Showing papers on "Tolerability published in 1981"

A double‐blind comparison of carbamazepine and clomethiazole in the treatment of alcohol withdrawal syndrome

Abstract: The efficacy and tolerability of carbamazepine and clomethiazole in the treatment of alcohol withdrawal symptoms were compared in a double-blind study with 68 hospitalized patients. Target withdrawal symptoms, the patient's subjective feeling and unwanted effects were recorded daily during the 1 week-treatment period. No significant differences between the two treatments could be demonstrated in the parameters studied. It appears that carbamazepine, which is widely used as an antiepileptic drug, well tolerated and not likely to produce any addiction as such, might offer a valuable alternative treatment for the symptoms of alcohol withdrawal.

Praziquantel in the treatment of mixed S. haematobium and S. mansoni infections.

Abstract: A randomized single blind stratified study involving 153 patients with mixed S. mansoni and S. haematobium infection showed that 2-cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one (praziquantel, EMBAY 8440, Biltricide) is effective in giving high cure rates in each infection separately, 66% (64 patients) and 77% (94 patients), respectively. The complete clearance of both infections (i.e., no eggs whether dead or alive) 6 months after treatment was 29% (43 patients). The side effects of the drug were minimal and transient, the most common being gastrointestinal ones. The assessment of the objective tolerability by clinical, haematological and biochemical tests showed also that the drug was very safe. It is thus concluded that the drug is a promising useful tool in the control of schistosomiasis in general and the treatment of the individual.

The treatment of high blood pressure in the elderly: A multi-centre evaluation of a fixed combination of metoprolol and hydrochlorothiazide ('Co-Betaloc') in general practice

Abstract: A post-marketing surveillance programme was carried out in general practice to evaluate the efficacy and tolerability of a fixed-dose combination of 100 mg metoprolol and 12.5 mg hydrochlorothiazide in the treatment of mild to moderate hypertension, with particular reference to elderly patients. Patients received a single daily dose over a period of 3 months. The results of the analysis of data from 1446 patients showed that, although the initial blood pressure was higher in the elderly, both the systolic and diastolic pressures were reduced by the same degree after 3-months' treatment, regardless of age. The incidence of side-effects was similar in all age groups, although a higher proportion of these side-effects led to treatment withdrawal in the elderly, possibly reflecting an increasing overall intolerance to drugs with age. The results suggest that treatment with the metoprolol/hydrochlorothiazide combination is effective and well tolerated in the majority of hypertensive patients, irrespective of age or previous antihypertensive therapy.

A double-blind comparison of nomifensine and amitriptyline in the treatment of depression.

Abstract: A double-blind study was carried out to compare the efficacy and tolerability of nomifensine and amitriptyline in 17 Malaysian patients with moderate to severe depression. The two drugs did not differ with regard to antidepressant effect but nomifensine-treated subjects report fewer side-effects with no complaints of palpitations. Nomifensine also increases capacity for work and activity.

Trial designs for multicentre clinical studies of investigational phases I B to III with praziquantel.

Abstract: Following very promising results with 2-cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a] isoquinolin-4-one (praziquantel, EMBAY 8440, Biltricide) in animal experiments on toxicity and efficacy and after confirming excellent tolerability in healthy volunteers, WHO could be won over to the further clinical development of this compound. In close cooperation trial protocols and case report sheets standardised as far as possible were set up for intercontinental multicentre trials in investigational phases II A, II B, and III, respectively. Thus, in investigational phase II A, studies were conducted simultaneously in Africa, Asia and South America. In all those endemic areas not only good tolerability in patients but also high efficacy against local Schistosoma species could be confirmed in double blind trials. In the extended phase II B, patients were allotted to 3 strata of different intensity of infection in order to find out if differentiating dosages would be necessary according to degree of worm burden, patient's age, and occurrence of more frequent and/or severe adverse reactions in patients with hepatolienal complications. There is not yet a satisfactory answer to all of these questions. In the investigational phase III already under way we hope to fill those gaps and also to find the optimum dosage for large scale use under field conditions. The profile of praziquantel, however, has already been established to an extent that first community health projects have been successfully started and others are in an advanced stage of planning.

A controlled trial to compare the therapeutic effects of dapsone in combination with daily or once-monthly rifampin in patients with lepromatous leprosy.

Abstract: In this controlled trial in 35 patients with lepromatous leprosy the therapeutic effects of adding rifampin 450 mg daily (Regimen A) or 1200 mg once a month (Regimen B) to a standard dapsone regimen of 50 mg daily were practically identical. Moderate to marked clinical improvement was observed in 88% and 83% of the patients treated with Regimens A and B respectively. The average rates of decrease in the MI of the skin smears and nose-blow smears were similar. The average decreases in the BI of the skin smears were 0.7 and 0.6 in patients on the Regimen A and B respectively. Following 6 months' treatment with Regimens A and B the average decreases in the Logarithmic Bacterial Indexes of Biopsies were 4.7% and 7% respectively. The once-monthly rifampin schedule was well tolerated and did not lead to "flu" syndrome, anuria, oliguria, hemolytic anemia, thrombocytopenia, or anaphylactic shock. This trial revealed the satisfactory efficacy, good tolerability, and practicability of a supervised once-monthly 1200 mg single oral dose rifampin schedule as a component of combination regimes for the initial treatment of patients with lepromatous (LLs and LLp) leprosy.

