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Archive for the ‘Antidiabetics’ Category

Brand Name: Lantus
Active Ingredient: insulin glargine (rDNA origin) injection
Indication: Treatment of adults and children with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus who require long-acting insulin for control of hyperglycemia
Company Name: Aventis Pharmaceuticals
Availability: FDA approved Lantus for marketing on April 24, 2000; may be available in late 2000

Lantus: Introduction

For many diabetics, each day is structured around the administration of multiple insulin injections to control their blood sugar levels. Now a new form of insulin will soon be available that may make life easier for many diabetics who require these daily injections. Called Lantus, it is the first once-a-day manmade insulin injection to be approved by the FDA. Aventis Pharmaceuticals, the manufacturer of Lantus, received FDA approval for the drug on April 24, 2000.

Lantus (insulin glargine [rDNA origin] injection) is indicated for the treatment of adults and children with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus who require long-acting insulin for control of hyperglycemia. Just one injection a day provides control of blood sugar (glucose) levels for a full 24 hours.

Lantus: How Does It Work?

Lantus is a “recombinant human insulin analog” — a manmade insulin that closely mimics human insulin. The chemical structure of Lantus regulates its release from the tissue under the skin into the bloodstream, providing a glucose-lowering effect that lasts for 24 hours. The longer duration of action of Lantus is directly related to its slower rate of absorption.

Lantus: Clinical Study Results

Several controlled clinical trials showed that Lantus was as effective as human insulin for controlling blood sugar levels. Moreover, the incidence of hypoglycemia – low blood sugar – was lower in patients who used Lantus than in those who took regular insulin. Lantus was effective in adults and children with type 1 (insulin-dependent) diabetes, as well as adults with type 2 diabetes who need insulin injections to control their blood sugar.

Lantus: What You Should Know

Human insulin therapy may be associated with hypoglycemia, worsening of diabetic retinopathy (a disorder of the retina of the eye), skin reactions (such as injection-site reaction, itching, and rash), allergic reactions, and retention of fluid. Hypoglycemia is the most common adverse effect of insulins, including Lantus. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes.

Any change in insulin should be made cautiously and only under medical supervision. In clinical studies of adult patients, there was a higher incidence of injection-site pain in patients who used Lantus than in those who took regular insulin. However, pain at the injection site was usually mild and did not result in discontinuation of therapy.

Lantus must not be diluted or mixed with any other insulin or solution, as it may result in a delayed onset of action. You should inform your health care provider about any other medications you may be taking, since they may alter the way Lantus works in your body.

Brand Name: Effexor XR
Active Ingredient: venlafaxine hydrochloride
Indication: Treatment of diabetic neuropathy (investigational)
Company Name: Wyeth-Ayerst
Availability: Approved by the FDA in 1993 for the treatment of depression and anxiety

Effexor: Introduction

The drug Effexor (venlafaxine hydrochloride) was approved by the FDA in 1993 for the treatment of depression and anxiety. An extended-release once-daily dosing preparation, Effexor XR, received marketing clearance in 1997. Now Effexor XR is showing promise for ameliorating the symptoms of another disorder: diabetic neuropathy. The results of the study were reported at the 60th annual meeting of the American Diabetes Association in June 2000.

In doses ranging from 150-225 mg/day, Effexor XR had significantly higher analgesic response rates compared to placebo. The drug is manufactured by Wyeth-Ayerst Laboratories, a division of American Home Products.

Effexor: How It Works

Effexor is a serotonin and norepinephrine reuptake inhibitor. Both serotonin and norepinephrine are involved not only in mediation of mood but also perception of pain.

Effexor: Clinical Study Results

The efficacy, safety, and tolerability of Effexor XR as a treatment for painful diabetic neuropathy were assessed in a double-blind, placebo-controlled, parallel-group multicenter study. A total of 244 patients age 18 or older with type 1 or type 2 diabetes were randomly assigned to receive treatment with Effexor XR 75 mg, 150-225 mg, or placebo for up to 6 weeks. Primary efficacy was measured by patient self-rating assessments of pain intensity and pain relief using a Visual Analog Scale (VAS-PI and VAS-PR). Secondary efficacy was determined by patient self-ratings of pain relief on the Patient Global Rating of Pain Relief scale, and by investigator-rated assessments of pain on the Clinical Global Impressions Severity of Illness (CGI-S) and Clinical Global Impressions Global Improvement (CGI-I) scales.

On both primary outcome measures, Effexor XR 150-225 mg produced significantly greater pain relief at all evaluations compared with placebo. Effexor XR 75 mg produced significant pain relief, compared with placebo, on the VAS-PR scale at weeks 2, 3, and 5. Additionally, by week 6, 56% of patients treated with Effexor XR 150-225 mg experienced significantly lowered pain intensity, compared with 39% treated with Effexor XR 75 mg and 34% given a placebo.

On all secondary measures, similar statistical superiority over placebo was demonstrated for Effexor XR 150-225 mg. Since the presence of major depressive disorder was an exclusion criterion in the study, symptom improvement was attributed to analgesic, rather than an antidepressant, effect.

Effexor: Adverse Events

The most common adverse event associated with Effexor XR was nausea. Other side effects that may occur with use of Effexor XR include insomnia and nervousness, anorexia and weight loss, and sustained hypertension. Because Effexor XR may interact with monoamine oxidase inhibitors, it is recommended that it not be used in combination with these agents, or within at least 14 days of discontinuing treatment with an MAO inhibitor.