerated, may be as efficient as previously advocated regimens, requires less hospitalization time and may be adopted routinely for therapy of neurocysticercosis.
Abstract: Standard therapeutic regimens of praziquantel for neurocysticercosis use daily doses of 50 mg/kg for 15–21 days, with prolonged remission being achieved in 60–80% patients. In this prospective study,
TL;DR: The design and the main therapeutic results of 3 controlled double‐blind studies comparing moclobemide with tricyclics and/or placebo in depressed patients are presented and it is shown that reversible inhibitors of MAO‐A demonstrate good efficacy independently of the diagnostic category of depression.
Abstract: The design and the main therapeutic results of 3 controlled double-blind studies comparing moclobemide with tricyclics and/or placebo in depressed patients are presented. Moclobemide, a reversible inhibitor of monoamine oxidase (RIMA), preferentially inhibits MAO-A. It showed good efficacy in major depression (DSM-III), both endogenous and non-endogenous. The 3 studies included a total of 763 patients. The therapeutic results are similar to those observed with tricyclics (2/3 good responders). Tolerability was significantly better. The onset of action was evaluated in 2 studies and was faster in the patients treated with moclobemide. The fact that reversible inhibitors of MAO-A demonstrate good efficacy independently of the diagnostic category of depression is an important new finding.
Journal Article•
TL;DR: The efficacy results for patients with the diagnosis of neurotic depression were similar for the intent-to-treat population, and safety and tolerability were evaluated for all study patients independent of diagnosis.
Abstract: Sixty-five inpatients of a psychosomatic hospital in the Federal Republic of Germany with the diagnosis of anxiety neurosis (n = 31) or neurotic depression (n = 34) as defined by the International Classification of Disease (ICD-9), were randomized to a 4-week course of ipsapirone at 7.5 mg t.i.d. or placebo in a prospective, double-blind clinical trial to assess safety, tolerability, and efficacy. This article reports the efficacy results for those patients with the diagnosis of neurotic depression. The primary efficacy variable for patients with neurotic depression was the change from baseline in the Hamilton Rating Scale for Depression (HAM-D) at 4 weeks of treatment. Considering all of the randomized patients with neurotic depression (n = 34, the intent-to-treat population), the mean change from baseline in the HAM-D at Week 4 (observed cases) was -13.13 +/- 6.06 (n = 16) for the ipsapirone group, and -3.19 +/- 5.99 (n = 16) for the placebo group (p less than .001). A parallel analysis of the change from baseline in the Core Depression score of the HAM-D (defined as the sum of items 1, 2, 3, 7, and 8) also showed a significant treatment difference (p less than .01). Results were similar for the intent-to-treat population, last observation carried forward. Safety and tolerability were evaluated for all study patients independent of diagnosis. Treatment-emergent events (n = 65) were reported by 76 percent of patients treated with ipsapirone (n = 33) and by 38 percent of patients treated with placebo (n = 32).(ABSTRACT TRUNCATED AT 250 WORDS)
TL;DR: It is concluded that moclobemide may be the second‐generation antidepressant doctors were waiting for, equally effective as the classical antidepressants but far better tolerated.
Abstract: Moclobemide, a new selective and reversible inhibitor of monoamine oxidase A (RIMA), has been compared with various tricyclic antidepressants (TCAs) in numerous controlled studies. Pooled data from these studies, comprising 1656 patients, as well as the consideration of individual trials, show that moclobemide is far better tolerated than the TCAs. Its side effects mainly comprise mild degrees of nausea and dizziness at the beginning of treatment in a small proportion of patients. Age and sex do not affect the tolerability of moclobemide: it is equally well tolerated by elderly patients. In 2300 patients treated with moclobemide in doses up to 600 mg/day, without dietary restrictions, there was no tyramine-related hypertensive reaction. It is concluded that moclobemide may be the second-generation antidepressant doctors were waiting for - equally effective as the classical antidepressants but far better tolerated.
TL;DR: Clinical data show that remoxipride has antipsychotic acticvity in patients with chronic schizophrenia, and acute exacerbation of Chronic schizophrenia, with activity on both positive and negative symptoms, and it appears to offer an important tolerability advantage over haloperidol.
