rolark
05-18-2007, 12:37 PM
This was in a newsletter from ALS Association I get monthly.
Paul Gordon, M.D., at Columbia University working with Robert Miller, M.D., and colleagues in the Western ALS Study Group, presented a Phase III trial of minocycline that showed an adverse effect in the primary outcome, the ALS functional rating scale (ALSFRS). This was a statistically significant difference with treated patients showing a 24% more rapid decline by this self-reported rating of activities of daily living. Not statistically significant, but accompanying this decline, was a 15% more rapid loss of breathing ability measured by the forced vital capacity (FVC, a breathing measure) and 14 % more accelerated loss of strength by manual muscle testing. No change appeared in survival time or need for tracheotomy or extensive non-invasive aid to breathing.
With the treatment there were increased reports of dizziness, diarrhea and headache. Weight loss did not accelerate in treated patients. Minocycline worsens self-rated function in ALS, according to the ALSFRS, but survival and other measures of quality of life were not statistically different, said Gordon, noting that the findings provide a word of caution in prescribing open label medications.
Paul Gordon, M.D., at Columbia University working with Robert Miller, M.D., and colleagues in the Western ALS Study Group, presented a Phase III trial of minocycline that showed an adverse effect in the primary outcome, the ALS functional rating scale (ALSFRS). This was a statistically significant difference with treated patients showing a 24% more rapid decline by this self-reported rating of activities of daily living. Not statistically significant, but accompanying this decline, was a 15% more rapid loss of breathing ability measured by the forced vital capacity (FVC, a breathing measure) and 14 % more accelerated loss of strength by manual muscle testing. No change appeared in survival time or need for tracheotomy or extensive non-invasive aid to breathing.
With the treatment there were increased reports of dizziness, diarrhea and headache. Weight loss did not accelerate in treated patients. Minocycline worsens self-rated function in ALS, according to the ALSFRS, but survival and other measures of quality of life were not statistically different, said Gordon, noting that the findings provide a word of caution in prescribing open label medications.
