SAN DIEGO (Reuters) Jun 27 - A new type of diabetes pill being developed by Bristol-Myers Squibb and AstraZeneca was effective in a two-year study but more bladder and breast cancers have been found in patients treated with the drug.
In all studies so far completed, 1.4% of patients treated with dapagliflozin developed some type of cancer, compared with 1.3% of patients in the control group, said Elisabeth Bjork, vice president of development for dapagliflozin at AstraZeneca.
Nine bladder cancers have been observed in 5,478 patients treated with the experimental drug, compared with one bladder cancer seen in the 3,156 patients in control groups.
Six of the 10 had hematuria at baseline. Five were diagnosed with bladder cancer within a year after enrollment.
The companies also said nine cases of breast cancer have occurred in 2,223 women on dapagliflozin and one has been observed out of 1,053 women in control groups. All were diagnosed within a year after studies started.
ISI Group analyst Mark Schoenebaum said the timing of diagnosis within a year of therapy initiation and hematuria at baseline could be mitigating factors but the cancer findings are sure to be discussed by regulators.
Bjork said studies of dapagliflozin in animals found no carcinogenic signals.
"Importantly, overall cancers are not imbalanced," she said.
Bristol and AstraZeneca filed earlier this year for U.S. and European regulatory approval of dapagliflozin. An advisory committee to the U.S. Food and Drug Administration is set to review the application on July 19.
It is potentially the first in a new class of diabetes drugs designed to block glucose from being absorbed into the bloodstream through the kidneys, allowing more sugar to be excreted with urine.
Dapagliflozin leads to more sugar in the urine, which may serve as a nutrient for bacteria and pathogens that can cause infections, said Elisabeth Svanberg, vice president of development for dapagliflozin at Bristol-Myers.
In a two-year trial, urinary tract infections developed in 8% of type 2 diabetics treated with a placebo and metformin, 8% of patients on a 2.5 mg dose of dapagliflozin plus metformin, 8.8%t of patients on a 5 mg dose and 13.3% of patients receiving dapagliflozin 10 mg.
Genital infections were seen in 5.1% of patients receiving placebo plus metformin, compared to 11.7% for patients on the lowest dose of dapagliflozin plus metformin, 14.6% of patients on the 5 mg dose and 12.6% of patients on the 10 mg dose.
Other side effects included back pain, influenza, diarrhea, headache, nasopharyngitis, upper respiratory tract infection, renal impairment or failure and events of hypoglycemia, according to data presented at the annual meeting of the American Diabetes Association.
Events of renal impairment or failure were reported in 1.5% of patients treated with placebo plus metformin, compared to 4.4% of patients on the lowest dose of dapagliflozin.
The 546-patient trial showed that the experimental drug resulted in greater and sustained improvements in glycemic control and sustained reductions in body weight compared to placebo, according to Cliff Bailey, head of diabetes research at Aston University, in Birmingham, England, and the study's lead investigator.
In all studies so far completed, 1.4% of patients treated with dapagliflozin developed some type of cancer, compared with 1.3% of patients in the control group, said Elisabeth Bjork, vice president of development for dapagliflozin at AstraZeneca.
Nine bladder cancers have been observed in 5,478 patients treated with the experimental drug, compared with one bladder cancer seen in the 3,156 patients in control groups.
Six of the 10 had hematuria at baseline. Five were diagnosed with bladder cancer within a year after enrollment.
The companies also said nine cases of breast cancer have occurred in 2,223 women on dapagliflozin and one has been observed out of 1,053 women in control groups. All were diagnosed within a year after studies started.
ISI Group analyst Mark Schoenebaum said the timing of diagnosis within a year of therapy initiation and hematuria at baseline could be mitigating factors but the cancer findings are sure to be discussed by regulators.
Bjork said studies of dapagliflozin in animals found no carcinogenic signals.
"Importantly, overall cancers are not imbalanced," she said.
Bristol and AstraZeneca filed earlier this year for U.S. and European regulatory approval of dapagliflozin. An advisory committee to the U.S. Food and Drug Administration is set to review the application on July 19.
It is potentially the first in a new class of diabetes drugs designed to block glucose from being absorbed into the bloodstream through the kidneys, allowing more sugar to be excreted with urine.
Dapagliflozin leads to more sugar in the urine, which may serve as a nutrient for bacteria and pathogens that can cause infections, said Elisabeth Svanberg, vice president of development for dapagliflozin at Bristol-Myers.
In a two-year trial, urinary tract infections developed in 8% of type 2 diabetics treated with a placebo and metformin, 8% of patients on a 2.5 mg dose of dapagliflozin plus metformin, 8.8%t of patients on a 5 mg dose and 13.3% of patients receiving dapagliflozin 10 mg.
Genital infections were seen in 5.1% of patients receiving placebo plus metformin, compared to 11.7% for patients on the lowest dose of dapagliflozin plus metformin, 14.6% of patients on the 5 mg dose and 12.6% of patients on the 10 mg dose.
Other side effects included back pain, influenza, diarrhea, headache, nasopharyngitis, upper respiratory tract infection, renal impairment or failure and events of hypoglycemia, according to data presented at the annual meeting of the American Diabetes Association.
Events of renal impairment or failure were reported in 1.5% of patients treated with placebo plus metformin, compared to 4.4% of patients on the lowest dose of dapagliflozin.
The 546-patient trial showed that the experimental drug resulted in greater and sustained improvements in glycemic control and sustained reductions in body weight compared to placebo, according to Cliff Bailey, head of diabetes research at Aston University, in Birmingham, England, and the study's lead investigator.
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