Abstract: Remoxipride is a substituted benzamide of the same class as sulpiride, and has a pharmacodynamic profile consistent with central antidopaminergic activity. It is a weak, but relatively selective, central dopamine D2-receptor antagonist and appears to have preferential affinity for extrastriatal dopamine D2-receptors. It also has marked affinity for central sigma receptors. Clinical data from noncomparative and comparative studies show that remoxipride has antipsychotic acticvity in patients with chronic schizophrenia, and acute exacerbation of chronic schizophrenia, with activity on both positive and negative symptoms. Its overall efficacy in these studies was similar to that of haloperidol. Importantly, however, remoxipride produced a substantially lower incidence of extrapyramidal effects than haloperidol. Further long term comparative studies are required to ascertain the relative suitability of remoxipride for preventing relapse in psychotic patients, and to determine whether tardive dyskinesia occurs in remoxipride recipients--the latter has not been reported with remoxipride to date. Thus, while further experience (particularly of a long term comparative nature) is needed, at present remoxipride appears to offer an important tolerability advantage over haloperidol.
Journal Article•
TL;DR: Selegiline therapy led to a global improvement in the capacity for the processing, storage, and retrieval of given information and was far more effective than L-acetylcarnitine with respect to the degree of improvement.
TL;DR: Results from a very small number of preliminary studies have suggested that oral bendazac lysine can stabilise the progression of lens opaciflcation in patients with cataract, and further clinical studies are required to fully establish its value in the management of this condition and its long term tolerability.
Abstract: Bendazac is an oxyacetic acid with anti-inflammatory, antinecrotic, choleretic and antilipidaemic properties, but its principal effect is to inhibit the denaturation of proteins. The lysine salt, which is better absorbed than the parent compound after oral administration, has been evaluated as a treatment for cataract, a condition which appears to result mainly from the denaturation, aggregation and precipitation of proteins within the lens. Results from a very small number of preliminary studies using objective photographic and densitometric methods have suggested that oral bendazac lysine, usually at a dosage of 500 mg 3 times daily, can stabilise the progression of lens opacification in patients with cataract. Significant improvements in individual and mean visual acuities in treated patients have been reported by several studies, but this parameter is not universally accepted as a reliable index of lens status. Preliminary studies evaluating bendazac lysine 0.5% eyedrops have reported comparable results to those obtained with oral treatment. Overall, tolerability of the drug has been good in studies to date. A dose-related laxative effect and other gastrointestinal disturbances are the most common adverse effects associated with oral therapy, and a transient burning sensation is the most commonly reported symptom occurring with eyedrop application. Bendazac lysine is one of a number of agents which have been introduced for the management of cataract. Although the results of preliminary studies have suggested that the drug may be useful for delaying the progression of cataract, further clinical studies using proven objective methods are required to fully establish its value in the management of this condition and its long term tolerability.
TL;DR: No clear relationship between withdrawal due to an adverse event attributed to sulphasalazine and the nature of the concomitant non-steroidal anti-inflammatory drug was identified.
Abstract: One thousand three hundred and eighty-two patients with rheumatoid arthritis requiring second-line therapy at 108 centres were entered into an open 6-months prospective tolerability study of enteric-coated sulphasalazine 2 g/day (Salazopyrin EN-tabs). Clinical and laboratory variables were measured, any adverse reactions and the reasons for withdrawal of medication were recorded. The outcome of therapy was known in 87.5% of patients entered of whom 65% continued with sulphasalazine beyond the 6-month study period. 3.2% withdrew for reasons unrelated to treatment, 5% for lack of effect and 26.8% due to an adverse event; gastrointestinal/central nervous 66.6%, rash 15.4%, haematological 5.1%, hepatic 4.7% and miscellaneous 8.1%. 1.2% of patients experienced potentially serious reactions: anaphylactic, haematological and hepatic. The majority of adverse events occurred early and were reversible upon cessation of medication. No clear relationship between withdrawal due to an adverse event attributed to sulphasalazine and the nature of the concomitant non-steroidal anti-inflammatory drug was identified.
Journal Article•
TL;DR: Analysis of the results demonstrates that, at the dosage used, selegiline is more effective than oxiracetam in improving higher cognitive functions and reducing impairment in daily living.
