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Reduction of weight can be assumed as surrogate parameter for a beneficial cardiovascular (CV) outcome and current EMA guidance phentermine on medicinal products used in weight control does not require demonstration of a positive effect on CV morbidity and mortality prior to approval .
However, weight reducing agents with a mechanism of action with a detrimental influence on heart rate, such as Qsiva, or on other cardiovascular parameters, may require further exclusion of a phentermine user reviews phentermine no weight loss adipex the weight loss drug that can kill you harmful CV effect .
Cardiovascular safety – The CHMP had methodological concerns with regard to the quality of the data source (with dropout rates of about 40%, and lost to follow duromine pills nz phentermine get you high phentermine 37.5 cut in half can adipex and lexapro be up rate above 10%) and the magnitude of the dose-dependent increase in heart rate (as heart rate measurement was not an end point in the Qsiva clinical program and no standardised methodology for accurate assessment was implemented) .
The Applicant presented phentermine hazard ratios for major cardiovascular events in Qsiva-treated subjects .
Although these showed no obvious increased frequency of events with treatment, the adipex-p amazon phentermine dosage increase phentermine hcl to buy is prozac and phentermine okay to data are of limited value as the duration of follow-up was relatively short and the total number of events was small .
Therefore, the lack phentermine of power, and thus reliability, of the post-hoc analysis of cardiovascular events during the Qsiva clinical development program remains a major concern, since with a total number of 1526 patients of low CV risk treated for one year the expected rate of CV events is extremely low and thus of little significance for the assessment of the CV risk .
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