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In an open study that was conducted in general practice, 22 patients with previously-untreated mild hypertension received an average daily dose of 11.7 mg of pindolol over a 50-week study period. The total cholesterol, high-density lipoprotein fraction and plasma triglyceride levels showed no significant change from baseline values at the conclusion of this period.

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Use of the whole-embryo culture system in drug safety assessment?

Toxicol In Vitro

October 2012

Toxicology Department, Drug Safety Assessment, Sandoz Ltd, CH-4002 Basel, Switzerland.

The embryotoxicity and, in particular, the teratogenic potential of three new drug combinations were investigated. The interactions of the single components (all already on the market) in the different drug mixtures were determined by testing the single components in addition to the drug combinations. In order to evaluate the usefulness of these results for safety assessment, the no-effect concentrations (NEC) of the single compounds or the mixed drug preparations, with respect to embryonic growth and differentiation and the presence of anomalies, were compared with human plasma/serum levels during therapeutic use.

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The effects of clopamide, pindolol and its combination on plasma lipids in 49 hypertensive patients (WHO I-II), divided into three parallel randomized groups, were studied over a 6 months period. Total cholesterol, triglycerides, HDL and LDL cholesterol fractions were determined twice during an initial 4-week washout phase, and after a 1-, 3- and 6-month active hypotensive drug phase. Patients were instructed to maintain their usual dietary habits.

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Two fixed combinations of beta-blockers and diuretics, penbutolol plus furosemide and pindolol plus clopamide, were compared with respect to efficacy, safety, and tolerability in hypertensive out-patients. The two preparations were equally effective in reducing blood pressure when given as a single daily dose. Doubling the dosage for those patients who responded poorly did not improve therapeutic response.

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This study compared the efficacy of a beta-blocker, pindolol, and a diuretic, clopamide, plus a vasodilator, endralazine, in the treatment of 30 patients suffering from moderate-to-severe hypertension. Different doses of endralazine were tested. This study showed that hypertension was controlled in 76,7% of patients receiving a combination of pindolol 10 mg and clopamide 5 mg (Viskaldix; Sandoz) plus endralazine 5 mg, and in 90% it was controlled by a combination of pindolol 10 mg, clopamide 5 mg and endralazine 10 mg daily.

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