TL;DR: There was a significant reduction in depressive symptoms severity in both groups and that fluvoxamine was significantly more effective than imipramine in reducing suicidal ideas and anxiety/somatic symptoms.
Abstract: SummaryA double-blind, controlled study was carried out in 20 patients diagnosed as suffering from depressive disorder according to DSM-III criteria to compare the effectiveness and tolerability of fluvoxamine, a serotonin re-uptake inhibitor, with that of imipramine. Patients were allocated at random to receive one or other drug for a period of 4 weeks, dosage starting at 50 mg for the first 3 days and increasing to 100 mg daily for a further 3 days. Dosage was continued at this level for the remainder of the trial but was increased, if necessary, to 150 mg daily in two divided doses. Assessments of symptom severity were made on entry and response after 1, 2 and 4 weeks of treatment using the Hamilton Rating Scale for Depression, the Clinical Global Impression and a Visual Analogue Scale. Tolerability was assessed using the Dosage Record and Treatment Emergent Symptom Scale. The results showed that at the end of the trial there was a significant reduction in depressive symptoms severity in both groups an...
TL;DR: Although clarithromycin and erythromycin were comparable in terms of efficacy, clarithroitcin was better tolerated and the severity of adverse events was greater for the patients treated with erystromycin, necessitating the discontinuation of therapy in 8 (6.7%) patients.
Abstract: The efficacy and tolerability of clarithromycin and erythromycin stearate in the treatment of documented Group A beta-haemolytic streptococcal pharyngitis were compared in a single-centre, open, out-patient study. One hundred and twenty patients were randomly assigned to each treatment group. Dosage of clarithromycin and erythromycin was 250 mg twice daily and 500 mg twice daily, respectively; each patient was given a 10-day supply of medication. Clinical success (cured or improved) was observed in 111 (96.5%) of 115 and in 108 (93.9%) of 115 clinically-evaluable patients treated with clarithromycin and erythromycin, respectively. Eradication of the pathogen occurred in 108 (97.3%) of 111 and in 98 (92.5%) of 106 bacteriologically-evaluable clarithromycin and erythromycin patients, respectively. Adverse events reported by 7 (5.8%) of the clarithromycin-treated and by 12 (10%) of the erythromycin-treated patients included epigastritis and nausea and vomiting. In general, the severity of adverse events was greater for the patients treated with erythromycin, necessitating the discontinuation of therapy in 8 (6.7%) patients treated with erythromycin as opposed to 1 (0.8%) patient treated with clarithromycin. Although clarithromycin and erythromycin were comparable in terms of efficacy, clarithromycin was better tolerated.
TL;DR: Clarithromycin was comparable to amoxycillin with respect to clinical efficacy and tolerability and offers a useful addition to the available therapies for the treatment of acute maxillary sinusitis.
Abstract: The efficacy and tolerability of clarithromycin and amoxycillin in the treatment of acute maxillary sinusitis were compared in an open, Phase III multi-centre study. Sixty-one out-patients (40 males, 21 females) received clarithromycin (two 250 mg tablets twice daily) and 59 (34 males, 25 females) out-patients received amoxycillin (two 500 mg capsules twice daily). Fifty-seven and 47 patients in the clarithromycin group were evaluable for clinical efficacy and bacteriological effectiveness, respectively. In the amoxycillin group, 57 and 40 patients were evaluated for clinical efficacy and bacteriological effectiveness, respectively. Body temperature, bacteriological culture results, blood and urine chemistries, and clinical signs and symptoms were evaluated prior to drug administration, between Days 4 to 6 and between Days 9 to 11 of treatment, and within 48 hours and, if required, 6 weeks after the end of treatment. Clinical signs and symptoms improved significantly (p less than 0.001) in both treatment groups. When evaluated within 48 hours after the end of treatment, there was no significant difference between the clinical success rate for clarithromycin (91%) and amoxycillin (84%) nor in the number of patients whose original pathogen was eradicated (89% clarithromycin, 93% amoxycillin). Six patients reported adverse events, 2 with clarithromycin (urticaria, gastro-intestinal) and 4 with amoxycillin (2 urticaria, 2 gastro-intestinal). Clarithromycin was comparable to amoxycillin with respect to clinical efficacy and tolerability and offers a useful addition to the available therapies for the treatment of acute maxillary sinusitis.