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Generic valtrex discontinued therapy because of an adverse event; no deaths occurred. 4.3 Clinical Studies 4.3.1 Txuloxale (Solubil) In three clinical studies, Txuloxale was used in the treatment of acute coronary syndrome (acute myocardial infarction) and acute coronary syndrome left ventricular hypertrophy in patients with coronary artery disease. These studies were of short duration (<4 months) and did not report the dose response. In a double-blind, placebo-controlled trial, Txuloxale was used in the treatment of acute coronary syndrome in patients with symptomatic acute coronary syndrome and artery disease. In the treatment arm, Txuloxale, at doses of 5.9 mg/day, 6.0 and 8.0 was equivalent in terms of safety parameters at week 4. In the treatment arm, mean increase in systolic blood pressure following treatment was 1.3 points. At week 4, a total of 27 subjects (8 with acute coronary syndrome and 21 with artery disease) remained on Txuloxale. The maximum dose of Txuloxale was 8.0 mg/day and the dose was tapered over time to reach 0.2 mg/day. In the treatment arm, all patients improved; most of these had previously received angiotensin-converting enzyme (ACE) inhibitors. All subjects were also able to complete the treatment process and mean time to initial return of blood pressure was 6.1 months in the Txuloxale arm versus 9.0 months in the placebo arm. study was stopped early when the primary efficacy endpoint was attained. In a similar double-blind, placebo-controlled trial, Txuloxale was used in the treatment of acute coronary syndrome and left ventricular hypertrophy in patients with coronary artery disease. In this study, no treatment effect was observed on systolic blood pressure any treatment day compared with the placebo group. No increase in the blood pressure measured on days 4 or 8 was seen in the Txuloxale arm. In a double-blind, randomized, placebo-controlled study, Txuloxale was used in the treatment of acute coronary syndrome in patients with symptomatic acute coronary syndrome and artery disease. This study compared the effect of treatment with either Txuloxale or Placebo on patients' left ventricular function. No significant difference was seen between Txuloxale and Placebo within any of the treatment groups (Table IV). Patients randomized to Txuloxale experienced a mean increase in systolic blood pressure of 1.3 vs 0.5 points from baseline for 24 hours (p = 0.0008). The maximum dose of Txuloxale was 4.0 mg/day, which tapered over time to achieve an average of 0.5 mg/day and then 0.1 over the duration of study. maximum dose Txuloxale was reduced throughout the study to 0.5 and valtrex generic alternative 0.1 mg/day, respectively, following completion of the treatment. In a 5-month prospective, randomized, placebo-controlled trial, patients were randomized to receive 20 mg (Txuloxale), 40 (Placebo), or a combination of 20 mg and 40 Txuloxale or placebo. Patients randomized to 20 mg or 40 Txuloxale (a dosage of 4.0 mg/day plus 1-mg/day for the first 72 hours) experienced an average increase in systolic blood pressure of 1.2 vs 1.0 points compared with the placebo arm, a reduction in mean left ventricular end-diastolic diameter by 1.2 cm (p = 0.0003) and a mean reduction in left ventricular end-systolic diameter of 1.0 cm (p = 0.0006). Patients randomized to 40 mg Txuloxale for the first 72 hours experienced a significant increase in left ventricular end-diastolic diameter of 1.5 cm (p = 0.01). 5.0 Other Comments 5.1 Contraindications Sudden death and life-threatening events may occur with concomitant use of thiazolidinediones, anticoagulants, calcium channel blockers, diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, calcium channel antagonists, and nitrates. 5.2 Dosing Treatment should be initiated and titrated as either 0.5 mg/day for days 1 through 7 or 1.0 mg/day thereafter based on responses to therapy. Discontinuation of treatment should be considered with each dose change.
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