Pharmaceutical compositions for combination therapy
This invention relates to the use of pharmaceutical compositions comprising a therapeutically effective combination of Tesofensine and Metoprolol for preventing the cardiovascular side effects of Tesofensine, while leaving the robust inhibitory efficacy on food intake and body weight loss unaffected.
1. A method of treating obesity in a human comprising a human
administering to the human, an amount of Tesofensine, or a pharmaceutically acceptable salt thereof; effective to decrease the body mass index of the human,
in combination with an amount of Metoprolol, or a pharmaceutically acceptable salt thereof, effective to treat the cardiovascular side effects of Tesofensine;
wherein the combination is effective in decreasing the body mass index of the human.
2. The method according to claim 1 , wherein Tesofensine is dosed in a range of from about 0.1 to about 1 mg API daily.
3. The method according to claim 1 , wherein Metoprolol is dosed in a range of from about 25 to about 200 mg API daily.
4. The method according to claim 1 , wherein the body mass index of the human is above 30 kg/m 2 .
5. A pharmaceutical composition comprising
an amount of Tesofensine, or a pharmaceutically acceptable salt thereof, that is effective in decreasing the body mass index of a human; and
an amount of Metoprolol, or a pharmaceutically acceptable salt thereof, that is effective in treating the cardiovascular side effects of Tesofensine;
together with one or more adjuvants, excipients, carriers and/or diluents.
6. A kit of parts comprising at least two separate unit dosage forms (A) and (B), wherein
(A) comprises Tesofensine, or a pharmaceutically acceptable salt thereof, in an amount that is effective in decreasing the body mass index of a human; and
(B) comprises Metoprolol, or a pharmaceutically acceptable salt thereof, in an amount that is effective in treating the cardiovascular side effects of Tesofensine;
and optionally
(C) instructions for the simultaneous, sequential or separate administration of the Tesofensine of (A) and the Metoprolol of (B), to a pre-obese human, an obese human, or a morbid obese human for reducing body mass index.
7. The method of claim 1 , wherein the body mass index of the human is between 25 and 30 mg/m 2 .
8. The method of claim 1 , wherein the body mass index of the human is above 35 mg/m 2 .
9. The method of claim 1 , wherein the obese human is a pre-obese human, an obese human, or a morbid obese human.