New cholesterol drug shows promise

Conclusion Media headlines reporting on this phase I trial concentrated on the secondary outcome (that ALN-PCS reduced LDL cholesterol levels). However, these results will need to be confirmed during phase II and phase III clinical trials, which will involve more participants who would normally receive cholesterol-lowering treatment. While it is tempting to focus on the results of the cholesterol levels, phase I clinical trials are designed to test the safety of a new drug to make sure it is safe enough to test further. They also aim to determine what the highest tolerable dose is, so the appropriate one can be used in later studies. For those reasons, they involve testing the drug in a small group of healthy individuals. The researchers note (although no media outlets seemed to report on this aspect of the study) that the study was too small to detect statistically significant changes in PCSK9 or LDL cholesterol levels compared with placebo group. The results of this study will be used to design further phase II and phase III trials, which will further characterise the safety profile of the drug and determine its effectiveness at reducing LDL cholesterol among people who need cholesterol-lowering medications. Only then can we determine whether the drug offers an effective option for managing high LDL cholesterol. While perhaps less immediately interesting from the general public’s perspective, one of the more exciting aspects of this research is that it is the first tim...
Source: NHS News Feed - Category: Consumer Health News Tags: Heart/lungs Medical practice Medication Source Type: news