[Comparative double-blind study on ciclopiroxolamine cream and placebo cream in dermatophytoses (author's transl)].

Abstract: In a controlled double-blind study involving 60 patients with dermatophytosis, cream containing 1% 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt (ciclopiroxolamine, Cic, Hoe 296, Batrafen cream) was compared with vehicle as to effectiveness and tolerability. Each treatment was applied to 30 patients, the compounds being assigned at random to be used for 21 days per patient. Assessed on clinical, cultural and microscopical findings. Cic cream proved to be significantly more effective than vehicle. Under the application of Cic cream, all (100%) of the cultures and native preparations became free of fungi (negative), whereas with vehicle only 27% and 23% negative cultures and native preparations, respectively, were obtained. The skin symptoms showed significantly more improvement with Cic cream than with vehicle. All 60 patients completed the study. No side effects occurred.

Tolmetin sodium in clinical practice: a survey of 32,207 treated patients.

Abstract: A total of32,207 patients with various rheumatic disorders were treated with the non-steroidal antiphlogistic tolmetin in the courseof a post-marketing survey performed in Italy with the co-operation of 4,205 general practitioners. The treatment proved effective in about 90%ofpatients treated. The tolerability of the drug was excellent or good in 91%of cases. Side­ effects involving mostly thegastro-intestinal tract occurred in 12 ·3% ofcases, but treatment was discontinued inonly 3 ·6% ofpatients. The results confirm the remarkable therapeutic activity and the good tolerabilityof tolmetin sodium.

Broncaspin in the therapy of pediatric diseases of the respiratory tract

Abstract: A paediatric suspension of Broncaspin was administered to 32 children aged 2-12 yr hospitalised for acute respiratory infection of the respiratory apparatus or hyperpirexia with no evident location. The drug was given as the sole treatment in 9 cases, whereas combination with antibacterial drugs proved indispensable in the other 23 cases. The satisfactory results obtained, together with its excellent tolerability, show that the new preparation is active, and is capable of rapidly eliminating the symptoms, so that the general clinical picture is both evidently and persistently improved.

Long-term treatment of hypertension with methyldopa. VIII. Overview.

Abstract: A multiclinic retrospective study in patients who received methyldopa, some for up to 10 years, has provided a large body of long-term data on the efficacy and tolerability of the drug as part of an antihypertensive regimen. Blood pressure and dosage data were analyzed over the first 4.5 years. The results of this survey are summarized here.

Efficacy and tolerability of CGP 9,000 ("Oraspor') in diabetic patients treated for urinary tract infections: a case control study.

Abstract: The new semi-synthetic oral cephalosporin, CGP 9,000, has been evaluated in a large number of hospitalized patients with urinary infections. A total of 57 of these patients suffering from concomitant diabetes was matched with an equal number of non-diabetic patients. Patients were treated for 10 days with either 500 mg or 1.0 g CGP, or 1.0 g cephalexin. The predominant pathogens isolated were E. coli, Strep. faecalis, Proteus mirabilis and Klebsiella spp. Comparison of the results showed that the eradication rate was similar in diabetic and non-diabetic patients and there were no significant differences between the three treatment groups. There was a similar improvement in pyuria, and therapeutic response was equally as good in diabetic patients on 500 mg CGP 9,000 per day as in non-diabetic patients and in the other treatment groups. No unwanted effects on renal function were observed in the high-risk diabetic group.

Long-term treatment of hypertension with methyldopa. III. Tolerability.

Abstract: Tolerability data recorded during long-term administration of methyldopa are presented here. Since diuretics and other antihypertensive agents were frequently coadministered with methyldopa, no attempt was made to assign possible drug relationships for any particular adverse effect. The most common clinical adverse effects among the entire study population were drowsiness and dizziness. Impotence was reported by 16% of 258 men.

[Study on the tolerability of high doses of praziquantel in Laotians with parasitic liver infections (author's transl)].

Abstract: 41 patients (20 females and 21 males aged from 8 to 68 years) were prescribed 2-cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one(praziquantel, EMBAY 8440, Biltricide) at a dose of 25 mg/kg body weight given three times on a single day at intervals of 4 h, for the treatment of opisthorchiasis. Clinical as well as biological tolerance was followed up very closely, first during a hospitalization period of 6 days, then on day 20, 40, 90 or more after treatment. None of the biological controls consisting of a total of 47 parameters (haematological, biochemical, urinary) showed any variation from before to after treatment. Clinical examinations, recorded in very carefully prepared case report sheets, served for systematically screening general signs and symptoms (fever, headache, etc.), digestive manifestations or neurological signs. Tolerability was absolutely perfect in 10 patients. In the remaining 31 cases the following signs were observed: lassitude or vertigo (15 times), headache (14 times), drowsiness and nausea (5 times), epigastric pain (9 times), arthralgia-myalgia (3 times), sweating (1 time). All these signs lasted one or two days only and were of weak or moderate intensity, thus allowing the conclusion that even at higher dosages tolerability to praziquantel is excellent.