Statins Not Linked to Earlier Death Among ALS Patients in Registry Study

Statins, often prescribed to lower cholesterol levels, are not associated with poorer overall survival in people with amyotrophic lateral sclerosis (ALS) and should not be discontinued on that basis, a German study has found.

The study, “Statins, diabetes mellitus, and prognosis of Amyotrophic Lateral Sclerosis: data from 501 patients of a population based registry in Southwest Germany,” was published in the European Journal of Neurology.

ALS patients often have high levels of cholesterol, low-density lipoproteins (LDL, “bad” cholesterol), and free fatty acids. In addition, metabolic disorders like type 2 diabetes and dyslipidemia — a condition in which blood levels of fatty molecules (lipids), including cholesterol and triglycerides, are excessively high — are also found to be relatively common in these people.

A previous study reported that ALS patients who have high blood levels of fatty molecules lived up to one year longer compared to those who did not, suggesting that dyslipidemia could be somewhat beneficial with ALS.

“Based on the assumption that high serum lipid levels are a possible positive prognostic factor, a potential effect of statins on survival has been discussed as well,” researchers wrote, adding that “lipid‐lowering drugs such as statins could have a negative effect accordingly.”

However, study findings have been inconsistent and no definite conclusions were drawn regarding the possible relationship between statins and patient survival.

A possible association between type 2 diabetes and the later onset of ALS is also suspected, based on patient data stored in large population registries. This potential link has never been confirmed.

To investigate the possible association between statin use and survival, and diabetes with disease onset and survival, researchers at the University of Ulm analyzed patient data stored in a German population-based ALS-registry called Swabia.

Data covered 501 ALS patients — 293 men and 208 women, with a mean age of 65.2 — who enrolled in the registry between October 2010 and April 2016.

All information, including demographic and clinical data, medical history and medication use, were collected through an interview-based questionnaire. The questionnaire was given at the time each patient was added to the registry, which happened within two to six months after being diagnosed with ALS.

At the time of registry inclusion, 65 (13.0%) patients were taking statins, and 59 (11.8%) had diabetes.

Among the 65 statin users, the majority was on simvastatin (83%), followed by atorvastatin (9%), pravastatin (5%), and fluvastatin (3%).

The median survival of ALS patients on statins was 29.2 months (2.4 years), and 32.3 months (2.7 years) among those not taking them.

Statistical analyses found that neither statin use nor the medication’s dosage were related to overall survival. Likewise, diabetes was not found to be associated with patients’ overall survival.

However, analyses found that diabetes did associate with a later onset of ALS, with diabetic patients developing the condition about 4.2 years, on average, later than those who were not diabetic.

Additional analyses also showed that patients who had higher (more than 27.0 kg/m²) body mass index (BMI) values at registry entrance tended to live longer — about five months longer — than those who had lower BMI values (less than 22.0 kg/m²).

These findings confirm “the protective role of a high BMI and are in line with our findings regarding DM [diabetes mellitus],” the researchers wrote.

They noted that “statins did not affect overall survival, suggesting that they do not induce a negative disease-modifying effect in ALS [and therefore] … may be continued in ALS.”

The team added that later ALS onset in diabetic patients indicates “a potential protective role of the metabolic profile associated with type 2 [diabetes] as suggested by previous studies.”

“However, further studies including an appropriate control group are needed to confirm these observations,” they concluded.