Cell Physiol Biochem. 2016;39(2):565-72. doi: 10.1159/000445648. Epub 2016 Jul 11.

two phase II randomised, double-blind, placebo-controlled studies.

CF patients

Patients were treated with 25 mg amitriptyline twice daily, i.e. a total dose of 50 mg/d. After those two studies part of the patients used amitriptyline in an off-lable-use for routine treatment. These patients were observed after one, two and three years after continuous use of amitriptyline and were matched with those patients who were not treated. These patients were used as a control group.

FEV1; weight.

After one year of treatment, forced expiratory volume in 1 sec predicted (FEV1) increased significantly by 7.6+/-7.0%, p=<0.001, and weight increased by 2.1+/-2.3kg, p=<0.001 in the amitriptyline population (n=20), whereas FEV1 decreased significantly in the control group by 1.8+/-3.3%, p=0.010, and weight increased by 1.1+/-2.7kg, p=0.010 (n=14). After two years of treatment, FEV1 increased significantly by 5.6+/-10.3%, p=0.009, and weight increased by 3.6+/-2.9kg, p=<0.001 in the amitriptyline population (n=12). In contrast, FEV1 decreased in the control group by 2.1+/-3.7%, p=0.051 and weight increased by only 0.4+/-2.9kg, p=0.31 (n=10). After three years of treatment, FEV1 increased significantly by 7.7+/-8%, p=0.050, and weight increased by 7.3+/-3.8kg, p=0.016, in the amitriptyline population (n=5), whereas FEV1 decreased in the control group by 1.0+/-1.3%, p=0.075 and weight increased by 0.4+/-1.5kg, p=0.29 (n=5).

Amitriptyline significantly increases FEV1, reduces ceramide in lung cells and increases weight of CF patients.