Verapamil: an effective therapy for type 1 diabetes

To promote the functioning of beta cells and insulin in patients with type 1 diabetes, researchers have developed a novel strategy that minimizes the requirements of insulin and the incidence of hypoglycemia. These researchers have worked at the Comprehensive Diabetes Center at the University of Alabama in Birmingham, USA.

The journal Nature Medicine published these findings recently. Verapamil is the most commonly used drug for controlling blood pressure; it was approved for oral administration in the year 1981. Following the administration of verapamil, type 1 diabetes patients were able to produce greater amounts of insulin. Thus, their daily requirement of insulin was reduced substantially and their blood sugar levels were also in control. The drug verapamil is not just safe and effective for type 1 diabetes but also a promising therapy that provides new hope to people living with this life-threatening condition. These were positive results confirmed in a human clinical trial that was randomized and double-blinded in nature; the clinical trial was controlled by placebo.

Verapamil has shown promising results in improving the function of beta cells in pancreas; the functioning of beta cells is related to the control of insulin production. Optimum levels of insulin ensure a good quality of life in patients. Under such a scenario, type 1 diabetes patients have new hope. It is otherwise difficult to control such a life-threatening condition that offers no hope. Although this drug does not sound like a complete cure for type 1 diabetes, it is however a promising therapy for altering a life-threatening condition: type 1 diabetes. Such patients need to boost the production of insulin in their body in order to have better disease control.

A clinical trial was conducted on animal models in the year 2014. In this clinical trial, it was reported that the condition of type 1 diabetes could be completely reversed by administering verapamil. Then, they conducted a human clinical trial to determine the effects of this drug. For more than three decades, the drug verapamil has been approved by the FDA for the treatment of high blood pressure. Current research findings are path-breaking in the sense that the drug is quite safe and effective in the treatment of type 1 diabetes patients. In patients with type 1 diabetes, the body’s immune system attacks beta cells of the pancreas. These beta cells are responsible for the production of insulin. Insulin is the hormone that controls blood sugar levels in the patient.

The production of insulin decreases substantially when the beta cells of pancreas are destroyed in the human body. Consequently, blood sugar levels would rise in the human body and the patient would become extremely dependent on external sources for insulin. The function of beta cells can be preserved effectively when a patient is administered verapamil. This drug induces the body to produce more insulin. In various clinical trials, it has been proved that the participants’ dependency on external insulin decreases substantially. Several individuals with type 1 diabetes can effectively regulate their blood sugar levels with this strategy.

In the human clinical trial, the drug verapamil was administered to 24 patients. These patients were in the age group of 18 to 45 years. Over the course of one year, verapamil was administered to 11 patients while a placebo drug was administered to 13 patients. Only patients with type 1 diabetes were included in this clinical trial. They received insulin therapy to manage their condition throughout the duration of this clinical trial. The total daily dose of insulin was monitored in both the groups, that is, the group that received verapamil and the group that received placebo. Moreover, we also monitored the amount of insulin produced in these groups. Factors such as the percentage of change in insulin and HbA1C levels were also monitored. There were patients who experienced hypoglycemic events; all such events of each patient were recorded in our human clinical trial. A continuous glucose monitoring system was used to determine the healthy blood glucose levels of each patient.

Patients with type 1 diabetes do have therapeutic options for hope. In fact, such patients should be able to deal with the illness in a promising way following the successful administration of verapamil. Insulin dependency was substantially reduced in patients with type 1 diabetes following the administration of verapamil. The quality of life was significantly improved in these patients. The risk of comorbidities would be improved when the overall blood sugar levels was controlled in patients. Thus, a patient with type 1 diabetes would not develop several other comorbidities, such as kidney disease, blindness, and heart attack.

 

 

New methods approved by FDA for treating digestive tract cancers

The drug Lutathera (lutetium Lu 177 dotatate) was approved by US FDA for treating  neuroendocrine tumors that originate in the gastrointestinal tract and pancreas (GEP-NETs). This is an important breakthrough as it is the first radioactive drug to have been approved by the FDA. It is now a novel treatment for GEP-NETs.

Lutathera drug was found to be quite effective in treating adult patients with GEP-NETs. The treatment options for GEP-NETs were limited as it is a rare type of cancer and the conventional therapy was not successful in preventing the proliferation of this cancer. With US FDA approving the drug Lutathera, it is a ray of hope for patients diagnosed with these rare type of cancer.

It also establishes that US FDA is now open to considering data from alternative therapies, which can provide hope to patients with this rare type of cancer. GEP-NETs develop not only in the pancreas but also in different parts of the digestive system, such as stomach, colon, intestine, and rectum.

Statistical data suggests that the diagnosis of GEP-NETs has been low each year. Only one out of 27,000 people develop this cancer in the United States of America. Lutathera is a radiopharmaceutical drug. It exerts its therapeutic activity by clinging to the somatostatin receptor, which is a component of cell and is present in certain types of tumors.

After clinging to  the receptor, the drug gets into the cell and exudes radiation to damage cancerous activity. The drug Lutathera was approved by two research studies: a randomized clinical trial was conducted on 229 patients, who were diagnosed with a certain type of advanced GEP-NET. These patients elicited a positive response to the drug.

In this clinical trial, a combination of Lutathera and octreotide drug was administered to some patients, while the remaining patients only received   octreotide drug. After providing treatment to patients, researchers measured the period of time for which tumors did not show any signs of grow or development. This period was defined as progression-free survival of patients.

Patients who consumed a combination of Lutathera and octreotide drugs had a longer period of progression-free survival as compared to patients who only consumed the drug octreotide. Moreover, the possibility of the growth of tumors or death was lower in patients who received both the drugs: Lutathera and octreotide .

The second research study was performed on 1,214 patients in Netherlands. These patients were diagnosed with tumors showing positive response to somatostatins, including GEP-NETS. The drug Lutathera was administered at a single site in these patients.

In a clinical trial that included 360 patients with GEP-NETs, it was found that tumors  either shrunk completely or partially in about 16 percent of included patients . These patients also received the drug Lutathera initially, and their responses were monitored by the US FDA.

The drug Lutathera has following side-effects: the white blood cells decrease sharply in patients (lymphopenia); the levels of enzymes become high in certain organs (increased GGT, AST and/or ALT); some patients may develop nausea and vomiting; there could be a sudden spike in blood sugar levels (hyperglycemia), and the levels of potassium become low in the blood (hypokalemia).

The drug Lutathera has following serious side-effects: blood cells may decrease sharply in numbers (myelosuppression); certain types of blood or bone marrow cancers may develop in patients(secondary myelodysplastic syndrome and leukemia);  some patients may witness a serious damage to their kidneys (renal toxicity); some patients may suffer from permanent liver damage (hepatotoxicity); the hormonal levels may become abnormal in the human body (neuroendocrine hormonal crises), and infertility.

The drug Lutathera can harm the fetus developing in the womb of a pregnant mother; therefore, pregnant women are educated about the potential damage caused to the fetus by this drug . In general, radiation exposure is provided to patients before administering the drug.